Taking jess inactive tablets can not be protected. Instructions for use Jess (Method and dosage)

One active Jess tablet (pink) contains 20 micrograms (0.02 mg) of ethinyl estradiol and 3 mg of drospirenone.

Jess is a monophasic oral contraceptive, which means that all pink pills contain the same amount of hormones. The inactive tablets (white) do not contain hormones and are dummy (placebo).

Jess packaging may contain 1 or 3 blisters (plates) of tablets. One blister contains 28 tablets: 24 active (pink) and 4 inactive (white).

WARNING: The drug has contraindications. Do not start using this drug without first talking to your doctor.

Analogues

Preparations Dimia, Jess Plus contain the same doses of hormones as Jess.

Benefits of Jess

Contraceptive pills Jess have an antiandrogenic effect. This means that they reduce the effect of male sex hormones (androgens), which are a common cause of oily facial skin and acne. Therefore, Jess may have a cosmetic effect - to eliminate or, at least, weaken acne (blackheads). Taking Jess to achieve a cosmetic effect is permissible from the age of 14 (in the absence of contraindications).

Jess tablets, unlike some other OK, do not retain water in the body, so when they are taken, the woman's weight does not increase.

How to start taking Jess?

You can start taking Jess on the first day of your menstrual cycle (first day of your period), or on the first Sunday after your period starts.

Starting on day 1 of your period: Take the first tablet (pink) on the first day of your period and then drink one tablet every day at about the same time. After finishing the pink tablets, take the white tablets (placebo) from day 25 to day 28. After finishing the placebo tablets, start a new pack of Jess. If you started taking Jess from the 1st day of your period, then the contraceptive effect occurs immediately, and you do not need to use additional contraceptives. If you take your pills correctly and without gaps, then you also do not need to use additional contraceptives while taking the placebo pills (white, inactive pills). If you started taking Jess not from the first day of menstruation, then you must use additional contraception for another 7 days after you start taking the pills.

Sunday start: You can start taking Jess the next Sunday after your next period (for example, if your period started on Tuesday, then the first tablet should be taken on the next Sunday). However, in this case, the possibility of pregnancy should be considered if you had unprotected intercourse before taking OCs. You will also need to use additional contraception for another 7 days after you start taking the pills (until next Sunday).

Rules for taking Jess

    After taking the first Jess pills, periods may stop or become less abundant than usual. This is normal and is due to the influence of hormones.

    In the first months of taking Jess, you may experience spotting. This is also normal.

    The tablets are taken every day at about the same hour. The tablets can be taken with or without food.

    It is advisable to drink the tablets in the order indicated on the package. This is done so that you don't get confused.

    If you accidentally mixed up the numbers of the pills, but at the same time you drank only pink pills, then nothing bad will happen, because all pink Jess pills contain the same dose of hormones.

    If you accidentally mixed up the numbers of the pills, but instead of the active (pink) drank the inactive (white), then the effect of the pills may decrease. What to do in this case, read below, in the section What to do if you miss a Jess tablet?

    After the end of one blister, the next day you need to drink the first tablet from the next blister. There are no breaks between blisters.

    Menstruation usually starts on the 27-28th tablet of the package. Reception of a new package must be started, even if menstruation has not yet begun or has not yet ended.

When will the effect of Jess come?

If you take Jess from the first day of your period, then the contraceptive effect occurs immediately and you no longer need to use it.

If you take Jess from 2-5 days of menstruation, or from the next Sunday, then in this case you need to use additional contraception for another 7 days after you start taking the pills.

How to switch to Jess from another OK?

If you have taken other birth control pills in the past month and want to switch to Jess, follow these rules:

    If there were 28 tablets in the previous OK package, then the first Jess tablet should be taken the next day after the end of the previous OK.

    If there were 21 tablets in the previous OK package, then the first Jess tablet can be started the next day after the end of the previous OK, or on the 8th day after the seven-day break.

How to switch to Jess from a vaginal ring or hormonal patch?

The first tablet of Jess in this case should be taken on the day when you removed the vaginal ring or removed it, or on the day when you need to put a new vaginal ring or stick a patch.

How to switch to Jess from an intrauterine device (IUD)?

When switching to Jess from an intrauterine device, the first Jess tablet should be taken on the day the device is removed. Within one week after starting Jess, use additional contraception.

How to start taking Jess after an abortion?

After an abortion in early pregnancy (up to 12 weeks), you can start taking Jess on the day of the abortion. If the abortion was late (more than 12 weeks), then Jess tablets can be started on the 21st or 28th day after the abortion. In this case, you need to additionally protect yourself for another 7 days. If before you started taking Jess you had unprotected sex, then you can start drinking pills only after you make sure that you are not pregnant.

How to start taking Jess after childbirth?

You can start taking Jess on the 21st or 28th day after delivery. In this case, you need to additionally protect yourself for another 7 days. If before you started taking Jess you had unprotected sex, then you can start drinking pills only after you exclude a possible pregnancy. If you are breastfeeding, then Jess tablets are contraindicated for you.

What to do in case of vomiting or diarrhea while taking Jess?

If vomiting or diarrhea occurs in the first 3-4 hours after taking the active Jess tablet, then its effectiveness may be reduced. In this case, the same measures should be taken as in the case of missing a tablet (depending on the number of the tablet).

If vomiting or diarrhea continues, then additional contraception should be used for the duration of the indigestion and for 7 more days after it ends.

What to do if you miss a Jess tablet?

First of all, look at which pill you missed: if it is white (inactive), then nothing bad will happen and the Jess effect will not decrease. Just throw this pill away so you don't accidentally lengthen the placebo pills and continue taking it as planned.

If it was a pink, active pill, then count how late you were in taking it. If less than 12 hours, then nothing terrible will happen and the effect of Jess will not decrease. Take the tablet as soon as you remember and continue with the schedule at your usual time.

If you are more than 12 hours late in taking the pill (that is, more than 36 hours have passed since taking the previous pill), then the contraceptive effect of the pills may decrease. See which pill you missed:

    1 to 7 tablets: Take this missed tablet of Jess as soon as you remember it, even if you have to take 2 tablets at once (yesterday and today). Then continue taking the tablets as planned at your usual time. Within a week after missing a pill, use additional contraception (for example,).

    8 to 14 tablets: Take this missed tablet of Jess as soon as you remember it, even if you have to take 2 tablets at once (yesterday and today). Then continue taking the tablets as planned at your usual time. If the last 7 days you took the pills according to the rules, then the probability of pregnancy is practically excluded. If you have also missed a pill in the last 7 days or are more than 12 hours late in taking a pill, then use additional contraception for a week after missing a pill.

    From 15 to 24 tablets: there are two options: 1) you need to take the missed tablet of Jess as soon as you remember about it, even if you have to take 2 tablets at once (yesterday and today). Then continue taking the tablets as planned at your usual time. After you have taken the 24th tablet, take the first tablet from the next blister the next day (that is, you do not take the white tablets). You do not need to take additional protection if you took Jess according to the rules for 7 days before missing the pill. If not, then you need to additionally protect yourself for 7 days after the pass. 2) discard this pack and start a new pack on day 5. There is no need to use additional contraceptives.

    25 to 28 pills: These pills are inactive, so skipping them is safe and you don't need to take any action. Throw away the missed pill so as not to stray and increase the duration of taking inactive pills.

What should I do if I miss a few Jess pills?

If you missed the white pills, then it's okay, because they do not contain hormones. The contraceptive effect of Jess in this case is not reduced. Throw away these pills so you don't lengthen the time you take the placebo pills.

If you missed 2 active pills in a row on week 1 or 2:

    Take two tablets as soon as you remember the pass, and 2 more tablets the next day.

    To avoid an unwanted pregnancy after missing 2 pills in a row, use additional contraception for another 7 days after missing.

If you missed 2 active pills in a row at week 3 or 4:

    This month you may not have "menstruation" - this is normal. If there is no "menstruation" for 2 months in a row, consult a gynecologist to rule out a possible pregnancy.

If you miss 3 or more active pills in a row:

    If you started taking the very first package of Jess from the first day of your period, then discard the current package of Jess and start taking a new package of Jess from the first pill on the same day, as soon as you remember the pass.

    If you started taking the very first pack of Jess the Sunday after your period started, continue taking one tablet a day until the next Sunday, then discard your current pack of Jess and start a new pack from the first pill on Sunday.

    You need to use additional contraception for 7 more days after the missed period to avoid an unwanted pregnancy.

    It must be borne in mind that you have an increased risk of pregnancy, so if there are no periods, contact your gynecologist.

If you are not sure how to proceed in your situation, in any case, use additional methods of contraception until you consult with your doctor.

You may experience spotting or breakthrough bleeding, similar to your period, 1 to 2 days after missing your pills. It's not dangerous and is related to Jess' passes. Continue to take the tablets as directed and the discharge will stop.

What should I do if I take several Jess pills on the same day?

Taking 2 tablets in one day is not dangerous. Simultaneous intake of 3 tablets can lead to overdose symptoms (nausea, vomiting), but, in principle, is not dangerous.

Bloody discharge while taking Jess

In the first 2-3 months after you start taking Jess, you may experience spotting brown discharge of varying degrees of abundance. It's not dangerous and you don't need to stop taking Jess because of it.

Some women may experience some spotting around the middle of the package while taking birth control pills. This is also normal and you do not need to stop taking Jess because of this.

Bleeding may occur when skipping 1 or more Jess tablets. This suggests that the contraceptive effect of Jess may be reduced, which means that you should use additional methods of contraception (for example, condoms) in case of sexual contact.

How to delay menstruation with Jess?

If you need to postpone your period while taking Jess, then after taking 24 tablets from the package (the last pink tablet), start a new blister the next day (the first pink tablet). Thus, you skip taking the inactive white pills.

With the Jess regimen described above, in the middle of the second package you may have, but usually this phenomenon quickly passes. The next period can only come at the end of the second package (on inactive tablets). The contraceptive effect is preserved in full.

Please note: you can postpone your period only if you took Jess at least one month before unwanted menstruation.

Jess and other medicines

The effect of the drug Jess may be reduced if you are taking the following medicines: antibiotics from the group of penicillins, tetracyclines (Doxycycline and others) or Rifampicin, Phenobarbital, anticonvulsant drugs for epilepsy (Phenytoin, Carbamazepine), Griseofulvin, drugs containing St. passit) and some others.

A decrease in the effectiveness of Jess while taking these drugs may cause spotting or breakthrough bleeding while taking active tablets. This is not dangerous and you should continue taking Jess as usual. The entire period of treatment and another 7 days after its completion, use additional contraceptives.

Jess and alcohol

Small doses of alcohol do not reduce the effectiveness of Jess tablets. However, the amount of alcohol allowed depends on your age, weight, metabolism, and some other factors. On average, during the reception of Jess, it is allowed to drink no more than 50 ml of vodka, 200 ml of wine or 400 ml of beer. If you drink more than this amount, you will need to use extra contraception for another week after drinking.

Jess and vomiting, diarrhea

The contraceptive effect of Jess can be reduced by vomiting and diarrhea. Read more about it here:

What to do if there is no menstruation while taking Jess?

If you don't get your period after you finish packing, remember if you skipped last month.

    If you did, then taking Jess should be postponed until you are sure that you are not pregnant. To do this, you can do or pass.

    If last month you took the pills according to the rules, then after the end of the blister, start a new blister. If at the end of the second blister period does not come, you need to postpone taking the pills and consult a doctor to rule out a possible pregnancy.

Attention: if in the previous month you had vomiting, diarrhea, you took a large amount of alcohol, or took medications that may reduce the effectiveness of Jess, you should consult a doctor to rule out a possible pregnancy. You can read about other reasons for the delay in the article.

What should I do if I get pregnant while taking Jess?

If pregnancy is confirmed, then immediately stop taking Jess and consult a gynecologist. If you plan to continue the pregnancy, then start taking it as soon as possible.

Taking Jess in early pregnancy cannot lead to abnormalities in the development of the fetus and does not affect the health of the unborn child. Therefore, you can safely leave a pregnancy that has arisen so unexpectedly.

What to do if menstruation came while taking active pills?

Against the background of Jess, you may experience spotting of varying degrees of profusion while taking active tablets: from 1 tablet to 24. Such situations are especially common in the first months of taking Jess.

Such secretions are acceptable, they do not reduce the contraceptive effect of the pills and do not harm your health. Despite these discharges, it is recommended to continue taking Jess as usual - one tablet per day. Do not stop taking Jess if you have spotting - the abolition of pills can significantly increase menstruation and lead to the development of uterine bleeding.

Taking Jess before surgery

If you are going to have an operation (for any reason), then you must stop taking Jess a month (4 weeks) before the operation. This is done in order to reduce the risk of blood clots. If an emergency operation is required, be sure to tell the anesthesiologist or surgeon that you are taking birth control pills. In this case, the doctor will take additional measures to reduce the risk of blood clots.

You can resume taking Jess 2 weeks after you can move around on your own.

How often do I need to visit a gynecologist while taking Jess?

Even if nothing bothers you, then you need to visit a gynecologist prophylactically at least once a year. If you have any complaints or side effects, contact your gynecologist as soon as possible.

(information for specialists)

Registration number LSR-008842/08-280313
Tradename
Jess®

International non-proprietary name or grouping name
Ethinylestradiol + Drospirenone

Dosage form
Film-coated tablets

Compound
Each active film-coated tablet contains:
Tablet core:
Active substances
Ethinyl estradiol (as betadex clathrate) 0.02 mg
Drospirenone 3.00 mg
Excipients
Lactose monohydrate, corn starch, magnesium stearate
Tablet shell: hypromellose, talc, titanium dioxide, iron oxide red dye.
Each placebo film-coated tablet contains:
Tablet core:
Active substances: absence
Excipients:
Lactose monohydrate, corn starch, povidone, magnesium stearate
Tablet shell: hypromellose, talc, titanium dioxide.

Description
Active film-coated tablets: round biconvex film-coated tablets, light pink. On one side of the tablet, "DS9" is engraved in a regular hexagon. Fracture view: core from white to almost white, shell - light pink.
Placebo film-coated tablets: round, biconvex, white film-coated tablets. On one side of the tablet, "DP" is engraved in a regular hexagon. View at the break: the core is from white to almost white, the shell is white.

Pharmacotherapeutic group
Combined contraceptive (estrogen + gestagen)

ATX code G03AA12

Pharmacological properties

Pharmacodynamics
Jess is a hormonal contraceptive with antimineralcorticoid and antiandrogenic effects.
The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which include the suppression of ovulation and a change in the properties of the vertical secret, as a result of which it becomes less permeable to spermatozoa.
When used correctly, the Pearl Index (number of pregnancies per 100 women per year) is less than 1. If pills are missed or used incorrectly, the Pearl Index may increase.
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of combined oral contraceptives reduces the risk of developing endometrial cancer and ovarian cancer.
Drospirenone, contained in Jess, has an antimineralocorticoid effect. Prevents weight gain and edema associated with estrogen-induced fluid retention, which ensures very good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). Jess has been shown to be clinically effective in relieving symptoms of severe PMS, such as severe psychoemotional disturbances, breast engorgement, headache, muscle and joint pain, weight gain, and other symptoms associated with the menstrual cycle. In the US, severe PMS is referred to as premenstrual dysphoric syndrome.
Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (blackheads), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body.
Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone.
In combination with ethinylestradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in HDL.

Pharmacokinetics
Drospirenone

When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral dose, the maximum serum concentration of drospirenone, equal to about 35 ng / ml, is reached after about 1-2 hours. Bioavailability ranges from 76 to 85%. Compared with taking the substance on an empty stomach, food intake does not affect the bioavailability of drospirenone.

After oral administration, a biphasic decrease in serum levels of the drug is observed, with elimination half-lives of 1.6 ± 0.7 hours and 27.0 ± 7.5 hours, respectively. Drospirenone binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). Only 3-5% of the total serum concentration of the substance is present as a free steroid. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent volume of distribution is 3.7±1.2 l/kg.

Following oral administration, drospirenone is extensively metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone.

The rate of metabolic clearance of drospirenone in serum is 1.5±0.2 ml/min/kg. Unchanged drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted in faeces and urine in a ratio of approximately 1.2:1.4. The elimination half-life for excretion of metabolites in urine and faeces is approximately 40 hours.

During cyclic treatment, the maximum steady-state serum concentration of drospirenone is reached between days 7 and 14 of treatment and is approximately 60 ng/ml. There was an increase in the concentration of drospirenone in serum by about 2-3 times (due to cumulation), which was determined by the ratio of the half-life in the terminal phase and the dosing interval. A further increase in the serum concentration of drospirenone is noted between 1 and 6 cycles of administration, after which no increase in concentration is observed.

Impact of kidney failure
Steady-state serum concentrations of drospirenone in women with mild renal insufficiency (creatinine clearance = 50–80 ml/min) were comparable to those in women with normal renal function (Cl.cr. > 80 ml/min). In women with moderate renal insufficiency (Cl. cr. = 30-50 ml / min), the serum level of drospirenone was on average 37% higher than in women with normal renal function. Treatment with drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on serum potassium concentration. Pharmacokinetics in severe renal insufficiency has not been studied.
Impact of liver failure
Drospirenone is well tolerated by patients with mild or moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.

Ethinylestradiol

After oral administration, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration after a single oral dose is reached after 1-2 hours and is about 88-100 pg / ml. Absolute bioavailability as a result of presystemic conjugation and first passage metabolism is approximately 60%. Concomitant food intake reduces the bioavailability of ethinylestradiol in about 25% of the examined, while in other subjects such changes were not observed.

The serum concentration of ethinylestradiol decreases biphasically, the terminal phase is characterized by an elimination half-life of approximately 24 hours. Ethinylestradiol is highly, but not specifically, bound to serum albumin (about 98.5%) and causes an increase in serum SHBG concentrations. The apparent volume of distribution is about 5 l/kg.

Ethinylestradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing a variety of hydroxylated and methylated metabolites, both as free metabolites and as conjugates with glucuronic and sulfuric acids. Ethinylestradiol is completely metabolized. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg.

Ethinylestradiol is practically not excreted unchanged. Metabolites of ethinyl estradiol are excreted in the urine and bile in the ratio. 4:6. The half-life for excretion of metabolites is approximately 1 day.

The state of equilibrium concentration is reached during the second half of the treatment cycle, and the serum level of ethinylestradiol increases by about 1.4-2.1 times.

Preclinical safety data

Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex steroids may promote the growth of certain hormone-dependent tissues and tumors.

Indications for use

Contraception
Contraception and treatment of moderate acne (acne vulgaris)
Contraception and treatment of severe premenstrual syndrome (PMS)

Contraindications

Jess should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be immediately discontinued.
Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders.
Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
Migraine with focal neurological symptoms, current or history
Diabetes mellitus with vascular complications.
Multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart; atrial fibrillation; diseases of the vessels of the brain or coronary arteries; uncontrolled arterial hypertension; major surgery with prolonged immobilization; smoking over the age of 35.
Pancreatitis with severe hypertriglyceridemia at present or in history.
Liver failure and severe liver disease (until liver tests return to normal);
Liver tumors (benign or malignant) at present or in history.
Severe renal failure, acute renal failure.
Adrenal insufficiency
Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
Vaginal bleeding of unknown origin.
Pregnancy or suspicion of it.
breastfeeding period.
Hypersensitivity to any of the components of the drug Jess.

Use with caution

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case:
Risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the immediate relatives; obesity; dyslipoproteinemia; arterial hypertension; migraine; heart valve disease; violation of the heart rhythm; prolonged immobilization; major surgical interventions; extensive trauma
Other diseases; in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic "uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; and phlebitis of superficial veins
hereditary angioedema
Hypertriglyceridemia
Liver disease
Diseases that first arose or worsened during pregnancy or due to previous use of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea)
postpartum period

Pregnancy and lactation

Jess is not prescribed during pregnancy and during lactation.
If pregnancy is detected while taking Jess, the drug should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of malformations in children born to women who received sex steroids (including combined oral contraceptives) before pregnancy or teratogenic effects when sex steroids were taken through negligence in early pregnancy.
Existing data on the results of taking Jess during pregnancy are limited, which does not allow drawing any conclusions about the effect of the drug on the course of pregnancy, the health of the newborn and fetus. There are currently no significant epidemiological data on Jess. Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is not recommended until breastfeeding is stopped. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

Dosage and administration

How to take Jess
The tablets should be taken in the order indicated on the package, every day at about the same time, with a little water. Tablets are taken without interruption in admission. One tablet should be taken per day consecutively for 28 days. Each subsequent pack should be started the next day after taking the last tablet from the previous pack. Withdrawal bleeding usually begins 2 to 3 days after inactive pills are started and may not end before the next pack.

How to start taking Jess
In the absence of taking any hormonal contraceptives in the previous month, Reception of Jess begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding), It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use barrier method of contraception during the first 7 days of taking the pills from the first package.
When switching from other combined oral contraceptives, vaginal ring or contraceptive patch.
It is preferable to start taking Jess the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Jess should be taken on the day the vaginal ring or patch is removed, but no later than the day a new ring is to be inserted or a new patch is pasted.
When switching from contraceptives containing only gestagens (“minipills”, injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena).
A woman can switch from a mini-pill to Jess any day (without a break), from an implant or an intrauterine contraceptive with a progestogen - on the day it is removed, from an injectable contraceptive - on the day the next injection is to be given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After an abortion in the first trimester of pregnancy.
A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy.
It is recommended to start taking the drug on the 21st - 28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Jess, or it is necessary to wait for the first menstruation.

Taking missed pills
Missing inactive tablets can be ignored. However, they should be discarded so as not to accidentally prolong the period of taking inactive tablets. The following recommendations apply only to the pass active tablets:
If the delay in taking the drug was less than 24 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next one at the usual time.
If the delay in taking the tablets was more than 24 hours, contraceptive protection may be reduced. The more pills missed, and the closer the missed pills to the inactive pill phase, the higher the chance of pregnancy. In this case, you can be guided by the following two basic rules:
the drug should never be interrupted for more than 7 days (please note that the recommended interval for taking inactive tablets is 4 days)
7 days of continuous tablet intake are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.
Accordingly, if the delay in taking active tablets was more than 24 hours, the following can be recommended:
From 1st to 7th day:
The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. In addition, for the next 7 days, she must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.
8th to 14th day
The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time.
Provided that the woman has taken her pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, and if two or more pills are missed, additional barrier methods of contraception (for example, a condom) should be used in within 7 days,
From the 15th to the 24th day
The risk of reduced reliability is inevitable due to the approaching phase of taking inactive pills. A woman must strictly adhere to one of the two following options. In this case, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, she must use the first of the following regimens and additionally use a barrier method of contraception (eg, a condom) for 7 days.
1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). The next tablets are taken at the usual time until the active tablets in the package run out. The four inactive tablets should be discarded and the tablets from the next pack should be started immediately. Withdrawal bleeding is unlikely until the active tablets in the second pack are used up, but spotting and breakthrough bleeding may occur while taking the tablets.
2. The woman may also stop taking the pills from the current package. Then she should take a break of no more than a day, including the days of skipping pills, and then start taking the drug from a new package.
If a woman missed active pills and no withdrawal bleeding occurred while taking inactive pills, pregnancy should be excluded.

Recommendations for gastrointestinal disorders
In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken.
If vomiting occurs within 4 hours after taking the active tablet, you should be guided by the recommendations for skipping tablets. If a woman does not want to change her usual dosing schedule and postpone the start of her period to another day of the week, an additional active tablet should be taken from another package.

How to change menstrual cycles or how to delay the onset of menstruation
To delay the onset of menstruation, a woman should continue taking the tablets from the next package of Jess, skipping the inactive tablets from the current package. Thus, the cycle can be extended, if desired, for any period until the active tablets from the second package run out. Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. The regular intake of Jess is then resumed after the end of the phase of taking inactive tablets.
To move the start of menstruation to another day of the week, a woman should reduce the next phase of taking inactive pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have spotting and breakthrough bleeding during the second pack.

Additional information for special categories of patients

Children and teenagers
The drug Jess is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
Elderly patients
Not applicable. Jess is not indicated after menopause.
Patients with liver disorders
Jess is contraindicated in women with severe liver disease until liver function tests return to normal. See also sections "Contraindications" and "Pharmacological properties".
Patients with kidney disorders
Jess is contraindicated in women with severe renal insufficiency or acute renal failure. See also sections "Contraindications" and "Pharmacological properties".

Side effect

The following most common adverse reactions were reported in women using Jess according to the indications "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)": nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin. These adverse reactions occurred in more than 3% of women. In patients using Jess for the indication "Contraception and treatment of severe premenstrual syndrome", the following most common adverse reactions (more than 10% of women) were reported: nausea, pain in the mammary glands, irregular uterine bleeding.

Serious adverse reactions are arterial and venous thromboembolism. The table below shows the frequency of adverse reactions reported in the course of clinical studies of the drug Jess according to the indications "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)" (N = 3565), as well as according to the indication "Contraception and treatment of severe forms of premenstrual syndrome" (N=289). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided into frequent (≥1/100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных реакции, выявленных только в процессе постмаркетинговых наблюдений, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота не известна»

System Organ Classes (MedRA version 12.0) Often Infrequently Rarely Frequency not known
Mental disorders Mood swings, depression/low mood Decrease or loss of libido 2
Nervous system Migraine
Vascular disorders Venous or arterial thromboembolism*
Gastrointestinal tract Nausea 1
Skin and subcutaneous tissues erythema multiforme
Reproductive system and mammary glands Pain in the mammary glands 1, irregular uterine
bleeding 1, bleeding from the genital tract, unspecified
genesis

Adverse events were codified using the MedDRA (Regulatory Medical Dictionary). Various MedDRA terms representing the same symptom have been grouped together and presented as a single adverse reaction to avoid diluting or blurring the true effect.
* - Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on very rare.
- "Venous or arterial thromboembolism" includes the following entities: peripheral deep vein occlusion, thrombosis and pulmonary embolism/occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and hemorrhagic stroke.
1 Incidence in studies evaluating PMS was very common >10/100
2 Incidence in studies evaluating PMS was common ≥1/100

For venous and arterial thromboembolism, migraine, see also "Contraindications" and "Special instructions.

Additional Information:
Listed below are adverse reactions with a very rare frequency of occurrence or with delayed symptoms, which are believed to be associated with taking drugs from the group of oral combined contraceptives (see also "Contraindications" and "Special Instructions").

Tumors
The frequency of diagnosing breast cancer in women taking combined oral contraceptives is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant in relation to the overall risk of this disease.
Tumors of the liver (benign and malignant).

Other states
Nodular erythema.
Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives).
Hypertension.
Conditions that develop or worsen while taking combined oral contraceptives, but their relationship has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis.
In women with hereditary angioedema, estrogen use may cause or exacerbate symptoms.
Liver dysfunction.
Changes in glucose tolerance or effects on insulin resistance.
Crohn's disease, ulcerative colitis.
Chloasma.
Hypersensitivity (including symptoms such as rash, urticaria).

Interaction
Interactions of oral contraceptives with other medicinal products (enzyme inducers, some antibiotics) may lead to breakthrough bleeding and/or reduced contraceptive efficacy (see "Interaction with other medicinal products").

Overdose

Serious violations in case of overdose have not been reported. Based on the overall experience with combined oral contraceptives, symptoms that may occur with an overdose of active tablets are nausea, vomiting, spotting or metrorrhagia.
There is no specific antidote, symptomatic treatment should be carried out.

Interaction with other drugs

Interactions of oral contraceptives with other medicinal products may result in breakthrough bleeding and/or reduced contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Jess, or choose another method of contraception.
Effects on hepatic metabolism: the use of drugs that induce microsomal liver enzymes may lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.
HIV proteases (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.
Effects on enterohepatic circulation: According to separate studies, some antibiotics (eg penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinylestradiol. While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.
While taking antibiotics (such as ampicillins and tetracyclines) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If during these 7 days of using a barrier method of contraception, active (light pink) pills run out, then you should skip taking the placebo pills (white) from the current package and start taking the pills from the next package of Jess. The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the influence of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.
Oral combined contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
Based on in vitro interaction studies, as well as an in vivo study in female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely.
There is a theoretical possibility of increasing the serum potassium level in women receiving Jess simultaneously with other drugs that can increase the serum potassium level. These drugs include ACE inhibitors, angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentrations compared with placebo. However, in women taking drugs that can increase the serum potassium level, it is recommended to determine the concentration of serum potassium during the first cycle of taking Jess.
To identify possible interactions, you should read the instructions for use of the relevant medicinal products.

special instructions

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or first appear, the woman should consult her physician, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of COCs and the repetition of the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare. The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show that this increased risk is predominantly present during the first 3 months.
The overall risk of venous thromboembolism (VTE) in patients taking low-dose combined oral contraceptives (VTE can be life-threatening or fatal (in 1-2% of cases).
Venous thromboembolism (VTE), manifested as deep vein thrombosis or pulmonary embolism, can occur with any combined oral contraceptive.
Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.
Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized fever in the affected leg, and redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden cough, including hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, "shortness of breath", "cough") are nonspecific and may be misinterpreted as signs of other more or less severe events (eg, respiratory tract infection)
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. The symptoms of a stroke are as follows: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden unilateral or bilateral loss of vision; sudden on-. gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, acute abdomen.
Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; fast or irregular heartbeat.
Arterial thromboembolism can be life threatening or fatal.
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
- obesity (body mass index more than 30 kg/m2);
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
- prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization;
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- diseases of the heart valves;
- atrial fibrillation.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.
An increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
In assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the respective condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (

Tumors
The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined, oral contraceptives. The relationship with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings are related to screening for cervical pathology or sexual behavior (lower use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women currently taking combined oral contraceptives or who have recently taken it is insignificant in relation to the overall risk of this disease. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effect of oral contraceptives, or a combination of both factors. In women who have used combined oral contraceptives, clinically less pronounced breast cancer is detected than in women who have never used them.
In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Tumors can be life threatening or fatal.

Other states
Clinical studies have shown no effect of drospirenone on the concentration of potassium in the blood serum in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial concentration of potassium at the upper limit of normal, while taking drugs that lead to potassium retention in the body. However, in women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of plasma potassium during the first cycle of taking Jess.
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.
Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and non-specific ulcerative colitis have also been described with the use of combined oral contraceptives.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require the withdrawal of combined oral contraceptives until liver function returns to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.
Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Laboratory tests
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect.

Medical examinations
Before starting or resuming the use of the drug Jess, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, body mass index) and gynecological examination (including examination of the mammary glands and cytological examination of vertical mucus), exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. In general, follow-up examinations should be carried out at least once a year.
A woman should be warned that combined oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced in the following cases: when missed, with vomiting and diarrhea, or as a result of drug interactions.

Insufficient control of the menstrual cycle
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.
Some women during a break in the reception active tablets (light pink) withdrawal bleeding may not develop. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.

Producer: Bayer HealthCare Pharmaceuticals (Bayer Helsiker Pharmasyutikal) Germany

ATC code: G03AM2

Farm group:

Release form: Solid dosage forms. Tablets.



General characteristics. Compound:

Active substances: drospirenone (micronized) 3,000 mg; ethinylestradiol betadex clathrate (micronized) in terms of ethinylestradiol 0.020 mg, calcium levomefolate (micronized) 0.451 mg;
Excipients: lactose monohydrate 45.329 mg, microcrystalline cellulose 24.800 mg, croscarmellose sodium 3.200 mg, hyprolose (5 cP) 1.600 mg, magnesium stearate 1.600 mg; shell
Lacquer pink 2.0000 mg or (alternatively): hypromellose (5 cP) 1.0112 mg, macrogol-6000 0.2024 mg, talc 0.2024 mg, titanium dioxide 0.5580 mg, iron dye red oxide
0.0260 mg;
Composition per supplementary vitamin tablet
Nucleus
Active substance: calcium levomefolate (micronized) - 0.451 mg; Excipients: lactose monohydrate 48.349 mg, microcrystalline cellulose 24.800 mg, croscarmellose sodium 3.200 mg, hyprolose (5 cp) 1.600 mg, magnesium stearate 1.600 mg;
shell
Lacquer light orange 2.0000 mg or (alternatively): hypromellose (5 cP) 1.0112 mg, macrogol-6000 0.2024 mg, talc 0.2024 mg, titanium dioxide 0.5723 mg, iron dye yellow oxide 0, 0089 mg, iron dye red oxide 0.0028 mg.

Description
Active combination tablet
Pink, round, biconvex, film-coated tablets, embossed with "Z+" in a regular hexagon on one side. Complementary vitamin tablet
Round, biconvex, film-coated tablets, light orange in color, on one side with embossed "M +" in a regular hexagon.


Pharmacological properties:

Pharmacodynamics. Jess Plus is a low-dose monophasic oral combined estrogen-progestin contraceptive drug that includes active tablets and
auxiliary vitamin tablets containing calcium levomefolate.
The contraceptive effect of Jess Plus is mainly carried out by suppressing ovulation and increasing the viscosity of cervical mucus.
In women taking combined oral contraceptives (COCs), the cycle becomes more regular, the pain, intensity and duration of menstrual-like decreases, resulting in a reduced risk. There is also evidence of a reduced risk of ovaries.
Drospirenone, contained in Jess Plus, has an antimineralocorticoid effect and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral. Drospirenone also has antiandrogenic activity and helps to reduce (acne), oily skin and hair. This effect of drospirenone is similar to the action of natural progesterone produced in the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. When used correctly, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or use them incorrectly, the Pearl index may increase.
The acidic form of calcium levomefolate is structurally identical to natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average plasma concentration in people who do not use food enriched with folic acid is about 15 nmol / l.
Levomefolate, unlike folic acid, is a biologically active form of folate. Because of this, it is absorbed better than folic acid. Lemofolate is indicated to meet the increased need and ensure the necessary content of folate in the body of a woman during pregnancy and lactation. The introduction of calcium levomefolate in the composition of an oral contraceptive preparation reduces the risk of developing a neural tube defect of the fetus if a woman becomes pregnant unexpectedly, immediately after stopping the use of contraception (or, in very rare cases, when using oral contraception).

Pharmacokinetics

Drospirenone Absorption
When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration, the maximum concentration (Cmax) of drospirenone in plasma
blood, equal to 35 ng / ml, is achieved in 1-2 hours. Bioavailability ranges from 76 to 85%. Compared to taking drospirenone on an empty stomach, food intake does not affect its bioavailability. Distribution
After oral administration, a biphasic decrease in serum levels of the drug is observed, with elimination half-lives of 1.6 ± 0.7 hours and 27.0 ± 7.5 hours, respectively. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). Only 3-5% of the total serum concentration of the substance is present as a free hormone. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins. The average apparent volume of distribution is 3.7±1.2 l/kg.

Metabolism
Following oral administration, drospirenone is extensively metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the involvement of the cytochrome P450 system. The cytochrome P450 3A4 isoenzyme is involved in the metabolism of drospirenone to a minimal extent, drospirenone is able to reduce the concentration of the enzyme in the blood plasma and the activity of cytochrome P450 1A1, P450 2C9 and P450 2C19 isoenzymes in vitro.

breeding
The rate of metabolic clearance of drospirenone in plasma is 1.5±0.2 ml/min/kg. Unchanged drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted through the gastrointestinal tract and kidneys in a ratio of approximately 1.2:1.4. The half-life for excretion of metabolites is about 40 hours.

Equilibrium concentration
During the first course of the drug, the equilibrium state of drospirenone with a plasma concentration of about 60 ng / ml is achieved from the 7th to the 14th day of the drug. There was an increase in the concentration of drospirenone in the blood plasma by about 2-3 times (due to cumulation), which was determined by the ratio of the half-life in the terminal phase and the dosing interval. A further increase in the concentration of drospirenone in the blood plasma is observed after 1-6 courses of the drug, after which no increase in concentration is observed.

In case of impaired renal function
The concentration of drospirenone in the blood plasma upon reaching the equilibrium state was comparable in women with mild renal impairment (creatinine clearance (CC) - 50-80 ml / min) and in women with preserved renal function (CC - more than 80 ml / min). However, in women with moderate renal impairment (CC - 30-50 ml / min), the average plasma concentration of drospirenone was 37% higher than in patients with preserved renal function. There was no change in the concentration of potassium in the blood plasma when using drospirenone.

In violation of liver function
In women with moderate hepatic impairment (Child-Pugh class B), the area under the concentration-time curve (AUC) is comparable to that in healthy women with similar Cmax values ​​in the absorption and distribution phases. T1 / 2 of drospirenone in patients with moderate liver dysfunction was 1.8 times higher than in healthy volunteers with preserved liver function.
In patients with moderate hepatic impairment, a decrease in drospirenone clearance of about 50% was noted compared with women with intact liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. There were no changes in the concentration of potassium, even in the case of a combination of factors predisposing to its increase (concomitant or treatment with spironolactone).

Ethinylestradiol Absorption
After oral administration, ethinylestradiol is rapidly and completely absorbed. Cmax - about 33
pg/ml is achieved within 1-2 hours. The drug undergoes first pass metabolism in the liver, its oral bioavailability averages about 60%. Simultaneous food intake in some cases is accompanied by a decrease in the bioavailability of ethinylestradiol by 25%. Distribution
The concentration of ethinylestradiol in plasma decreases in 2 phases, the half-life of ethinylestradiol in the second phase is about 24 hours. Ethinylestradiol has a non-specific but strong binding to plasma albumin (about 98.5%) and induces an increase in plasma concentration of SHBG. The estimated volume of distribution is about 5 l/kg. Metabolism
Ethinylestradiol undergoes presystemic conjugation in the liver and in the mucosa of the small intestine. The main route of metabolism of ethinylestradiol is aromatic hydroxylation with the formation of numerous metabolites, which are both in a bound and unbound state. The rate of excretion of ethinylestradiol is about 5 ml / min / kg.

breeding
Ethinylestradiol is excreted only as metabolites by the kidneys and through the gastrointestinal tract in a ratio of 4:6 with a half-life of about 24 hours.

Equilibrium concentration
The equilibrium state is reached in the second half of the course of treatment, the concentration of ethinylestradiol in the blood plasma increases by about 1.4-2.1 times.

Ethnicity
The effect of ethnicity on pharmacokinetic parameters was studied in studies with single and multiple dosing of drospirenone and ethinyl estradiol in healthy Caucasian women, as well as in Japanese women. The influence of ethnicity on the pharmacokinetic parameters of drospirenone and ethinyl estradiol has not been established.

Calcium Levomefolate Absorption
After oral administration of calcium, levomefolate is rapidly absorbed and incorporated into the body's folate pool. After a single oral administration of 0.451 mg calcium levomefolate after 0.5 - 1.5 hours, Cmax becomes 50 nmol / l higher than the initial concentration.
Distribution
The pharmacokinetics of folate has a biphasic character: a pool of folates with fast and slow metabolism is determined. The rapidly metabolizing pool is likely to represent newly ingested folates, consistent with calcium T1/2
levomefolate, which is about 4-5 hours after a single oral dose of 0.451 mg. The slow metabolizing pool reflects the conversion of folate polyglutamate, which has a T1/2 of about 100 days. Externally supplied folates and folates passing through the enterohepatic cycle maintain a constant concentration of L-5-methyl-THF in the body.
L-5-methyl-THF represents the main form of folate in the body, in which it is delivered to peripheral tissues to participate in cellular folate metabolism.

Metabolism
L-5-methyl-THF is the major transportable form of folate in plasma. When comparing 0.451 mg calcium levomefolate and 0.4 mg folic acid, similar metabolic mechanisms were established for other significant folates. Folate coenzymes are involved in 3 main conjugated cycles of metabolism in the cytoplasm of cells. These cycles are necessary for the synthesis of thymidine and purines, precursors of deoxyribonucleic (DNA) and ribonucleic (RNA) acids, as well as for the synthesis of methionine from homocysteine ​​and the conversion of serine to glycine.

breeding
L-5-methyl-THF is excreted by the kidneys unchanged and as metabolites, as well as through the gastrointestinal tract.
Equilibrium concentration
The equilibrium state of L-5-methyl-THF in plasma after ingestion of 0.451 mg calcium levomefolate is achieved after 8-16 weeks and depends on its initial concentration. In erythrocytes, the equilibrium concentration is reached at a later date due to the life span of erythrocytes, which is about 120 days.

Indications for use:

Contraception intended primarily for women with symptoms of hormone-dependent fluid retention in the body. Contraception and treatment of moderate acne (acne vulgaris) Contraception in women with folate deficiency.
Contraception and treatment of severe form (PMS)


Important! Familiarize yourself with the treatment , Contraception

Dosage and administration:

How to take Jess Plus
Tablets should be taken orally in the order indicated on the package, every day at the same time, without chewing, with a small amount of water. Take 1 tablet per day continuously for 28 days. Taking the tablets from the next package begins immediately after the completion of taking the tablets from the previous package. "Withdrawal" bleeding usually begins 2-3 days after the start of inactive pills and may not end before the next pack of pills is started.
Start taking Jess Plus
. In the absence of taking any hormonal contraceptives in the previous month.
Taking the drug Jess Plus begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from other combined oral contraceptives, vaginal ring or contraceptive patch

It is preferable to start taking Jess® Plus the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Taking Jess® Plus should begin on the day the vaginal ring or patch is removed, but no later than the day a new ring is to be inserted or a new patch is pasted.

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive ("Mirena").

A woman can switch from a “mini-pill” to Jess® Plus any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injectable contraceptive - on the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

After an abortion in the first trimester of pregnancy.

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy.

It is recommended to start taking the drug on the 21st - 28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual intercourse has taken place, pregnancy should be excluded before taking Jess® Plus, or it is necessary to wait for the first menstruation.
Taking missed pills

Missing inactive tablets can be ignored. However, they should be discarded so as not to accidentally prolong the period of taking inactive tablets. The following recommendations only apply to missing active tablets:

If the delay in taking the drug was less than 24 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next one at the usual time.

If the delay in taking the tablets was more than 24 hours, contraceptive protection may be reduced. The more pills missed, and the closer the missed pills to the inactive pill phase, the higher the chance of pregnancy.

In this case, you can be guided by the following two basic rules:
. the drug should never be interrupted for more than 7 days (please note that the recommended interval for taking inactive tablets is 4 days)
. to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, if the delay in taking active tablets was more than 24 hours, the following can be recommended:

From 1st to 7th day:

The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.

8th to 14th day
The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time.

Provided that the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

From the 15th to the 24th day

The risk of reduced reliability is inevitable due to the approaching phase of taking inactive pills. A woman must strictly adhere to one of the two following options. In this case, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, she must use the first of the following regimens and additionally use a barrier method of contraception (eg, a condom) for 7 days.
1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). The next tablets are taken at the usual time until the active tablets in the package run out. The four inactive tablets should be discarded and the tablets from the next pack should be started immediately. "Withdrawal" bleeding is unlikely until the active tablets in the second pack are finished, but spotting and breakthrough bleeding may occur while taking the tablets.
2. The woman may also stop taking the pills from the current package. Then she should take a break of no more than 4 days, including the days of skipping pills, and then start taking the drug from a new package.

If a woman missed active pills, and there was no “withdrawal” bleeding while taking inactive pills, it is necessary to make sure that she is not pregnant.

If vomiting occurs within 3-4 hours after taking the active tablet, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual dosing schedule and postpone the start of her period to another day of the week, an additional active tablet should be taken from another package.

How to change cycles or how to delay withdrawal bleeding

To delay the onset of bleeding, a woman should continue taking the tablets from the next package of Jess® Plus, skipping the inactive tablets from the current package. Thus, the cycle can be extended, if desired, for any period until the active tablets from the second package run out. While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Regular intake of Jess® Plus is then resumed after the end of the phase of taking inactive tablets.

To reschedule the onset of "withdrawal" bleeding to another day of the week, the woman should shorten the next inactive pill phase by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have spotting and breakthrough bleeding while taking the pills from the second pack.

Application in certain groups of patients In children
The effectiveness and safety of Jess Plus as a contraceptive have been studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in post-pubertal age up to 18 years are similar to those in women after 18 years. The use of the drug before the onset of menarche is not indicated. In the elderly
®
The drug Jess Plus is not used after menopause. For impaired liver function
The drug is contraindicated for use in women with severe liver dysfunction.
For impaired renal function
The drug is contraindicated for use in women with severe renal impairment and in acute renal failure.

Application Features:

If any of the conditions, diseases, and risk factors listed below are present in
Currently, the potential risk and expected benefit of using Jess Plus should be carefully weighed in each individual case and discussed with the woman before she decides to start taking this drug. Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare. The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show that this increased risk is predominantly present during the first 3 months.
The overall risk of venous thromboembolism VTE in patients taking low-dose combined oral contraceptives (< 50 мкг этинилэстрадиола) в два-три раза выше, чем у небеременных пациенток, которые не принимают КОК, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах.
VTE can be life-threatening or fatal (in 1-2% of cases). VTE manifesting as deep veins or pulmonary artery can occur with any combined oral contraceptive. Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.
Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower limb or along the vein of the lower limb, pain or discomfort in the lower limb only when standing or walking, localized temperature increase in the affected lower limb, redness or discoloration of the skin on the lower limbs.
Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden, including with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; strong; fast or irregular heartbeat. Some of these symptoms (eg, "shortness of breath", "cough") are nonspecific and may be misinterpreted as signs of other more or less severe events (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms are as follows: sudden weakness or loss of sensation in the face, upper or lower extremities, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, acute abdomen.
Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweat, or dizziness, severe weakness, or; fast or irregular heartbeat. Arterial thromboembolism can be life threatening or fatal. The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
- obesity (body mass index more than 30 kg/m2);
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide whether it is possible to take Jess Plus;
- prolonged immobilization, major surgery, any operation
on the lower extremities or extensive trauma. In these situations, it is advisable to stop using Jess Plus (in the case of a planned operation, at least four weeks before it) and not resume taking it within two weeks after the end of immobilization;
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- diseases of the heart valves;
- atrial fibrillation.
The question of the possible role of varicose veins and superficial veins in the development of venous thromboembolism remains controversial.
An increased risk of thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders can also occur with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or) and.
An increase in frequency and severity during the use of Jess Plus (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of this drug.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, lack of antithrombin-III, lack of protein C, lack of protein S, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
In assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the respective condition may reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (< 0,05 мг этинилэстрадиола). Опухоли
The most significant risk factor for developing the cervix is ​​persistent human papillomavirus infection. There are reports of some increased risk of development with long-term use of COCs. However, the connection with the use of COCs has not been proven. The possibility of the relationship of these data with the screening of diseases of the cervix and with the peculiarities of sexual behavior (more rare use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that it is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently taking COCs or have recently taken them is insignificant in relation to the overall risk of this disease. Its association with COC use has not been proven. The observed increase in risk may be due to careful monitoring and earlier diagnosis of breast cancer in women using COCs. In women who have ever used COCs, earlier stages of breast cancer are detected than in women who have never used them.
In rare cases, against the background of the use of COCs, the development of benign, and in extremely rare cases, malignant neoplasms of the liver, which in some patients led to life-threatening intra-abdominal bleeding, was observed.
If there is severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Tumors can be life threatening or fatal. Other states
Clinical studies have shown no effect of drospirenone on plasma potassium concentration in patients with mild to moderate renal insufficiency. However, in patients with impaired renal function and an initial concentration of potassium at the upper limit of the norm, the risk of development while taking medications leading to potassium retention in the body cannot be ruled out.
In women with hypertriglyceridemia (or a family history of the condition)
may increase the risk of development while taking COCs.
Although a slight increase in blood pressure has been described in many women,
taking COCs, clinically significant increases were rare. However, if a persistent, clinically significant increase in blood pressure develops while taking Jess Plus, this drug should be discontinued and treatment should be started. The drug can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and when taking COCs, but their relationship with the use of COCs has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; ; ; ; Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of Jess Plus until the liver function returns to normal. Recurrent cholestatic jaundice that develops for the first time during
pregnancy or previous use of sex hormones, requires discontinuation of Jess Plus.
Although COCs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using Jess Plus. However, diabetic women should be closely monitored while taking this drug.
Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking Jess Plus should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Folate may mask vitamin B12 deficiency. Preclinical safety data
Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors. Preclinical data obtained in the course of standard studies of calcium levomefolinate to detect toxicity with repeated doses of the drug, as well as genotoxicity and toxicity to the reproductive system, do not indicate a particular risk to humans. Laboratory tests
Taking Jess Plus may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma concentration of transport proteins, carbohydrate metabolism, blood coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values. Drospirenone increases plasma renin activity and aldosterone concentration, which is associated with its antimineralocorticoid effect.
There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving the drug Jess Plus simultaneously with other drugs that can increase the content of potassium in the blood plasma. These drugs include angiotensin II receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with angiotensin-converting enzyme (ACE) inhibitors or indomethacin, no significant difference was found between plasma potassium concentrations compared with placebo.
Reduced efficiency
The effectiveness of the drug Jess Plus may be reduced in the following cases: when missing tablets, with vomiting and diarrhea, or as a result of drug interactions. Frequency and severity of menstrual bleeding.
While taking Jess Plus, irregular (acyclic) spotting and bleeding from the vagina (spotting spotting or "breakthrough" uterine bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.
Some women may not develop "withdrawal" bleeding during a pill break. If the drug Jess Plus was taken according to the recommendations, it is unlikely that the woman is pregnant. However, with irregular use of Jess Plus and the absence of two consecutive "withdrawal" bleedings, the drug cannot be continued until pregnancy is excluded. Medical examinations
Before starting or resuming the use of the drug, it is necessary to familiarize yourself with the history of life, the woman's family history, conduct a thorough physical examination (including measurement of blood pressure, heart rate, determination of body mass index, examination of the mammary glands), gynecological examination, cytological examination of the cervix (Papanicolaou test ) to rule out pregnancy. When you resume taking Jess Plus, the volume of additional studies and the frequency of follow-up examinations are determined individually, but at least 1 time in 6 months.

A woman should be warned that Jess Plus does not protect against other sexually transmitted diseases! Influence on the ability to drive vehicles and mechanisms.
No cases of adverse effects of Jess Plus on the speed of psychomotor reactions have been reported; studies to study the effect of the drug on the speed of psychomotor reactions have not been conducted.

Interaction with other drugs:

Interactions of oral contraceptives with other drugs may lead to "breakthrough" uterine bleeding and / or reduce the reliability of contraception.

Interactions leading to a decrease in the effectiveness of the drug Jess Plus Effect on hepatic metabolism: the use of drugs that induce microsomal liver enzymes may lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort. HIV protease inhibitors (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.
Effect on enterohepatic recirculation: According to separate studies, some antibiotics (for example, penicillins and tetracyclines) can reduce the enterohepatic recirculation of estrogens, thereby reducing the concentration of ethinyl estradiol.
While taking drugs that affect microsomal liver enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

While taking antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their cancellation, an additional barrier method of contraception should be used. If the period of use of the barrier method of contraception ends later than the hormone-containing pink tablets in the package, you should skip taking the remaining auxiliary light orange tablets and start taking Jess Plus from a new package without interrupting the pills. Interactions that reduce the effectiveness of calcium levomefolate Effect on folate metabolism: some drugs reduce the concentration of folate in the blood or reduce the effectiveness of calcium levomefolate by inhibiting the enzyme dihydrofolate reductase (for example, methotrexate, trimethoprim, sulfasalazine and triamterene) or by reducing the absorption of folate (for example, cholestyramine) or through unknown mechanisms (eg, antiepileptic drugs: carbamazepine, phenytoin, phenobarbital, primidone, and valproic acid).
Effects on the metabolism of COCs (enzyme inhibitors)
The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.
The effect of COCs or calcium levomefolate on the activity of other drugs
COCs can interfere with the metabolism of other drugs, resulting in either an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
Based on interaction studies, as well as studies involving female volunteers taking omeprazole, simvastatin and midazolam as test substrates, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely.
Folates can alter the pharmacokinetics or pharmacodynamics of some drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (generally reversible, subject to an increase in the dose of the drug affecting folate metabolism) of their therapeutic effect. The use of folate during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.

Contraindications:

The drug Jess Plus is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time while taking the drug, the drug should be immediately discontinued.
. Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
. Conditions preceding thrombosis (including transient ischemic attacks,) at present or in history.
. The presence of multiple or pronounced risk factors for venous or.
Migraine with focal neurological symptoms at present or in history.
. Diabetes mellitus with vascular complications.
. Liver failure and severe (until normalization of liver tests).
. Heavy and/or
. Liver tumors (benign or malignant) at present or in history.
. Identified hormone-dependent malignant neoplasms (including the genital organs or mammary glands) or suspicion of them.
. Bleeding from the vagina of unknown origin.
. Pregnancy or suspicion of it.
. breastfeeding period.
. Hypersensitivity or intolerance to any of the components of Jess Plus.
. The drug Jess Plus contains lactose, therefore it is contraindicated in patients with rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully
The potential risk and expected benefit of the drug should be assessed
Jess Plus in each individual case in the presence of the following diseases / conditions and risk factors:
. Risk factors for thrombosis and thromboembolism: smoking, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives) ;
. Other diseases in which peripheral circulatory disorders may occur: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, superficial veins;
. Hereditary angioedema;
. Hypertriglyceridemia;
. Liver diseases not related to contraindications (see "Contraindications");
. Diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, hearing loss, porphyria, herpes pregnant, Sydenham's chorea);
. postpartum period.
Use during pregnancy and lactation
Pregnancy
The drug is contraindicated during pregnancy. If pregnancy is detected while taking Jess Plus, the drug should be discontinued immediately. Data on the results of taking Jess Plus during pregnancy are limited, and do not allow any conclusions to be drawn about the negative impact of the drug on pregnancy, the health of the fetus and newborn. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took COCs before pregnancy or teratogenic effects in cases
taking COCs by negligence in early pregnancy. Specific epidemiological studies in relation to the drug Jess Plus have not been conducted. Lactation
The drug is contraindicated during lactation. Taking COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites can be excreted in milk, but there is no evidence of their negative impact on the health of the child.

Overdose:

No cases of Jess Plus overdose have been reported.
Symptoms that may occur in case of overdose: nausea, vomiting, spotting vaginal discharge or metrorrhagia (more often in young women). There is no specific antidote, symptomatic treatment should be carried out. Calcium levomefolate and its metabolites are identical to folates, which are part of natural products, the daily consumption of which does not harm the body. Taking calcium levomefolate at a dose of 17 mg / day (the dose is 37 times higher than that contained in 1 tablet of Jess Plus) for 12 weeks was well tolerated.

Storage conditions:

At a temperature not higher than 25 °C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package.

Leave conditions:

On prescription

Package:

Film-coated tablets. Set: 24 active combined tablets and 4 auxiliary vitamin tablets are placed in a blister pack (blister) made of a multilayer material - PVC-PE-EVOH-PE-PCTFE and sealed with aluminum foil. 1 blister (set) is glued directly into a folding cardboard book. 1 or 3 folding books with a glued block of self-adhesive stickers for registration of the appointment calendar, together with instructions for use, are sealed in a transparent film. In the case of 3 sets, a packaging sticker is applied to the film.


Contraceptive pills Jess plus have proven themselves in the market of hormonal contraception.

This drug belongs to monophasic microdosed hormonal tablets.

Contraceptive Jess Plus is produced by the German company Bayer Schering Pharma AG.

The international name for Jess plus is Yaz plus (Jazz plus).

In this article, we will look at a detailed description of the drug, what hormones it contains, what side effects it can cause, how to take it, etc.

IMPORTANT! The information is given for reference. Do not self-medicate, for the selection of OK, contact a specialist, undergo an examination and take tests.

Indications for use

  • Prevention of unwanted pregnancy
  • Treatment of moderate forms of acne (pimples and blackheads)
  • Settlement of the menstrual cycle and removal of painful symptoms of PMS
  • Compensation for the lack of folate in the body
  • Elimination of hormone-dependent fluid retention in the body

Jess plus for polycystic ovaries. In order for the drug to have a positive effect, it should be taken for at least six months.

Jess plus for ovarian cyst. As a drug for the treatment of cysts, Jess is prescribed only with a doctor's prescription. Only your attending gynecologist can tell you in detail about dosages, regimen and duration of administration.

Jess plus for mastopathy. A common cause of the development of mastopathy is a hormonal imbalance in the female body (sex hormones and thyroid hormones). Therefore, drinking OK with mastopathy is a good solution, but again, only with a doctor's prescription.

Jess plus for endometriosis. Oral contraceptives Jess plus are used in the complex treatment of endometriosis along with other drugs. COCs are needed to balance the hormonal balance in the female body.

Compound

One COC Jess Plus tablet contains the following: active substances:

  • – 3 µg; has antiandrogenic activity.
  • Ethinylestradiol (aethinyloestradiolum) - 20 mcg; analogue of endogenous estradiol.
  • Calcium levomefolate (calcii levomefolinas) - 451 mcg; biologically active formula of folic acid. This is a medicinal substance designed to eliminate folate deficiency in the female body. The presence of this component in the composition is the difference between Jess plus and

In total, the blister contains 28 tablets (24 active + vitamins and 4 just vitamin).

Excipients:

  • lactose monohydrate - 45.329 mg
  • microcrystalline cellulose - 24.8 mg
  • croscarmellose sodium - 3.2 mg
  • giprolose (5 cP) - 1.6 mg
  • magnesium stearate - 1.6 mg

Action Jess Plus

  • Suppress ovulation, i.e. interfere with the development and release of the egg
  • They make the cervical mucus thick, and therefore the cervix becomes impassable for sperm
  • They change the structure of the endometrium (the lining of the uterus), as a result, the fertilized egg cannot attach to the walls of the uterus
  • Compensate for the lack of folate in the body of a woman

A detailed annotation is included in each package of Jess Plus.

Price where to buy

It is impossible to give a 100% correct answer to the question “how much does Jess Plus cost?” the price of the drug varies from the place of purchase (city, pharmacy, etc.)

The average cost of a package of 28 pieces (per month) ranges from 915 to 1112 rubles. The average price for 84 tablets (packing for 3 months) is from 2678 to 2986 rubles. Again, these are just indicative prices.

You can buy Jess plus in pharmacies. Hormonal pills are dispensed by prescription.

Beware of fakes!

Instruction: admission rules

You need to take COC Jess Plus every day at the same time, without taking a break between packs.

Because in the package of Jess plus there are 28 tablets (24 active and 4 vitamin), then there is no need to take a break in taking: as soon as one blister is over, the next day we start a new one.

When can you not protect yourself?

The most popular question on the Internet related to OK Jess Plus is “How long can you go without protection?”

So when does the contraceptive effect come?

If you have not taken OK before (how to take it for the first time):

  • You start taking Jess Plus on the first day of your cycle. In this case, after the lapse of menstruation, you may not be protected additionally during sexual intercourse.
  • If you started taking OK for 2-3 days, then you can also not use protection.
  • If you started taking OK after the 3rd day of the cycle, then we recommend using additional contraceptives for another week.

The second package of Jess Plus should be started immediately without interruption.

If you are switching from other OKs, you need to finish a pack of previous COCs. If there were 21 tablets in the pack, then you need to take a break for 7 days, and on the eighth start taking Jess Plus. If the pack had 28 tablets, then upon completion, you need to start taking Jess Plus immediately without interruption.

After the abortion(in the early stages) the reception can be started immediately - additional contraception is not needed.

After an abortion (second trimester) or miscarriage reception begins on the 21-28th day.

ATTENTION! During lactation (breastfeeding), taking COCs is not recommended.

Jess plus and smoking incompatible. Especially after 35 years.

Jess plus and alcohol. The compatibility of these two substances is questionable. Yes, the instructions do not say about the prohibition of alcohol while taking Jess Plus. As well as it is not said whether it is possible to drink alcohol with Jess Plus.

When taking them together, be prepared for the consequences. COCs already thicken the blood, affect pressure and put a heavy burden on the liver. Plus, under the influence of alcohol, you can simply forget to take a pill on time. 1-2 glasses of wine from time to time may not be scary, but you can’t abuse alcohol while taking OK. This can lead to health problems. So think twice before drinking alcohol while taking Jess Plus.

Missing a pill

If you forgot to take a pill, then you need to act according to the following scheme:

  • If no more than 12 hours have passed since missing the pill, then take the drug as soon as possible. The next tablet will need to be taken on your regular schedule.
  • If more than 12 hours have passed since missing a pill, then take a pill immediately (the rest will be taken according to the usual schedule). You will also need to rule out pregnancy. Plus, you will need to use additional contraception for seven days.
  • If you miss more than one tablet (2 or 3), then withdrawal bleeding may begin. The first step is to exclude pregnancy (do a test or go to a gynecologist) and take a pill, because. you can not take a break in the middle of taking OK. Use additional contraception during the week.

ATTENTION! Diarrhea or vomiting less than 5 hours after taking an OC is equivalent to missing a pill. In this case, proceed as if you were skipping.

In case of skipping inactive pills, nothing bad will happen. But you must start taking active tablets on time, namely on the first day of the next cycle (on the 29th day from the start of the previous package).

If you take an extra pill, then there is nothing wrong. Continue taking as usual.

Cancel Jess Plus

You can stop taking COCs only after you have finished taking all the active tablets from the blister. It is undesirable to stop taking Jess plus in the middle of the pack, because. hormonal failure and deterioration of well-being may occur against the background of side effects of a sharp interruption of the course. You can abruptly stop taking OK only with a doctor's prescription and only in exceptional cases.

ATTENTION! When taking COCs, visit an obstetrician-gynecologist at least once every six months.

Side effects

  • Weight fluctuations (weight gain, weight loss)
  • Increased blood pressure (BP)
  • Liver dysfunction
  • Allergic reactions to the components of the drug (urticaria, itching, redness, rash, etc.)
  • Decreased libido (sex drive)
  • Nausea, vomiting, stomach pain
  • Mood swings, apathy, depression, anxiety
  • Headache
  • Dizziness
  • Swelling of the mammary glands
  • Pain in the mammary glands
  • Failure of the menstrual cycle
  • Breakthrough bleeding
  • Intermenstrual discharge of unknown origin
  • Thromboebolism (venous, arterial)
  • Erythema multiforme
  • Varicose veins

Rare but possible:

  • hypertension
  • Chloasma
  • Tumors
  • Liver dysfunction
  • erythema nodosum
  • Crohn's disease
  • Worsening of symptoms of angioedema
  • Nonspecific ulcerative colitis
  • Influence on insulin resistance, change in glucose tolerance

Interaction with other drugs

Simultaneous use with antibiotics and enzyme inducers can cause breakthrough bleeding and reduced protection.

Simultaneous administration with a number of drugs (barbiturates, primidone, carbamazepine, phenytoin, rifampicin, etc.) increases the clearance of sex hormones.

Read the instructions carefully and consult with a specialist.

Contraindications

  • Intolerance to the components in the composition of the drug
  • Venous and arterial thrombosis
  • Thromboembolism
  • Cerebrovascular disorders
  • angina pectoris
  • transient ischemic attacks
  • Migraine
  • Diabetes
  • pancreatitis
  • Liver failure
  • kidney failure
  • Lactation period (breastfeeding)
  • Pregnancy
  • Hormone-dependent malignant neoplasms
  • Smoking
  • Obesity
  • Ulcerative colitis
  • Crohn's disease
  • Cerebral circulation disorders
  • myocardial infarction
  • lactose intolerance
  • Systemic lupus erythematosus
  • sickle cell anemia
  • Hemolytic uremic syndrome
  • Phlebitis of superficial veins
  • Climax

Indications for the appointment of the drug "Jess" are: contraception, treatment of severe premenstrual syndrome, acne therapy. "Jess" is taken 1 time per day, preferably at the same time, in accordance with the order indicated on the package. There should be no break between packs. Withdrawal bleeding begins 2-3 days after taking the inactive tablet and may not end before the next pack is used.

The drug is started on the 1st day of the cycle (on the 1st day of bleeding). It is allowed to start taking it on the 2nd-5th day of the cycle, in this case it is necessary to additionally use barrier contraception during the 1st week of using the drug. In the case of switching from other oral combined contraceptive preparations, it is recommended to start taking Jess the next day after the last active tablet was drunk from the previous package, but in no case later than the next day after a 7-day break (for contraceptives containing 21 tab.) or after taking the last inactive tablet (for contraceptives containing 28 tab.).

When switching from preparations containing gestagens (the so-called "mini-pills"), "Jess" can be taken on any day (without a break), barrier contraception must be used for a week. The drug is started on the day of removal of the progestogen-releasing intrauterine contraceptive, while barrier contraception should be used during the 1st week of taking the tablets.

Side effects, contraindications to the use of "Jess"

When taking Jess, the following side effects may occur: irregular bleeding, abdominal pain, vomiting, nausea, diarrhea, headache, syndrome, decreased mood, nervousness, migraine, decreased or increased libido. There may be: pain and / or engorgement of the mammary glands, vaginal candidiasis, discharge from the mammary glands, vaginal discharge, acne, rash, urticaria, erythema. Sometimes body weight increases or decreases, hypersensitivity reactions appear. In rare cases, thrombosis and thromboembolism develop. In women with hereditary angioedema, taking the drug may aggravate its symptoms.

"Jess" is contraindicated in arterial and venous thrombosis, thromboembolism, cerebrovascular disorders, migraine, diabetes mellitus, cardiac arrhythmias, diseases of the cerebral vessels or coronary arteries, uncontrolled arterial hypertension. The drug can not be used for pancreatitis, liver failure, severe liver pathologies, hormone-dependent malignant tumors, vaginal bleeding of unknown origin, during pregnancy and lactation.

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