The analogue of the regulon is more modern. "Regulon": analogues, instructions for use. Application and dosage

Compound

Active ingredients: 0.03 mg ethinylestradiol and 0.15 mg desogestrel per film-coated tablet
Tablet core: all-rac-a-tocopherol, magnesium stearate, anhydrous colloidal silicon dioxide, stearic acid, povidone K-30, potato starch, lactose monohydrate.
Sheath: propylene glycol, macrogol 6000, hypromellose.

Description

White or almost white, round, biconvex film-coated tablets, marked "P8" on one side, and"RG" - on the other side.

Indications for use

Regulon is an oral contraceptive preparation containing a synthetic follicular hormone and progesterone, which is used to prevent pregnancy. The effect of the drug is due to the suppression of ovulation.
The use of oral contraceptives has a number of advantages over other methods of contraception, which are listed below:
- It is a reliable method of contraception; after stopping the drug, you can become pregnant.
- Menstruation will become shorter and easier to bear.
- Menstrual pain may become less pronounced or disappear completely.
- Use of the drug may reduce the incidence of anemia (blood loss), pelvic organ infections, ectopic pregnancies (ectopic pregnancies), and some uterine, ovarian, and breast complications.
Regulon, like other hormonal contraceptives, does not protect you from HIV infection (AIDS) and other sexually transmitted diseases.

Contraindications

If you are allergic (hypersensitive) to the active ingredients (desogestrel or ethinyl estradiol) or any of the other ingredients of Regulon.
If you are pregnant or breastfeeding.
If you currently or at any time in the past have had any of the following conditions:
Myocardial infarction.
Stroke.
Thrombosis (formation of blood clots in the vessels).
Pulmonary embolism.
Malignant tumors of the mammary glands or uterus.
Vaginal bleeding of unknown origin.
Severe liver disease or liver tumor.
Hearing impairment (otosclerosis) that worsened during a previous pregnancy.
Severe disorders of fat metabolism.
Moderate or severe hypertension.
Severe forms of diabetes with complications.
Bile spillage or itching during a previous pregnancy or while taking another oral contraceptive drug.
In the case of hepatitis (inflammation of the liver caused by a virus), until the liver function tests return to normal values. An autoimmune disease that affects certain organ systems (erythema nodosum).
Gallbladder stones.

Pregnancy and lactation

Before you start taking Regulon, pregnancy must be excluded. If you become pregnant, you should stop taking Regulon immediately.
Since the active substance of the drug Regulon can penetrate into breast milk and lead to a decrease in the amount of milk, it is not recommended to use Regulon during breastfeeding.

Dosage and administration

One tablet should be taken every day, preferably at the same time, starting on the first day of the menstrual cycle, for 21 days. This is followed by a 7-day break during which no pills need to be taken and during which menstrual-like withdrawal bleeding occurs. The next series of 21 tablets should be started on the eighth day, even if the withdrawal bleeding has not ended.
Taking Regulon for the first time
. Wait until your period starts and use additional barrier methods of contraception (condom or birth control cap and spermicide). The first tablet should be taken on the first day of your period.
If you are already on your period, you can start taking the tablets from day 2 to day 5 of your cycle, whether or not the bleeding has stopped. In this case, use additional barrier methods of contraception for the first 7 days of the first pill cycle.
If menstruation began earlier than 5 days ago, you should wait until the first day of the next menstruation and use additional barrier methods of contraception. Start taking the tablets on the first day of your next period.
If You Want No Withdrawal Bleeding Next Cycle You may find yourself in a situation where you want no withdrawal bleeding, such as when you are planning to go on vacation, take an exam, or for some other reason. In this case, you should start taking the tablets from the next package of Regulon without taking a 7-day break. You can skip as many withdrawal bleeds as you like, however it is not recommended to skip more than 3 cycles in a row as this can lead to bleeding disorders (spotting or breakthrough bleeding).
Switching from another oral contraceptive to Regulon
You should stop taking the previous package of oral contraceptive drug. The first tablet of Regulon should be taken the next day, that is, without taking a 7-day break between packs of tablets, it is not necessary to wait for withdrawal bleeding. It is also not necessary to use additional barrier methods of contraception.
If you switch to Regulon from a minipill, the first Regulon tablet should be taken on the first day of your period. If your period has not started, you can start taking Regulon any day, but you should use additional barrier methods of contraception during the first 7 days of taking Regulon.
After childbirth
The use of the drug Regulon can be started on the 21-28th day after childbirth. If intercourse occurs during this period, additional barrier methods of contraception should be used, and you can start taking the pills with the onset of your first period. If you started taking the pill later than 3 weeks after giving birth, you must use additional barrier methods of contraception for the first 7 days.

Side effect

Like all medicines, Regulon can cause side effects, although not everyone experiences them.
When taking the drug Regulon, the following undesirable effects may occur more often than usual:
. Genital organs - bleeding between periods, absence or decrease in the usual amount of menstrual bleeding after taking the drug, change in the nature of vaginal discharge, increase in the size of uterine fibroids (benign uterine tumor), worsening of endometriosis (abnormal thickening of the inner lining of the uterus) and certain vaginal infections, for example , thrush (candidiasis).
Mammary glands: tenderness, soreness, enlargement, discharge.
Gastrointestinal tract: nausea, vomiting (xc lelitiasis),
yellowing of the skin (cholestatic jaundice).
Skin: rash, yellowish brown spots
Eyes: Discomfort when wearing contact lenses.
Central nervous system: headache, migraine, mood changes, depression. metabolic
changes: glucose tolerance.
fluid retention, changes in body weight, decreased
Rare adverse events: Symptoms due to otosclerosis (ossification
labyrinth of the inner ear), such as tinnitus, dizziness, hearing loss; thrombosis (formation of blood clots in the vessels); embolism (blockage of a blood vessel).
Yellowish-brown spots on the skin (chloasma) sometimes appear, especially in women with a history of chloasma during pregnancy. Women with a tendency to develop chloasma should refrain from sunbathing and avoid exposure to ultraviolet rays while taking contraceptives.
In the first few months of taking the pills, there may be irregularities in menstrual bleeding, such as irregular bleeding, bleeding between two withdrawal bleeds, which may be heavy (breakthrough bleeding) or light (spotting), or withdrawal bleeding may not start at the scheduled time. These fluctuations do not mean that the drug is not suitable for you. However, if necessary, you can discuss this with your healthcare provider.

Precautionary measures

If you forget to take your pill on time
Do not stop taking the tablets for more than 7 days.
If you forget to take a tablet at the usual time, you should take it within 12 hours. The next tablet should be taken at the usual time. In this case, additional barrier methods of contraception are not required.
If you forget to take one or more tablets and do not take them within 12 hours, the contraceptive effect may decrease. It is recommended that you take the last missed tablet as soon as you remember, even if it means you have to take two tablets on the same day and then take your tablets as usual. In this case, you must use additional barrier methods of contraception for the next 7 days.
If you decide to stop taking Regulon
If you stop taking Regulon tablets before the end of the package, the contraceptive effect may not be complete, so it is recommended to use additional barrier methods of contraception.
If you have any questions about taking this drug, ask your doctor.
What to do if you have vomiting or diarrhea
If you have an upset stomach and intestines, accompanied by vomiting and diarrhea, the reliability of the contraceptive effect of the drug Regulon may decrease. If the symptoms of the disorder disappear within 12 hours, take an additional tablet from the spare pack and continue taking the remaining tablets at the usual time. If the symptoms of the disorder persist for more than 12 hours, use additional barrier methods of contraception while you are suffering from a gastrointestinal disorder and for the next 7 days.

Best before date

Do not use Regulon after the expiry date which is stated on the package. The expiration date refers to the last day of the month.

pharmachologic effect

Monophasic oral contraceptive. The main contraceptive action is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg.

Ethinylestradiol is a synthetic analog of endogenous estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, weak androgenic and anabolic activity.

Regulon has a beneficial effect on lipid metabolism: it increases the concentration of HDL in the blood plasma, without affecting the content of LDL.

When taking the drug, the loss of menstrual blood is significantly reduced (with initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.

Pharmacokinetics

Desogestrel

Suction

Desogestrel is rapidly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized to 3-keto-desogestrel, which is the biologically active metabolite of desogestrel.

C max is reached after 1.5 h and is 2 ng / ml. Bioavailability - 62-81%.

Distribution

3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone-binding globulin (SHBG). V d is 1.5 l / kg. C ss is established by the second half of the menstrual cycle. The level of 3-keto-desogestrel increases 2-3 times.

Metabolism

In addition to 3-keto-desogestrel (which is formed in the liver and in the intestinal wall), other metabolites are formed: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (metabolites of the first phase). These metabolites do not have pharmacological activity and are partially, by conjugation (the second phase of metabolism), converted into polar metabolites - sulfates and glucuronates. Clearance from blood plasma is about 2 ml / min / kg of body weight.

breeding

T 1/2 3-keto-desogestrel is 30 hours. Metabolites are excreted in the urine and feces (in a ratio of 4:6).

Ethinylestradiol

Suction

Ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. C max is achieved 1-2 hours after taking the drug and is 80 pg / ml. The bioavailability of the drug due to presystemic conjugation and the effect of "first pass" through the liver is about 60%.

Distribution

Ethinylestradiol is completely bound to plasma proteins, mainly to albumins. Vd is 5 l/kg. C ss is established by 3-4 days of administration, while the level of ethinylestradiol in serum is 30-40% higher than after a single dose of the drug.

Metabolism

Presystemic conjugation of ethinylestradiol is significant. Bypassing the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinylestradiol and its conjugates of the first phase of metabolism (sulfates and glucuronides) are excreted into the bile and enter the enterohepatic circulation. Clearance from blood plasma is about 5 ml / min / kg of body weight.

breeding

T1 / 2 ethinylestradiol averages about 24 hours. About 40% is excreted in the urine and about 60% in the feces.

Indications

- contraception.

Dosing regimen

The drug is prescribed inside.

Reception of tablets is begun from the 1st day of a menstrual cycle. Assign 1 tablet / day for 21 days, if possible at the same time of day. After taking the last pill from the package, a 7-day break is taken, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), the drug is resumed from the next package, also containing 21 tablets, even if the bleeding has not stopped. This scheme of taking pills is followed as long as there is a need for contraception. Subject to the rules of admission, the contraceptive effect persists for the duration of the 7-day break.

First dose of the drug

The first tablet should be taken from the first day of the menstrual cycle. In this case, you do not need to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, additional methods of contraception should be used in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, you should postpone the start of taking the drug until the next menstruation.

Taking the drug after childbirth

Women who are not breastfeeding can start taking pills no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If after childbirth there was already sexual contact, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then in the first 7 days it is necessary to use additional methods of contraception.

Taking the drug after an abortion

After an abortion, in the absence of contraindications, pills should be started from the first day after the operation, and in this case there is no need to use additional methods of contraception.

Switching from another oral contraceptive

When switching from another oral preparation (21- or 28-day): the first tablet of Regulon is recommended to be taken the next day after the completion of the course of the 28-day package of the drug. After completing the 21-day course, you must take the usual 7-day break and then start taking Regulon. There is no need to use additional methods of contraception.

Switching to Regulon after using progestogen-only oral hormonal preparations ("mini-pill")

The first tablet of Regulon should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.

If menstruation does not occur when taking the "mini-pill", then after the exclusion of pregnancy, you can start taking Regulon on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days (use of a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.

Postponement of the menstrual cycle

If there is a need to delay menstruation, it is necessary to continue taking the tablets from the new package, without a 7-day break, according to the usual scheme. With a delay in menstruation, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular intake of Regulon can be restored after the usual 7-day break.

Missed pills

If a woman forgot to take a pill in a timely manner, and after the missed no more than 12 hours, you need to take the forgotten pill, and then continue taking it at the usual time. If it has passed between taking the pills more than 12 hours - this is considered a missed pill, contraceptive reliability is not guaranteed in this cycle, and additional methods of contraception are recommended.

When one tablet is missed first or second week of the cycle, you need to take 2 tab. the next day and then continue regular intake using additional methods of contraception until the end of the cycle.

When you miss a tablet third week of the cycle you need to take a forgotten pill, continue regular intake and do not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and / or bleeding increases when a pill is missed, and therefore the use of additional methods of contraception is recommended.

Vomiting/diarrhea

If vomiting or diarrhea occurs after taking the drug, then the absorption of the drug may be defective. If the symptoms have stopped within 12 hours, then you need to take another tablet in addition. After that, you should continue taking the tablets in the usual way. If vomiting or diarrhea continues for more than 12 hours, then additional methods of contraception should be used during vomiting or diarrhea and for the next 7 days.

Side effect

Side effects requiring discontinuation of the drug

From the side of the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the sense organs: hearing loss due to otosclerosis.

Others: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects that are more common but less severe. The expediency of continuing the use of the drug is decided individually after consultation with a doctor, based on the benefit / risk ratio.

From the reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, enlargement of the mammary glands, galactorrhea.

From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma.

From the side of the central nervous system: headache, migraine, mood lability, depression.

From the side of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, a change (increase) in body weight, a decrease in carbohydrate tolerance.

Others: allergic reactions.

Contraindications for use

- the presence of severe and / or multiple risk factors for venous or arterial thrombosis (including severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);

- the presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina pectoris);

- migraine with focal neurological symptoms, incl. in history;

- venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in history;

- the presence of venous thromboembolism in history;

- diabetes mellitus (with angiopathy);

- pancreatitis (including history), accompanied by severe hypertriglyceridemia;

- dyslipidemia;

- severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in history (before the normalization of functional and laboratory parameters and within 3 months after their normalization);

- jaundice when taking GCS;

- cholelithiasis at present or in history;

- Gilbert's syndrome, Dubin-Johnson syndrome, Rotor's syndrome;

- liver tumors (including history);

- severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;

- hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);

- vaginal bleeding of unknown etiology;

- smoking over the age of 35 (more than 15 cigarettes per day);

- pregnancy or suspicion of it;

- lactation period;

- Hypersensitivity to the components of the drug.

WITH caution the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg / m 2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular defects heart, atrial fibrillation, prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, severe depression (including history), changes in biochemical parameters (resistance of activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver disease.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

During lactation, it is necessary to resolve the issue of either discontinuing the drug or stopping breastfeeding.

Overdose

Symptoms: nausea, vomiting, in girls - bloody discharge from the vagina.

Treatment: in the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

drug interaction

Drugs that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort, reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually reached no earlier than 2-3 weeks, but may last up to 4 weeks after discontinuation of the drug.

Ampicillin and tetracycline reduce the effectiveness of Regulon (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15 ° to 30 ° C. Shelf life - 3 years.

Application for violations of liver function

Contraindicated in liver failure.

WITH caution the drug should be prescribed for acute and chronic liver diseases.

Application for violations of kidney function

WITH caution and only after a careful assessment of the benefits and risks of using the drug should be prescribed for renal failure (including history).

Use in elderly patients

Contraceptive drug, in the elderly is not used.

special instructions

Before starting the use of the drug, it is necessary to conduct a general medical (detailed family and personal history, measurement of blood pressure, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). A similar examination during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 1 year), when used correctly, is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The state of health of women must be carefully monitored. If any of the following conditions / diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

- diseases of the hemostasis system;

- conditions / diseases predisposing to the development of cardiovascular, renal failure;

- epilepsy;

- migraine;

- the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;

- diabetes mellitus, not complicated by vascular disorders;

- severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used to correct it);

- sickle cell anemia, tk. in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism;

- the appearance of deviations in laboratory tests for assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic disease has been proven, but it is significantly less than during pregnancy (60 cases per 100,000 pregnancies).

Some researchers suggest that the likelihood of developing venous thromboembolic disease is greater with the use of drugs containing desogestrel and gestodene (drugs of the third generation) than with drugs containing levonorgestrel (drugs of the second generation).

The frequency of spontaneous occurrence of new cases of venous thromboembolic disease in healthy non-pregnant women not taking oral contraceptives is about 5 cases per 100,000 women per year. When using second-generation drugs - 15 cases per 100 thousand women per year, and when using third-generation drugs - 25 cases per 100 thousand women per year.

When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of developing arterial or venous thromboembolic diseases increases:

- with age;

- when smoking (heavy smoking and age over 35 are risk factors);

- if there is a family history of thromboembolic diseases (for example, in parents, a brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;

- with obesity (body mass index more than 30 kg / m 2);

- with dyslipoproteinemia;

- with arterial hypertension;

- in diseases of the heart valves, complicated by hemodynamic disorders;

- with atrial fibrillation;

- with diabetes mellitus complicated by vascular lesions;

- with prolonged immobilization, after major surgery, after surgery on the lower extremities, after a severe injury.

In these cases, a temporary discontinuation of the drug is expected (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

It should be borne in mind that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin III, the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit / risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. The symptoms of thromboembolism are:

- sudden chest pain that radiates to the left arm;

- sudden shortness of breath;

- any unusually severe headache that lasts a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of one half of the body, movement disorders, severe unilateral pain in calf muscle, acute abdomen.

Tumor diseases

Some studies have reported an increase in the incidence of cervical cancer in women who have taken hormonal contraceptives for a long time, but the results of the studies are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection of breast cancer could be associated with more regular medical examinations. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women who take hormonal contraceptives for a long time. This should be kept in mind in the differential diagnostic evaluation of abdominal pain, which may be associated with an increase in the size of the liver or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women who have a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with the sun's rays or ultraviolet radiation while taking Regulon.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that can reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they are finished in the next package. If at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After suffering acute viral hepatitis, the drug should be taken after normalization of liver function (not earlier than after 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking the drug, it is necessary to use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35) and on the number of cigarettes smoked.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and control mechanisms

The drug does not affect the ability to drive a car and work with mechanisms.

Regulon is a monophasic contraceptive drug for internal use. It is used to protect against unwanted pregnancy and eliminate menstrual irregularities.

Active ingredients - Ethinylestradiol + Desogestrel.

Combined hormonal contraceptive drug for systemic use, the action of which is associated with inhibition of the effect of gonadotropins and inhibition of ovulation, as well as preventing the penetration of spermatozoa through the cervical mucus and the implantation of a fertilized egg.

The action of Regulon is due to the effects of its components: synthetic estrogen - ethinyl estradiol and synthetic progestogen - desogestrel, oral administration of which has a pronounced inhibitory effect on ovulation.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa.

Regulon has a beneficial effect on the skin, especially improving its condition with acne vulgaris, with regular use it also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, including tumoral nature.

The composition of the drug:

• Ethinylestradiol: 0.03 mg Desogestrel: 0.15 mg;
• Auxiliary components: stearic acid, alpha-tocopherol, lactose monohydrate, povidone, magnesium stearate, potato starch, colloidal silicon dioxide;
• The composition of the film shell: macrogol 6000, hypromellose, propylene glycol.

Indications for use

What helps Regulon? According to the instructions, the drug is prescribed in the following cases:

• Prevention of unwanted pregnancy;
• Treatment of menstrual disorders - dysmenorrhea, PMS, dysfunctional uterine bleeding.

Instructions for use Regulon, dosage

The drug is taken orally as a whole at the same time of day, washed down with water. The standard dosage is 1 tablet per day.

The beginning of the reception is the 1st day of the menstrual cycle, the duration is 21 days, then there is a break for 7 days. If more than 5 days have passed since the onset of menstruation, then the pills are started from the next cycle.

If the start of taking the drug occurred on the 2-5th day of the menstrual cycle, the instructions for use Regulon recommends using additional contraceptives in the first 7 days.

If it is necessary to delay menstruation, it is necessary to continue taking the tablets without a 7-day break. During this period, menstrual bleeding may appear. The usual intake of the drug can be restored after a break of 7 days.

Switching to Regulon from other birth control pills

When switching from another oral contraceptive with a course of 21 days, the first pill should be taken the day after the seven-day break of the previous cycle.

When switching from the drug with a course of 28 days, the first tablet is taken the next day after taking the last tablet from the package of the previous remedy. If these recommendations are followed, additional methods of contraception are not required.

When switching from hormonal oral contraceptives, mini-drinks (containing only progestogen) 1st Regulon tablet should be taken on the 1st day of the menstrual cycle without additional use of barrier methods of contraception.

If menstruation did not occur during the use of the mini-pill, then only after the exclusion of pregnancy, you can start taking Regulon on any day of the cycle using additional contraceptives or abstinence from sexual intercourse for the first 7 days.

I missed taking Regulon tablets - what should I do?

If the tablet was missed for less than 12 hours, then it is taken as soon as possible.

If more than 12 hours have passed, then this pill is skipped and the next pill is taken the next day, while it is advisable to use additional methods of contraception during the week.

If the missed tablet occurred on the 1st or 2nd week of the MC, you should take 2 tablets at once (as usual) and use additional barrier contraceptives until the end of the cycle.

If you miss a pill on the 3rd week of the cycle, you must take the forgotten pill, continue to take it regularly and do not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and / or bleeding increases when a pill is missed - the use of additional methods of contraception is recommended.

special instructions

The appearance of irregular, spotting or breakthrough bleeding after several months of using the drug may indicate a decrease in its effectiveness.

If at the end of the second cycle menstrual-like bleeding does not begin, you should stop taking the tablets and resume it only after a possible pregnancy has been excluded.

Gastrointestinal disorders

If vomiting or diarrhea is noted after taking the drug, the absorption of its components may be incomplete. If vomiting and diarrhea have stopped within 12 hours, you need to take 1 additional tablet, then continue taking the drug as usual.

If vomiting and diarrhea last more than 12 hours, additional contraceptive methods must be used on the current day and for the next 7 days.

Side effects

The instruction warns of the possibility of developing the following side effects when prescribing Regulon (requiring discontinuation of the drug):

• Arterial hypertension;
• Thromboembolism of veins and arteries (including the formation of blood clots in deep veins, stroke, myocardial infarction, etc.);
• Thromboembolism of the veins and arteries of the liver and kidneys, as well as thromboembolism of the retial and / or mesenteric veins and arteries (very rarely);
• Hearing loss provoked by otospongiosis;
• porphyrin disease;
• Hemolytic-uremic syndrome;
• Exacerbation of the course of reactive systemic lupus erythematosus (in rare cases);
• Disappearing after the abolition of the drug rheumatic chorea (in extremely rare cases).

If the following adverse reactions occur, further use of the drug is at the discretion of the doctor:

• Acyclic spotting or bleeding from the genital tract;
• Amenorrhea after discontinuation of the drug;
• Inflammatory processes in the genital tract;
• Change in the state of the vaginal secretion;
• Thrush;
• Galactorrhea;
• Increase in size, tension and soreness of the mammary glands;
• Nausea;
• Crohn's disease;
• Vomit;
• Ulcerative colitis;
• Headache;
• cholelithiasis;
• Erythema (nodular or exudative);
• Chloasma;
• Rash;
• Development/exacerbation of itching and/or jaundice associated with cholestasis;
• Migraine attacks;
• Mood lability;
• Depression;
• Increased sensitivity of the cornea of ​​​​the eye (which can cause intolerance to contact lenses);
• Fluid retention in the body;
• Decreased tolerance to carbohydrates;
• Change in weight (usually upward);
• Hypersensitivity reactions.

Contraindications

Regulon is contraindicated in the following cases:

• Migraine with focal neurological symptoms (including history);
• Moderate or severe severity of arterial hypertension (blood pressure (BP) above 160 per 100 mm Hg) and other pronounced and / or multiple risk factors for arterial or venous thrombosis;
• Venous or arterial thromboembolism, thrombosis, including stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis of the lower leg (including history);
• Angina pectoris, transient ischemic attack and other precursors of thrombosis (including history);
• Pancreatitis (including history) against the background of severe hypertriglyceridemia;
• Diabetes mellitus with vascular damage (angiopathy);
• Dyslipidemia;
• Jaundice when taking glucocorticosteroids (GCS);
• Severe liver pathology, hepatitis, cholestatic jaundice (including during pregnancy) (including history);
• Gallstone disease (including history);
• Tumors of the liver (including history);
• Dubin-Johnson syndrome, Gilbert's syndrome, Rotor's syndrome;
• Hormone-dependent malignant tumors of the mammary glands and genital organs or suspicion of them;
• The presence of severe itching, otosclerosis and its progression during a previous pregnancy or while taking GCS;
• Smoking (more than 15 cigarettes per day) over the age of 35;
• Vaginal bleeding of unknown etiology;
• The period of pregnancy or suspicion of it;
• Breast-feeding;
• Individual intolerance to the components of the drug.

Assign with caution:

• Smoking;
• Epilepsy;
• Family history;
• Age over 35;
• Severe injury;
• Obesity;
• Migraine;
• Dyslipoproteinemia;
• Arterial hypertension;
• Major surgery;
• Varicose veins or superficial thrombophlebitis;
• Surgical operation on the lower extremities;
• Change in biochemical parameters;
• Severe depression (including history);
• postpartum period;
• Diabetes mellitus without vascular complications;
• Morphological changes in the heart valve;
• Systemic lupus erythematosus (SLE);
• Prolonged immobilization;
• Ulcerative colitis;
• atrial fibrillation;
• Crohn's disease;
• Sickle cell anemia.

Overdose

Symptoms of an overdose are nausea, vomiting, bloody discharge from the vagina.

In the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

Analogues Regulon, price in pharmacies

If necessary, you can replace Regulon with an analogue of the active substance - these are drugs:

1. Mercilon,
2. munali,
3. Tri-merci,

ATX code matches:

• Benidetta
• Daisy-30,
• marvilon,
• Mercilon,

When choosing analogues, it is important to understand that the instructions for use of Regulon, price and reviews, do not apply to drugs of similar action. It is important to consult a doctor and not to make an independent replacement of the drug.

Price in pharmacies in Moscow and Russia: Regulon 21 tablets - from 395 to 499 rubles, the cost of a package of 63 tablets - from 1018 rubles, according to 792 pharmacies.

Keep out of the reach of children at a temperature of 15° to 30°C. Shelf life - 3 years.

Conditions for dispensing from pharmacies - by prescription.

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Hello, please tell me, I had an abortion 2 weeks ago, I couldn’t drink Regulon right away, I started taking it only yesterday, is it possible to do this, and does it wake up the effect so as not to get pregnant ???

Girls, I have been drinking regulon for 4 months now, doctor's prescription. For the first 2 weeks of admission recovered by +2 kg. I talked with the doctor, read a lot for him and came to the conclusion that you just need to control yourself. Now -5 kg. No side effects. Menstruation goes on the 3rd day after the cancellation and only 3 ... Girls, I have been drinking regulon for 4 months now, doctor's prescription. For the first 2 weeks of admission recovered by +2 kg. I talked with the doctor, read a lot for him and came to the conclusion that you just need to control yourself. Now -5 kg. No side effects. Menstruation goes on the 3rd day after the cancellation and only 3 days. It pleases me. One of the simple drugs, and acceptable for the price. Good luck to all)

please tell me, the doctor prescribed these pills for me, after an abortion and take 21 days. Why? These are hormonal contraceptives, I don’t need them and so 21 days of no sex life

Please tell me, the doctor prescribed these pills for me, after an abortion and take 21 days. Why? These are hormonal contraceptives, I don’t need them and so 21 days of no sex life please tell me, the doctor prescribed these pills for me, after an abortion and take 21 days. Why? These are hormonal contraceptives, I don’t need them and so 21 days of no sex life

I decided to change the method of contraception I bought regulon I started drinking from the first day and today is the 18th day I did not stop menstruation for a single day, the meager truth, but still

The first three months everything was fine, I stopped drinking because the cycle returned to normal, a year later they were prescribed again and didn’t finish it for a month: headache, nausea, vomiting, dizziness, on this the desire to take hormonal drugs - passed!

I have been taking this drug for over two years. For the first three months there was discomfort, as described. The doctor assured me that everything would pass and this drug could be taken for five years without me. For all the time, there was no weight gain, rather, even a couple of kg left.

I took Regulon for more than 4 years, others were prescribed before him (I don’t remember the names), they all felt terribly sick, and Regulon tolerated it perfectly, a couple of kg. I gained in the first months, but by the third I had already returned to my weight. Having decided to give birth to a second child, she stopped drinking and in the third month she already became pregnant, although the doctor said ... I took Regulon for more than 4 years, others were prescribed before him (I don’t remember the names), they all felt terribly sick, and Regulon tolerated it perfectly, a couple of kg. I gained in the first months, but by the third I had already returned to my weight. Having decided to give birth to a second child, she stopped drinking and in the third month she already became pregnant, although the doctor said that it might not work out from 6 months to a year. The little girl is already three, and I'm starting to take them again.

The drug is excellent, especially for such money. No hormonal contraceptive causes weight gain. Appetite may increase, but she covered her mouth and all the problems. In the first months, intermenstrual breakthroughs (daub) are possible - I took a pill in the morning and in the evening and everything stopped. The maximum weight gain in 3 months is 4 kg. AND... The drug is excellent, especially for such money. No hormonal contraceptive causes weight gain. Appetite may increase, but she covered her mouth and all the problems. In the first months, intermenstrual breakthroughs (daub) are possible - I took a pill in the morning and in the evening and everything stopped. The maximum weight gain in 3 months is 4 kg. And this is only because of fluid retention in the intercellular space. Then everything comes full circle. And weight and regular painless "menstruation". Girls, do not be afraid of hormonal drugs! Picking the right one is one thing! And then, a tablet a day and no problems... I ADVISE!!!

Regulon is a very bad drug. It was prescribed to me by a gynecologist as a contraceptive. I started taking it, after 2 days I noticed that I had a blood spot. Thought it might pass... NO! This went on for a week. I went to the gynecologist, she said - hormonal failure !!! Horror. I gave up those pills. You won't believe it, even without Regulon... Regulon is a very bad drug. It was prescribed to me by a gynecologist as a contraceptive. I started taking it, after 2 days I noticed that I had a blood spot. Thought it might pass... NO! This went on for a week. I went to the gynecologist, she said - hormonal failure !!! Horror. I gave up those pills. You will not believe, even without Regulon I was getting better. Half a year has passed, and I just couldn’t lose those 7 kg that I gained because of the Regulon drug (((Rare disgusting ...

The average prices for medicines of the same dosage dispensed from Russian pharmacies in 2019 are indicated. Share your experience of using Regulon

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