Table janine. How to take Janine correctly: a hormonal contraceptive drug. Release form and composition


The world's first contraceptive pill appeared in the United States in 1960. By modern standards, it contained a monstrous amount of hormones: 10 mg of norethinodrel acetate and 150 mcg of mestranol. The drug was called Enovid and was not particularly popular, mainly due to severe side effects.

Of course, modern contraceptives have come a long way from their ancestors. A correctly selected drug does not have negative effects on a woman’s body, has a minimum of side effects and allows you to plan a pregnancy. One such means is the birth control pill Janine.

Mechanism of action

According to the classification, Zhanine belongs to monophasic low-dose contraceptives. That is, it contains the same amount of hormones in all tablets, of which there are 21 in a package. In other words, you will receive the same dose of hormones throughout your entire menstrual cycle.


Janine is a combination drug containing two hormones. Each tablet contains the hormone dienogest, obtained synthetically. It is a complete analogue of progesterone produced by the female body. The second hormone is ethinyl estradiol, which is identical to female estrogens.

The contraceptive effect of Janine develops in several directions:

  • The hormones included in the composition create a certain background in the body in which the next egg does not mature and does not leave the follicle, that is, they suppress ovulation.
  • Hormones block the release of substances that are responsible for stimulating the ovulation process itself.
  • They cause changes in the endometrium and thereby prevent the implantation of the egg, if, by an incredible coincidence, ovulation and fertilization did occur.
  • They increase the viscosity of the secretion in the cervix, and it becomes almost completely impermeable to sperm.

Thanks to this multi-level mechanism of protection against pregnancy, Janine is one of the most effective means of family planning.

If you use Zhanine correctly and do not miss taking pills, then the Pearl index, which determines the reliability of all contraceptives, will be less than one.

This means that in one hundred women who protected themselves for a year without interruption with this drug, only one became pregnant.

Features of application

Some women are frightened by the fact that Janine prevents the onset of ovulation. It may seem that he is forever able to suppress it. However, this is not at all true. Janine does not affect the number of eggs that can mature during a normal cycle. It simply “turns off” the ovaries for a while and gives them the opportunity to rest. But when you stop taking them, they begin to work in full force again.

Indications

The main indication for use of Janine is contraception. However, there are a number of conditions for which hormonal and contraceptive drugs can also be prescribed. At the same time, the opportunity to plan a pregnancy will be a bonus to the action that you need to get in the end. These conditions include:

  • Seborrhea, acne or hirsutism, in which women's hair grows in a male pattern.
  • Baldness, which also occurs in the male pattern, when hair loss begins mainly in the frontal and parietal region, caused by a lack of female hormones.
  • Endometriosis, in which Janine helps mainly by suppressing the growth of the endometrium of the uterus and reducing such manifestations of the disease as heavy bleeding, disrupted cycles and pain.
  • Some types of ovarian cysts.
  • Delaying or changing the next date of the onset of menstrual bleeding.

Contraindications

Despite the fact that modern hormonal drugs are a fairly safe group of drugs, contraindications to their use still exist. In some conditions, the use of Janine is absolutely contraindicated; in others, it can be used, but only under the strict supervision of a doctor.

Absolute contraindications:

  • Suspicion of pregnancy.
  • Uterine bleeding of unknown origin.
  • Lactation period.
  • Allergy to the components that make up Janine, including auxiliary ones.

If you have at least one of these conditions, then you should absolutely not take the drug. In addition, Janine should not be drunk:

  • For thrombosis, thromboembolism, regardless of the reasons that caused them and whether you have them now or have had them in the past.
  • For any other pathologies associated with disorders that occur in the vascular system, especially after strokes or heart attacks.
  • For migraines with aura, which are characterized by the presence of various neurological symptoms. Often these are visual and hearing impairments, clouding of consciousness, fainting and panic attacks.
  • For severe liver diseases.
  • For diabetes mellitus, especially with vascular complications.
  • For any hormone-dependent diseases that are difficult to treat.

Relative contraindications

There are conditions in which taking Janine is not prohibited, but it should only be used if the benefit obtained will outweigh the risk of exacerbations or complications. These include:

  • Conditions associated with a high risk of blood clots, such as being overweight, smoking, or migraines without aura.
  • Hereditary predisposition to the formation of blood clots. It is possible for you if one of your close relatives suffered from venous diseases, suffered a stroke or heart attack.
  • Angioedema is also hereditary.
  • Pathologies that can provoke circulatory disorders. For example: Crohn's disease, ulcerative colitis, systemic lupus erythematosus, inflammation of the superficial veins or some types of anemia.
  • Hypertriglycerdemia is a disease, often also of a hereditary nature, in which high levels of lipids are found in a person’s blood.

If any of these conditions first appeared to you while taking Janine, then you should stop taking the drug and be sure to consult a doctor as soon as possible.

Side effects

In most cases, Janine is tolerated quite well. However, side effects also occur when taking it. They will be most pronounced at the very beginning of use; as a rule, they go away on their own over time and do not require discontinuation of the drug. According to the instructions, most often the following may occur:

  • Headache, appearance or exacerbation of existing migraines, dizziness, surges in blood pressure.
  • Nausea, upset, pain in the lower or upper abdomen.
  • Pain, engorgement of the mammary glands.
  • Changes in mood, fatigue, and sometimes insomnia.

More serious side effects occur much less frequently, according to clinical studies, no more than one case per thousand doses of the drug. These include:

  • Exacerbation of genitourinary system infections, the appearance of thrush or vulvovaginitis.
  • Allergic reactions are usually allergic dermatitis.
  • Pain in the back or limbs, myalgia.
  • Various disorders associated with the vascular system, such as varicose veins, thromboembolism, and the formation of spider veins.

How to drink Janine?

Perhaps the main feature of the use of Janine, however, like all contraceptives, is a certain scheme of use. You cannot start drinking them any day of your own free will. Moreover, if you take such pills, you should not throw them away halfway through the package.

It is better to take Janine at the same time of day. This way, your body will quickly get used to the incoming hormones, which means the likelihood of developing side effects will be lower. According to the instructions, you need to start drinking Janine if:

  • In the previous month you did not take other hormonal contraceptives, then on the first day of your next period.
  • In the previous month, you took a contraceptive, the package of which contained 28 tablets, or used a hormonal patch or ring, then you should take the first tablet the next day, after the end of taking the drug or the effect of the ring or patch. That is, in this case you should not have any break.
  • In the previous month, you took a hormonal contraceptive containing 21 tablets. Then you need to start taking Janine after a seven-day break. If before this you were protected with drugs containing gestagens, for example, injection drugs Norplant, Depo-Provera or mini-pills, such as Charozetta or Excluton, then you need to take Janine without interruption.
  • After an abortion or childbirth, the drug should be taken as prescribed by a doctor, who will select the optimal day for this.

Janine is a drug containing synthetic hormones and is available with a prescription. This means that it should be prescribed by a doctor who can take into account all the characteristics of your body.

Taking hormonal contraceptives requires attention, especially if you are starting to take such a drug for the first time. Don't forget to take your next pill on time, be sure to follow the instructions and follow your doctor's recommendations.

Janine, a drug that is essential for a woman’s health. The instructions for use describe all its advantages from contraceptive action to restoration of pathological hormonal imbalance.

Release form and cost

1. Tablets:

2. Dragee:

  • round in shape, milky in color, covered with a gelatin shell;
  • the price of Janine dragees varies from 1020 rubles. up to 2700 rub. for 1 package.

Compound

Janine (instructions for use of tablets and dragees contain the names of its constituent elements) has the following composition:

1. tablets:

  • ethylestrateriene diol;
  • a progestin available in combination with estrogen – dienogest;
  • carbohydrate of the disaccharide group;
  • carbohydrate polymer, transparent paste – corn starch;
  • incompletely fermented hydrolyzed starch - molasses;
  • cane sugar;
  • aqueous concentrate of monosaccharides;
  • polyethylene glycol;
  • wax from Brazilian palm leaves;
  • amphoteric titanium oxide;

2. dragees:

  • ethinyl estratriene diol;
  • progestin, in combination with estrogen;
  • milk sugar;
  • potato leucoplasts;
  • hydrolyzed collagen protein;
  • silicate mineral;
  • magnesium salt and stearic acid;
  • cane disaccharide;
  • grape sugar;
  • polyethylene glycol;
  • carbonic acid and calcium salt;
  • polyvinylpyrrolidone;
  • tetravalent titanium;
  • palm waxy substance.

Advantages of the drug

The drug Janine is a complex drug consisting of hormones for planning pregnancy and treating inflammatory hormonal imbalance in a woman’s body.

The value of the medicine Janine lies in the following action:


Disadvantages of the drug

Janine (the instructions for use do not describe the disadvantages of the drug) has special instructions that should be followed:


Medicinal properties

The drug Janine has medicinal properties and is used for many pathological conditions of the body:

  • acute and chronic diseases of the ovaries, uterine cavity, paired tubes that connect the female organs;
  • with low hemoglobin;
  • prevents the formation of tumors in the ovaries and uterus;
  • treats some forms of mastopathy;
  • used in the treatment of acne;
  • with diffuse baldness;
  • the drug Zhanine reduces the functioning of the exocrine glands, which helps treat seborrhea;
  • strengthens bones;
  • treats pathological fragility of bones due to impaired metabolic processes;
  • relieves pain in the mammary glands during mastopathy;
  • relieves premenstrual edema.

Indications for use

Janine (instructions for use explain that first of all this drug is an oral contraceptive) has indications for the following diseases:


Contraindications for use

Janine, like any pharmacological agent, has contraindications, which are described in the instructions for use:

Side effects and overdose

The instructions for use of the drug Janine describe the side effects that you may encounter while taking this medicine.

1. Infections:

  • mucous inflammatory process in the vagina;
  • vaginal candidiasis;
  • inflammation of the ovaries and tubes;
  • cystitis;
  • inflammation of the cervix;
  • herpetic lesions of the oral cavity;
  • inflammation of the bronchi;
  • sinusitis;
  • flu.

2. Tumors of unknown etiology:

  • fibroids;
  • fatty breast tumor;

3. Blood and lymph:

  • decrease in hemoglobin.

4. Immunity:

  • allergic reactions;
  • autoimmune pathologies.

5. System of endocrine glands:

  • Manifestation of male characteristics in women (hair growth, deepening of the voice).

6. Metabolic processes:

  • increased desire to eat;
  • psycho-emotional disorder due to excess weight.

7. Mental disorders:


8. Neurological disorders:

  • migraine pain;
  • violation of movement coordination;
  • cerebral hemorrhages;
  • encephalopathy;
  • syndrome of nervous excitability disorder.

9. Visual system:

  • Sjögren's syndrome;
  • redness of the eye membranes;
  • escillopsia;
  • decreased vision.

10. Hearing aid:


11. Cardiac system:

  • increased blood pressure;
  • lowering blood pressure;
  • arrhythmia.

12. Vascular system:

  • varicose veins;
  • Raynaud's disease;
  • thrombosis of veins and arteries.

13. Organs of the chest:

  • respiratory failure;
  • decrease in the level of carbon dioxide in the blood.

14. Abdominal cavity:

  • inflammation of the stomach;
  • intestinal inflammation;
  • stool disorder;
  • urge to vomit;
  • nausea.

15. Skin:


16. Connective tissue system:

  • lower back pain;
  • pain in the body and joints;
  • muscle inflammation;
  • pain in arms and legs.

17. Reproductive system:

  • chest pain;
  • bleeding of unknown etiology;
  • swelling;
  • vaginal leucorrhoea;
  • pain in the uterine cavity;
  • diffuse damage to the mammary glands.

18. Disorders:

  • fatigue;
  • general swelling;
  • local swelling.

19. Research:

  • weight gain;
  • increased levels of cholesterol and glucose in the blood;
  • weight loss.

20. Genetic pathologies:

  • the appearance of excess mammary glands.

Overdose symptoms

Severe symptoms of exceeding the permissible dose of the drug Janine are unlikely.

They can only appear in hormonally immature girls in the form of:


This condition does not require special treatment. In rare cases, it is necessary to rinse the stomach and use enterosorbents.

How to switch to taking the drug from other contraceptives

Janine (the instructions for use provide clear and understandable recommendations) requires a special transition to this drug from other means that protect against unwanted pregnancy.

1. Changing oral contraceptives:

  • It is imperative to take the drug Janine the next day after taking another type of pharmacological agent.

2. Changing the latex ring and TTS:

  • It is necessary to take the tablet or dragee Janine on the day when the latex ring or TTC was removed, but no later than the next day.

Choosing the first day of admission

If the body has not taken any contraceptive medications, then you need to start taking the drug Janine from the 2-4th day of the monthly cycle.

Prescription in case of change in the onset of the menstrual cycle

If there is a violation of the menstrual cycle, then it is necessary to exclude a possible pregnancy.

In case of a negative test, you need to take Janine’s medicine until the start of a new cycle, and drink the drug 2-4 days after the return of menstruation.

In case of violation of the dosage regimen

There are certain rules according to which you need to take the drug Janine.

If you miss a medication dose, you must:

1. At 1 – 2 weeks you need to take the forgotten dose of the drug. You can take several tablets or pills at once. After that, you need to use the drug as prescribed according to the instructions. But in the next week you need to use a condom during sexual relations.

2. At 3 weeks. The danger of falling protection and the occurrence of unwanted pregnancy, after a week's break in the use of the drug Janine, the following occurs very acutely:

  • you need to take a forgotten dose of medicine and need to take several pills or tablets. Then continue therapy as usual according to the regimen. There should be no breaks between the plates of the drug. There may be slight bleeding from the vagina after starting the next plate. This shouldn't be alarming.
  • There is another option for taking the medicine if you miss it in the third week. It is necessary to leave the use of Janine from the remaining plate. In this situation, the period of absence of the drug Janine should not be a week.

Further use of tablets or dragees should be continued with the next tablet of the drug. In the absence of bloody discharge, which is mandatory if the regimen for using the drug Janine is violated, an unwanted pregnancy may occur.

Rules for admission after childbirth or abortion

There are certain rules for taking the drug Janine after childbirth and abortion:


Selection of drug by age

The drug Janine does not require special dosage selection according to age. The only exception is that this drug does not need to be used during the postmenopausal period.

Instructions for use

Zhanine tablets or dragees must be consumed according to the scheme - 1 pc. per day, constantly, at approximately equal intervals. If necessary, drink it with a small amount of water. The medicine must be taken every day in a row for 21 days, without omissions or breaks.

The use of dragees or tablets from the subsequent plate should be started after a week's rest. During this period there will be bleeding without stopping. This type of bleeding, starting 2-3 days after the last dose of the medicine from the plate, will end with the start of a new three-week course of contraceptive therapy.

Janine and endometriosis

The drug Janine is a combination medicine that is not only a contraceptive, but is also used for the growth of connective tissue of the uterine cavity - endometriosis.

One of the components of the drug Janine is a progestin in combination with estrogen. This combination affects the unnatural growth of endometrial connective tissue, stopping it.

For pathologies of the uterine cavity, Janine’s tablets or dragees must be used according to a special regimen - it is called “long-term”. What distinguishes Janine from the usual use of the drug is the continuous use of pills or tablets for 63 days.

During therapy it is necessary to consume 3 tablets of the medicine. Then you need to rest for a week. With this type of treatment, there will be no menstrual cycle for the entire 3 months.

Scheme for using the drug for uterine fibroids

Fibroids should be treated with Janine if certain rules are followed. Tablets or pills should be used for 3 months without interruption.

Every day you need to drink 1 pill or tablet at a certain time. For therapy, 3 tablets of the drug are required. After the course of therapy, you need to take a week's rest. During this period there will be bleeding associated with the menstrual cycle.

In the future, it is necessary to conduct a follow-up examination. If necessary, the course of therapy is extended for an additional 90 days.

Why is Janine prescribed after surgery to remove fibroids?

As a rule, during surgical treatment of all types of fibroids, the uterus must be removed. Therefore, the prescription of the drug Janine is necessary to restore hormonal imbalance.

The effectiveness of drug treatment

The decision to treat with Zhanine is made only by a doctor, in accordance with the examination and the presence of chronic pathologies.

It is necessary to use Janine only either until the lump has grown to 2 cm, or in the postoperative period, as hormone replacement therapy.

The effectiveness of using the drug Janine is high, within 80%. But treatment should be carried out only as prescribed and under the supervision of a doctor.

Analogs of the drug Janine

The drug Janine has analogues or drugs with a corresponding effect and composition.

1. Tablets Silhouette:


2. Naadin tablets:

  • The drug contains progestin, estradiol, polyvinylpyrralidone, milk sugar, ethylene glycol polymer, amphoteric titanium oxide, thermoplastic polymer, corn starch paste, molasses, carbonic acid and calcium salt
  • Naadin tablets must be used as a systemic oral contraceptive drug;
  • the price for this type of tablet varies from 410 rubles. up to 580 rub.

The hormonal drug Zhanine in the instructions for use is described as a modern, effective, contraceptive drug, which, if used correctly, can protect not only from unwanted pregnancy, but also cure hormonal imbalance and its consequences, such as fibroids and the proliferation of endometrial connective tissue.

Article format: Vladimir the Great

Video about Zhanine tablets and other contraceptive drugs

Hormonal contraception. What is this:

Content

To prevent unwanted pregnancy and for drug therapy of gynecological pathologies, the contraceptive drug Janine is used. The medication belongs to the group of combined oral contraceptives with a low dosage of estrogens. Pills with a contraceptive effect Janine - instructions for use are in each package - are prescribed to prevent ovulation and normalize the menstrual bleeding cycle.

Birth control pills Janine

The drug Janine is a low-dose oral combined hormonal drug. The contraceptive effect is achieved through special complementary mechanisms, one of which is the suppression of ovulation and an increase in the viscosity of cervical mucus, as a result of which the cervical canal becomes impermeable to sperm.

When the pill is used correctly, the rate of unwanted pregnancy is less than 1 in 100 women who took this hormonal contraceptive for a year. In girls who took combined oral contraceptives (COCs), the menstrual cycle becomes more regular, pain is less common, and the intensity and duration of bleeding are significantly reduced. In addition, there is clinical evidence of a reduced risk of endometriosis, ovarian and cervical cancer.

Composition and release form

The drug is available in the form of biconvex tablets, white, pale yellow or cream in color. The tablets are placed in a plastic blister of 28 pieces and in a cardboard package with instructions for use of the medication. Compound:

Pharmacodynamics and pharmacokinetics

After oral administration, the drug is quickly and completely absorbed from the gastrointestinal tract, the maximum concentration of the active component in the blood plasma is reached after approximately 2-3 hours. Bioavailability is about 90%. The components of the drug bind to serum proteins by 80%. The medication Janine is completely metabolized by liver enzymes. The half-life is approximately 10-12 hours. A small amount unchanged is excreted by the kidneys in the urine.

Indications for use

Contraceptives Zhanine are indicated for use by women and girls of fertile age to prevent unwanted pregnancy, reduce the symptoms of premenstrual syndrome, equalize hormonal levels and resume regular cycles in various systemic endocrine pathologies. The medication is prescribed for the treatment of functional ovarian cysts, for the treatment of secondary infertility, and cervical cancer.

When taking Zhanine to prevent pregnancy, you must remember that this method of contraception does not protect against sexually transmitted diseases (HIV infection, hepatitis, chlamydia, etc.). If you do not have a permanent sexual partner or if your spouse has bacterial and viral sexually transmitted diseases, it is strongly recommended to use barrier contraceptive methods (condoms).

How to drink Janine

To achieve a contraceptive effect, Janine's medication must be taken orally for 21 days in the order indicated on the package, daily, with a small amount of water or any other drink (except alcohol-containing drinks). Taking tablets from the next package must be started after a 7-day break, during which withdrawal bleeding occurs, similar to menstruation. Normally, menstrual flow begins 2-3 days after taking the last pill and lasts 5-7 days.

If you miss a pill, you need to take two tablets the next day and then take the drug according to the previous regimen. In this case, spotting may occur for several days. If after taking the medicine for 3-4 hours a woman has vomiting or diarrhea, then she should take another tablet, because absorption of the drug components may be insufficient.

How to take Janine for the first time

The initial use of Zhanine or its use after an artificial or spontaneous abortion to establish a cycle must be carried out on the first day of menstruation (even with irregular bleeding). Sometimes it is allowed to start taking pills on the 2-3rd day of the cycle, but it is necessary to additionally use a barrier method of contraception during the first week of using the pills from the first package.

special instructions

During pharmacological therapy with drugs that affect microsomal enzymes, and for 30 days after discontinuation, it is necessary to additionally use a barrier method of contraception. When using antibiotics, it is also necessary to take additional precautions. In addition, the medication should be discontinued to prevent the risk of thrombosis during and immediately after elective surgery. You should take Zhanine birth control pills with caution in the following cases:

  • lipid metabolism disorders;
  • excess sex hormones;
  • arterial thromboembolism;
  • epilepsy;
  • migraine;
  • autoimmune diseases;
  • renal or liver failure;
  • anemia;
  • colitis;
  • hypertension.

During pregnancy

Janine is contraindicated for use during pregnancy and lactation. If pregnancy is detected while using the medicine, then taking the tablets should be stopped. However, large-scale clinical and epidemiological studies have not revealed any correlation between the increased risk of pathologies in children who were exposed to hubbub during fetal development.

Alcohol compatibility

The simultaneous use of ethyl alcohol and contraceptive drugs significantly reduces the normal absorption of the latter, so tablets should not be taken less than 3-4 hours before drinking alcohol and earlier than 2-3 hours after. In addition, alcohol-containing drinks contribute to the frequent development of side effects (especially thrombosis, nausea, migraines).

Drug interactions

Long-term therapy with drugs that induce liver enzymes can lead to severe breakthrough bleeding from the uterus and a decrease in the effectiveness of the contraceptive drug Janine. When used simultaneously with antibiotics, the intrahepatic circulation of estrogens decreases and the concentration of estradiol, which has a contraceptive effect, decreases. Oral combination hormonal drugs may affect the metabolism of other drugs.

Side effects of Janine

With long-term use of a contraceptive or with individual intolerance to the drug, the following side effects of Zhanine are observed:

  • soreness of the mammary glands;
  • spotting and breakthrough uterine bleeding;
  • headache;
  • vaginal breakthrough bleeding;
  • venous hypertension;
  • early menopause;
  • migraine;
  • change in libido;
  • dyspepsia (nausea, vomiting, diarrhea, constipation);
  • fluid retention, tissue swelling;
  • weight gain;
  • allergies.

Contraindications

Zhanine tablets are a hormone-containing drug, so they can significantly affect the functioning of almost all organs and systems. The medication should be taken only if there are no contraindications for use. It is prohibited to use the medication under the following conditions:

  • vascular thrombosis;
  • arterial thromboembolism;
  • atherosclerotic lesion;
  • pancreatitis;
  • liver tumors;
  • malignant neoplasms;
  • endocrine disorders;
  • individual hypersensitivity to the components of the drug.

Terms of sale and storage

The drug must be stored in a dry, cool place, protected from direct sunlight, out of reach of small children and animals. Janine is available from pharmacies without a doctor's prescription.

Analogues of Janine

Medicines with a similar composition and effect are prescribed in cases where Zhanine tablets are contraindicated for use by a sick patient. The following medications are identified on the pharmaceutical market, identical in properties to Janine:

  1. Dimia. Zhanin's analogue is used for contraceptive and cosmetological effects. Thanks to this medicine, the condition of the skin, nails, and hair improves. In addition, women report a decrease in the manifestations of premenstrual syndrome.
  2. Lendinet-20. The medicine is prescribed, as a rule, to adolescents, because has a significantly lower concentration of the active component and rarely causes side effects even with long-term use. The medication is indicated for violations of the frequency, duration and regularity of menstruation.

Price Janina

The cost of the medicine depends on the form of the drug, the degree of purification, the quality of the main active substance and auxiliary components. The price of the drug may be influenced by the region and pharmacy in which it is sold. The cost of the medicine can be set by the manufacturer. The approximate price of the medicine in Moscow is indicated in the table.

Janine is a monophasic drug that has a contraceptive effect. The composition combines unique components (artificial analogues of female hormones) that prevent the onset of unplanned pregnancy.

The drug helps regulate the menstrual cycle, as well as eliminate intermediate bleeding and pain, especially with irregular and heavy menstrual bleeding (which can lead to everything else anemia).

In this article we will look at why doctors prescribe the drug Zhanine, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Janine, leave your feedback in the comments.

Release form and composition

The drug is produced in the form of white smooth tablets, every 21 of which are packaged in blisters. One or three blisters are included in a cardboard pack of the drug.

Each dragee contains:

  • active ingredients: 0.03 mg ethinyl estradiol and 2.0 mg dienogest.
  • excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, sugar syrup, polyvidone K 25, macrogol 35000, calcium carbonate, titanium dioxide (E 171), carnauba wax.

Clinical and pharmacological group: monophasic oral contraceptive with antiandrogenic properties.

What is Janine used for?

According to the instructions, Zhanine is recommended to be taken by women who have regular sex life to prevent unwanted pregnancy. In addition, in medical practice, Zhanine tablets are often used as the main and auxiliary treatment for the following conditions and diseases:

  • endometriosis;
  • reproductive dysfunction;
  • dysmenorrhea (painful menstruation);
  • amenorrhea (lack of menstruation);
  • menorrhagia (heavy menstruation);
  • the period after gynecological surgical interventions (for the purpose of recovery after surgery and consolidation of its results);
    increased levels of male sex hormones in a woman’s blood (which often results in acne, very oily skin, and excessive hair growth of the skin).

pharmachologic effect

The contraceptive effect of Janine is carried out through complementary mechanisms, the most important of which include suppression of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.

When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the 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 menstruation is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of developing iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

Instructions for use

The pills should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Janine should be taken 1 tablet/day continuously for 21 days. Each subsequent package begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually begins on the 2-3rd day after taking the last pill and may not end until you start taking a new package.

  • How to start taking Janine if you have not taken any hormonal contraceptives in the previous month. Taking Janine 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 at 2-5 menstrual cycles, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills from the first package.
  • When switching from combined oral contraceptives, a vaginal ring, or a transdermal patch, taking Zhanine should begin the day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.
  • When switching from oral contraceptives containing only gestagen (mini-pills), you can stop taking the mini-pill on any day and start taking Zhanine the next day at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
  • When switching from an injectable contraceptive, an implant, or from a progestogen-releasing intrauterine contraceptive (Mirena). Start taking Janine on the day your next injection is due or on the day your implant or intrauterine device is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
  • 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 protection.
  • After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy should be excluded before taking Zhanine or she must wait until her first menstruation.

If no more than 12 hours have passed since you missed taking the pill, the contraceptive effect of the drug is not reduced. It is necessary to take the missed pill as soon as possible. Next, switch to the normal reception mode.

Taking missed pills

If the gap exceeds 12 hours, then contraceptive protection is reduced. There are two basic rules you should know:

  1. You cannot stop taking the pills for more than 7 days.
  2. Over the course of 7 days of continuous use of the pills, adequate suppression of the hypothalamic-pituitary-ovarian system is achieved.
  • 1 Week. The last missed pill should be taken as soon as possible. Even if you have to take two pills at a time. Then continue to take the pills at the usual time. Over the next 7 days, it is recommended to use an additional method of protection, such as a condom. If sexual intercourse took place in the previous 7 days, the possibility of pregnancy should not be ruled out. The closer the break in taking the drug and the more tablets missed, the higher the risk of pregnancy.
  • Week 2. A woman should take the last pill she missed as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time. Provided that the woman took the pill correctly during 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 pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
  • Week 3. As the break in taking the pills approaches, unreliability increases. But if you follow the dosage regimen, a decrease in contraceptive protection can be avoided. The need to use additional contraceptives will not arise if you adhere to one of the following options, if there were no violations in taking pills for 7 days before the missed dose. The recommendations of the following options should be explored. If there were violations before. then take additional protection for the next 7 days.

You can stop taking the pills from the current package. In this case, including days missed, the break in taking the drug should be up to 7 days. You need to start taking the pills with a new package. If there are disturbances from the gastrointestinal tract, then absorption of the drug will not be complete, which means that additional means of protection must be used. It is advisable to skip taking the pill if vomiting occurs within 3-4 hours after taking it. If you do not want to change your usual regimen of taking the drug, then you need to take additional pill(s) from a different package.

To delay the appearance of menstruation, there is no need to take a break from taking the drug, but continue taking the drug from a new package. Reception can be continued until the end of the second package. Bloody or breakthrough bleeding cannot be ruled out. After a 7-day break, the usual use of the drug Janine is restored.

To shift the onset of menstruation to another day of the week, it is recommended to reduce the break in taking the pills by the required number of days. The duration of the break affects the absence/presence of menstrual-like bleeding and breakthrough or bloody bleeding.

Contraindications

Janine should not be used if you have any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be discontinued immediately.

  1. Bleeding from the vagina of unknown origin.
  2. Pregnancy or suspicion of it.
  3. Breastfeeding period.
  4. Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
  5. Migraine with focal neurological symptoms currently or in history.
  6. Diabetes mellitus with vascular complications.
  7. Pancreatitis with severe hypertriglyceridemia, currently or in history.
  8. Liver failure and severe liver disease (until normalization of liver tests).
  9. Liver tumors (benign or malignant) currently or in history.
  10. Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
  11. Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
  12. Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.

Side effects

Soreness and tension of the mammary glands, enlargement of the mammary glands, discharge from the mammary glands; spotting and breakthrough uterine bleeding; headache; visual impairment; nausea; vomit; stomach ache; changes in vaginal secretion; skin rash; erythema nodosum; migraine; change in libido; decreased/changes in mood; poor tolerance to contact lenses; erythema multiforme; generalized itching; cholestatic jaundice; fluid retention; change in body weight; allergic reactions.

Rarely - increased levels of plasma triglycerides, decreased tolerance to carbohydrates, increased fatigue, diarrhea. As with other combined oral contraceptives, in rare cases the development of thrombosis and thromboembolism is possible.

Changing the start day of the menstrual cycle

To delay the onset of menstruation, a woman should continue taking pills from a new package of Janine immediately after taking all the pills from the previous one, without interruption. The pills from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Janine from a new package after the usual 7-day break.

To move the start of menstruation to another day of the week, a woman should shorten the next break in taking the pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).

If a woman has vomiting or diarrhea within 4 hours of taking active tablets, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping pills.

special instructions

The use of the drug Zhanine is contraindicated before the onset of menarche and after the onset of menopause.

In some cases, the use of sex hormones can cause the development of tumors in the liver. An increase in the size of the liver, severe abdominal pain, as well as signs of intraperitoneal bleeding must be taken into account when making a differential diagnosis.

Taking the drug Janine may be accompanied by irregular bleeding (both in the form of spotting and breakthrough bleeding), especially in the first months of therapy. In this regard, assessment of irregular bleeding should be carried out only after an adaptation period of approximately 3 cycles.

If such bleeding recurs or occurs after previous regular cycles, a non-hormonal cause should be sought. Diagnosis is carried out to exclude the presence of a malignant neoplasm or pregnancy in the patient. In some cases, diagnostic curettage may be required.

Janine does not protect against STDs and HIV infection.

Analogs

Analogues of Zhanin by mechanism of action: Belara, Yarina, Dayla, Midiana, Jess, Logest, Evra, Lindinet 30, Mercilon, Marvelon, Egestrenol, Femoden, Oralcon, Dimia.

Prices

The average price in pharmacies (Moscow) is 1178 rubles.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life – 3 years.

Manufacturer: Bayer HealthCare Pharmaceuticals (Bayer Healthcare Pharmaceutical) Germany

ATC code: G03AA

Farm group:

Release form: Solid dosage forms. Dragee.



General characteristics. Compound:

Active ingredients: ethinyl estradiol 0.03 mg and dienogest 2.0 mg.
Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogol 35000, calcium carbonate, povidone K25, titanium dioxide (E 171), carnauba wax.
Description. White smooth dragees.


Pharmacological properties:

Pharmacodynamics. Zhanine is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.
The contraceptive effect of Janine is carried out through complementary mechanisms, the most important of which include suppression of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.
When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.
The gestagenic component of Janine - dienogest - has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of high-density lipoproteins).
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity and duration decrease, resulting in a reduced risk. In addition, there is evidence of a reduced risk of developing and.

Pharmacokinetics.

Dienogest Absorption. When taken orally, dienogest is rapidly and completely absorbed, its maximum serum concentration of 51 ng/ml is achieved after approximately 2.5 hours. Bioavailability is approximately 96%.
Distribution. Dienogest binds to serum albumin and does not bind to sex steroid binding globulin (SGBS) and corticoid binding globulin (CBG). About 10% of the total concentration in the blood serum is found in free form; about 90% are not specifically associated with serum albumin. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein.
Metabolism. Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h.
Excretion. The half-life is about 8.5-10.8 hours. A small amount in unchanged form is excreted by the kidneys in the form of metabolites (half-life - 14.4 hours), which are excreted by the kidneys and through the gastrointestinal tract in a ratio of approximately 3:1.
Equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHPS in the blood serum. As a result of daily administration of the drug, the level of the substance in the serum increases approximately 1.5 times.
. Ethinyl estradiol
Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. The maximum serum concentration of approximately 67 pg/ml is achieved within 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability averaging about 44%.
Distribution. Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8 - 8.6 l/kg.
Metabolism. Ethinyl estradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation. The clearance rate from blood plasma is 2.3 - 7 ml/min/kg.
Excretion. The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6 with a half-life of about 24 hours.
Equilibrium concentration. Equilibrium concentration is achieved during the second half of the treatment cycle.

Indications for use:

Contraception.


Important! Learn about contraception treatment

Directions for use and dosage:

The pills should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Take one tablet per day continuously for 21 days. The next package begins after a 7-day break from taking the pills, during which withdrawal bleeding usually develops. Bleeding, as a rule, begins 2-3 days after taking the last pill and may not stop until you start taking the pill from a new package.
How to start taking Janine
. If you have not taken any hormonal contraceptives in the previous month.
Taking Janine 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 days 2-5 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 pills from the first package.
. When switching from other combined hormonal contraceptives (combined oral contraceptives (COCs), vaginal ring, transdermal patch).
It is preferable to start taking Janine the 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 package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.
. When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant) or from a gestagen-releasing intrauterine contraceptive (Mirena).
A woman can switch from a mini-pill to Janine on any day (without a break), from an implant or intrauterine contraceptive with a gestagen - on the day of its removal, from an injection form - from the day when the next injection would have been given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.
. 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 protection.
. After childbirth or abortion in the second trimester of pregnancy.
It is recommended to start taking the drug 21-28 days after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy should be excluded before taking Zhanine or she must wait until her first menstruation.
Taking missed pills
If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next one should be taken at the usual time.
If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:
. The drug should never be interrupted for more than 7 days.
. 7 days of continuous administration of the pills are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.
Accordingly, the following advice can be given if the delay in taking the pill is more than 12 hours (the interval since the last pill was taken is more than 36 hours):
. First week of taking the drug
A woman should take the last pill she missed as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before missing the pills, the possibility of pregnancy must be taken into account. The more tablets are missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.
. Second week of taking the drug
A woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time.
Provided that the woman took the pill correctly during 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 pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
. Third week of taking the drug
The risk of decreased reliability is inevitable due to the upcoming break in taking the pill.
A woman must strictly adhere to one of the following two options. Moreover, if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.
1. A woman should take the last missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time, until the pills from the current package run out. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pill.
2. A woman can also stop taking pills from the current package. She should then take a break for 7 days, including the day she missed the pills, and then start taking a new pack.
If a woman misses taking the pill and then does not have withdrawal bleeding during the break from taking the pill, pregnancy must be ruled out.
Recommendations in case of vomiting and diarrhea
If a woman has vomiting or diarrhea within 4 hours of taking active tablets, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping pills.
Changing the start day of the menstrual cycle
In order to delay the onset of menstruation, a woman should continue taking pills from a new package of Janine immediately after all the pills from the previous one have been taken, without interruption. The pills from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Janine from a new pack after the usual 7-day break.
In order to postpone the start of menstruation to another day of the week, a woman should shorten the next break in taking the pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, there will be spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).

Additional information for special categories of patients
Children and teenagers
The drug Zhanine is indicated only after the onset of menarche. Elderly patients
Not applicable. The drug Zhanine is not indicated after menopause. Patients with liver disorders
Zhanine is contraindicated in women with severe liver disease until liver function tests return to normal. See also section "Contraindications".
Patients with kidney problems
Zhanine has not been specifically studied in patients with renal impairment. Available data do not suggest changes in treatment in these patients.

Features of application:

If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking drug. If any of these conditions, diseases or risk factors worsen, intensify or manifest for the first time, a woman should consult her doctor, 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 an increased 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 greatest in the first year of taking such drugs. An increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients suggest 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 КПК, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах.
VTE can be fatal (in 1-2% of cases).
Venous thromboembolism (VTE), manifesting as deep vein or pulmonary embolism, can occur with the use of any combined oral contraceptives.
It is extremely rare that when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. 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 up or when walking, localized warmth in the affected leg, redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism (PE) include: difficulty or rapid breathing; sudden, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; 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 include: sudden weakness or loss of feeling in the face, arm or leg, especially on one side of the body, sudden confusion, trouble speaking and understanding; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; 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 blue discoloration of the extremities, acute abdomen.
Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or chest; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, or dizziness, severe weakness, or; fast or irregular heartbeat. Arterial thromboembolism can be 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 leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not resume use for two weeks after the end of immobilization;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
- diseases of the heart valves;
- atrial fibrillation.
The question of the possible role of varicose veins and superficial ones in the development of venous thromboembolism remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders can also be observed in 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 combined oral contraceptives (which may precede cerebrovascular events) 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, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant 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 (< 0,05 мг этинилэстрадиола).
. Tumors
The most significant risk factor for cervical development is persistent papilloma viral infection. There are reports of a slight increase in the risk of development with long-term use of combined oral contraceptives. However, the connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies found that there is a slightly increased relative risk of breast cancer diagnosed in women who used combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because it is rare in women under 40 years of age, the increase in breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small relative to the overall risk of the disease. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives are diagnosed with earlier stages of breast cancer than women who have never used them.
In rare cases, during the use of combined oral contraceptives, development was observed, which in some cases led to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.
. Other states
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of development while taking combined oral contraceptives.
Although slight increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment 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 while taking combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; ; ; hemolytic uremic syndrome; Sydenham; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives may have an effect on 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.
Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.
Preclinical safety data
Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.
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 normal values.
Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced in the following cases: missed pills, vomiting and or as a result of drug interactions.
Effect on the menstrual cycle
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop withdrawal bleeding during a pill-free break. If combined oral contraceptives are taken as directed, the woman is unlikely to be pregnant. However, if combined oral contraceptives have not been taken regularly before or if there are no consecutive withdrawal bleeds, pregnancy should be ruled out before continuing to take the drug.
Medical examinations
Before starting or resuming the use of the drug Zhanine, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical examination (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and cytological examination of scrapings from the cervix ( Papanicolaou test) to exclude pregnancy. The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once a year.
A woman should be warned that drugs like Janine do not protect against (AIDS) and other sexually transmitted diseases!

Impact on the ability to drive a car and equipment.
Not found.

Side effects:

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

While taking the drug Zhanine, women experienced other undesirable effects listed in the table below. Within each group, allocated depending on the frequency of the undesirable effect, undesirable effects are presented in order of decreasing severity.

The following undesirable effects have been reported in women receiving COCs (see also section "Special Instructions"):

· Venous thromboembolic complications;

· Arterial thromboembolic complications;

· Cerebrovascular complications;

· Changes in glucose tolerance or effects on insulin resistance of peripheral tissues;

· Liver tumors (benign or malignant);

· Liver dysfunction;

· Chloasma;

· In women with hereditary angioedema, exogenous estrogens may exacerbate symptoms;

· The emergence or worsening of conditions for which the relationship with the use of COCs has not been clearly proven: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; ; chorea; herpes during pregnancy; with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

Women who use PDAs experience a very small increase in the incidence of breast cancer detection. Since breast cancer rarely occurs in women under 40 years of age, given the overall risk of developing breast cancer, the additional number of cases is very small. The relationship with the use of COCs is not known. Additional information is provided in the sections “Contraindications” and “Special instructions”.

Interaction with other drugs:

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability. The following types of interactions have been reported in the literature.
Effect on hepatic metabolism: the use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones. Such 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.
Effect on enterohepatic circulation: According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic circulation of estrogens, thereby reducing the concentration of ethinyl estradiol.
During any of the above medications, a woman should additionally use a barrier method of contraception (for example, a condom).
Substances affecting the metabolism of combined hormonal contraceptives (enzyme inhibitors)
Dienogest is a substrate of cytochrome P450 (CYP)3A4. Known CYP3A4 inhibitors, such as azole antifungals (eg, ketoconazole), cimetidine, verapamil, macrolides (eg, erythromycin), diltiazem, antidepressants, and grapefruit juice, may increase plasma levels of dienogest.
While taking medications that affect microsomal enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.
While taking antibiotics (except for rifampicin and griseofulvin) and for 7 days after their discontinuation, you should additionally use a barrier method of contraception. If the period of use of the barrier method of contraception ends later than the tablets in the package, you need to move on to the next package of Janine without the usual break in taking the pills.
Oral combination contraceptives may affect the metabolism of other drugs, resulting in increased (eg cyclosporine) or decreased (eg lamotrigine) plasma and tissue concentrations.

Contraindications:

Janine should not be used if you have any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be discontinued immediately.
. Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
. Conditions preceding thrombosis (including transient ischemic attacks) currently or in history.
. Migraine with focal neurological symptoms currently or in history.
. Diabetes mellitus with vascular complications.
. Multiple or pronounced risk factors for venous or heart disease, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
. Pancreatitis with severe hypertriglyceridemia, currently or in history.
. Liver failure and severe (until liver tests normalize).
. Liver tumors (benign or malignant) currently or in history.
. Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
. Bleeding from the vagina of unknown origin.
. Pregnancy or suspicion of it.
. Breastfeeding period.
. Hypersensitivity to any of the components of the drug Janine.
With caution
The potential risks and expected benefits of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors:
. Risk factors for the development of thrombosis and thromboembolism: smoking; ; dyslipoproteinemia, arterial hypertension; migraine; heart valve defects; prolonged immobilization, serious surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives)
. Other diseases in which peripheral circulatory disorders may occur: ; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; superficial veins
. Hereditary angioedema
. Hypertriglyceridemia
. Liver diseases
. Diseases that first appeared or worsened during pregnancy or during previous use of sex hormones (for example, jaundice, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes of pregnancy, Sydenham's chorea)
. Postpartum period

Pregnancy and lactation
Janine is not prescribed during pregnancy and breastfeeding.
If pregnancy is detected while taking Janine, the drug should be discontinued immediately. However, extensive epidemiological studies have not shown an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken in early pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

Overdose:

No serious adverse events have been reported following overdose. Symptoms that may occur in case of overdose: nausea, vomiting, spotting or metrorrhagia. There is no specific antidote; symptomatic treatment should be carried out.

Storage conditions:

Store at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life: 3 years. Do not use after expiration date!

Vacation conditions:

On prescription

Package:

Dragee. 21 tablets per blister made of polyvinyl chloride film and aluminum foil. 1 or 3 blisters along with instructions for use are placed in a cardboard box.


Related publications