Side effects from Janine what to do. Janine: reviews and instructions for use. Directions for use and doses

Today there are hormonal contraceptives “Janine”, which belong to a new generation of drugs. They were developed by specialists from a German pharmaceutical company called Schering. She spent a long period of time researching sex hormones in order to develop drugs that could help in the treatment of many gynecological diseases.

Composition of the medicinal product

The main topic that worries the fair sex is the medicine “Janine” and endometriosis. After all, they so want to get rid of such a disease by any means. Hormonal contraceptives contain synthetic analogs of progesterone and estrogens, which are female sex hormones. They are able to stop the release and synthesis of pituitary hormones. Consequently, the egg does not mature and is not released from the follicle under the influence of hormones. In other words, ovulation does not occur. This is why a woman does not get pregnant. At the time when Janine is taken, the mucus in the cervix becomes quite viscous, and it is very difficult for sperm to get inside to fertilize the egg. Even if fertilization has occurred, the mucous membrane in the uterine cavity changes, and it is very difficult for the egg to penetrate into it. This contraceptive contains ethinyl estradiol and dienogest - analogues of female hormones, which have quite few side effects, since, despite the fact that they are quickly absorbed into the body, they are just as quickly decomposed and excreted.

Impact on the female body

This hormonal contraceptive has not only a contraceptive effect. It has a great effect on the entire female body. The menstrual cycle is considered one of the painful topics for many women. This drug not only brings it back to normal, but also reduces pain during this period. As for the connection between Janine and endometriosis, it should be noted that it can help prevent the development of this disease and restore a woman’s ability to give birth to children. Additional pleasant moments are the improvement of skin condition, the disappearance of oily sheen and acne. This drug also has a great effect on hair and nails. They become strong and healthy.

Help in treating diseases

To understand the connection between the drug “Zhanine” and endometriosis, you first need to find out how the medicine acts on the body and what effect to expect from it. This disease causes very unpleasant sensations. Many women cannot get pregnant or bear a child normally because of it. But this is the main mission of the fair sex. Today progress does not stand still. And ladies who have learned about such an illness should not despair. This is not a verdict yet. Now this disease is treated quite successfully.

But this will take a lot of time. Many people don’t know anything about the nature of enometriosis, so it’s worth understanding it a little. As a rule, the inside of a healthy woman’s uterus is covered with special cells. They are the ones who respond to various hormonal changes. They are able to grow, be rejected and be restored again. Such processes occur monthly, which allows a woman to conceive a baby. Hereditary predisposition, chronic gynecological diseases, traumatic births, abortions lead to the fact that endometrioid growths appear in other organs, and during the menstrual cycle they become larger and begin to put pressure on neighboring organs. There is a feeling of severe pain, sometimes the membranes and tissues grow together, and adhesions appear. So, what is the connection between the Janine contraceptive and endometriosis? This drug does not treat the disease, but fights its symptoms.

Indications and contraindications

A woman begins to take contraceptives in order to avoid unwanted pregnancy. But it happens that the doctor prescribes it to those girls in whose blood a large amount of androgens, male hormones, is found. This becomes noticeable externally as well. Acne, seborrhea or baldness begins to appear. Those ladies who are prone to the formation of blood clots or have increased sensitivity to certain components of the drug may suffer from varicose veins, coronary heart disease and other similar ailments. It is also not recommended for people who have liver dysfunction. Therefore, before you start taking the drug "Zhanine", you should be thoroughly examined and consult with your doctor.

Side effects

As a rule, this contraceptive is well tolerated. But every woman needs to know all the possible side effects in order to be prepared for them. Thus, bleeding between periods, nausea, headache, decreased or increased libido, soreness and engorgement of the mammary glands may occur. However, you should not immediately stop taking this drug. You just need to go to the doctor, and he will make the appropriate decision. However, if an allergic reaction, liver disease, or thrombosis occurs, then taking this drug must be stopped.

Correct reception

The package of the drug "Zhanine" contains 21 tablets. You should start taking it from the first day of your period and do it every day, preferably at the same time. 12 hours late is allowed. You need to drink this drug for three weeks, after seven days do not take it, and then start again with the next package. If you do everything correctly, then pregnancy will not occur. Many women are interested in the question: “Does the medicine “Zhanine” have analogues?” Indeed, they exist. These are the tablets "Dienogest + Ethinyl estradiol", "Diecyclen" and "Siluet". However, you should not make the choice yourself. It is better to consult a doctor about this.

Selecting a hormonal drug for contraception is not easy. In addition to protecting against pregnancy, many of these products help cope with skin problems (acne), menstrual irregularities, and ovarian cysts. “Janine” is able to interfere with the balance of sex hormones, reducing the manifestations of hyperandrogenemia. This is his positive side. But the instructions for use of “Zhanine” indicate many side effects. How is the drug tolerated and is it safe?

1 Composition and principle of action
2 When to use
3 Limitations
4 How it is transferred
5 “Janine”: instructions for use
- 5.1 Common clinical situations
- 5.2 If a tablet is missed
6 What affects efficiency
7 Analogs
8 Reviews

Hormonal medications should be selected together with a gynecologist. Despite their general similarity (they contain estrogens and gestagens), the effect of use can vary greatly. “Janine” is a drug that is not suitable for everyone.

Composition and principle of action

"Zhanine" is a low-dose monophasic combined oral contraceptive. Each concept has an important meaning:

low-dose- the hormone content is relatively low;
monophasic- each tablet contains the same dose of medication;
To combined - the composition contains estrogens and gestagens, which imitate a woman’s two-phase menstrual cycle;
oral- tablets are taken orally.

The composition includes the following hormones.

0.03 mg ethinyl estradiol. Mimics the effect of estrogen. Ethinyl estradiol increases the viscosity of cervical secretions, which impairs sperm motility in the cervical canal.
2 mg dienogest. Acts on the pituitary gland, suppressing the production of follicle-stimulating hormone (FSH), which leads to a lack of growth of new follicles. As a result, the ovaries are in a “dormant state” without ovulation. The distinctive ability of dienogest is that it has antiandrogenic activity. Thanks to this, after some time of use, the manifestations of acne and hirsutism decrease.

Constant low concentrations of hormones in the blood affect the endometrium of the uterine cavity, leading to its atrophy. This entails a decrease in the abundance and duration of menstrual bleeding, as well as a decrease in foci of endometriosis throughout the body.

After entering the intestine, the drug is absorbed into the systemic circulation. It undergoes transformation in the liver, creating additional stress on the organ and bile ducts. Metabolic products of “Zanina” are excreted in feces and urine.

When to use

The main purpose of hormonal tablets "Zhanine" is to provide protection against pregnancy. Additionally, the drug is used to treat the following conditions:

endometriosis- thanks to the “dormant state” of the ovaries and a decrease in the activity of the pituitary gland of the brain, all foci of endometriosis (including adenomyosis) are significantly reduced, which leads to a decrease in the severity of pain, spotting, and heavy menstruation;
with an ovarian cyst- prescribed after conservative and surgical treatment of ovarian cysts, including endometriotic ones, for a period of three to six months;
uterine fibroids - like all contraceptives, it can somewhat reduce the growth rate of nodes;
for mastopathy - regular use reduces the likelihood of developing mastopathy by half, and also reduces symptoms such as pain and tension in the mammary glands;
with endometrial hyperplasia - can be used as a treatment for benign endometrial hyperplasia and glandular polyps;
with polycystic disease - the drug normalizes the menstrual cycle, reduces the manifestations of hyperandrogenemia and its effect on the entire body;
for chronic adnexitis - regular use leads to attenuation of inflammatory processes in the appendage area, reducing the likelihood of ovarian dysfunction;
for cosmetic effect- while taking “Janine”, the severity of acne (pimples) on the face, back and arms decreases, however, the effect does not last long after stopping the medication (one to two months).

In addition, "Janine", like other contraceptives, has a rebound effect - after discontinuation, the likelihood of multiple pregnancies increases due to the activation of the ovaries and the simultaneous maturation of several follicles.

Restrictions

Contraindications to taking the drug correspond to those common to all hormonal drugs containing estrogens and gestagens. The list includes the following states:

allergic reactions to drug components;
history of blood clots, tendency to them;
migraines, even if the last episode was a long time ago;
diabetes;
prosthetic heart valves;
arterial hypertension of the third and fourth degree;
prolonged immobility, for example, after fractures;
diseases of the liver, biliary tract;
pancreatic diseases;
pregnancy and breastfeeding;
suspected or specified malignant tumors;
vaginal bleeding of unknown cause;
smoking;
overweight with an index of more than 40;
systemic connective tissue diseases;
menopause

How is it transferred

With careful selection of the drug, “Zhanine” is well tolerated. However, during use, the following side effects may occur with a frequency of more than one case per thousand women taking the medicine:

headache, migraine;
dizziness;
nausea and vomiting, bowel dysfunction;
increased appetite and weight gain;
hair loss, rash and itchy skin;
increased blood pressure;
decreased sexual desire (libido);
recurrent candidal colpitis;
increased blood sugar levels;
thrombosis and thromboembolism;
tearfulness, irritability, depression.

Reviews about birth control pills "Janine" are contradictory. Some people do not observe side effects and use the drug for contraception or treatment for many years, while others cannot withstand even a week of use due to unpleasant changes in their well-being and behavior.

With a frequency of less than one case per thousand of women taking the drug, the following side effects occur:

relapses of viral and bacterial infections;
insomnia;
dry mucous membranes;
skin diseases such as seborrhea, psoriasis;
bronchial asthma;
enteritis, gastritis.

In cases of overdose, side effects intensify. Treatment in these cases is symptomatic.

In addition, in the first months when taking Janine, a woman may be bothered by periodic spotting from the genital tract and even intermenstrual bleeding. This is explained by the body getting used to the new regimen of a fixed dose of hormones. Usually the adaptation period takes no more than two to three months, otherwise it is necessary to replace the drug or adjust the dosage regimen.

"Janine": instructions for use

The regimen for taking Zhanine tablets is no different from that of other oral contraceptives. The main postulates are as follows:

pills are taken - inside, wash down with a small amount of water; for 21 days, take one tablet from the package;
start of reception - must coincide with the first day of menstruation in the first month;
time of receipt - strictly fixed, for example, always in the morning at 6.00;
after finishing packaging - it is necessary to take a seven-day break, usually on the second or third day menstrual flow appears;
after a seven-day break - you should start taking a new package.

“Janine” can be drunk without interruption for many years. After discontinuation, ovarian function is restored within three to six months. To delay menstruation, you can take two packages of the drug without a seven-day break. In this case, the cycle will be 42-45 days. However, you should not get carried away with such properties of the drug, as this can lead to acyclic discharge and bleeding.

Frequent clinical situations

Often indications for use of the drug are various situations and diseases. You should take Zhanine tablets taking into account the following points.

After an abortion, miscarriage. If the pregnancy was terminated in the first trimester, you should start taking the pills on that day or the next day. If an abortion or miscarriage occurs in the second trimester, it is recommended to start taking it on days 21-28; you don’t even have to wait for menstruation, provided that pregnancy is excluded.
After childbirth. The drug is allowed to be used only after completion of lactation. If a woman does not support breastfeeding, starting is possible no earlier than 21-28 days after birth.
After others OK. You should start drinking Janine during a seven-day break or taking dummy tablets. If a transdermal patch, Mirena intrauterine device or vaginal ring is removed, it is recommended to take the first tablet on the same day. If injections of hormonal drugs were used, the start should coincide with the first day of the intended injection. When switching from mini-pills (containing only gestagen), the intake can be timed to any day.

If you miss a pill

Reviews from doctors and women point to the fact that most often one has to deal with a violation of the pill regimen. How to take “Janine” correctly in such cases? If 12 hours have not passed since the scheduled time, you must take the missed tablet, and then the next one at the appointed time. If 12 hours have already passed, the action algorithm is as follows:

first week of admission- take the missed pill as quickly as possible, and the next one according to the usual schedule; additional methods of protection must be used within a week;
second week of admission- take the missed pill immediately, no additional protection is needed if the dosage regimen has been followed up to this point;
third week of admission- you can either continue taking the pack and start the next one without a seven-day break, or take a break of a week on the missed pill and then start a new pack.

What affects efficiency

While taking Janine, various situations are possible, including illness conditions. You need to know that some drugs and symptoms can reduce the contraceptive effect of pills:

antibiotics- macrolides (for example, Azithromycin, Johamycin, Clarithromycin, Erythromycin), penicillins (Amoxiclav, Ampicillin), tetracyclines (Doxycycline);
antifungal drugs -"Ketoconazole";
antidepressants - "Fluoxetine";
anticonvulsants -"Carbamazepine";
from pressure -"Diltiazem."
vomiting and diarrhea- if the episode occurs within four hours of taking the pill, additional contraception must be used in the next week; if after four hours, the protective effect remains, the drug is already completely in the blood.

Considering the interaction with other medications, side effects and contraindications for use, “Zhanine” should only be prescribed by a doctor. He must be made aware of the regular use of other medications.

Analogs

There are complete analogues of the drug with the same composition and dose of active substances. The list is as follows:

"Silhouette";
"Diecyclen";
"Bonade."

Tablets "Zhanine" for endometriosis, hyperandrogenemia, after removal of ovarian cysts are the drug of choice. The medicine is suitable for the prevention of acne in women with disrupted hormonal levels, as well as simply for contraception. The drug is prescribed only on the recommendation of a doctor, as it has contraindications and complications from use.

Janine is a low-dose combined oral contraceptive of estrogen-progestogen nature. The drug belongs to the monophasic group, that is, each capsule contains the same dose of active ingredients. The dosage does not depend on the phase of the menstrual cycle. The drug can be taken only after the first menstruation and before menopause.

The effectiveness of Janine is due to complementary mechanisms of action, the most important of which is the suppression of ovulation. As a result of exposure to active substances, the viscosity of cervical mucus changes, it becomes impenetrable to male germ cells. When taking combined oral contraceptives, the hormonal cycle is stabilized, the duration of menstruation and its intensity are reduced. This helps reduce the risk of iron deficiency anemia, endometrial and ovarian cancer.

One package can contain one or three blisters, each containing 21 tablets. The average price of a package of Janine is 900 rubles. Special packaging designed for three months costs about 2 thousand rubles.

An advantageous difference between Zhanin and other oral contraceptives is the low content of active substances. This provides high protection against unwanted pregnancy, and the intensity and frequency of side effects is reduced.

To whom it is prescribed:

girls in the early reproductive period who have given birth or have not given birth if microdosed contraceptives are not suitable for them;
women over 35 years old.

Therapeutic indications:

pain due to endometriosis;
correction of menstrual irregularities;
impact on the ovaries after detection of cysts;
hyperplastic processes in the uterine mucosa;
normalization of hormonal levels after surgical treatment of endometriosis and leiomyoma;
acne disease.

The main components of Janine are ethinyl estradiol and dienogest. The composition additionally includes lactose monohydrate, magnesium stearate, calcium carbonate, starch, gelatin, talc, sucrose, dextrose, titanium dioxide, povidone.

Ethinyl estradiol is a synthetic analogue of the hormone estradiol, which belongs to the group of estrogens. The substance completely copies the chemical structure of natural estrogen, and therefore performs similar functions.

Preparations with ethinyl estradiol are intended for the treatment of infertility, uterine bleeding, vaginitis, ovarian dysfunction, menopause, acne and even some forms of cancer. However, the compound is often included in combined contraceptives.

Dienogest is a derivative of nortestosterone. It has antiandrogenic activity and a strong progestogenic effect. Dienogest reduces the secretion of estradiol, weakening its effect on the endometrium of the uterus. Long-term use of drugs with dienogest causes atrophy of endometriosis foci, so they are often prescribed for uterine enlargement.

The substance is also capable of reducing the concentration of androgens in a woman’s body. This is a useful property, because an excess of male sex hormones can cause acne, increase sweating and oily skin, and provoke strong hair growth in places unusual for women. Janine will help combat these symptoms.

Active components of the drug

Dienogest

The main gestagenic component of the drug is dienogest. It has an antiandrogenic effect and improves the blood lipid profile, increasing the amount of high-density lipoproteins.

When taken orally, dienogest is absorbed completely and very quickly. After 2.5 hours, its maximum concentration in the blood reaches 51 ng/ml. Bioavailability is 96%.

In blood serum, dienogest combines with albumin, but does not react with sex steroid-binding globulin and corticoid-binding globulin. The concentration of free dienogest in the blood is 10%, the rest is nonspecifically bound to albumin.

Dienogest is metabolized almost completely. The half-life is 8-10 hours. Metabolites are excreted by the kidneys and through the gastrointestinal system within 14 hours, a small amount of unchanged dienogest is excreted in the urine.

The level of sex steroid binding globulin in the blood does not affect the pharmacokinetics of the substance. When taken daily, the concentration of the substance in the blood serum increases by one and a half times.

Ethinyl estradiol

The substance is absorbed quickly and completely. The maximum concentration (67 ng/ml) is achieved in 2-4 hours. When taken orally, only 44% of the substance reaches the site of action, which is due to the peculiarities of absorption and passage through the liver.

Up to 98% of ethinyl estradiol binds nonspecifically to albumin. The substance induces the synthesis of globulin that binds sex steroids. Ethinyl estradiol is transformed in the mucosa of the small intestine and liver, but the main route of metabolism is aromatic hydroxylation. The clearance rate is 2.3-7 ml/min/kg.

The concentration of ethinyl estradiol in the blood decreases during two phases: the first half-life is 1 hour, the second half-life is 10-20 hours. The substance leaves the body only in a modified form. Metabolites are excreted in bile and urine. The equilibrium concentration of ethinyl estradiol is achieved in the second half of the treatment cycle.

Contraindications

Any of these conditions is a reason to choose another method of contraception. If disturbances occur during the use of contraceptives, the drug should be discontinued.

For what diseases should you not take Janine?

hypersensitivity to components;
diseases of the cardiovascular system, in which the risk of blockage of veins or arteries is increased (stroke, varicose veins, heart defects, angina pectoris, hypertension);
diseases of the endocrine system (thyroid disorders);
venous and arterial thrombosis, thromboembolism (at the time of admission or in history);
deep vein thrombosis;
myocardial infarction;
cerebrovascular disorders;
precursors of thrombosis (angina pectoris, transient ischemic attacks);
migraine with neurological symptoms;
diabetes mellitus, which is accompanied by vascular disorders;
risk factors for thrombosis (severe or multiple);
heart valve lesions, atrial fibrillation, cerebral vascular disease or heart artery disease;
severe arterial hypertension;
major surgical operations;
active smoking at the age of 35 years;
pancreatitis and severe hypertriglyceridemia;
severe liver disease, liver failure;
tumor formations in the liver (benign and malignant);
suspicion or presence of hormone-dependent malignant pathologies;
vaginal bleeding of unknown nature;
pregnancy and lactation.

Janine is prescribed with caution for obesity, the presence of risk factors in a family history (for example, thromboembolism), migraine, hypertension, heart valve disease, dyslipoproteinemia, atrial fibrillation. The final decision is made by the doctor, based on the results of the examination.

Side effects

Common side effects from taking Janine:

scanty bleeding between menstruation;
nonspecific vaginal discharge;
vaginal pain;
nausea and vomiting;
diarrhea;
bloating;
fluid retention in the body;
headache;
allergic reaction;
discomfort in the chest;
hardening, tenderness of the mammary glands;
secretion of fluid from the mammary glands;
mood swings;
emotional outbursts and even depression;
insomnia;
increased or decreased libido;
visual discomfort when wearing contact lenses.

Some side effects occur only at the beginning of taking Janine, while others appear with long-term treatment. Often women who were overweight before therapy gain even more weight.

Rare but possible side effects:

anemia;
absentmindedness;
disorders of autonomic regulation;
drying of the mucous membrane of the eye;
prolonged ringing in the ears;
hypotension;
dyspnea;
inflammation of the gastrointestinal tract;
gingivitis;
hirsutism;
dandruff;
dermatitis;
back pain;
convulsions;
infectious diseases of the urinary tract;
tides;
vaginal dryness;
vaginal candidiasis;
formation of cysts in the ovaries;
pelvic pain;
cystic fibrosis diseases.

Symptoms of an overdose of Janine include nausea and vomiting, spotting,. With a slight overdose, serious violations are not observed. Treatment of overdose is symptomatic.

Janine during pregnancy and lactation

The drug is not intended for use during pregnancy. If pregnancy is detected, the contraceptive should be discontinued. However, even when receiving hormones before pregnancy and in the early stages of pregnancy, there is no increase in the risk of fetal developmental defects.

During lactation, combined oral contraceptives are also prohibited. They can reduce breast milk production and change its composition. A certain amount of sex steroids and their metabolites can enter the newborn’s body through milk.

Methods of administration and dosage

Janine is taken orally with clean water. The drug must be taken at the same time of day. The order indicated on the packaging should be followed.

The contraceptive is taken continuously for 21 days, one tablet per day. The next package should be started after a week break. During the break, as a rule, withdrawal bleeding occurs on day 2-3 (heavy discharge, similar to menstruation). If the bleeding continues for several days, you need to consult a specialist, but often the discharge continues until you start a new package of contraceptives.

Reception features:

No hormone intake in the previous month. You should start on the first day of the cycle (the first day of menstruation). You can shift the time of administration by 2-5 days, but in this case it is necessary to resort to barrier contraception in the first week of taking the first package of Zhanine.
Switching from other oral contraceptives (vaginal ring, transdermal patch). They start taking Janine the next day after the last tablet, but no later than the next day after a week-long break (with 21 tablets per package). If the package of contraceptives contains 28 tablets, start taking them after taking the last inactive capsule. When removing a vaginal ring or patch, Janine is taken on the same day, but no later than the day the new ring or patch is applied.
Switching from gestagen contraceptives or a gestagen-releasing intrauterine system. You can switch from “ ” to Janine any day. When switching from an implant or intrauterine system, you need to start taking it on the day of removal. If the injectable form was used, Janine is taken on the last day when the last injection was due.
After an abortion in the first trimester. You can start taking Janine immediately (without additional protection).
After an abortion or childbirth in the second trimester. The drug can be used from 21-28 days after the procedure. If you start later, you need additional barrier protection in the first week of use. When a woman has had sexual intercourse after an abortion or childbirth, she must rule out pregnancy and wait for menstruation.

What to do if you missed an appointment

If you are late up to 12 hours, the degree of protection is not reduced. It is necessary to take Janine as quickly as possible, and carry out the next dose on time. If the delay time exceeds 12 hours, the protection is reduced.

You cannot interrupt taking Zhanine for a week or more: in order for the suppression of hypothalamic-pituitary-ovarian regulation to be sufficient, it is necessary to take the contraceptive continuously for a week.

If the delay is more than 12 hours, the following recommendations should be followed:

First week of admission. You need to take a pill, even if you have to take two at once. The next one is taken at the usual time. You need to use barrier protection for a week. If you had sexual intercourse in the week before the missed period, you need to check for pregnancy. It is important to consider that the closer to the break you miss, the greater the likelihood of getting pregnant.
Second week of admission. The pills are taken as soon as possible. If the woman took Janine correctly in the first week before the missed period, there is no need for additional protection. Barrier contraception is needed if two or more capsules are missed or taken incorrectly in the first week.
Third week. During this period, the reliability of contraceptives decreases due to the upcoming break. If all pills have been taken correctly in the first week before skipping, there is no need for additional contraception. You can act in different ways: quickly take the missed pill and start the next pack immediately after the existing one, or stop taking it, take a break (including the day you missed it) and start a new pack. In the first case, withdrawal bleeding occurs after the second pack, but spotting may occur.

If there is no withdrawal bleeding after skipping a pill during the break, pregnancy should be ruled out. If vomiting and diarrhea are observed within four hours after taking the active pill, absorption of the drug may be impaired, so additional protection should be taken. In such a situation, you need to focus on the rules for skipping pills.

How to change a cycle using Janine

To delay the onset of menstruation, you need to start taking a new package of Janine immediately after the previous one. You can take the pills until the end of the package, but spotting and bleeding may occur. The next pack should be started after a week's break.

If you need to postpone the onset of menstruation, you need to shorten the next interval by several days. The shorter the break, the lower the risk of withdrawal bleeding and spotting and bleeding when taking the second pack of Janine.

Interaction with other drugs

The drug Zhanine is theoretically compatible with alcohol, which when combined significantly increases the load on the liver. The contraceptive and therapeutic effects of the drug are weakened when Janine is combined with drugs that induce microsomal oxidation enzymes in the liver. These are some antibiotics (tetracyclines), barbiturates, phenytoins, rifampin, primidone and carbamazepine. When treating with drugs that affect enzymes, you need to use barrier contraception for 28 days.

Combining oral contraceptives with other medications may cause bleeding. Some medications reduce the effectiveness of Janine. Caution should be used when combining Janine with topiramate, felbamate, oxcarbazepine, griseofulvin and preparations with St. John's wort. In addition, HIV proteases and non-nucleoside transcriptase inhibitors affect hepatic metabolism.

Precautionary measures

In case of extensive injury, you should stop taking Janine. Before the operation, it is necessary to stop using contraception for a month, and resume taking it only two weeks after immobilization.

After stopping antibiotics, additional protection should be used for a week. If the period of barrier contraception ends later than the capsules in the current package, you should move on to the next one without interruption.

The effect of Zhanine on patients with renal impairment has not been specifically studied, but the available data do not require dose adjustment. However, the drug is contraindicated in severe liver pathologies. In case of acute and chronic disorders of liver function, oral contraceptives are canceled until the parameters normalize. If symptoms of recurrent cholestatic jaundice occur during contraception, it is necessary to stop taking hormones.

Although combined contraception may affect glucose tolerance and insulin resistance, the therapeutic regimen of contraception in patients with diabetes mellitus does not change if they are taking low-dose medications. However, women with diabetes need to be monitored more closely.

An increase in migraine attacks and a worsening of a woman’s condition is grounds for urgent cessation of hormonal contraceptives. It is necessary to undergo additional examination to exclude cerebrovascular disorders.

Possible complications

In patients with angioedema, exogenous estrogens cause or worsen symptoms. There are cases of ulcerative colitis and Crohn's disease with combined contraception.

Women with a history of chloasma may experience a recurrence of the disease. If you are predisposed to chloasma, you should avoid sunbathing while using oral contraceptives.

Other dangers:

Hypertriglyceridemia increases the risk of pancreatitis.
Increased blood pressure. This complication occurs in many women who take combined contraceptives. A dangerous increase is rarely detected, but if a persistent increase develops, you need to abandon Janine and treat arterial hypertension.

Some conditions may develop or get worse while taking combined contraceptives, but this can also happen during pregnancy. This applies to jaundice, porphyria, kidney stones, systemic lupus erythematosus, herpes, hemolytic uremic syndrome and otosclerosis.

Diseases of the cardiovascular system

Research results show that there is a connection between the use of combined contraceptives and the development of thrombosis and thromboembolism. The risk of venous thromboembolism in the first year of taking contraceptives is greatest.

The danger is present after the first use of combined contraceptives or the resumption of use of one or different methods (provided that the break is more than 4 weeks). Research shows that the increased risk persists throughout the first three months.

The overall risk is 2-3 times higher in women who take low-dose oral contraceptives (ethinyl estradiol content less than 50 mcg) than in non-pregnant patients. However, the risk is still lower than in pregnant and laboring women. It must be remembered that in 1-2% of cases, severe VTE leads to death.

It is noteworthy that deep vein thrombosis and pulmonary embolism can occur with the use of any other combined contraceptives. Thrombosis of other vessels (liver, kidney, brain, eye) occurs less frequently. Some symptoms of these conditions are nonspecific (shortness of breath and cough), so they are often misinterpreted. They may indicate other, more severe conditions.

Arterial thromboembolism can result in stroke, heart attack and vascular occlusion. These are serious conditions that require emergency treatment, so you need to respond to any symptoms in a timely manner.

Tumors and cancer

The main risk factor for cervical cancer is, but with long-term use of combined contraceptives, the likelihood of cancer also increases (although the connection has not been experimentally proven). Sometimes this risk is associated with screening for diagnosing cervical pathologies and characteristics of sexual activity.

Some studies show that long-term use of combined oral contraceptives increases the risk of breast development. The number of diagnoses among women who are taking or have recently taken Janine does not greatly exceed the overall risk. This may be due to early cancer diagnosis: patients who took combined oral contraceptives are diagnosed with breast cancer earlier than those who have never used such protection. The danger decreases within 10 years.

Sometimes the use of combined contraceptives is combined with the development of tumors in the liver. In rare cases, this condition can be life-threatening (intra-abdominal bleeding).

Janine with endometriosis

Janine is prescribed not only for contraception. Often, such hormonal drugs are prescribed for diseases of the reproductive system. With endometriosis, the lining of the uterus (endometrium) grows. Therapy may include conservative and surgical methods. Janine helps reduce the symptoms of endometriosis and improve treatment results.

In a healthy woman, in the first phase, a dominant follicle is formed in the ovary. At this time, the uterus grows epithelium and prepares to receive a fertilized egg. The second phase is the time of production of progesterone, which maintains pregnancy when it occurs. The hormone prevents uterine contractions and provokes epithelial growth. During a malfunction, too many hormones begin to be produced, which provoke the growth of the endometrium, and its active growth occurs.

The effectiveness of Zhanin in the treatment of endometriosis is due to its composition. Janine contains progestin and estrogen elements. Dienogest is a progesterone derivative that inhibits the division of endometrial cells, relaxes the uterus and reduces unpleasant symptoms during menstruation. Ethinyl estradiol suppresses the secretion of estrogen, a hormone that stimulates the growth of the uterine lining, including in endometriosis.

Janine passed all the necessary tests that proved the effectiveness of the drug. In 85% of women who took it for six months for endometriosis, symptoms weakened or disappeared. During the research, a positive effect of Janine on skin condition and body weight was noted. Women noticed a normalization of their cycles and a weakening of PMS symptoms.

How to take for endometriosis

For endometriosis, the drug can be prescribed for contraception and directly for treatment. In the first case, a cyclic intake of Zhanine is required, and for the treatment of endometriosis - continuous.

Reception regimens:

Cyclical. Reception begins on the first day of the cycle. The tablets are taken every day for three weeks at regular intervals. After the course, take a break until the next menstruation begins. Cyclic therapy is effective in the early stages of endometriosis, when it is necessary to suppress small lesions and prevent unwanted pregnancy.
Continuous. Janine is taken daily for six months or more. Continuous treatment is prescribed to patients with severe endometriosis, which is accompanied by pain and disturbances in the cycle.

With continuous use of Zhanine, dienogest provokes the creation of a hypoestrogenic environment, which is favorable for the decidualization of endometrial tissue. As a result, atrophy of endometrioid foci develops, which leads to a weakening of the symptoms of endometriosis.

Is pregnancy possible after treatment?

When used correctly, Janine does not reduce the ability to conceive. Every year you need to take a break to give the reproductive system a chance to recover. Otherwise, the chances of pregnancy may actually decrease, and the risk of fetal death may increase.

However, in the treatment of endometriosis, the drug is often prescribed to achieve a rebound effect: after stopping contraceptives, the ovaries begin to work more efficiently, ovulation is restored and the chances of conception increase. The maximum effect lasts for 2-3 months after stopping Janine, but doctors recommend waiting out this period to minimize the risk of fetal death.

Analogues of Janine

Birth control pills provide reliable protection, are easy to use and versatile, but all oral contraceptives have a large number of contraindications and unpleasant side effects.

From the large list of Janine analogues, Regulon can be distinguished. This is another effective remedy, which also has a combined composition, acts on a monophasic principle and contains a low dose of hormones.

However, desogestrel, which is part of Regulon, does not affect the concentration of male hormones in a woman’s body, and therefore does not help fight the symptoms of their excess. Regulon is usually cheaper than Janine.

Another popular remedy is. If the estrogen in Zhanin and Yarina is similar, then the latter uses drospirenone as a gestagen.

Drospirenone, like dienogest, has an antiandrogenic effect, but additionally removes excess fluid from the body. For this reason, Yarina is recommended for women who suffer from edema and excess body weight.

Analogues of Janine can also include Silhouette and Diane-35. The silhouette is similar in composition, so it is considered a cheap alternative to Janine. Diana-35 uses cyproterone acetate as a gestagen. The contraceptive is classified as a medium-dose drug, since the concentration of estrogen in it is higher. These oral contraceptives are intended for women over 30 years of age who have given birth.

Microdosed analogues

When choosing a replacement, you can pay attention to microdosed drugs. They include a minimum of hormones, so they have fewer side effects. The effectiveness of such products is due to new generation gestagens.

Jess belongs to this group. The drug is prescribed to girls under 25 years of age who have not given birth and have regular sex life, as well as women over 35 years of age who are using hormonal contraceptives for the first time. You can also replace Janine with the help of Klaira, Dimia, Novinet and Logest.

Mirena is considered an alternative to oral hormonal contraception. This is a sterile system that is placed in the uterus and it begins to release levonorgestrel, which has a contraceptive effect.

The advantages of the spiral include long-term use. The IUD can be placed for 3-5 years, and the installation procedure causes only mild discomfort.

The hormonal IUD does not cause side effects that occur when taking oral contraceptives. In addition to protecting against unwanted pregnancy, Mirena can be used as a treatment for certain diseases of the reproductive system. A hormonal IUD can be installed immediately after childbirth or abortion. Mirena will provide protection even during breastfeeding.

Use is dangerous due to displacement and even ingrowth of the device into the uterine cavity, as well as the possibility of injury to the genital organs during installation. Oral contraceptives are safer if a woman has chronic infections or inflammation.

Conclusion

Janine is one of the best combined hormonal contraceptives. Despite the fact that taking the drug is associated with the risk of side effects, it creates powerful protection against unwanted pregnancy and even helps cure endometriosis. Given the large list of contraindications, you should entrust the choice of contraception to an experienced doctor.

Low-dose monophasic oral combined estrogen-progestogen contraceptive
Drug: JANINE®
Active substance of the drug: dienogest, ethinylestradiol
ATX coding: G03AA
KFG: Monophasic oral contraceptive with antiandrogenic properties
Registration number: P No. 013757/01
Registration date: 04/04/08
Owner reg. cert.: JENAPHARM GmbH & Co.KG (Germany)

Release form of Janine, drug packaging and composition.

The dragees are white, smooth.
1 dragee
ethinylestradiol
30 mcg
dienogest
2 mg

Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate.

Shell composition: sucrose, dextrose, macrogol 35,000, calcium carbonate, polyvidone K25, titanium dioxide (E171), carnauba wax.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Janine

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 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.

Pharmacokinetics of the drug.

Dienogest

Suction

After oral administration, dienogest is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached after 2.5 hours and is 51 ng/ml. 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 nonspecifically associated with serum albumin. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein.

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 dienogest in the serum increases approximately 1.5 times.

Metabolism

Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h.

Removal

T1/2 is about 8.5-10.8 hours. A small part of dienogest is excreted by the kidneys unchanged. Metabolites are excreted in urine and bile in a ratio of about 3:1 with a T1/2 of 14.4 hours.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is rapidly and completely absorbed. Cmax in blood serum is reached after 1.5-4 hours and is 67 pg/ml. During absorption and “first pass” 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 to albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent Vd of ethinyl estradiol is 2.8-8.6 l/kg.

Css is achieved during the second half of the treatment cycle.

Metabolism

Ethinyl estradiol undergoes presystemic conjugation, both in the mucous membrane 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.

Removal

The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by T1/2 of the first phase - about 1 hour, T1/2 of the second phase - 10-20 hours. It is not excreted unchanged from the body. Metabolites of ethinyl estradiol are excreted in urine and bile in a ratio of 4:6 with T1/2 for about 24 hours.

Indications for use:

Contraception.

Dosage and method of administration of the drug.

The pills should be taken 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 from taking the last pill and may not end until you start taking a new package.

If you have not taken any hormonal contraceptives in the previous month, you should begin taking Zhanine on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the tablets 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 pill with the active components of the previous drug, 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 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, Janine can be used without interruption. When switching from the “mini-pill” - any day without a break. When using injectable forms of contraceptives, Janine begins to be taken on the day when the next injection is due. When switching from an implant or intrauterine contraceptive with gestagen - on the day of its removal. 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. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the second trimester of pregnancy, taking the drug should begin on the 21-28th day. 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 was sexually active in the period between childbirth or abortion and the start of taking Zhanine, then pregnancy should first be excluded or it is necessary to wait until the first menstruation.

A woman should take the missed pill as soon as possible, and the next pill should be taken at the usual time.

If the delay in taking the pill is less than 12 hours, the reliability of contraception does not decrease.

If the delay in taking the pill is more than 12 hours, the reliability of contraception may be reduced. It should be borne in mind that the administration of the tablet should never be interrupted for more than 7 days, and that 7 days of continuous administration of the tablet are required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.

If the delay in taking the pill is more than 12 hours (the interval since taking the last pill is more than 36 hours) during the first week of taking the drug, then the 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. Additionally, you should use a barrier method of contraception for the next 7 days. If a woman has been sexually active for a week before skipping the pills, the risk of pregnancy must be taken into account. The more pills you miss and the closer this skip is to the 7-day break in taking the pills, the higher the risk of pregnancy.

If the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the second week of taking the drug, then the woman should take the last missed pill as soon as possible, as soon as she remembers (even if this requires 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.

If the delay in taking the pill is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the third week of taking the drug, the risk of decreased reliability is inevitable due to the upcoming break in taking the pill. The woman must strictly adhere to one of the following two options (in this case, if during the 7 days preceding the first missed tablet, all tablets were taken correctly, there is no need to use additional contraceptive methods).

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, 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.

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.

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.

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).

Side effects of Janine:

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

While taking combined oral contraceptives in women, other undesirable effects were observed, which were classified as follows: often (1/100), infrequently (1/1000, but<1/100), редко (<1/1000).

From the digestive system: often - nausea, abdominal pain; infrequently - vomiting, diarrhea.

From the reproductive system: often - engorgement, soreness of the mammary glands; infrequently - hypertrophy of the mammary glands; rarely - vaginal discharge, discharge from the mammary glands.

From the side of the central nervous system: often - headache, decreased mood, mood swings; uncommon - decreased libido, migraine; rarely - increased libido.

On the part of the organ of vision: rarely - intolerance to contact lenses (unpleasant sensations when wearing them).

Dermatological reactions: infrequently - rash, urticaria; rarely - erythema nodosum, erythema multiforme.

Other: often - weight gain; infrequently - fluid retention in the body; rarely - weight loss, allergic reactions.

As with other combined oral contraceptives, in rare cases the development of thrombosis and thromboembolism is possible.

Contraindications to the drug:

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.

The presence of thrombosis (venous and arterial) currently or in history (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

The presence or history of conditions preceding thrombosis (for example, transient ischemic attacks, angina pectoris);

Diabetes mellitus with vascular complications;

Current or history of migraine with focal neurological symptoms;

The presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart, uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years);

Liver failure and severe liver disease (until normalization of liver tests);

Current or history of pancreatitis with severe hypertriglyceridemia;

The presence or history of benign or malignant liver tumors;

Identified or suspected hormone-dependent malignant diseases of the genital organs or mammary glands;

Vaginal bleeding of unknown origin;

Pregnancy or suspicion of it;

Breastfeeding period;

Hypersensitivity to the components of the drug.

Carefully

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, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, prolonged immobilization, major surgery, extensive trauma, hereditary predisposition to thrombosis/thrombosis, myocardial infarction or cerebrovascular accident at a young age in anyone - or one of the closest relatives/);

Other diseases in which peripheral circulatory disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins);

Hereditary angioedema;

Hypertriglyceridemia;

Liver diseases;

Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, pregnancy herpes, Sydenham's chorea);

Postpartum period.

Use during 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 can be excreted in milk, but there is no evidence of their negative effects on the health of the newborn.

Special instructions for use of Janine.

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 (test Papanicolaou), 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.

The woman should be informed that Janine is not being protected from HIV infection (AIDS) and other sexually transmitted diseases.

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 risk factors become more severe, intensify, or when risk factors first appear, it may be necessary to discontinue the drug.

There is epidemiological evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) 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. The estimated incidence of VTE when taking low-dose estrogen oral contraceptives (less than 50 mcg ethinyl estradiol) is up to 4 cases per 10,000 women per year, compared with 0.5-3 cases per 10,000 women per year in women not taking contraceptives. However, the incidence of VTE when taking combined oral contraceptives is lower than the incidence of VTE associated with pregnancy (6 cases per 10,000 pregnant women per year).

It should be taken into account that the risk of developing venous or arterial thrombosis and/or thromboembolism increases with age; in smokers (with increasing number of cigarettes or increasing age, the risk further increases, especially in women over 35 years of age); if there is a family history (for example, venous or arterial thromboembolism ever occurred in close relatives or parents at a relatively young age; in the case of a hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives); obesity (body mass index more than 30 kg/m2); dyslipoproteinemia; arterial hypertension; migraine; heart valve diseases; atrial fibrillation; prolonged immobilization; major surgery; any surgery on the legs or major trauma. In these situations, it is advisable to stop using Janine (in the case of a planned operation, at least 4 weeks before it) and not to resume use for 2 weeks after the end of immobilization.

The possible role of varicose veins and superficial thrombophlebitis 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, Crohn's disease, UC, and sickle cell anemia.

An increase in the frequency and severity of migraine during use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant diseases can reduce the associated risk. 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 (less than 50 mcg ethinyl estradiol).

The most significant risk factor for developing cervical cancer is persistent papilloma viral infection. There are reports of a slight increase in the risk of developing cervical cancer 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. The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer 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 breast cancer. 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, the development of liver tumors has been 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.

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis 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 of hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and 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; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; 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 (less than 50 mcg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking combined oral contraceptives.

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.

The effectiveness of combined oral contraceptives may be reduced if pills are missed, vomiting or diarrhea occurs, or due to drug interactions.

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.

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.

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.

Impact on the ability to drive vehicles and operate machinery

Not found.

Drug overdose:

No serious adverse events have been reported following overdose.

Symptoms: nausea, vomiting, spotting or metrorrhagia.

Treatment: carry out symptomatic therapy. There is no specific antidote.

Interaction of Janine 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.

The use of drugs that induce microsomal liver 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 protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.

According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

While taking any of the above medications, a woman should additionally use a barrier method of contraception (for example, a condom).

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 (with the exception of 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 protection ends later than the pill in the package, you need to move on to the next package of Janine without the usual break in taking the pill.

Oral combination contraceptives may affect the metabolism of other drugs, resulting in increased (eg cyclosporine) or decreased (eg lamotrigine) plasma and tissue concentrations.

Terms of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions for the drug Janine.

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

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 infections of the genitourinary system, 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.