Pregnancy

Janine: instructions for use

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

If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If you skip pills or misuse, the Pearl Index may increase.

The progestin component of Zhanin ® - dienogest - has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the lipid profile of the blood (increases the amount of HDL).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, less frequent painful menstruation, decreases the intensity and duration of bleeding, resulting in reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer.

Pharmacokinetics

Absorption. When taken orally, dienogest is rapidly and completely absorbed, its Cmax in serum, equal to 51 ng / ml, is reached in approximately 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex hormone-binding globulin (SHGP) and corticoid-binding globulin (CGC). In free form is about 10% of the total concentration in serum, about 90% - are not specifically associated with serum albumin. Induction of ethynyl estradiol synthesis of SHBG does not affect the binding of dienogest to serum albumin.

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

Derivation. T1/2 from plasma it is about 8.5–10.8 hours. In an unchanged form, the urine is excreted in small quantities, in the form of metabolites by the kidneys and through the gastrointestinal tract in a ratio of about 3: 1 with T1/2 - 14.4 h.

Equilibrium concentration. The pharmacokinetics of dienogest are not affected by the serum level of serum serum glucose levels. As a result of the daily intake of the drug, the level of the substance in the serum increases about 1.5 times.

Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. Cmax in serum, equal to about 67 ng / ml, is reached in 1.5–4 hours. During absorption and the first passage through the liver, ethinyl estradiol is metabolized, with the result that its bioavailability upon ingestion is on average about 44%.

Distribution. Ethinyl estradiol is almost completely (approximately 98%), although not specific, bound by albumin. Ethinyl estradiol induces synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8–8.6 l / kg.

Metabolism. Ethinyl estradiol is subjected to presystemic biotransformation both in the mucous membrane of the small intestine and in the liver. The main pathway of metabolism is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3-7 ml / min / kg.

Derivation. The decrease in the concentration of ethinyl estradiol in the serum is biphasic, the first phase is characterized by T1/2 about 1 h, the second - T1/2 10–20 hours. Unchanged from the body is not excreted. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4: 6 with T1/2 about 24 hours

Equilibrium concentration. Equilibrium concentration is achieved during the second half of the treatment cycle.

Contraindications

Janine ® should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while receiving, the drug should be immediately canceled:

hypersensitivity to any of the components of Janine ®,

thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders),

the conditions preceding thrombosis (including transient ischemic attacks, angina) now or in history,

migraine with focal neurological symptoms now or in history,

diabetes with vascular complications,

multiple or pronounced risk factors of venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries,

uncontrolled arterial hypertension,

serious surgical intervention with prolonged immobilization,

smoking over the age of 35,

pancreatitis with severe hypertriglyceridemia now or in history;

liver failure and severe liver disease (before normalization of liver tests),

liver tumors (benign or malignant) now or in history,

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them,

vaginal bleeding of unknown origin,

pregnancy or suspicion of her,

breastfeeding period.

The potential risk and the expected benefit of using combined oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:

risk factors for thrombosis and thromboembolism: smoking, obesity (dyslipoproteinemia), arterial hypertension, migraine, valvular heart disease, prolonged immobilization, serious surgical interventions, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis) any of the next of kin),

other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins,

hereditary angioedema,

diseases first arisen or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder diseases, otosclerosis with impairment of hearing, porphyria, herpes of pregnant women, Sydengam's chorea),

Use during pregnancy and lactation

Janine ® is not prescribed during pregnancy and during breastfeeding.

If pregnancy is detected while taking Janin ®, it should be canceled immediately. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received sex hormones prior to pregnancy, or to teratogenic effects, when sex hormones were taken by negligence in the early stages of pregnancy.

Reception of the combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore their use is contraindicated during lactation. A small amount of sex steroids and / or their metabolites can be excreted in milk.

Side effects

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

Against the background of taking Janin ®, women also had other undesirable effects indicated in the table below. Within each group, allocated depending on the frequency of the undesirable effect, unwanted effects are presented in order of decreasing severity.

In terms of frequency, unwanted effects are divided into frequent (≥1 / 100 and ® begin:

- in the absence of taking any hormonal contraceptives in the previous month. Reception Zhanin ® begins on the first day of the menstrual cycle (ie, on the first day of menstrual bleeding). It is allowed to start taking on the 2–5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills from the first package,

- when switching from other combined oral contraceptives (from the vaginal ring, transdermal patch). It is preferable to start taking Janine ® the next day after taking the last active dragee 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 pills in the package). When switching from the vaginal ring or transdermal patch, it is preferable to start taking Zanin ® 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 stuck,

- when switching from contraceptives containing only gestagens (“mini-pili”, injection forms, implant), or releasing gestagen intrauterine contraceptive (Mirena). A woman can switch from “mini-pili” to Jeanine ® any day (without a break), from an implant or an intrauterine contraceptive with a progestogen — on the day of its removal, from an injection form — from the day when the next injection should have been given. In all cases, you must use an additional barrier method of contraception during the first 7 days of dragee

- after 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 birth or abortion in the second trimester of pregnancy. If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. If a woman has already lived sexually, before pregnancy Zanin ® should be excluded pregnancy or you must wait for the first menstruation.

Reception missed dragees. If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. A woman should take dragee as soon as possible, the following is taken at the usual time.

If the delay in taking the dragee is more than 12 hours, contraceptive protection can be reduced. In this case, you can follow the following two basic rules:

- the drug should never be interrupted for more than 7 days,

- To achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation, 7 days of continuous dragee ingestion are required.

If the delay in receiving the dragee is more than 12 hours (the interval since the reception of the last dragee is more than 36 hours), the following tips can be given.

The first week of taking the drug

A woman should take the last missed dragee as soon as possible (even if it means taking two dragees at the same time). The following pills are taken at the usual time. Additionally, a barrier method of contraception (eg a condom) should be used within the next 7 days. If sexual intercourse took place during the week before skipping the dragees, it is necessary to consider the probability of pregnancy. The more jelly beans are missed and the closer the break in taking active substances, the greater the likelihood of pregnancy.

Second week of taking the drug

A woman should take the last missed dragee as soon as possible (even if it means taking two dragees at the same time). The following pills are taken at the usual time.

Provided that the woman took the pills correctly for 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of reducing the reliability is inevitable due to the upcoming break in the reception of pills.

A woman should strictly adhere to one of the following two options (if in the 7 days preceding the first missed pills, all pills were taken correctly, there is no need to use additional contraceptive methods):

1. A woman should take the last missed dragee as soon as possible (even if it means taking two dragees at the same time). The following dragees are taken at the usual time, until the dragees from the current package run out. The following packaging should begin immediately. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking pills.

2. A woman may also interrupt the taking of pills from the current package. Then she should take a break for 7 days, including the day of skipping pills, and then start taking a new package.

If a woman misses taking pills and then during a break in taking pills, she has no withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations in case of vomiting and diarrhea

If a woman had vomiting or diarrhea within up to 4 hours after taking active dragees, absorption may not be complete, and additional contraceptive measures should be taken. In these cases, you should focus on the recommendations when skipping pills.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue to take drops from the new Zhanin ® package immediately after all the drops are taken from the previous one, without interruption in reception. Drops from this new package can be taken as long as the woman wants (until the package is finished). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Resume taking Janine ® from a new pack should be after the usual 7-day break.

In order to postpone the start of menstruation to another day of the week, a woman should be advised to shorten the closest interruption in taking pills for 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 (as well as when she would like to delay the onset of menstruation).

Additional information for specific patient categories

Children and teenagers. The drug Janine ® is indicated only after the onset of menarche.

Elderly patients. Not applicable. The drug Janine ® is not indicated after the onset of menopause.

Patients with impaired liver. Janine ® is contraindicated in women with severe liver disease until liver function returns to normal (see also the section "Contraindications").

Patients with kidney impairment. Janine ® was not specifically studied in patients with renal impairment. Available data do not imply a change in treatment in these patients.

special instructions

If any of the conditions, diseases, and risk factors listed below are presently present, then the potential risk and expected benefits of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start. taking the drug. In the event of a worsening, aggravation, or first manifestation of any of these conditions, diseases, or an increase in risk factors, the woman should consult with her physician, who may decide to discontinue the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of CPC and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.

The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs. Increased risk is present after the initial use of combined oral contraceptives or the resumption of the use of the same or different combined oral contraceptives (after a break between taking the drug in 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (ethinyl estradiol content - 2),

- family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age). In the case of 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, serious surgery, any surgery on the legs or an extensive injury.In these situations, it is desirable to stop the use of combined oral contraceptives (in the case of the planned operation, at least 4 weeks before it) and not to resume reception within two weeks after the end of immobilization,

- valvular heart disease,

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

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

The biochemical indices indicating a hereditary or acquired susceptibility to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin III, lack of protein C, lack of protein S, antiphospholipid antibodies (anti-cardiolipin antibodies, anti-phosphorylipine III, anti-thrombin III, anti-thrombin III).

When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (ethinyl estradiol - ® content should be reviewed with the history of life, the family history of women, thorough general medical (including measurement of blood pressure, heart rate, body mass index) and gynecological examination, including the examination of the mammary glands and cytological examination of a scraping from the cervix (Pap test), exclude pregnancy. The frequency of control examinations is determined individually. Usually, control examinations should be carried out at least once a year.

A woman should be warned that drugs like Janine ® do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

pharmachologic effect

Combined contraceptive (estrogen + progestogen)

Janine is a low-dose monophasic oral combined estrogen-gestagenic contraceptive drug.

Zanin’s contraceptive effect is accomplished through complementary mechanisms, the most important of which are the suppression of ovulation and changes in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.

When used correctly, the indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year is less than 1. If you skip pills or use it incorrectly, this indicator may increase. In women taking combined oral contraceptives (COCs), the menstrual cycle becomes more regular, painful menstruation is less common, the intensity and duration of bleeding decrease, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer.

Pregnancy and lactation

Janine can not be used during pregnancy and lactation. If pregnancy is detected while taking the drug Janine, it should be immediately canceled and consult a doctor. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or when they received sex hormones through negligence in the early stages of pregnancy.

Reception of the combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is not recommended until the end of breastfeeding.

Pharmacological properties

Janine is a low-dose monophasic oral combined estrogen-progestin contraceptive drug.

Zanin’s contraceptive effect is accomplished through complementary mechanisms, the most important of which are the suppression of ovulation and changes in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.

When used correctly, the indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year is less than 1. If you skip pills or misuse, this figure may increase.

In women taking combined oral contraceptives (COCs), the menstrual cycle becomes more regular, painful menstruation is less common, the intensity and duration of bleeding decrease, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer.

Contraception (prevention of unwanted pregnancy).

Carefully

The potential risk and the expected benefit of using combined oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:

  • Risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, hypertension, migraine, valvular heart disease, prolonged immobilization, serious surgery, extensive trauma, hereditary thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, hereditary predisposition to thrombosis) -or nearest relatives)
  • Other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and non-specific ulcerative colitis, sickle cell anemia, phlebitis of superficial veins
  • Hereditary Angioedema
  • Hypertriglyceridemia
  • Liver diseases
  • Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with impaired hearing, porphyria, herpes of pregnant women, Sydengam's chorea).
  • Postpartum period.

Pregnancy and lactation

Janine can not be taken during pregnancy and lactation. If pregnancy is detected while taking the drug Janine, it should be immediately canceled and consult a doctor. However, extensive epidemiological studies have not revealed the risk of development defects in children born to women who received sex hormones before pregnancy or when taking sex hormones through negligence in the early stages of pregnancy.

Reception of the combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is not recommended until the end of breastfeeding.

When and how to take dragees

Calendar pack contains 21 dragees. In the package, each dragee is labeled the day of the week in which it should be taken. Take the pills inside at the same time every day with a little water. Follow the direction of the arrow until all 21 dragees are taken. For the next 7 days, you are not taking the drug. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually starts 2-3 days after taking the last dragee Janine. After a 7-day break, start taking pills from the next package, even if the bleeding has not stopped. This means that you will always start a new package on the same week, and that every month the withdrawal bleeding will occur approximately on the same day of the week.

Taking the first pack of Janine

  • When no hormonal contraceptive was used in the previous month.

Start taking Janine on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the dragee, which is marked with the appropriate day of the week. Then take the pills in order. You can also start taking for 2-5 days of the menstrual cycle, but in this case, you must use an additional barrier contraceptives (condoms) during the first 7 days of taking pills from the first package.

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

You can start taking Janine the next day after taking the last pill of the current package of the combined oral contraceptive (i.e., without interruption in the intake). If the current package contains 28 tablets, you can start taking Zanin the next day after taking the last one. active pill. If you are not sure which tablet to use, ask your doctor. You can also start taking it later, but in no case no later than the next day after the usual break in reception (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per pack).
Reception of Zhanin should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new patch is to be inserted or a new patch is pasted.

  • When moving from oral contraceptives containing only gestagen (miles-drank)

You can stop taking the mini-drink on any given day and start taking Zanin the next day, at the same time. During the first 7 days of taking dragee, you must also use additional barrier contraceptives.

  • When switching from an injection contraceptive, an implant or a progestogen-releasing intrauterine contraceptive (Mirena)

Start taking Janine on the day when the next injection is to be given or on the day of the removal of the implant or intrauterine device. During the first 7 days of taking pills, you must also use an additional barrier method of contraception.

If you have just given birth to a child, the doctor may recommend that you wait until the end of the first normal menstrual cycle before you begin to take Zanin. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.

Check with your doctor. It is usually recommended to start taking it immediately

Reception of the missed dragees

  • If the delay in taking the next dragee is less than 12 hours, Zanin’s contraceptive effect is preserved. Take dragee as soon as you remember it. Take the next dragee at the usual time.
  • If the delay in taking the dragee is more than 12 hours, contraceptive protection can be reduced. The more consecutive pills are missed, and the closer this pass is to the beginning of reception or to the end of reception, the higher the risk of pregnancy.
    In this case, you can follow the following rules:
    • Forgotten more than one tablet from the package
    Consult a doctor.
    • One dragee missed in the first week of taking the drug
    Take the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before skipping the dragees, it is necessary to take into account the probability of pregnancy. Consult a doctor immediately.
    • One dragee missed in the second week of taking the drug
    Take the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. If you took dragee correctly for the 7 days preceding the first missed dragee, Zanin’s contraceptive effect remains, and you do not need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier contraceptives for 7 days.
    • One dragee missed on the third week of taking the drug
    If during the 7 days preceding the first missed pills, all the pills were taken correctly, there is no need to use additional contraceptive methods. You can stick to either of the following two options.
    1. Take the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. Start the next package immediately after taking the dragee from the current package, so there will be no break between the packages. Withdrawal bleeding is unlikely until the dragees from the second package run out, but there may be a "spotting" discharge or breakthrough bleeding on the days of taking the drug.
    2. Stop taking pills from the current package, take a break for 7 days or less (including the day of skipping pills) and then start taking pills from the new packaging.
      Using the scheme, you can always start taking pills with the next package on the day of the week when you usually do it.
      If, after a break in the reception of dragees, there is no expected menstruation, you may be pregnant. Consult with your doctor before you start taking pills from the new package.

In situations where you are advised to stop taking the combined oral contraceptive, or when the reliability of the COC can be reduced, you should refrain from sex or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). Do not use rhythmic or temperature methods. These methods may be unreliable, because COC administration leads to changes in temperature and cervical mucus.

Delay in the onset of menstruation

You can postpone the onset of menstruation if you start taking drops from the next package of Zhanin immediately after the end of the current package. You can continue to take pills from this package for as long as you wish, or until the package is finished. If you want your period to start, stop taking dragees. During the reception of Zhanin from the second package, "spotting" discharge or bleeding can be observed on the days when the dragee is taken. Next pack start the usual 7-day break.

Change the day of the onset of menstruation

If you take dragee in accordance with the recommendations, you will have menstruation approximately on the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the time interval, free from taking dragees. For example, if your menstrual cycle usually begins on Friday, and in the future you want it to start on Tuesday (3 days earlier), the next pack should be started three days earlier than usual. In this case, bleeding or spotting may be noted while taking pills from the next package.

Side effect

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

Other adverse effects may be observed while taking the drug, Janine, although their appearance is not necessary in all patients.

Interaction with other drugs

Some medicines can reduce the effectiveness of Zhanin. These include drugs used to treat epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiromat, felbamate), tuberculosis (for example, rifampicin, rifabutin), and HIV infection (for example, ritonavir, nevirapine), anti-tuberculosis, anti-rifabutin, and HIV infection (for example, ritonavir, nevirapine), anti-tuberculosis, anti-rifabutin, and HIV infection (for example, ritonavir, nevirapine), anti-tuberculosis, anti-rifabutin, and HIV infection (for example, ritonavir, nevirapine), anti-tuberculosis, anti-rifabutin, anti-HIV, and anti-HIV (antibiotics) some other infectious diseases (for example, penicillin, tetracyclines, griseofulvin), and also Hypericum-based medicines (used mainly in the treatment of depressed mood).

Oral combined contraceptives can affect the metabolism of other drugs (for example, cyclosporine and lamotrigine).

Some drugs can affect the metabolism of the active components of the drug Janine. These include antifungal agents (eg, ketoconazole), H2-blockers for the treatment of gastric ulcer and duodenal ulcer (for example, cimetidine), some drugs for the treatment of arterial hypertension (for example, verapamil, diltiazem), antibiotics for the treatment of bacterial infections (macrolides, for example, erythromycin), antidepressants, grapefruit juice.

Always tell the doctor Janin prescribing you which medicines you are already taking. In some cases, the doctor may recommend that you additionally use a barrier method of contraception.

Intermenstrual bleeding

When taking Zhanin during the first few months, there may be irregular vaginal bleeding ("spotting" bleeding or breakthrough bleeding) during the intermenstrual period. Use hygiene products and continue taking the pills as usual. Intermenstrual vaginal bleeding usually stops as your body adapts to Zanin (usually after 3 cycles of taking pills). If they continue, become heavy or resume after termination, consult a doctor.

When you need to consult a doctor

Regular checkups

If you are taking Janine, the doctor will tell you about the need for regular checkups, at least not less than 1 time per year.

  • in case of any changes in health, especially any conditions listed in the instructions for use of the drug (see also "Contraindications"),
  • with local compaction in the mammary gland, if you intend to use other drugs (see also "Interaction with other drugs"),
  • if prolonged immobility is expected (for example, a plaster is applied to the leg), hospitalization or surgery is planned.
  • in case of unusual severe vaginal bleeding,
  • if you forgot to take dragees in the first week of the package and had sexual intercourse 7 days before,
  • You did not have another menstruation twice in a row or you suspect that you are pregnant (do not start taking the next pack until you consult with your doctor).

Stop taking pills and immediately consult with your doctor if you notice possible signs of thrombosis that first appeared: unusual cough, unusually severe chest pain, giving to the left arm, sudden shortness of breath, unusual, severe or prolonged headache or migraine attack, partial or complete loss of vision or double vision, slurred speech, sudden changes in hearing, smell or taste, dizziness or fainting, weakness or loss of sensation in any part of the body, severe pain in being alive those severe pain in the leg or suddenly arising from any swelling down.

Janine is recommended to you personally, do not pass the drug to others!

Dosage Form

Each dragee contains:

- active ingredients: ethinylestradiol 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 C25, titanium dioxide (E 171), carnauba wax.

White smooth dragee.

Dosage and administration

Calendar pack contains 21 dragees. In the package, each dragee is labeled the day of the week in which it should be taken. Take the pills inside at the same time every day with a little water. Follow the direction of the arrow until all 21 dragees are taken. For the next 7 days, you are not taking the drug. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually starts 2-3 days after taking the last dragee Janine. After a 7-day break, start taking pills from the next package, even if the bleeding has not stopped. This means that you will always start a new package on the same day of the week, and that every month the withdrawal bleeding will occur approximately on the same day of the week.

• When no hormonal contraceptive was used in the previous month.

Start taking Janine on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the dragee, which is marked with the appropriate day of the week. Then take the pills in order. You can also start taking for 2-5 days of the menstrual cycle, but in this case, you must use an additional barrier method of contraception (condom) during the first 7 days of taking pills from the first package.

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

You can start taking Janine the day after you take the last pill of the current package of the combined oral contraceptive (i.e., without interruption in the intake). If the current package contains 28 tablets, you can start taking Zanin the next day after taking the last active tablet. If you are not sure which tablet to use, ask your doctor. You can also start taking it later, but in no case no later than the next day after the usual break in reception (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per pack).

Reception of Zhanin should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new patch is to be inserted or a new patch is pasted.

• When switching from oral contraceptives containing only gestagen (mini-drank)

You can stop taking the mini-drink on any given day and start taking Zanin the next day, at the same time. During the first 7 days of taking pills, you must also use an additional barrier method of contraception.

• When switching from an injection contraceptive, an implant, or a progestogen-releasing intrauterine contraceptive (Mirena)

Start taking Janine on the day when the next injection is to be given or on the day of the removal of the implant or intrauterine device. During the first 7 days of taking pills, you must also use an additional barrier method of contraception.

If you have just given birth to a child, the doctor may recommend that you wait until the end of the first normal menstrual cycle before you begin to take Zanin. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.

• After a spontaneous miscarriage or abortion in the first trimester of pregnancy. Consult your doctor. It is usually recommended to start taking it immediately

Reception of the missed dragees

• If the delay in taking the next dragee less than 12 hours, Zanin's contraceptive effect is preserved. Take dragee as soon as you remember it. Take the next dragee at the usual time.

• If the delay in taking the dragee is more than 12 hours, contraceptive protection may be reduced. The more consecutive pills are missed, and the closer this pass is to the beginning of reception or to the end of reception, the higher the risk of pregnancy.

In this case, you can follow the following rules:

• Forgotten more than one tablet from the package. Consult your doctor.

• One dragee missed in the first week of taking the drug

Take the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place during the week before skipping the dragees, it is necessary to consider the probability of pregnancy. Consult a doctor immediately.

• One dragee missed in the second week of taking the drug

Take the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. If you took dragee correctly for the 7 days preceding the first missed dragee, Zanin’s contraceptive effect remains, and you do not need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception for 7 days.

• One dragee missed on the third week of taking the drug

If during the 7 days preceding the first missed pills, all the pills were taken correctly, there is no need to use additional contraceptive methods. You can stick to either of the following two options.

1. Accept the missed dragee as soon as possible, as soon as you remember (even if it means taking two dragees at the same time). Take the next dragee at the usual time. Start the next package immediately after taking the dragee from the current package, so there will be no break between the packages. Withdrawal bleeding is unlikely until the dragees from the second pack run out, but there may be spotting or breakthrough bleeding on the days of taking the drug.

2. Stop taking pills from the current package, take a break for 7 days or less (including the day of skipping pills) and then start taking pills from a new package. Using this scheme, you can always start taking pills from the next pack on the day of the week when you usually do it.

If, after a break in the reception of dragees, there is no expected menstruation, you may be pregnant. Consult with your doctor before you start taking pills from the new package.

In situations where you are advised to stop taking the combined oral contraceptive, or when KOC's reliability may be reduced, you should refrain from sex or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). Do not use rhythmic or temperature methods. These methods may be unreliable, because COC administration leads to changes in temperature and cervical mucus.

Recommendations in case of vomiting and diarrhea

If you had vomiting or diarrhea (an upset stomach) within up to 4 hours after taking Zanin’s pills, the active substances may not have fully absorbed. This situation is similar to skipping the drug. Therefore, follow the instructions for missed dragees.

Delay in the onset of menstruation

You can postpone the onset of menstruation if you start taking drops from the next package of Zhanin immediately after the end of the current package. You can continue

Take pills from this package as long as you wish, or until the package is finished. If you want your period to start, stop taking dragees. During the reception of Janine from the second package, there may be spotting or bleeding on the days of taking the pills. Start the next pack after the usual 7-day break.

Change the day of the onset of menstruation

If you take dragee in accordance with the recommendations, you will have menstruation approximately on the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the time interval, free from taking dragees. For example, if your menstrual cycle usually begins on Friday, and in the future you want it to start on Tuesday (3 days earlier), the next pack should be started 3 days earlier than usual. If the break free from taking pills will be very short (for example, 3 days or less), menstruation during the break may not occur. In this case, bleeding or spotting may be noted while taking pills from the next package.

Release form, composition and packaging

Dragee white color, smooth.

Excipients: lactose monohydrate - 27.97 mg, potato starch - 15 mg, gelatin - 1.5 mg, talc - 1.5 mg, magnesium stearate - 0.5 mg.

The composition of the shell: sucrose - 23.6934 mg, dextrose - 1.65 mg, macrogol 35 000 - 1.35 mg, calcium carbonate - 2.4 mg, polyvidone K25 - 0.15 mg, titanium dioxide (E171) - 0.74244 mg, carnauba wax - 0.01416 mg.

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

Dosing regimen

Drops should be taken orally in the order indicated on the packaging, every day at about the same time, drinking a small amount of water. Janine ® should be taken for 1 tablet / day continuously for 21 days. Reception of each next package begins after a 7-day break, during which withdrawal bleeding is observed (menstrual-like bleeding). It usually starts on the 2-3rd day after taking the last dragee and may not end before the start of taking a new package.

Start taking Zanin

In the absence of taking any hormonal contraceptives in the previous month, Zhanin's intake is started on the 1st day of the menstrual cycle (that is, on the 1st day of menstrual bleeding). It is allowed to start taking 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 pills from the first package.

When switching from combined oral contraceptives, vaginal ring, transdermal patch, Zanin’s intake should be started the next day after taking the last active dragee from the previous package, but in no case, no later than the next day after the usual 7-day break in reception (for drugs containing 21 dragees) or after taking the last inactive dragee (for preparations containing 28 dragees per pack). When switching from the vaginal ring, transdermal patch, it is preferable to start taking Zanin 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 glued.

When switching from contraceptives containing only gestagens (mini-pili, injection forms, implant) or from the progestin-releasing intrauterine contraceptive (Mirena), a woman can switch from taking mini-pili to Jeanine ® any day (without a break), from an implant or an intrauterine contraceptive with a progestogen - on the day of its removal, from an injection contraceptive - on the day when the next injection should be given. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

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, it is recommended to start taking the drug on the 21-28th day after delivery or abortion in the second trimester of pregnancy. If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. However, if a woman has already lived sexually, before pregnancy Zanin is started, pregnancy should be excluded or it is necessary to wait for the first menstruation.

Reception of the missed dragees

If the delay in taking pills less than 12 hours, contraceptive protection is not reduced. The woman should take the missed dragee as soon as possible, the next dragee is taken at the usual time.

If the delay in taking the dragee is more than 12 hours, contraceptive protection can be reduced.

In this case, you can follow the following two basic rules:

- the drug should never be interrupted for more than 7 days,

- To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous dragee ingestion are required.

Accordingly, if the delay in taking active dragees was more than 12 hours (the interval from the moment of receiving the last active tablet is more than 36 hours), the following can be recommended:

The first week of taking the drug

You need to take the last missed dragee as soon as possible, as soon as the woman remembers this (even if you need to take two dragees at the same time). The following pills are taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used within the next 7 days. If sexual intercourse took place during the week before skipping the dragees, it is necessary to consider the probability of pregnancy. The more jelly beans 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

You need to take the last missed dragee as soon as possible, as soon as the woman remembers this (even if you need to take two dragees at the same time). The following pills are taken at the usual time. Provided that the woman took the pills correctly for 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming break in taking pills. A woman should strictly adhere to one of the following two options. Moreover, if during the 7 days preceding the first missed pills, all the pills were taken correctly, there is no need to use additional contraceptive methods.

1. You must take the last missed pills as soon as possible, as soon as the woman remembers this (even if you need to take two pills at the same time). The following dragees are taken at the usual time, until the dragees from the current package run out. The next package should start immediately without a break. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking pills.

2. A woman may also interrupt the taking of pills from the current package. Then she should take a break for 7 days, including the day of skipping the dragees, and then start taking new packaging.

If a woman misses a dragee, and then during a break in reception she has no withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations in case of vomiting and diarrhea

If a woman has vomiting or diarrhea within up to 4 hours after taking active dragees, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on the recommendations when skipping dragees.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue to take pills from the new Zhanin package immediately after all pills from the previous one are taken, without interruption in reception. Drops from this new package can be taken as long as the woman wants (until the package is finished). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Zanin from a new package should be after the usual 7-day break.

To postpone the start of menstruation to another day of the week, a woman should shorten the next break in the reception of pills for 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 pack (just as if she would like to delay the onset of menstruation).

Additional information for specific patient categories

Children and teenagers drug Janine ® is indicated only after the onset of menarche.

After menopause drug Janine ® not shown.

The drug Janine ® is contraindicated for womenwith severe liver disease until the liver function normalizes.

The drug Janine ® was not specifically studied in patients with impaired renal function. Available data do not imply a change in treatment in these patients.

Drug interaction

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive reliability.

The following types of interaction have been reported in the literature.

Impact on hepatic metabolism

The use of drugs that induce liver microsomal enzymes, can lead to an increase in the clearance of sex hormones. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and 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.

Influence on the enterohepatic circulation

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

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

Substances that affect the metabolism of combined hormonal contraceptives (enzyme inhibitors)

Dienogest is a substrate of cytochrome P450 (CYP) 3A4. Known inhibitors of CYP3A4, such as azole antifungal drugs (for example, ketoconazole), cimetidine, verapamil, macrolides (for example, erythromycin), diltiazem, antidepressants and grapefruit juice, can increase plasma levels of dienogest.

During the taking of drugs that affect microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be additionally used.

During the reception of antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of using the barrier protection method ends later than the pills in the package, you need to proceed to the next package of Zhanin without the usual interruption in taking the pills.

Oral combined contraceptives can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) their concentration in plasma and tissues.

Application for violations of the liver

In the event of an abnormal liver function, it may be necessary to cancel Zanin temporarily until laboratory values ​​are normalized. With the development of cholestatic jaundice or cholestatic itch (first appeared during pregnancy or previous intake of sex hormones) Janine ® should be canceled.

Release form and composition

Janine is made in the dosage form of oral pills (oral) intake. They have a white color, rounded shape and a smooth surface. Pills contain 2 main active ingredients, which include ethinyl estradiol (0.03 mg in 1 tablet) and dienogest (2 mg in 1 tablet). Also included in the dragee are auxiliary components.

Janine tablets are packaged in blisters of 21 pieces. The carton pack contains one (21 tablets) or three (63 tablets) blisters and instructions for use of the drug.

Instructions for use

Janine dragee should be taken orally in the order indicated on the packaging, every day at about the same time, with a small amount of water. Janine should be taken 1 tablet a day continuously for 21 days.

Reception of each next package begins after a 7-day break, during which withdrawal bleeding is observed (menstrual-like bleeding). It usually starts on the 2-3rd day after taking the last dragee and may not end before the start of taking a new package.

Start taking Zanin

In the absence of taking any hormonal contraceptives in the previous month, Zhanin's intake is started on the 1st day of the menstrual cycle (that is, on the 1st day of menstrual bleeding). It is allowed to start taking 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 pills from the first package.

When switching from combined oral contraceptives, vaginal ring, transdermal patch, Zanin’s intake should be started the next day after taking the last active dragee from the previous package, but in no case, no later than the next day after the usual 7-day break in reception (for drugs containing 21 dragees) or after taking the last inactive dragee (for preparations containing 28 dragees per pack).

When switching from the vaginal ring, transdermal patch, it is preferable to start taking Zanin 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 glued.

When switching from contraceptives containing only gestagens (mini-pili, injection forms, implant) or from progestin-releasing intrauterine contraceptive (Mirena), a woman can switch from taking mini-pili to Jeanine on any day (without a break), an implant or an intrauterine contraceptive with a gestagen - on the day of its removal, from an injection contraceptive - on the day when the next injection should be given.

In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

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 2nd trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after birth or abortion in the second trimester of pregnancy.

If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. However, if a woman has already lived sexually, before the beginning of Zanin's reception, pregnancy should be excluded or it is necessary to wait for the first menstruation.

The first week of taking the drug

You need to take the last missed dragee as soon as possible, as soon as the woman remembers this (even if you need to take two dragees at the same time). The following pills are taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used within the next 7 days.

If sexual intercourse took place during the week before skipping the dragees, it is necessary to consider the probability of pregnancy. The more jelly beans 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

You need to take the last missed dragee as soon as possible, as soon as the woman remembers this (even if you need to take two dragees at the same time). The following pills are taken at the usual time.

Provided that the woman took the pills correctly for 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming break in taking pills. A woman should strictly adhere to one of the following two options. Moreover, if during the 7 days preceding the first missed pills, all the pills were taken correctly, there is no need to use additional contraceptive methods.

You need to take the last missed dragee as soon as possible, as soon as the woman remembers this (even if you need to take two dragees at the same time). The following dragees are taken at the usual time, until the dragees from the current package run out. The next package should start immediately without a break.

Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking pills. A woman can also interrupt the taking of pills from the current package. Then she should take a break for 7 days, including the day of skipping the dragees, and then start taking new packaging. If a woman misses a dragee, and then during a break in reception she has no withdrawal bleeding, it is necessary to exclude pregnancy.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue to take pills from the new Zhanin package immediately after all pills from the previous one are taken, without interruption in reception. Drops from this new package can be taken as long as the woman wants (until the package is finished).

While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Zanin from a new package should be after the usual 7-day break.

To postpone the start of menstruation to another day of the week, a woman should shorten the next break in the reception of pills for 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 pack (just as if she would like to delay the onset of menstruation).

Side effects

  • Allergic reactions: rarely - allergic dermatitis and other manifestations of allergic reactions, possibly - erythema nodosum, urticaria.
  • Psychiatric disorders: infrequently - decrease in mood, rarely - mental disorders, depression, sleep disorders, insomnia, aggression, possibly - decrease or increase in libido, mood changes.
  • Since the cardiovascular system: rarely - arterial hypotension or hypertension, rarely - tachycardia (including an increase in heart rate), cardiovascular disorders, thrombosis or thromboembolism of the pulmonary artery, thrombophlebitis, orthostatic circulatory dystonia, diastolic hypertension, frost, veins (including varicose and pain in the veins).
  • Dermatologic reactions: infrequently - acne, alopecia, macular and other rash, pruritus (including generalized) rarely - eczema, hirsutism, atopic dermatitis or atopic dermatitis, psoriasis, chloasma, rash, pigmentation disorders or hyperpigmentation, dandruff, seborrhea, pathological skin changes ( orange peel, spider veins), perhaps - erythema multiforme.
  • On the part of the nervous system: often - headache, infrequently - migraine, dizziness, rarely - cerebrovascular disorders, ischemic stroke, dystonia.
  • Genetic and congenital disorders: rarely - polymastic.
  • Survey results: infrequently - changes in body weight (decrease, increase or fluctuation), rarely - an increase in blood triglycerides, hypercholesterolemia.
  • On the part of the respiratory system: rarely - bronchial asthma, hyperventilation.
  • On the part of the digestive system: infrequently - pain in the upper and lower abdomens, bloating or discomfort, nausea, vomiting, diarrhea, rarely - dyspepsia, gastritis, enteritis.
  • On the part of metabolism: infrequently - increased appetite, rarely - anorexia.
  • On the part of the reproductive system and the mammary glands: often - breast engorgement, pain and / or discomfort in the mammary glands, infrequently - intermenstrual bleeding (including metrorrhagia and vaginal bleeding), abundant withdrawal bleeding (including menorrhagia, hypomenorrhea, amenorrhea, and oligorema bleeding (including menorrhagia, hypomenorrhea, amenorrhea, and oligorema bleeding). ), mammary gland swelling, increase (swelling and a feeling of fullness) of breast size, dysmenorrhea, ovarian cysts, vaginal or genital tract discharge, pain in the pelvic area, rarely - cervical dysplasia, Ki You breasts, cysts of the uterus, pain in the uterus, menstrual disorders, dyspareunia, fibrocystic breast disease, galactorrhoea, perhaps - discharge from the breast.
  • On the part of the musculoskeletal system: rarely - myalgia, discomfort in the bones and muscles, pain in the back and / or limbs.
  • Malignant, benign and unspecified tumors, including cysts and polyps: rarely - breast lipoma, uterine myoma, Common symptoms: infrequently - fatigue, poor health, asthenia, rarely - peripheral edema, chest pain, irritability, flu-like symptoms (increase temperature and inflammation), possibly - fluid retention.
  • On the part of the endocrine system: rarely - virilization, On the part of the sense organs: rarely - dizziness, oscillopsia, irritation and / or dryness of the mucous membrane of the eyes, tinnitus, impairment or sudden hearing loss, possibly - intolerance (discomfort when wearing) contact lenses .
  • On the part of the lymphatic system and blood: rarely - anemia.
  • Infections and infections: infrequently - vaginal candidiasis, vaginitis and other vulvovaginal infections, rarely - salpingo-oophoritis (adnexitis), cystitis, urinary tract infections, mastitis, fungal infections, cervicitis, candidiasis, viral infections, including influenza, herpetic oral cavity disease, sinusitis, bronchitis, upper respiratory tract infections.

In addition, Janine can cause irregular bleeding, in the form of spotting bleeding or breakthrough bleeding, especially in the first months of use.

While taking Janine, women may develop the following side effects: venous and / or arterial thromboembolic complications, hypertension, cerebrovascular complications, hypertriglyceridemia, effect on insulin resistance of peripheral tissues, altered glucose tolerance, functional disorders of the liver, healthy, non-malignant, non-viral, peripheral tissues, changes in glucose tolerance, functional disorders of the liver, healthy, non-malignant, peripheral tissue insulin resistance, changes in glucose tolerance, functional disorders of the liver, healthy, non-malignant, peripheral tissue insulin resistance, changes in glucose tolerance, functional disorders of the liver, normal, non-viral, peripheral tissues, changes in glucose tolerance, functional disorders of the liver, healthy, non-malignant, peripheral tissue insulin resistance, changes in glucose tolerance, functional disorders of the liver, healthy, non-malignant, peripheral tissue insulin resistance, changes in glucose tolerance, functional disorders of the liver, healthy, non-viral, peripheral tissues. .

Exogenous estrogens in women with the pathology of hereditary angioedema can intensify the exacerbation of symptoms.

Vacation conditions and price

The average cost of Janine (pill number 21) in Moscow is 1045 rubles. In pharmacies pills Zhanin released only by prescription. It is not recommended to start their own reception or use on the advice of third parties.

Store at temperatures up to 25 C. Keep out of the reach of children. Shelf life - 3 years.

Release form Janine, product packaging and composition.

Dragee white smooth.
1 dragee
ethinyl estradiol
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 pieces - blisters (1) - packs cardboard.
21 pieces - blisters (3) - packs cardboard.

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

Dosage and method of use of the drug.

Dragee should be taken in the order indicated on the package, every day at about the same time, drinking a small amount of water. Janine should be taken for 1 tablet / day continuously for 21 days. Reception of each next package begins after a 7-day break, during which withdrawal bleeding is observed (menstrual-like bleeding). It usually begins on the 2-3rd day from the reception of the last dragee, and may not end before the start of taking a new package.

In the absence of taking any hormonal contraceptives in the previous month, Zhanin's intake is started on the 1st day of the menstrual cycle (that is, on the 1st day of menstrual bleeding). It is allowed to start taking 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 pills from the first package.

When switching from combined oral contraceptives, vaginal ring, transdermal patch, Zanin’s treatment should be started the next day after taking the last dragee with the active components of the previous drug, but in no case later than the next day after the usual 7-day break in reception (for drugs containing 21 dragees) or after taking the last inactive dragee (for preparations containing 28 dragees per package). When switching from the vaginal ring, transdermal patch, it is preferable to start taking Zanin 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 glued.

When switching from contraceptives containing only gestagens (“mini-pili”, injection forms, implant) or from the progestogen-releasing intrauterine contraceptive Janine, you can start using it without interruption. In the transition from the "mini-drank" - any day without a break.When using injectable forms of contraceptives, Janine is started on the day when the next injection should be given. When moving from the implant or intrauterine contraceptive with the progestogen - on the day of its removal. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

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, the drug should be started on the 21-28th day. If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. However, if a woman lived sexually in the period between childbirth or abortion and the beginning of Zanin's intake, then pregnancy should be excluded first or you should wait for the first menstruation.

The woman should take the missed dragee as soon as possible, the next dragee is taken at the usual time.

If the delay in taking pills less than 12 hours, the reliability of contraception is not reduced.

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

If the delay in taking the pills was more than 12 hours (the interval since the last tablet was taken is more than 36 hours) during the first week of taking the drug, the woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time ). The following dragee is taken at the usual time. Additionally, you should use a barrier method of contraception for the next 7 days. If a woman had sex life for a week before skipping the dragees, it is necessary to consider the risk of pregnancy. The more pills are missed and the closer this pass is to the 7-day break in taking pills, the higher the risk of pregnancy.

If the delay in taking the pills was more than 12 hours (the interval since the last tablet was taken is more than 36 hours) during the second week of taking the drug, the woman should take the last missed tablet as soon as possible as soon as she remembers (even if you need to take two dragee at the same time). The following pills are taken at the usual time. Provided that the woman took the pills correctly for 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

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

- A woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two dragees at the same time). The following dragees are taken at the usual time, until the dragees from the current package run out. The following packaging should begin immediately. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking pills.

- A woman can also interrupt the taking of pills from the current package. Then she should take a break for 7 days, including the day of skipping the dragees, and then start taking new packaging. If a woman misses pills, and then during a break in taking pills, she has no withdrawal bleeding, it is necessary to exclude pregnancy.

If a woman has vomiting or diarrhea within up to 4 hours after taking active dragees, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on the recommendations when skipping dragees.

In order to delay the onset of menstruation, a woman should continue to take pills from the new Zhanin package immediately after all pills from the previous one are taken, without interruption in reception. Drops from this new package can be taken as long as the woman wants (until the package is finished). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Zanin from a new package should be after the usual 7-day break.

To postpone the start of menstruation to another day of the week, a woman should shorten the next break in the reception of pills for 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 pack (just as if she would like to delay the onset of menstruation).

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