Jeanine (Valette) dragee #21

21 dragee

Jeanine is a hormonal birth control pill, a so-called oral contraceptive (commonly referred to as ’the pill’)

Pharmacological Effects:

Jeanine - low-dose monophasic oral combined estrogen-progestin birth control pills.
The contraceptive effect Jeanine performed through three complementary mechanisms:

• Suppression of ovulation at the hypothalamic-pituitary regulation;
• Changes in the properties of cervical secretions, causing it to become impervious to sperm;
• Changes in the endometrium, which makes it impossible fertiliziation.

In women taking combined oral contraceptives, menstrual cycle becomes more regular, less frequently observed in painful menstruation, decreases the amount of bleeding, resulting in reduced risk of iron deficiency anemia.

Pharmacokinetics:

• Dienogest

Absorption. After oral administration of dienogest is rapidly and completely absorbed, and its maximum concentration in blood serum equal to 52 ng / ml, reached after about 2.5 hours. Bioavailability of approximately 91-96%.

Distribution. Dienogest binds to albumin and blood serum does not bind to globulin, sex hormone binding (SHBG) and corticoid binding globulin (GLCs). In the free form is about 10% of the total concentration in blood serum, about 90% - are not specifically related to serum albumin. Induction of ethinylestradiol synthesis of SHBG does not affect the binding of dienogest with whey protein.

Metabolism. Dienogest is almost completely metabolized. Clearance from serum is about 3,4-3,7 l / h.

Excretion. The half-life is about 8,5-10,8 h. A small amount of unchanged form excreted in the urine as metabolites (T1 / 2 - 14.4 hours) are excreted in urine and bile in a ratio of about 3:1.

Equilibrium concentration. On the pharmacokinetics of dienogest does not affect the level of SHBG in serum. As a result, daily administration of the drug substance levels in serum increased approximately 1.5 times.

• Ethinylestradiol

Absorption. After oral ethinylestradiol is rapidly and completely absorbed. The maximum concentration in serum, which is equal to about 67 pg / ml, achieved 1,5-4 hours. During the intake and the first passage through the liver ethinylestradiol is metabolized, resulting in its oral bioavailability is on average about 44%.

Distribution. Ethinyl estradiol almost completely (approximately 98%), although not specific, binds albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8 - 8.6 L / kg.

Metabolism. Ethinylestradiol undergoes presystemic conjugation, as in the mucosa of the small intestine and the liver. The main pathway - aromatic hydroxylation. The rate of clearance from plasma is 2.3 - 7 ml / min / kg.

Excretion. Reduction of concentration of ethinyl estradiol in the blood serum is biphasic, the first phase is characterized by half-life of about 1 hour, the second - 10-20 hours. Unchanged from the body is not displayed. Ethinyl estradiol metabolites excreted in urine and bile in the ratio 4: 6 with a half-life of about 24 h.

Equilibrium concentration. Equilibrium concentration is achieved throughout the second half of the therapeutic cycle.

Indications:

• Contraception.

How to use:

Dragees, taken orally in order specified on the package every day at about the same time, with a little water. Take one tablet daily continuously for 21 days. Reception begins next pack after the 7-day break in taking pills, during which usually occurs withdrawal bleeding. Bleeding usually starts 2-3 days after the last tablet and may not end before starting a new package.

How to start taking Jeanine:

• If you do not receive any hormonal contraceptive in the previous month.

Receiving Janine begins on the first day of the menstrual cycle (ie the first day of menstrual bleeding). Allowed to start taking on 2-5 of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of pills from the first package.

• When switching from other COCs.

Preferably start accepting Janine the next day after taking the last active tablet from the previous packaging, but in any case not later than the day after the usual 7-day break (for products containing 21drazhe) or after the last inactive tablet (for products containing 28 Pills in packaging).

• When switching from contraceptives containing only progestogens ("mini-pill, injectable form, the implant) or progestogen releasing intrauterine devices (Mirena).

A woman can go with the mini-pill on Jeanine any day (no break), with implants or intrauterine devices with progestogen - the day of his removal from the injection form - from the day would have to be made following injection. In all cases, you must additionally use a barrier method of contraception during the first 7 days of pills.

• After the abortion in the first trimester of pregnancy.

A woman can start taking the drug immediately. Subject to this condition, the woman needs no additional contraceptive protection.

• After childbirth or abortion in the second trimester of pregnancy.

We recommend you start taking the drug for 21-28 days after delivery or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to additionally use a barrier method of contraception during the first 7 days of pills. However, if a woman is already living a sexual life, prior to receiving Jeanine pregnancy must be excluded or must wait for the first menstruation.

Receiving missed pills:

If the delay in receiving the drug was less than 12 hours, contraceptive protection is not reduced. Should take the pills as soon as possible, should be taken at the usual time.

If the delay in taking pills to more than 12 hours contraceptive protection may be reduced. Be guided by the following two basic rules:

• The drug should never be interrupted by more than 7 days.
• 7 days of continuous reception of pills required to achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation.

Respectively, may be given the following advice, if the delay in taking pills to more than 12 hours (the interval from the date of reception of the last drops more than 36 hours):

• The first week of dosing

A woman should take the last missed tablet as soon as possible, as soon as you remember (even if it means taking two tablets at once). Next take the pills at the usual time. Must additionally be used a barrier method of contraception (eg condoms) for the next 7 days. If intercourse took place during the week before skipping pills, you must consider the likelihood of pregnancy.

The more pills missed, and the closer they are to break in the admission of active substances, the greater the chance of pregnancy.

• The second week of dosing

A woman should take the last missed tablet as soon as possible, as soon as you remember (even if it means taking two tablets at once). Next take the pills at the usual time.

Provided that the woman took tablets correctly in the 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as skipping of two or more pills in addition to use barrier methods of contraception (eg condoms) for 7 days.

• The third week of dosing

The risk of reliability degradation is inevitable due to the upcoming break in the reception drops.

1. A woman must strictly adhere to one of the following two options. Moreover, if the 7 days preceding the first missed pills, all pills are taken correctly, there is no need to use additional contraceptive methods.
2. A woman should take the last missed tablet as soon as possible, as soon as you remember (even if it means taking two tablets at once). Next take the pills at the usual time, until the end drops from the current package. Next pack should be started immediately. Withdrawal bleeding is unlikely until the end the second pack, but may experience spotting and breakthrough bleeding while taking pills.
3. A woman may also interrupt the reception drops from the current package. Then it should take a break for 7 days, including day pass drops and then begin receiving a new package.
4. If a woman misses pills, and then during a break from taking pills she had no withdrawal bleeding, you need to exclude pregnancy.
5. If a woman has had vomiting or diarrhea within 4 hours after taking the active pills, suction may not be complete and must be taken additional contraceptive measures. In these cases, should be guided by the recommendations while skipping pills.

In order to delay the onset of menstruation, women should continue taking pills from a new package Jeanine immediately after taken all the pills from the previous one, without a break in the reception. Sugar Plum out of this new package can be accepted as long as a woman wants (as long as the package is complete). In patients receiving the drug from the second pack of women may experience spotting or breakthrough uterine bleeding. Resume reception Jeanine from a new package follows the usual 7-day break.

In order to move the first day of menstruation on the day of the week, a woman should be advised to shorten the nearest break in the reception drops in as many days, how much she wants. The shorter the interval, the higher the risk that it will not have withdrawal bleeding, and in the future, will be spotting and breakthrough bleeding during the second pack (just as in the case when she wished to delay the onset of menstruation. In order to postpone the onset of menstruation, the woman should continue taking the drug, using the last 10 tablets from another pack Janine, without making a break in the reception. Thus, the cycle may be extended for up to 10 days until the end of the second pack. Against the background of the drug from the second Packing a woman may experience spotting or breakthrough uterine bleeding. Regular use of Jeanine and then resumed after the usual 7-day break in taking pills.

In order to move the first day of menstruation on the day of the week, a woman should be reduced following a break in the reception drops to the desired number of days. The shorter the interval, the higher the risk that it will not have withdrawal bleeding in the future, will be spotting and breakthrough bleeding during the second pack (just as in the case when she wished to delay the onset of menstruation).

Side effects:

Soreness and tension of the mammary glands, breast enlargement, secretion from the mammary glands, spotting and breakthrough uterine bleeding, headache, migraine, changes in libido, decrease / mood changes, poor tolerance of contact lenses, visual disturbances, nausea, vomiting, pain abdomen; changes of vaginal secretion, skin rash, erythema nodosum, erythema multiforme, generalized pruritus, cholestatic jaundice, fluid retention, weight change, allergic reactions. Rarely - increased triglyceride levels of blood plasma, decreased carbohydrate tolerance, fatigue and diarrhea.

Sometimes it can develop chloasma, especially in women with a history of chloasma during pregnancy.

As with the admission of other COCs in rare cases may develop thrombosis and thromboembolism.

Contraindications:

Jeanine should not be applied if any of the states listed below. If any of these conditions develop for the first time while taking the drug should be immediately repealed.

• Thrombosis (venous and arterial) and venous thromboembolism in the present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
• Conditions prior thrombosis (including transient ischemic attack, angina), now or in history.
• Migraine with focal neurological symptoms in history.
• Diabetes mellitus with vascular complications.
• Multiple or severe risk factors for venous or arterial thrombosis, including valvular heart lesions, cardiac arrhythmias, cerebrovascular disease or coronary heart uncontrolled hypertension.
• Pancreatitis with severe hypertriglyceridemia, now or in history.
• Liver failure and severe liver disease (as long as liver tests do not come back to normal).
• Liver tumors (benign or malignant), now or in history.
• Identification of hormone-dependent malignant disease (including the genitals or mammary glands) or suspicion on them.
• Vaginal bleeding of unknown origin.
• Pregnancy or suspicion of it.
• The period of lactation.
• Hypersensitivity to any component of the drug Jeanine.
• Prolonged immobilization, major surgery, surgery on his feet, extensive injuries.

Pregnancy:

Janine is not appointed during pregnancy and lactation.

If pregnancy is detected during treatment Jeanine, the drug immediately canceled. However, extensive epidemiological studies have revealed no increased risk of developmental defects in children born to women treated with hormones prior to pregnancy or teratogenicity when sex hormones are taken inadvertently in early pregnancy.

COC may reduce the amount of breast milk and alter its composition, therefore, their use is contraindicated during lactation. A small amount of sex steroids and / or their metabolites can be displayed with the milk, but there is no confirmation of their negative impact on the health of the newborn.

Interaction with other drugs:

Sulfonamides, pyrazolone derivatives can enhance the metabolism of members of the steroid drug.

Prolonged treatment with drugs that induce liver enzymes, which resulted in increased clearance of sex hormones can lead to breakthrough bleeding and / or reduce the contraceptive efficacy of Jeanine.

These medicines include: phenytoin, barbiturates, primidone, carbamazepine and rifampicin; also has suggestions for oxcarbazepine, topiramate, felbamate, ritonavir, and griseofulvin and products containing St John's wort.

Contraceptive protection is reduced by antibiotics (such as ampicillin and tetracyclines), because, according to some sources, some antibiotics may reduce intrahepatic circulating estrogen, thereby lowering the concentration of ethinyl estradiol.

Combined oral contraceptives can affect the metabolism of other drugs (including cyclosporin), which leads to a change in their concentrations in plasma and tissues.

When receiving estrogen-progestin drugs may require adjustment of hypoglycemic drug dosage regimen and indirect anticoagulants.

Overdose:

Symptoms that may occur in overdose: Nausea, vomiting, spotting or metrorrhagia.

There is no specific antidote, treatment should be symptomatic.

Product:

21 pills in a package (blister) of PVC film and coated with aluminum foil to cover. Blister of 21 tablets or 3 blisters on 21 tablets with instructions for use is placed in a cardboard box.

Storage Conditions:

Store at temperatures not above 25 ° C in places inaccessible to children.

Shelf life - 3 years.

You can not use after expiry date.

Ingredients:

Smooth white pills.

Each tablet contains:

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

The drug should be used with caution in the following cases:

• Expressed by fat metabolism disorders (obesity, hyperlipidemia);
• Thrombophlebitis of superficial veins;
• Otosclerosis with hearing loss, idiopathic jaundice or itching during previous pregnancy;
• Epilepsy;
• Migraine with aura;
• Congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor);
• Diabetes;
• Systemic lupus erythematosus;
• Hemolytic uremic syndrome;
• Crohn's disease;
• Sickle-cell anemia;
• Arterial hypertension.

In the case of the planned operation is recommended to stop taking the drug for at least 4 weeks prior to her and not to resume reception for 2 weeks after immobilization.

While taking the drugs that affect microsomal enzymes, and within 28 days after their cancellation should additionally use a barrier method of contraception.

During antibiotic treatment (such as ampicillin and tetracycline) and within 7 days after their cancellation should additionally use a barrier method of contraception.

If the period of use of barrier methods of protection ends later than the pills in a package, you need to move to the next pack without the usual interval Jeanine admission drops.

If any of the conditions / risk factors listed below are currently available, it should carefully weigh the potential risks and expected benefits of the treatment Jeanine in each individual case and discuss it with the woman before she decides to start taking the drug. In the case of aggravation, amplification, or the first manifestation of any of these conditions or risk factors, the woman should consult with their physician, who may decide to repeal the drug.

Diseases of the cardiovascular system:

There is evidence of increased incidence of venous and arterial thrombosis and thromboembolism with COC.

However, the frequency of venous thromboembolism (VTE), developed during COC use is less than the frequency associated with pregnancy (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, are described extremely rare cases, thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, central retinal vein and its branches. Communication with COC has not been proved.

Woman should stop taking the drug and consult a doctor if symptoms develop venous or arterial thrombosis or cerebrovascular disorders, which may include: unilateral leg pain and / or swelling, sudden severe chest pain, with or without irradiation in the left arm, sudden shortness of breath; sudden attack of coughing, any unusual, severe, prolonged headache, sudden partial or complete loss of vision, diplopia, slurred speech or aphasia, dizziness, loss of consciousness with or without seizures, weakness or very marked numbness suddenly appeared on the one hand or one part of the body, movement disorders, symptoms of "acute abdomen".

Risk of thrombosis (venous and / or arterial) and venous thromboembolism is increased:

• With age;
• Smokers (with an increase in the number of cigarettes or increasing age the risk further increases, especially in women older than 35 years);

If:

• Family history (ie venous or arterial thromboembolism ever have relatives or parents at a relatively young age) in the case of hereditary predisposition, a woman should be assessed and appropriate referrals to address the issue of the possibility of COCs;
• Obesity (body mass index over 30 kg/m2);
• Dyslipoproteinemia;
• Hypertension;
• Migraine;
• Valvular heart disease;
• Atrial fibrillation;
• Prolonged immobilisation, major surgery, any surgery on the feet or major trauma. In these situations it is desirable to discontinue the use of combined oral contraceptives (in the case of the planned operation, at least four weeks before her) and not to renew the reception for two weeks after immobilization.

Should take into account the increased risk of thromboembolism in the postpartum period.

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

Increased frequency and severity of migraine during the use of combined oral contraceptives (which may be preceded by cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

Biochemical parameters which may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin-III, deficiency of protein C deficiency protein S, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).

Tumors:

There are reports of increased risk of cervical cancer with prolonged use of combined oral contraceptives. His connection with the COC has not been proved. Reserved controversy regarding the extent to which these findings relate to the peculiarities of sexual behavior and other factors, such as human papillomavirus (HPV).

It was also revealed that there are slightly elevated relative risk of breast cancer diagnosed in women who used combined oral contraceptives. His connection with the COC has not been proved. The observed increase in risk may be due to earlier diagnosis of breast cancer among women using combined oral contraceptives.

In rare cases during treatment with COCs observed the development of liver tumors. In case of severe abdominal pain, liver enlargement or signs of intraabdominal bleeding is to be considered in the differential diagnosis.

Other states:

Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant improvement occurred rarely. Nevertheless, if during the COC develops persistent, clinically significant increase in blood pressure, these drugs should be abolished and begin treatment of hypertension. COC can be extended if with antihypertensive therapy achieved normal blood pressures.

The following conditions were reported, develop or worsen as during pregnancy and during COC use, but their connection with the COC has not been proved: jaundice and / or itching associated with cholestasis, the formation of gallstones; porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, chorea, herpes, pregnancy, hearing loss associated with otosclerosis. Also described cases of Crohn's disease and ulcerative colitis during treatment with combined oral contraceptives.

Acute or chronic liver function abnormalities may require a cessation of the use of combined oral contraceptives, as long as liver function tests are not back to normal. Recurrent cholestatic jaundice, which developed the first time during pregnancy or a previous admission of sex hormones, requires discontinuation of COCs.

Although combined oral contraceptives may have an impact on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetics using low-dose combined oral contraceptives (<0.05 mg ethinyl estradiol). Nevertheless, women with diabetes should be monitored closely while taking combined oral contraceptives.

Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged sun exposure and ultraviolet radiation.

COC may affect the results of certain lab tests, including indicators of liver function, kidney, thyroid and adrenal glands, levels of transport proteins in plasma, indicators of glucose metabolism, parameters of coagulation and fibrinolysis. Changes do not usually go beyond the normal range.

While taking combined oral contraceptives may experience irregular bleeding (spotting or breakthrough bleeding) especially during the first months of use. Therefore, evaluation of any irregular bleeding should be undertaken only after an adaptation period of approximately three cycles.

If irregular bleeding recur or develop after the previous regular cycles, you should conduct a thorough examination to exclude malignancy or pregnancy.

In some women, during a break in the reception pills may not develop withdrawal bleeding. If combined oral contraceptives are taken according to instructions, it is unlikely that a woman is pregnant. However, if before that combined oral contraceptives are taken irregularly or if there are no two consecutive withdrawal bleeding, to continue taking the drug should be ruled out pregnancy.

Before starting the drug Jeanine woman advised to undergo a thorough general medical and gynecological examination (including a study of breast and cytology of cervical mucus) to exclude pregnancy. Furthermore, it should eliminate violations of the blood coagulation system.

In case of prolonged use of the drug should be every 6 months to carry out control examinations.

Should notify the woman that drugs such as Janine did not protect against HIV infection (AIDS) and other sexually transmitted infections!

Impact on driving ability and technique is not revealed.

Attention!

Before using the drug Jeanine you should consult your doctor. This instruction is given a free transfer and is intended solely for information. For more information, please contact the manufacturer annotations.

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