Jeanine is a low-dose monophasic oral combined estrogen-gestagenic contraceptive product.
The contraceptive effect of Zhanin is carried out through three complementary mechanisms:
– inhibition of ovulation at the level of hypothalamic-pituitary regulation;
– changes in the properties of the cervical secret, as a result of which it becomes impermeable to spermatozoa;
– changes in the endometrium, which makes it impossible to implant a fertilized egg.
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity is reduced, resulting in a reduced risk of iron deficiency anemia.
Absorption. After oral administration, dienogest is rapidly and completely absorbed, its highest serum concentration of 52 ng / ml is reached after about 2.5 hours. Bioavailability is approximately 91-96%.
Distribution. Dienogest binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) and corticoid-binding globulin (CBG). In free form, it is within 10% of the total concentration in blood serum; within 90% – not specifically associated with serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to whey protein.
Metabolism. Dienogest is almost completely metabolized. Serum clearance is approximately 3.4-3.7 l/h.
Withdrawal. The half-life is within 8.5-10.8 hours. A small amount in unchanged form is excreted in the urine, in the form of metabolites (T1 / 2 – 14.4 hours), excreted in the urine and bile in a ratio of approximately 3: 1.
equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHBG in the blood serum. As a result, every day of taking the product, the level of the substance in the serum increases by about 1.5 times.
Absorption. After oral administration, ethinylestradiol is rapidly and completely absorbed. The maximum concentration in blood serum, equal to approximately 67 pg / ml, is reached in 1.5-4 hours. During absorption and first passage through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability of approximately 44%.
Distribution. Ethinylestradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8 – 8.6 l / kg.
Metabolism. Ethinylestradiol undergoes presystemic conjugation both in the small intestine mucosa and in the liver. The main metabolic pathway is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3 – 7 ml / min / kg.
Withdrawal. The decrease in the concentration of ethinylestradiol in the blood serum is biphasic; the first phase is characterized by a half-life within 1 hour, the second – 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of 4: 6 with a half-life of 24 hours.
Equilibrium concentration. The equilibrium concentration is reached during the second half of the treatment cycle.
Jeanine (Zhanin) method of administration and doses:
Dragee should be taken orally in the order indicated on the pack, every day at about the same time, with a little water. Take one tablet per day continuously for 21 days. The next pack is started after a 7-day break in taking the pills, during which withdrawal bleeding usually occurs. Bleeding, as a rule, begins 2-3 days after taking the last dragee and may not end before the start of a new package.
How to start taking Jeanine
• In the absence of taking any hormonal contraceptives in the previous month.
Janine is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking 2-5 menstrual cycles, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.
• When switching from other combined oral contraceptives.
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 products containing 21 pills) or after taking the last inactive dragee ( for products containing 28 tablets per pack).
• When switching from contraceptives containing only gestagens (mini-pili, injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive (Mirena).
A woman can switch from a mini-pill to Jeanine any day (without a break), from an implant or intrauterine contraceptive with a progestogen – every day of its removal, from an injection form – from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
• After an abortion in the first trimester of pregnancy.
The woman can start taking the product 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 product 21-28 days after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had a sexual life, pregnancy must be excluded before taking Zhanina, or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking the product was less than 12 hours, contraceptive protection is not reduced. A woman is obliged to take the pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:
• The product should never be interrupted for more than 7 days.
• 7 days of continuous intake of dragees are required to achieve adequate inhibition of the hypothalamic-pituitary-ovarian regulation.
Accordingly, the following advice can be given if the delay in taking the dragee was more than 12 hours (the interval from the moment of taking the last dragee is more than 36 hours):
• First week of taking the product
A woman is obliged to take the missed pill later on as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before skipping the dragee, it is necessary to take into account the likelihood of pregnancy.
The more pills missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.
• Second week of taking the product
A woman is obliged to take the missed pill later on as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next dragee is taken at the usual time.
Provided that the woman has taken the pill correctly for 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, also when missing two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
• Third week of taking the product
The risk of reduced reliability is inevitable due to the impending break in taking pills.
A woman must strictly adhere to one of the two following options. Moreover, if in the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.
1. A woman is obliged to take the last missed pill as soon as possible, as soon as she remembers (even if it means taking two pills at the same time). The next dragee is taken at the usual time until the dragees from the current package run out. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pills.
2. A woman can also stop taking the dragee from the current package. Then she must take a break for 7 days, including the day of skipping the dragee, and then start taking a new package.
If a woman misses taking the pills, and then during the break in taking the pills she does not have withdrawal bleeding, pregnancy should be excluded.
If a woman has had vomiting or diarrhea up to 4 hours after taking active pills, absorption may not be complete and additional contraceptive measures should be taken. In these cases, it is necessary to focus on the recommendations when skipping the dragee.
In order to delay the onset of menstruation, a woman must continue taking the pills from the new Jeanine package immediately after taking all the pills from the previous one, without interrupting the intake. Dragees from this new package can be taken for as long as the woman wishes (until the pack runs out). While taking the product from the second package, a woman may experience spotting or breakthrough uterine bleeding. It is necessary to resume taking Jeanine from a new pack after the usual 7-day break.
In order to move the day of the onset of menstruation to another day of the week, a woman should be advised to shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and subsequently spotting and breakthrough bleeding during the second pack (as in the case when she would like to delay the onset of menstruation. In order to delay the beginning of menstruation, the woman is obliged to continue taking the product, using the next 10 tablets from another package of Jeanine, without interrupting the intake.Thus, the cycle can be extended for a period of up to 10 days until the end of the second package. While taking the product from the second package, a woman may experience spotting or breakthrough uterine bleeding. The regular intake of Jeanine is then resumed after the usual 7-day break in taking the dragee.
In order to move the day of the onset of menstruation to another day of the week, a woman should shorten the next break in taking pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, spotting and breakthrough bleeding later on while taking the second pack (same as if she would like to delay the onset of her period).
Jeanine 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 taking the drug, the product should be immediately discontinued.
• Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
• Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
• Migraine with a history of focal neurological symptoms.
• Diabetes mellitus with vascular complications.
• Multiple or prominent risk factors for venous or arterial thrombosis, including valvular heart disease, cardiac arrhythmias, cerebrovascular or coronary artery disease; uncontrolled arterial hypertension.
• Pancreatitis with severe hypertriglyceridemia at present or in history.
• Liver failure and severe liver disease (until liver tests return to normal).
• Liver tumors (benign or malignant) at present or in history.
• Identified hormone-dependent malignant diseases (including the genital organs or mammary glands) or suspicion of them.
• Vaginal bleeding of unknown origin.
• Pregnancy or suspicion of it.
• Breastfeeding period.
• Hypersensitivity to any of the components of the Janine product.
• Prolonged immobilization, major surgery, leg surgery, extensive trauma.
Jeanine (Zhanin) side effects:
Soreness and tension of the mammary glands, enlargement of the mammary glands, discharge from the mammary glands; spotting and breakthrough uterine bleeding; headache; migraine; change in libido; decrease/changes in mood; poor tolerance to contact lenses; visual impairment; nausea; vomit; stomach ache; changes in vaginal secretion; skin rash; erythema nodosum; erythema multiforme; generalized itching; cholestatic jaundice; fluid retention; change in body weight; allergic reactions. Rarely – an increase in the level of plasma triglycerides, a decrease in carbohydrate tolerance, high fatigue, diarrhea.
Occasionally, chloasma may develop, especially in women with a history of chloasma during pregnancy.
As with other combined oral contraceptives, in rare cases, thrombosis and thromboembolism may develop.
Jeanine is not prescribed during pregnancy and lactation.
If pregnancy is detected while taking Janine, the product should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of developmental defects in babies born to women who received sex hormones before pregnancy or teratogenic effects when sex hormones were inadvertently taken in early pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. A small amount of sex steroids and / or their metabolites can be excreted in milk, but there is no evidence of their negative impact on the health of the newborn.
There is no specific antidote, symptomatic treatment should be carried out.
Use with other drugs:
Sulfonamides, pyrazolone derivatives, can increase the metabolism of steroid hormones that make up the product.
Long-term treatment with products that induce liver enzymes, resulting in increased clearance of sex hormones, may lead to breakthrough bleeding and / or a decrease in the contraceptive effectiveness of Jeanine.
These drugs include: phenytoin, barbiturates, primidone, carbamazepine and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and products containing St. John’s wort.
Contraceptive protection is reduced when taking antibiotics (such as ampicillins and tetracyclines), since, according to some reports, some antibiotics can reduce the intrahepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.
Oral combined contraceptives can affect the metabolism of other products (including cyclosporine), which leads to a change in their concentration in plasma and tissues.
When taking estrogen-progestin products, it may be necessary to adjust the dosing regimen of hypoglycemic products and indirect anticoagulants.
21 pills in a pack (blister) made of PVC film and covered with coated aluminum foil. A blister of 21 tablets or 3 blisters of 21 tablets, together with instructions for use, is placed in a cardboard box.
Store at a temperature not exceeding 25 ° C in places inaccessible to children.
The shelf life is 3 years.
Cannot be used after the expiration date.
Conditions for dispensing from pharmacies – by prescription.
Jeanine (Zhanin) composition:
White smooth pills.
Each dragee contains:
– active ingredients: 0.03 mg of ethinyl estradiol and 2.0 mg of dienogest.
– excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, sugar syrup, polyvidone K 25, macrogol 35000, calcium carbonate, titanium dioxide (E 171), carnauba wax.
The drug should be used with caution in the following cases:
– severe disorders of fat metabolism (obesity, hyperlipidemia);
– thrombophlebitis of superficial veins;
– otosclerosis with hearing impairment, idiopathic jaundice or itching during a previous pregnancy;
– migraine with aura;
– congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
– systemic lupus erythematosus;
– hemolytic uremic syndrome;
– Crohn’s disease;
– sickle cell anemia;
– arterial hypertension.
In the case of a planned operation, it is recommended to stop taking the product at least 4 weeks before it and not to resume taking it for 2 weeks after the end of immobilization.
During the intake of products that affect microsomal enzymes, and for 28 days after their withdrawal, it is necessary to additionally use a barrier method of contraception.
While taking antibiotics (such as ampicillins and tetracyclines) and for 7 days after their withdrawal, an additional barrier method of contraception should be used.
If the period of using the barrier method of protection ends later than the pills in the pack, you need to move on to the next pack of Jeanine without the usual break in taking the pills.
If any of the conditions/risk factors listed below are currently present, then the potential risk and expected benefit of treatment with Jeanine should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the product. In case of worsening, worsening or first manifestation of any of these conditions or risk factors, the woman is obliged to consult her doctor, who can decide whether to discontinue the product.
• Diseases of the cardiovascular system
There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.
However, the frequency of venous thromboembolism (VTE) developing when taking combined oral contraceptives is less than the frequency associated with pregnancy (6 per 10,000 pregnant women per year).
In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The relationship with the use of combined oral contraceptives has not been proven.
A woman should stop taking the product and consult a doctor if symptoms of venous or arterial thrombosis or cerebrovascular disorders develop, which may include: unilateral leg pain and / or swelling; sudden severe chest pain, with or without radiating to the left arm; sudden shortness of breath; a 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 a seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; movement disorders; symptoms of an acute abdomen.
The risk of thrombosis (venous and / or arterial) and thromboembolism increases:
– in smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old);
in the presence of:
– a family history (i.e. venous or arterial thromboembolism ever or in close relatives or parents at a relatively young age); in the case of a hereditary predisposition, the woman must be examined by an appropriate specialist to decide on the possibility of taking COCs;
obesity (body mass index over 30 kg/m2);
– arterial hypertension;
– diseases of the heart valves;
– atrial fibrillation;
– prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking it for two weeks after the end of immobilization.
An increased risk of thromboembolism in the postpartum period should be taken into account.
Circulatory disturbances 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 disorders) may be grounds for immediate discontinuation of these products.
Biochemical parameters that may be indicative of a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
There have been reports of an increased risk of developing cervical cancer with long-term use of combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings relate to sexual behavior and other factors such as human papillomavirus (HPV).
It has also been found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives.
In rare cases, against the background of the use of combined oral contraceptives, the development of liver tumors was observed. In the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
• Other states
Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of developing 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 increases were not often noted. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these products should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn’s disease and non-specific ulcerative colitis have also been described with the use of combined oral contraceptives.
Acute or chronic liver dysfunction may require discontinuation of the use of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of combined oral contraceptives.
Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0.05 mg ethinyl estradiol). However, women with diabetes should be closely monitored while taking combined oral contraceptives.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be carried out only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops as a result of previous regular cycles, a thorough examination should be carried out to rule out malignant neoplasms or pregnancy.
Some women may not develop withdrawal bleeding during the pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy must be excluded before continuing to take the product.
Before starting the use of the Janine product, a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy. In addition, it is necessary to exclude violations of the blood coagulation system.
In the case of long-term use of the product, it is necessary to carry out control examinations after 6 months.
A woman should be warned that products like Jeanine do not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Effects on the ability to drive a car and machinery have not been identified.