In this article, you can read the instructions for using contraceptive medicinal product Janine. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Zhanin in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Zhanin analogues in the presence of existing structural analogues. Use for contraception in healthy women. Side effects(bleeding, pain), as well as during pregnancy while taking the drug.
Janine- low-dose monophasic oral combined estrogen-progestin contraceptive drug.
The contraceptive effect of Jeanine is mediated through complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, making it impermeable to spermatozoa.
At correct application the Pearl index (an indicator that reflects the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If you miss pills or misuse, the Pearl index may increase.
The gestagenic 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 high density lipoproteins).
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of developing iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial cancer and ovarian cancer.
Pharmacokinetics
After oral administration, dienogest is rapidly and completely absorbed from the gastrointestinal tract. Dienogest is almost completely metabolized. A small part of dienogest is excreted by the kidneys in an unchanged state. Metabolites are excreted in the urine and bile in a ratio of about 3:1.
After oral administration, ethinylestradiol is rapidly and completely absorbed. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6.
Indications for admission
Release form
Dragee 2mg + 30mcg (not available as tablets).
Instructions for use and dosing regimen
Dragee should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Jeanine should be taken 1 tablet per day continuously for 21 days. Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.
Start taking Jeanine
In the absence of taking any hormonal contraceptives in the previous month, Zhanin is started on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the pills from the first package.
When switching from combined oral contraceptives, vaginal ring, transdermal patch, Jeanine should be started the next day after taking the last active pill from the previous package, but in no case not later than the next day after the usual 7-day break in taking (for preparations containing 21 pills) or after taking the last inactive pill (for preparations containing 28 pills per pack). When switching from a vaginal ring, a transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day a new ring or patch is to be inserted or pasted.
When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive (Mirena), a woman can switch from taking "mini-pill" to Jeanine on any day (without a break), with implant or intrauterine contraceptive with a progestogen - on the day of its removal, from an injectable contraceptive - on the day when the next injection should be 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 1st 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 childbirth or abortion in the 2nd 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 dragee. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Zhanin, or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking pills is less than 12 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, the next pill 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:
Accordingly, if the delay in taking active dragees was more than 12 hours (the interval from the moment of taking the last active dragee is more than 36 hours), the following can be recommended:
First week of taking the drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets 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 within a week before skipping the dragee, the likelihood of pregnancy should be considered. 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 drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next dragee is taken at the usual time. Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the drug
The risk of pregnancy increases due to the upcoming break in taking pills. A woman must strictly adhere to one of the two following options. Moreover, if during the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.
If a woman misses taking the pills, and then during the break in taking 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, you should be guided by the recommendations when skipping the dragee.
Changing the start date of the menstrual cycle
To delay the onset of menstruation, a woman should continue taking the pills from the new Jeanine package immediately after all the pills from the previous one have been taken, without interruption in the reception. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Janine from a new package after the usual 7-day break.
To move the day of the start of menstruation to another day of the week, a woman should 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 will have spotting in the future. bloody issues and breakthrough bleeding while taking the second pack (same as when she would like to delay the onset of her period).
Additional information for special categories of patients
For children and adolescents, Jeanine is indicated only after the onset of menarche.
After the onset of menopause, Jeanine is not indicated.
Jeanine is contraindicated in women with severe liver disease until liver function tests return to normal.
Side effects
Contraindications
Jeanine should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be immediately discontinued.
Use during pregnancy and lactation
Jeanine is not prescribed during pregnancy and during breastfeeding.
If pregnancy is detected while taking Janine, the drug should be discontinued immediately. However, extensive epidemiological studies have not found an increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken in early dates pregnancy.
Taking combined oral contraceptives may reduce the number of breast milk and change its composition, therefore, their use is contraindicated in lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.
special instructions
Before starting or resuming the use of the drug Jeanine, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and cytological examination scraping from the cervix (Pap test), to exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. In general, follow-up examinations should be carried out at least once a year.
A woman should be informed that Jeanine does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased 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 have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs 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.
Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in patients diabetes using low-dose combined oral contraceptives (less than 50 micrograms of ethinyl estradiol). However, women with diabetes should be closely monitored while taking combined oral contraceptives.
The effectiveness of combined oral contraceptives may be reduced by missing pills, vomiting and diarrhea, or as a result of drug interactions.
Effect on the menstrual cycle
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles. If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude 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 should be excluded before continuing to take the drug.
Impact on lab test scores
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.
Influence on the ability to drive vehicles and control mechanisms
Not found.
drug interaction
Interactions of oral contraceptives with other medicinal products may result in breakthrough bleeding and/or reduced contraceptive reliability.
According to separate studies, some antibiotics (eg, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol.
While taking any of the above medicines a woman should additionally use a barrier method of contraception (for example, a condom).
Dienogest is a cytochrome P450 (CYP)3A4 substrate. Known inhibitors of CYP3A4, such as azole antifungals (eg, ketoconazole), cimetidine, verapamil, macrolides (eg, erythromycin), diltiazem, antidepressants, and grapefruit juice, may increase dienogest plasma levels.
While taking antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If the period of using the barrier method of protection ends later than the pills in the package, you need to move on to the next package of Jeanine without the usual break in taking the pills.
Oral combined contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
Zhanin's analogues
Structural analogues for the active substance:
In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.
Jeanine (ethinylestradiol + dienogest) - combined oral contraceptive from the German pharmaceutical company Bayer Schering Pharma AG. The products of this company are known all over the world. Suffice it to say that Anovlar, the first oral contraceptive in Europe, is also a merit of Bayer Schering Pharma AG. Since then, work on the development of effective and safe contraceptives has advanced significantly. Research has developed in two directions: determining the optimal dose of estrogen and creating improved next-generation progestins. The crown of this work was the development of dienogest, an innovative progestin, which is the active ingredient in the contraceptive Jeanine. Unlike progestins of earlier generations, dienogest does not contain an ethynyl group, which excludes the possibility of its effect on cytochrome-dependent liver enzymes. In addition to this, dienogest has a very short half-life, so it does not accumulate in the body. The innovativeness of the composition gives Jeanine a high degree of contraceptive reliability, the ability to have a positive effect on the menstrual cycle (reduce the intensity and reduce the duration of bleeding, eliminate their pain), which, in turn, minimizes the risk of developing iron deficiency anemia. Dienogest is devoid of androgenic properties (what other gestagens "sin" with). Moreover, it has the most positive effect on hair and skin (reduces the size of the sebaceous glands, suppresses excessive secretion of sebum), which gives Jeanine not only a therapeutic, but also an aesthetic effect. The results of multicenter, randomized, placebo-controlled clinical trials have demonstrated the high efficacy and favorable safety profile of Zhanin.
The same was confirmed by post-marketing studies conducted after the release of the drug on the global pharmaceutical market.
The contraceptive action of Jeanine is realized through several physiological patterns that complement each other, the key of which are the obstruction of ovulation and the increase in the density of cervical mucus in the epithelium of the cervical canal, due to which spermatozoa cannot penetrate the egg. Rules for taking the drug - every day at approximately the same time in strict accordance with that indicated in the leaflet. The beginning of the reception should coincide with the beginning of the menstrual cycle. Duration of admission - 3 weeks. Multiplicity of reception - once a day. A new pack of Jeanine must be started seven days after the previous one has ended. Skipping the next dose within 12 hours does not reduce contraceptive protection. In this case, the next dose should be taken as soon as possible. If more than 12 hours late, the contraceptive effect is reduced. A decrease in the contraceptive effect also occurs in case of vomiting and diarrhea within 4 hours after taking the drug. Janine is not indicated for women during menopause. Before prescribing the drug, it is necessary to collect comprehensive anamnestic data about the woman and her family, conduct a series of diagnostic studies, including measuring blood pressure, heart rate, determining BMI, examining the mammary glands, and a Papanicolaou test. The need for additional laboratory and instrumental studies is determined individually in each case.
Low-dose monophasic oral combined estrogen-progestogen contraceptive drug.
The contraceptive effect of Jeanine is mediated through complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, making it impermeable to spermatozoa.
When used correctly, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.
The gestagenic component of 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 high density lipoproteins).
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of developing iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial cancer and ovarian cancer.
Dienogest
Suction
After oral administration, dienogest is rapidly and completely absorbed from the gastrointestinal tract. C max is reached after 2.5 hours and is 51 ng / ml. Bioavailability is approximately 96%.
Distribution
Dienogest binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% - non-specifically associated with serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to serum protein.
The pharmacokinetics of dienogest is not affected by the level of SHBG in the blood serum. As a result of daily administration of the drug, the level of dienogest in serum increases by about 1.5 times.
Metabolism
Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 l/h.
breeding
T1 / 2 is about 8.5-10.8 hours. A small part of dienogest is excreted by the kidneys in an unchanged state. Metabolites are excreted in the urine and bile in a ratio of about 3:1 with a T 1/2 equal to 14.4 hours.
Ethinylestradiol
Suction
After oral administration, ethinylestradiol is rapidly and completely absorbed. C max in blood serum is reached after 1.5-4 hours and is 67 pg / ml. During absorption and "first pass" through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability averaging about 44%.
Distribution
Ethinylestradiol is almost completely (approximately 98%), although non-specifically bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent V d of ethinylestradiol is 2.8-8.6 l / kg.
C ss is achieved during the second half of the treatment cycle.
Metabolism
Ethinylestradiol undergoes presystemic conjugation, both in the mucosa of the small intestine 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.
breeding
The decrease in the concentration of ethinylestradiol in the blood serum is biphasic; the first phase is characterized by T 1/2 of the first phase - about 1 hour, T 1/2 of the second phase - 10-20 hours. It is not excreted unchanged from the body. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6 with a T 1/2 of about 24 hours.
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.
Shell composition: 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 pcs. - blisters (1) - packs of cardboard.
21 pcs. - blisters (3) - packs of cardboard.
Dragee should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Janine ® should be taken 1 tablet / day continuously for 21 days. Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.
Start taking Jeanine
In the absence of taking any hormonal contraceptives in the previous month, Zhanin is started on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the pills from the first package.
When switching from combined oral contraceptives, a vaginal ring, a transdermal patch, Janine should be taken 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 taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). When switching from a vaginal ring, a transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day a new ring or patch is to be inserted or pasted.
When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive (Mirena), a woman can switch from taking "mini-pill" to Jeanine ® on any day (without interruption), from an implant or intrauterine contraceptive with a progestogen - on the day of its removal, from an injectable contraceptive - on the day when the next injection should be 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, 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 II trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the II 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 dragee. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Zhanin, or it is necessary to wait for the first menstruation.
Taking missed pills
If the delay in taking pills is less than 12 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, the next pill 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:
Accordingly, if the delay in taking active dragees was more than 12 hours (the interval from the moment of taking the last active dragee is more than 36 hours), the following can be recommended:
First week of taking the drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets 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 within a week before skipping the dragee, the likelihood of pregnancy should be considered. 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 drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next dragee is taken at the usual time. Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the drug
The risk of pregnancy increases due to the upcoming break in taking pills. A woman must strictly adhere to one of the two following options. Moreover, if during the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.
1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers it (even if this requires taking two tablets 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 without interruption. 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 should take a break for 7 days, including the day she skipped the dragee, and then start taking a new package.
If a woman misses taking the pills, and then during the break in taking 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, you should be guided by the recommendations when skipping the dragee.
Changing the start date of the menstrual cycle
To delay the onset of menstruation, a woman should continue taking the pills from the new Jeanine package immediately after all the pills from the previous one have been taken, without interruption in the reception. Dragees from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Janine from a new package after the usual 7-day break.
To move the day of the start of menstruation to another day of the week, a woman should 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 will have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).
Additional information for special categories of patients
For children and adolescents, Jeanine ® is indicated only after the onset of menarche.
After the onset of menopause, the drug Janine ® is not indicated.
Jeanine ® is contraindicated in women with severe liver disease until liver function tests are normal.
Janine® has not been specifically studied in patients with impaired renal function. Available data do not suggest a change in treatment in these patients.
Serious violations in case of overdose have not been reported.
Symptoms: nausea, vomiting, spotting or metrorrhagia.
Treatment: carry out symptomatic therapy. There is no specific antidote.
Interactions of oral contraceptives with other medicinal products may result in breakthrough bleeding and/or reduced contraceptive reliability.
The following types of interaction have been reported in the literature.
Effect on hepatic metabolism
The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.
HIV protease inhibitors (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and combinations thereof also have the potential to interfere with hepatic metabolism.
Effects on enterohepatic circulation
According to separate studies, some antibiotics (eg, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol.
While 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 cytochrome P450 (CYP)3A4 substrate. Known inhibitors of CYP3A4, such as azole antifungals (eg, ketoconazole), cimetidine, verapamil, macrolides (eg, erythromycin), diltiazem, antidepressants, and grapefruit juice, may increase dienogest plasma levels.
While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.
While taking antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If the period of using the barrier method of protection ends later than the pills in the package, you need to move on to the next package of Jeanine without the usual break in taking the pills.
Oral combined contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. While taking the drug Janine ® in women, other undesirable effects were observed, indicated in the table below. Within each group, allocated depending on the frequency of an undesirable effect, undesirable effects are presented in order of decreasing severity.
Determining the frequency of adverse reactions: often (≥1 / 100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000). Для дополнительных побочных реакций, выявленных только в процессе постмаркетинговых наблюдений и для которых оценку частоты провести не представляется возможным, указано - частота неизвестна.
| Often (≥1/100 and<1/10) | Infrequently (≥1/1000 and<1/100) | Seldom (≥1/10,000 and<1/1000) | Frequency unknown |
| Infections and contagion | |||
| Vaginitis/vulvovaginitis Vaginal candidiasis or other vulvovaginal infections | Salpingoophoritis (adnexitis) Urinary tract infections Cystitis Mastitis cervicitis Fungal infections Candidiasis Herpetic lesions of the oral cavity Flu Bronchitis Sinusitis Upper respiratory tract infections Viral infections | ||
| Benign, malignant and unspecified tumors (including cysts and polyps) | |||
| uterine fibroids Breast lipoma | |||
| Blood and lymphatic system | |||
| Anemia | |||
| Endocrine system | |||
| virilization | |||
| Metabolism | |||
| Increased Appetite | Anorexia | ||
| Psychiatric disorders | |||
| Decreased mood | Depression Mental disorders Insomnia Sleep disorders Aggression | Mood changes Decreased libido Increased libido |
|
| Nervous system | |||
| Headache | Dizziness Migraine | Ischemic stroke Cerebrovascular disorders Dystonia | |
| sense organs | |||
| Dryness of the mucous membrane of the eyes Irritation of the mucous membrane of the eyes Oscillopsia Sudden hearing loss Noise in ears Dizziness Hearing loss | Contact lens intolerance (discomfort when wearing them) | ||
| The cardiovascular system | |||
| Arterial hypertension Arterial hypotension | Cardiovascular disorders Tachycardia, including increased heart rate Thrombosis/thromboembolism of the pulmonary artery Thrombophlebitis diastolic hypertension Orthostatic circulatory dystonia tides Phlebeurysm Vein pathology Pain in the veins | ||
| Respiratory system | |||
| Bronchial asthma Hyperventilation | |||
| Digestive system | |||
| Abdominal pain, including upper and lower abdominal pain, discomfort/bloating Nausea Vomit Diarrhea | Gastritis Enteritis Dyspepsia | ||
| Dermatological reactions | |||
| acne Alopecia Rash, including macular rash Itching, including generalized itching | Atopic dermatitis/neurodermatitis Eczema Psoriasis Hyperhidrosis Chloasma Impaired pigmentation/hyperpigmentation seborrhea Dandruff hirsutism Pathological skin changes Orange peel Vascular asterisks | Erythema multiforme | |
| allergic reactions | |||
| Manifestations of allergic reactions, including allergic dermatitis | Hives erythema nodosum |
||
| Musculoskeletal system | |||
| Back pain Feeling of discomfort in the muscles and bones Myalgia Pain in the limbs | |||
| Reproductive system and mammary glands | |||
| Breast pain, discomfort, breast engorgement | Abnormal withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, and amenorrhea Intermenstrual bleeding, including vaginal bleeding and metrorrhagia An increase in the size of the mammary glands, swelling and a feeling of fullness of the mammary glands Swelling of the mammary gland Dysmenorrhea Discharge from the genital tract/discharge from the vagina ovarian cysts Pain in the pelvic area | cervical dysplasia Adnexal cysts Pain in the uterine appendages Breast cysts Fibrocystic mastopathy Dipareunia Galactorrhea Menstrual irregularities | Discharge from the mammary glands |
| General symptoms | |||
| Fatigue Asthenia Bad feeling | Chest pain Peripheral edema Flu-like symptoms Inflammation Temperature rise Irritability | Fluid retention | |
| Survey results | |||
| Changes in body weight (increase, decrease and fluctuations in body weight) | An increase in the level of TG in the blood Hypercholesterolemia | ||
| Congenital and genetic disorders | |||
| Detection of an additional mammary gland / polymastia | |||
In women receiving combined oral contraceptives, the following undesirable effects have been reported: venous thromboembolic complications, arterial thromboembolic complications, cerebrovascular complications, arterial hypertension, hypertriglyceridemia, changes in glucose tolerance or effects on insulin resistance of peripheral tissues, liver tumors (benign or malignant), disorders liver function, chloasma.
In women with hereditary angioedema, exogenous estrogens may exacerbate symptoms.
The occurrence or aggravation of conditions for which the relationship with the use of combined oral contraceptives has not been clearly proven: jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus; hemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnancy, otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.
In women using combined oral contraceptives, there is a very small increase in the incidence of breast cancer. Because breast cancer rarely occurs in women under 40 years of age, given the overall risk of developing breast cancer, the additional number of cases is very small. The relationship with the use of combined oral contraceptives is not known.
Janine ® should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be immediately discontinued.
Carefully
The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases / conditions and risk factors:
Jeanine ® is not prescribed during pregnancy and during breastfeeding.
If pregnancy is detected while taking Janine, the drug should be discontinued immediately. However, extensive epidemiological studies have not found an increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenicity when sex hormones were inadvertently taken early in pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.
If abnormal liver function occurs, Zhanin may need to be temporarily discontinued until laboratory parameters return to normal. With the development of cholestatic jaundice or cholestatic pruritus (first encountered during pregnancy or previous use of sex hormones), Janine ® should be discontinued.
Before starting or resuming the use of the drug Janine ®, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and a cytological examination of a scraping from the cervix (test Papanicolaou), exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. In general, follow-up examinations should be carried out at least once a year.
A woman should be informed that Jeanine ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
If any of the conditions, diseases and risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. With weighting, strengthening, or at the first manifestation of risk factors, drug withdrawal may be required.
Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease) when taking combined oral contraceptives. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 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 (< 50 мкг этинилэстрадиола), в 2-3 раза выше, чем у небеременных пациенток, которые не принимают комбинированные пероральные контрацептивы, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах. ВТЭ может привести к летальному исходу (в 1-2% случаев).
Venous thromboembolism (VTE), manifested as deep vein thrombosis or pulmonary embolism, can occur with any combined oral contraceptive.
Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized fever in the affected leg, redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as symptoms of other more or less severe events (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems speaking and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, acute abdomen.
Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; fast or irregular heartbeat.
Arterial thromboembolism can be fatal.
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. An increased risk of thromboembolism in the postpartum period should be taken into account.
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 disorders) may be grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin III, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
In assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the respective condition may 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 (< 50 мкг этинилэстрадиола).
The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives. However, the relationship with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these data are related to screening for cervical pathology or to sexual behavior (more rare use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women currently taking combined oral contraceptives or who have recently taken it is insignificant in relation to the overall risk of this disease. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may also be due to earlier diagnosis of breast cancer in women using combined oral contraceptives. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.
In rare cases, against the background of the use of combined oral contraceptives, the development of liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. 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
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased 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 have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs 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 of Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of combined oral contraceptives.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require the withdrawal of combined oral contraceptives until liver function returns 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 (less than 50 micrograms of ethinyl estradiol). However, women with diabetes should be closely monitored while taking combined oral contraceptives.
Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
The effectiveness of combined oral contraceptives may be reduced by missing pills, vomiting and diarrhea, or as a result of drug interactions.
Effect on the menstrual cycle
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles. If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude 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 should be excluded before continuing to take the drug.
Impact on lab test scores
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.
Preclinical safety data
Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex steroids may promote the growth of certain hormone-dependent tissues and tumors.
Influence on the ability to drive vehicles and control mechanisms
The instructions say:
If the delay in taking pills is less than 12 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, the next pill 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:
