Novinet - instructions for use, analogs, reviews and release forms (tablets) of the contraceptive for contraception in women, including during pregnancy and lactation. Side effect

In this article, you can read the instructions for using the drug Novinet. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors specialists on the use of Novinet in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Novinet analogs in the presence of existing structural analogues. Use for contraception in women, including during pregnancy and lactation. Side effect of the drug.

Novinet - monophasic hormonal contraceptive for oral administration, containing a combination of estrogen (ethinyl estradiol) and gestagen (desogestrel). The main contraceptive effect is the inhibition of gonadotropins and the suppression of ovulation. In addition, by increasing the viscosity of the cervical fluid, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic action, similar to endogenous progesterone, weak androgenic and anabolic activity.

The drug has a beneficial effect on lipid metabolism: increases the level of HDL in the plasma, without affecting the content of LDL.

When taking the drug, the loss of menstrual blood is significantly reduced (with the initial menorrhagia), the menstrual cycle is normalized, a favorable effect on the skin is noted, especially with acne vulgaris (acne).

Pharmacokinetics

Desogestrel

Desogestrel is rapidly and almost completely absorbed from the digestive tract and is metabolized to 3-keto-desogestrel, which is a biologically active metabolite of desogestrel. Metabolites are excreted in the urine and with feces (in a ratio of 4: 6).

Ethinylestradiol

Ethinyl estradiol is rapidly and completely absorbed from the digestive tract. About 40% is excreted in the urine and about 60% - with feces.

Indications

• contraception;
• acne (pimples).

Forms of release

Film-coated tablets.

Instructions for use and reception scheme

The drug is prescribed inside.

The intake of tablets starts from the 1st day of the menstrual cycle. Assign 1 tablet per day for 21 days, if possible at the same time of day. After taking the last pill from the package, a 7-day break occurs, during which menstrual bleeding occurs due to withdrawal of the drug. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), the drug is resumed from the next package, also containing 21 tablets, even if the bleeding did not stop. Such a regimen of taking tablets is adhered to as long as there is a need for contraception. If the rules of admission are observed, the contraceptive effect is maintained even for a 7-day break.

The first drug intake

The first pill should be taken from the first day of the menstrual cycle. In this case, no additional methods of contraception are needed. You can start taking pills from the 2nd-5th day of menstruation, but in this case, in the first cycle of using the drug, you need to apply additional methods of contraception in the first 7 days of taking the tablets.

If more than 5 days have passed since the onset of menstruation, it should be postponed the start of the drug until the next menstruation.

Taking the drug after giving birth

Non-breastfeeding women can start taking pills no earlier than 21 days after giving birth, after consulting with a doctor. In this case, there is no need to use other methods of contraception. If after the birth had already had sexual contact, then taking pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after the birth, then in the first 7 days it is necessary to use additional methods of contraception.

Admission after abortion

After abortion, in the absence of contraindications, the taking of tablets should begin from the first day after the operation,and in this case there is no need for additional methods of contraception.

Transition from another oral contraceptive

After using another hormonal oral contraceptive containing 30 μg ethinylestradiol, according to the 21 day schedule, the first Novinet tablet is recommended to be taken the day after the completion of the previous drug course. It is not necessary to withstand a 7-day break or wait for the onset of menstruation. There is no need for additional methods of contraception.

When switching from a drug containing 28 tablets, the next day after the tablets have ended in the package, you should start a new Novinet package.

The transition to Novinet after the use of oral hormone preparations containing only progestogen ("minipili")

The first pill Novinet should be taken on the 1st day of the cycle. There is no need for additional methods of contraception.

If there is no menstruation when taking "mini-drunk", then after the exclusion of pregnancy, you can begin taking Novinet on any day of the cycle, but in this case, in the first 7 days you need to apply additional methods of contraception(use of a cervical cap with a spermicidal gel, a condom, or abstinence from sexual contacts). The use of the calendar method in these cases is not recommended.

Delayed menstrual cycle

If there is a need to delay menstruation, you should continue taking the pills from the new package, without a 7-day break, according to the usual scheme. When delaying menstruation, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular reception Novinet can be restored after an ordinary 7-day break.

Missed tablets

If the woman forgot to take the pill on time, and after the pass was no more than 12 hours, you need to take a forgotten pill, and then continue the reception at the usual time. If more than 12 hours have passed between taking the tablets - this is considered a missing tablet, the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss one tablet on the first or second week of the cycle, you need to take 2 tablets the next day and then continue with regular reception, using additional contraceptive methods until the end of the cycle.

If you miss a pill on the third week of the cycle, you must take a forgotten pill, continue with regular intake and do not take a 7-day break. It is important to remember that in connection with the minimal dose of estrogen, the risk of ovulation and / or bleeding is increased when a pill is missed and therefore additional methods of contraception are recommended.

Vomiting / nausea

If vomiting or diarrhea occurs after taking the drug, then the absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take another pill in addition. After this, you should continue taking the tablets in the usual way. If vomiting or diarrhea lasts more than 12 hours, then you need to use additional methods of contraception during vomiting or diarrhea and for the next 7 days.

Side effect

• arterial hypertension;
• arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism of the pulmonary artery);
• hearing loss due to otosclerosis;
• hemolytic-uremic syndrome;
• porphyria;
• exacerbation of reactive systemic lupus erythematosus;
• acyclic bleeding / spotting from the vagina;
• amenorrhea after drug withdrawal;
• change in the state of vaginal mucus;
• development of inflammatory processes of the vagina;
• candidiasis;
• tension, pain, enlargement of the mammary glands (breast engorgement);
• galactorrhea;
• nausea, vomiting;
• Crohn's disease;
• ulcerative colitis;
• erythema nodosum;
• exudative erythema;
• headache;
• migraine;
• mood lability;
• depression;
• increased sensitivity of the cornea (when wearing contact lenses);
• fluid retention in the body;
• change (increase) in body weight;
• allergic reactions.

Contraindications

• presence of severe and / or multiple risk factors for venous or arterial thrombosis (including severe or moderate arterial hypertension with BP ≥ 160/100 mm Hg);
• presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina pectoris);
• Migraine with focal neurologic symptoms, incl. in the anamnesis;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in the anamnesis;
• presence of a venous thromboembolism in the anamnesis;
• diabetes mellitus (with angiopathy);
• pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in the anamnesis (before normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking glucocorticosteroids;
• cholelithiasis at present or in the anamnesis;
• Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including in the anamnesis);
• severe itching, otosclerosis or its progression with a previous pregnancy or SCS;
• hormone-dependent malignant neoplasms of genital organs and mammary glands (including when suspected of them);
• vaginal bleeding of unclear etiology;
• Smoking over the age of 35 (more than 15 cigarettes a day);
• pregnancy or suspected of it;
• lactation period;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Novinet is contraindicated for use in pregnancy and lactation (breast-feeding).

special instructions

Before starting the drug, it is necessary to conduct general medical (detailed family and personal history, measurement of blood pressure, laboratory tests) and gynecological examination (including examination of mammary glands, pelvic organs, cytological analysis of cervical smear). Such a survey during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: Perl index (the indicator of the number of pregnancies that occurred during the application of the method of contraception in 100 women for 1 year), with proper application is about 0.05.

In each case, before the appointment of hormonal contraceptives individually evaluated the benefits or possible negative effects of their reception. This issue should be discussed with the patient, who after receiving the necessary information will make a final decision on the preferences of hormonal or some other method of contraception.

The state of women's health must be carefully monitored. If during the reception of the drug appears or worsens any of the below listed conditions / diseases, you must stop taking the drug and go to another, non-hormonal method of contraception:

• diseases of the hemostasis system;
• conditions / diseases, predisposing to the development of cardiovascular, renal failure;
• epilepsy;
• migraine;
• risk of developing estrogen-dependent tumors or estrogen-dependent gynecological diseases;
• diabetes mellitus not complicated by vascular disorders;
• severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B6 can be used to correct it);
• sickle cell anemia, tk. in some cases (for example, infections, hypoxia), estrogen-containing drugs can provoke thromboembolic events in this pathology;
• the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a link between the intake of oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). The increased risk of venous thromboembolic diseases has been proven, but it is significantly less than in pregnancy (60 cases per 100,000 pregnancies).When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal vessels or retinal vessels is very rare.

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (intensive smoking and age over 35 are among the risk factors);
• if there is a family history of thromboembolic diseases (for example, in parents, a brother or a sister). If you suspect a genetic predisposition, you must consult a specialist before using the drug;
• with obesity (body mass index more than 30 kg / m2);
• with dyslipoproteinemia;
• with arterial hypertension;
• with diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus, complicated by vascular lesions;
• with prolonged immobilization, after a large surgical intervention, after surgery on the lower limbs, after severe trauma.

In these cases, a temporary discontinuation of the use of the drug is contemplated (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

In women after childbirth, the risk of venous thromboembolic disease increases.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle-cell anemia, increase the risk of venous thromboembolic diseases.

It should be noted that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin 3, the presence of antiphospholipid antibodies, increase the risk of arterial or venous thromboembolic diseases.

When assessing the benefit / risk of taking the drug, it should be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

• sudden pain in the chest, which radiates into the left arm;
• sudden shortness of breath;
• any unusually severe headache that lasts a long time or appears for the first time, especially when combined with a sudden total or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or marked numbness of the body, motor disorders,strong one-sided pain in the gastrocnemius muscle, sharp abdomen.

Tumor diseases

Some studies have reported increased incidence of cervical cancer in those women who have long taken hormonal contraceptives, but the results of research are contradictory. In the development of cervical cancer, sexual behavior, infection with human papillomavirus and other factors play a significant role.

A meta-analysis of 54 epidemiological studies has shown that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but a higher detection of breast cancer could be associated with a more regular medical examination. Breast cancer is rare among women younger than 40, regardless of whether they take hormonal contraceptives or not, and increases with age. The intake of tablets can be regarded as one of many risk factors. However, a woman should be advised of the possibility of a risk of developing breast cancer, based on an assessment of the benefit-risk ratio (protection against ovarian cancer and endometrium).

There are few reports of the development of a benign or malignant liver tumor in women who take long-term hormonal contraceptives. This should be borne in mind in the differential diagnosis of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chlazmy

Chloasma can develop in women who have this disease in a history of pregnancy. For women who are at risk of developing chloasma, avoid contact with sunlight or ultraviolet light while taking Novinet.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed tablets, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient simultaneously takes another drug that may decrease the effectiveness of birth control pills, additional contraceptive methods should be used.

The effectiveness of the drug may decrease if after several months of their application irregular, spotting or breakthrough bleeding occurs,in such cases, it is advisable to continue taking the tablets before their completion in the next package. If at the end of the second cycle menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the pills and resume it only after the pregnancy is excluded.

Changes in laboratory indicators

Under the influence of oral contraceptive pills - in connection with the estrogen component - the level of certain laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis, levels of lipoproteins and transport proteins) can vary.

Additional Information

With diarrhea or intestinal disorders, vomiting contraceptive effect may decrease. Do not stop taking the drug, you need to use additional non-hormonal methods of contraception.

Smoking women have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on the age (especially in women older than 35 years) and on the number of cigarettes smoked.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and manage mechanisms

Studies on the study of the effect of Novine's drug on the abilities necessary for driving and production mechanisms have not been carried out.

Drug Interactions

Medicines that induce hepatic enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort preparations reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks after drug withdrawal.

Ampicillin and Tetracycline reduce the effectiveness of Novinet (the mechanism of interaction is not established). If it is necessary to share, it is recommended to use an additional barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - for 28 days) after drug withdrawal.

Oral contraceptives can reduce tolerance to carbohydrates, increase the need for insulin or oral antidiabetics.

Analogues of the drug Novinet

Structural analogs for the active substance:

• Marvelon;
• Mersilon;
• Regulon;
• Three-Mercy.

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