Novinet tablets No. 21x3

Novinet

Use during pregnancy and breastfeeding

Novinet® is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

Contraindicated in severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization). The drug should be prescribed with caution for acute and chronic liver diseases.

Use for renal impairment

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for renal failure (including a history),

special instructions

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

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

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

Thromboembolic diseases

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

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (heavy smoking and age over 35 years are risk factors);
• if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
• for obesity (body mass index more than 30 kg/m2);
• with dislipoproteinemia;
• with arterial hypertension;
• for diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus complicated by vascular lesions;
• with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed that the use of the drug should be temporarily discontinued (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

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

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they take hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Novinet.

Efficiency

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

If the patient is concomitantly taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills, due to the estrogen component, the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

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

The 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 operate machinery

No studies have been conducted to study the effect of Novineta on the abilities necessary to drive a car and operate machinery.

Instructions for use NOVYNETTE®

In the presence of any of the listed diseases or conditions that are relative contraindications to the prescription of the drug, the benefits and risks of its use should be carefully assessed and the patient should be informed about this, who, after receiving complete information, makes the final decision on the need to take an oral hormonal contraceptive:

• blood clotting disorder;
• other diseases associated with an increased risk of developing circulatory disorders, for example, latent or overt heart failure, impaired renal function, or a history of these diseases;
• epilepsy (including history);
• migraine (including history);
• history of cholelithiasis;
• the presence of one of the risk factors for the development of estrogen-dependent tumors, estrogen-sensitive gynecological diseases, such as fibroma and endometriosis;
• diabetes;
• severe depression at the moment or in history (if this disease is accompanied by impaired tryptophan metabolism, administration of vitamin B6 may improve the clinical condition);
• sickle cell hemoglobinopathy, because in certain circumstances, for example, in the presence of infection or hypoxia, estrogen-containing drugs can induce thromboembolic processes in patients with this disease;
• If the results of liver function tests deviate from normal values, it is necessary to stop using the drug.

It is necessary to carefully monitor the patient's health status. In case of deterioration, exacerbation or appearance of any of the above diseases while taking the drug, you should stop using it and use non-hormonal methods of contraception.

Although oral contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, there are no indications for a mandatory change in treatment regimen in women with diabetes when using oral contraception.

Thromboembolic diseases

According to epidemiological studies, the use of oral contraceptives may be associated with an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. However, these complications are rare. The increased risk of venous thromboembolic disease (VTD) associated with oral contraceptive use is well recognized. However, it is lower than the risk of developing VTD during pregnancy, which is 60 cases per 100,000 pregnancies. Some epidemiological studies have shown an increased risk of developing VTD in women taking oral contraceptives containing desogestrel and gestodine (so-called 3rd generation oral contraceptives) than in women using levonorgestrel-based oral contraceptives (so-called 2nd generation oral contraceptives).

The spontaneous incidence of VTD in healthy, non-pregnant women not using oral contraceptives is approximately 5 cases per 100,000 women per year. The incidence of VTD in women using 2nd and 3rd generation oral contraceptives is 15 and 25 cases per 100,000 women per year, respectively. The risk of developing VTD increases with age, in addition, there are other factors for the development of VTD, for example, excess body weight.

Very rarely, while taking oral contraceptives, arterial or venous thrombosis of the vessels of the liver, mesentery, kidneys or retina is observed.

The risk of developing arterial and/or venous thromboembolism increases under the following conditions:

• with age;
• in smokers (heavy smoking and increasing age increase the risk, especially in women over 35 years of age);
• indications in family history (for example, thromboembolism in a sibling or parent at a young age). If a hereditary predisposition is suspected, the patient should seek advice from a specialist before deciding to use oral contraception;
• overweight (BMI more than 30 kg/m2);
• dyslipoproteinemia;
• arterial hypertension;
• heart valve diseases;
• ventricular fibrillation;
• diabetes;
• prolonged immobilization, major surgery, lower limb surgery or major trauma. In these cases, it is recommended to stop taking oral contraceptives (at least 4 weeks before elective surgery) and not to restart for 2 weeks after full recovery.

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in VVT (venous thromboembolism).

In the postpartum period, a possible increase in the risk of thromboembolism should be taken into account.

Other diseases associated with circulatory complications include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell hemoglobinopathy.

If the frequency or severity of migraines increases while using oral contraceptives, you should immediately stop taking the pills.

Inherited or acquired biochemical factors may indicate the presence of venous or arterial thrombosis, particularly activated protein C resistance (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C and protein S deficiency, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When weighing the risks and benefits, the physician should take into account that effective treatment of the existing disease may reduce the risk of developing thrombosis, and that the risks associated with pregnancy exceed the risks associated with taking oral contraceptives.

Symptoms indicating the development of thrombosis:

• sudden severe chest pain that may spread to the left arm;
• sudden shortness of breath;
• any unusual, severe or prolonged headache, especially if it is new or stronger than usual, or accompanied by the following symptoms: sudden partial or complete loss of vision or diplopia, aphasia, dizziness, severe dizziness, collapse, with or without focal epileptic seizure , weakness or severe numbness on one side of the body, motor disturbances, severe pain in one of the legs and acute pain in the abdomen.

Oncological diseases

Hormonal contraceptives containing estrogen promote the growth of hormone-dependent tumors. Therefore, the use of hormonal contraceptives in patients with such tumors is contraindicated.

A number of studies have been conducted to examine the incidence of ovarian, endometrial, breast and cervical cancer in women taking oral contraceptives. These studies suggest that oral contraceptives provide significant protection against ovarian and endometrial cancer.

Some studies have shown an increase in the incidence of cervical cancer in women who took oral contraceptives for a long time, but these results are quite controversial. The development of cervical cancer can also be influenced by sexual behavior and a number of other factors.

A meta-analysis of data from 54 epidemiological studies showed that the risk of developing breast cancer is increased in women taking oral contraceptives for a long time. However, these women had breast cancer previously diagnosed.

Breast cancer is rare in women under 40 years of age, regardless of whether they use combined oral contraceptives. The risk increases with age. The proportion of breast cancer diagnoses in women taking oral contraceptives has been low, and oral contraceptive use is considered one of several risk factors.

Women should be informed about the risk of developing breast cancer, and the decision to start using oral contraceptives should be made taking into account the possible benefits and risks (the use of oral contraceptives provides significant protection against ovarian and endometrial cancer).

In rare cases, benign and malignant liver tumors have been discovered with long-term use of oral contraceptives. This can be a problem in the differential diagnosis of abdominal pain, which can also be a symptom of liver enlargement or intra-abdominal bleeding.

Medical examination

Before starting to take oral contraceptives, it is necessary to carefully review the patient’s family and personal history, as well as order a general physical and gynecological examination, including blood pressure measurement, laboratory tests, examination of the mammary glands and pelvic organs and cytological examination of the vagina, and regularly repeat these examinations.

Regular medical examination is also important because... in its process, contraindications and risk factors can be identified at the very beginning of taking oral contraceptives.

It is necessary to inform the woman that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted diseases.

Changes in laboratory test parameters

Oral contraceptives, due to the presence of estrogen in their composition, can affect the results of a number of laboratory tests, incl. functional tests of the liver, kidneys, adrenal glands and thyroid gland, indicators of blood coagulation and fibrinolysis, levels of lipoproteins and carrier proteins in the blood plasma.

Chloasma

In some cases, chloasma develops while taking oral contraceptives, especially in women with a history of chloasma during pregnancy. Women at risk should avoid exposure to UV and solar radiation while taking oral contraceptives.

Reduced reliability of the contraceptive effect of the drug

The contraceptive effectiveness of combined oral contraceptives may be reduced if pills are missed, vomiting, diarrhea, or the concomitant use of certain other medications.

If the patient is taking medications that can reduce the contraceptive effectiveness of Novinet®, a barrier method of contraception should be additionally used while taking another medication. The contraceptive effect of Novinet® may be reduced if, after taking it for several months, the patient experiences irregular withdrawal bleeding, spotting or breakthrough bleeding. If withdrawal bleeding does not occur, or if withdrawal bleeding disorders develop, pregnancy is unlikely and the drug should be continued until the end of the next package. If, at the end of the second cycle, withdrawal bleeding has not occurred again or withdrawal bleeding disturbances have not disappeared, then the drug should be interrupted and pregnancy should be ruled out before continuing to take the oral contraceptive.

Impact on the ability to drive vehicles and operate machinery

There was no effect of the drug Novinet® on the ability to drive a car or operate machinery.