Novinet

Novinet – a monophase oral contraceptive.

Form of release and structure

Dosage form – tablets, film coated: a round biconvex form, light yellow color, with marking of "RG" on one party, "P9" – on another (on 21 pieces in blisters, in a cardboard pack 1 or 3 blisters).

Content of active ingredients is to 1 tablet of Novinet:

• Ethinylestradiol – 20 mkg;
• Dezogestrel – 150 mkg.

Auxiliary components: alpha tocopherol, silicon dioxide colloid, magnesium stearate, stearic acid, potato starch, povidone, lactoses monohydrate, dye quinolinic yellow (E104).

Structure of a film cover: gipromelloza, macrogoal 6000, propylene glycol.

Indications to use

Novinet's use is shown to women for peroral contraception.

Contraindications

• Stenocardia, the tranzitorny ischemic attack and other harbingers of thrombosis (including at the instruction in the anamnesis);
• Arterial hypertension of average or heavy degree (the arterial pressure (AP) of 160/100 mm of a mercury column and more) and other multiple and/or expressed risk factors of arterial or venous thrombosis;
• Migraine with focal neurologic symptomatology, including the anamnesis;
• Venous thromboembolism in the anamnesis;
• Myocardial infarction, shin deep vein thrombosis, stroke, embolism of a pulmonary artery and other forms of venous or arterial thrombosis or thromboembolism now and in the anamnesis;
• Dislipidemiya;
• Diabetes mellitus (with an angiopatiya);
• Cholelithiasis, including the anamnesis;
• Liver new growths, including the anamnesis;
• Serious illness of a liver, cholestatic jaundice (including the pregnancy period), hepatitis, including in the anamnesis (before normalization of laboratory and functional indicators and within 3 months after it);
• The pancreatitis (including the anamnesis) proceeding with the expressed gipertriglitseridemiya;
• Jaundice against the background of glucocorticosteroids (GKS);
• Syndrome Cudgel Johnson, Gilbert's syndrome, Rotor syndrome;
• Severe skin itch, otosclerosis and its progressing against the background of reception of GKS or at the previous pregnancy;
• Vaginal bleedings of unspecified genesis;
• Hormonedependent malignant tumors of mammary glands and generative organs or suspicion on them;
• Breastfeeding;
• The pregnancy period, including suspicion on it;
• Smoking more than 15 cigarettes in day is aged more senior than 35 years;
• Hypersensitivity to drug components.

It is necessary to be careful to women with the states promoting increase in risk of development of arterial or venous thrombosis and thromboembolism: obesity (the index of body weight exceeds 30 ^kg/sq.m), smoking, age is more senior than 35 years, the family anamnesis, a dislipoproteinemiya, migraine, arterial hypertension, epilepsy, fibrillation of an auricle, valve heart diseases, ulcer colitis, a disease Krone, a sickemia, chronic and acute pathologies of a liver, a gipertriglitseridemiya (including the family anamnesis), a long immobilization, extensive surgical intervention, the lower extremity operations, superficial thrombophlebitis, a varicosity, a severe injury, the puerperal period, a heavy depression (including the anamnesis), the system lupus erythematosus (SLE), a diabetes mellitus (without vascular complications), change of biochemical indicators, including a gipergomotsisteinemiya, resistance of the activated protein of C, deficit of antithrombin III and a protein of S or C, anti-phospholipidic antibodies, including antibodies to cardiolipin, lupoid anticoagulant.

Route of administration and dosage

Novinet is accepted within 21 days, since first day of menstrual bleeding, inside on 1 tablet at the same time days. Having taken all pill from the blister, do 7 days of a break during which there passes menstrualnopodobny bleeding. Reception of tablets from the following blister needs to be begun next day after a break, even at the proceeding bleeding. This scheme of administration of drug provides effect of contraception until in it there is a need.

If the woman begins reception of the first tablet in the first day of a menstrual cycle, additional measures of contraception are not required. At the beginning of use from the second to the fifth day of periods in the first cycle it is necessary to use barrier methods of contraception during the first 7 days. If from the moment of the beginning of periods there passed more than 5 days it is not necessary to begin reception of tablets in this cycle.

After the delivery administration of drug can be begun not earlier than in 21 days without additional measures of contraception on condition of preliminary consultation of the doctor and lack of breastfeeding. If during the specified period the woman had a sexual contact, the beginning of therapy should be moved prior to the beginning of the first periods. In case of the beginning of use during the period exceeding 21 days after the delivery during the first 7 days it is necessary to apply barrier contraceptives at the same time.

In case of lack of contraindications, reception of tablets after abortion needs to be begun in day of operation without use of additional measures of contraception.

Upon transition from an oral hormonal contraceptive with the content of ethinylestradiol of 30 mkg and accepted according to the 21-day scheme, Novinet's reception is begun next day after reception of the last tablet of the previous contraceptive without seven-day break and use of additional contraception.

Upon transition from the means containing 28 tablets, Novinet's use is begun next day after reception of the last tablet from packaging of the previous contraceptive.

After the previous use of peroral hormonal drugs mini-saw, containing only progestogen, transition to Novinet is recommended to be begun in the 1st day of a cycle without use of additional methods of contraception.

In case of lack of periods at reception mini-saw it is necessary to exclude existence of pregnancy and only after that to pass to Novinet's reception in any day of a menstrual cycle with use of additional methods of contraception during the first 7 days. As additional contraceptive methods during this period it is recommended to use condom, a cervical cap with spermicidal gel or sexual abstention. Use during the first 7 days of administration of drug of a calendar method of protection is not recommended.

If the woman wishes to move the beginning of periods, then reception of tablets from the following blister needs to be begun at once, according to the usual scheme, without doing a 7-day break. During this period emergence of the breakthrough or smearing bleedings which do not reduce contraceptive effect of drug is possible. After the put 7-day break regular administration of drug is recovered.

At the accidental admission of reception at the scheduled time, the pill should be taken at once as soon as remembered. If the delay period contraceptive effect of drug is not broken less than 12 hours, further reception can be continued in the usual mode. Delay is considered more than 12 hours the admission of one tablet and breaks reliability of contraception in this cycle (use of additional methods of contraception is required).

If the admission of one tablet happened during the first two weeks of a cycle, next day it is necessary to take 2 pill and to continue reception with use of additional methods of contraception until the end of a cycle.

If the tablet is passed on the third week of a cycle, it is necessary to accept it, having continued Novinet's reception without 7-day break in this cycle. As the content of estrogen minimum at the admission of the next dose increases risk of bloody allocations and/or ovulations therefore use of additional methods of contraception is obligatory.

In case of vomiting or diarrhea right after reception of the next tablet, process of absorption can be incomplete. If gastric frustration stopped within 12 hours, it is necessary to take an additional pill and to continue the usual mode of contraception. If duration of vomiting or diarrhea exceeds 12 hours, the woman needs to apply barrier methods of contraception in the period of an indisposition and during the next 7 days.

Side effects

• Reproductive system: an amenorrhea against the background of drug withdrawal, vulval bloody allocations or acyclic bleedings, change of a condition of vulval slime, candidiasis, development of processes of an inflammation of a vagina, a galactorrhoea, pain, tension, increase in mammary glands;
• Nervous system: headache, instability of mood, depression, migraine;
• Alimentary system: nausea, vomiting, ulcer colitis, a disease Krone, an aggravation or development of jaundice and/or the itch caused by a cholestasia, a cholelithiasis;
• Metabolism: increase in body weight, a liquid delay in an organism, decrease in tolerance to carbohydrates;
• Organ of sight: patients with contact lenses have an increase in sensitivity of a cornea;
• Dermatological reactions: rash, knotty erythema, hloazma, exudative erythema;
• Others: development of allergic reactions.

Novinet's use can cause side effects which demand immediate drug withdrawal:

• Cardiovascular system: arterial hypertension; seldom – a venous and arterial thromboembolism (including a thromboembolism of a pulmonary artery, a stroke, a myocardial infarction, a deep vein thrombosis of legs); very seldom – a venous or arterial thromboembolism of renal, hepatic, mezenterialny, retinal veins and arteries;
• Sense bodys: the hearing loss caused by an otosclerosis;
• Others: porphyria, gemolitiko-uraemic syndrome; seldom – an aggravation of a reactive system lupus erythematosus; very seldom – a passing chorea of Sidenkhem.

Special instructions

Novinet is a well-tried remedy of hormonal contraception.

Use of drug should be begun after carrying out full all-medical and gynecologic examination, including detailed personal and family anamnesis, laboratory researches, measurement of the ABP, inspection of bodies of a small pelvis, mammary glands, the cytologic analysis of a cervical smear. The conclusion of the gynecologist about a possibility of use of drug is made on the basis of the obtained data. Having informed the patient on possible negative effects and advantages of hormonal contraception, the doctor grants it the right about acceptance of the final decision.

Use of drug has to take place with regular (1 time in 6 months) survey at the gynecologist and careful individual control of the state of health. The woman has to know that the basis for immediate drug withdrawal is emergence of one of the following deviations:

• The diseases or states promoting development of renal, cardiovascular failure;
• Deviations in laboratory tests of assessment of function of a liver;
• Pathologies of system of a hemostasis;
• Migraine;
• Epilepsy;
• Threat of development of estrogenzavisimy gynecologic diseases or estrogenzavisimy new growth;
• Heavy depression (it is recommended to accept B6 vitamin for correction of the state connected with tryptophane exchange pathology);
• Diabetes mellitus without vascular complications;
• Sickemia.

Against the background of reception of oral hormonal contraceptives the risk of development of venous and arterial thromboembolic pathologies, especially at women at age or with thromboembolic diseases in the family anamnesis (parents, the sister, the brother) increases. The risk increases at intensive smoking, dislipoproteinemiya, obesity, a diabetes mellitus with vascular defeats, diseases of valves of heart with hemodynamic disturbances, arterial hypertension, fibrillation of auricles, in the period of the long immobilization connected with an extensive operative measure (including the lower extremity operations) or after a severe injury.

Novinet's use should be stopped in 4 weeks prior to planned operation and to resume reception in 2 weeks after a remobilization.

After the delivery the probability of emergence of venous thromboembolic diseases increases.

The diabetes mellitus, gemolitiko-uraemic syndrome, system lupus erythematosus, disease Krone, a sickemia, nonspecific ulcer colitis promote increase in risk of development of venous thromboembolic diseases.

At deficit of proteins of C and S, resistance to the activated protein of C, a gipergomotsisteinemiya, existence of anti-phospholipidic antibodies, a lack of antithrombin III the probability of development of venous or arterial thromboembolic pathologies increases.

Purposeful therapy of the states stated above promotes decrease in risk of a thromboembolism with characteristic symptoms of manifestation in the form of a sudden stethalgia with irradiation in the left hand, a sudden asthma, unusually severe headache proceeding long time (especially if the headache develops for the first time in combination with dizziness, weakness, an acute abdomen, partial or total loss of sight, a diplopia, aphasia, focal epilepsy, a collapse, motive disturbances, numbness of a half of a body, severe unilateral pain in a gastrocnemius muscle).

Novinet's reception can be regarded as one of many risk factors of development of a breast cancer.

Against the background of prolonged use of drug development of high-quality or malignant new growths of a liver is possible. It should be considered at differential and diagnostic assessment of abdominal pains which can be connected with intraperitoneal bleeding or increase in the size of a liver.

The women having this pathology in the anamnesis during pregnancy therefore they are recommended to avoid direct sunshine or ultraviolet radiation are subject to risk of development of a hloazma.

Simultaneous use of other medicines can exert impact on efficiency of peroral contraception, in this case use of additional barrier contraceptive methods is required.

Effect of drug decreases against the background of the irregular, smearing or breakthrough bleedings which developed after several months of contraception. In this case it is necessary to continue reception of tablets before the termination of the following cycle and in the absence of menstrualnopodobny bleeding in a 7-day break or continuation of acyclic bloody allocations, to cancel reception of tablets until a pregnancy exception.

Besides, the admission of reception of a tablet, vomiting or diarrhea can break effect of drug.

Action of tablets can cause change of laboratory indicators of function of kidneys, adrenal glands, a liver, a thyroid gland, level of transport proteins and lipoproteins, hemostasis indicators.

After an acute viral hepatitis it is possible to begin use of drug after a complete recovery of function of a liver (6 months and more).

Novinet does not protect from diseases, sexually transmitted, including HIV infection (AIDS).

Influence of drug on ability to control of vehicles and mechanisms is not studied.

Medicinal interaction

Simultaneous use of Novinet with the drugs inducing liver enzymes (barbiturates, hydantoin, Primidonum, rifampicin, carbamazepine, окскарбазепин, фелбамат, medicines of a St. John's Wort ordinary, топирамат, griseofulvin), reduces efficiency of contraception and increases risk of breakthrough bleedings. It is necessary to consider that the maximum extent of induction of any of the specified means is reached after 2-3 weeks of use, but can last up to 4 weeks after drug withdrawal.

As tetracycline and ampicillin reduce efficiency of drug, it is necessary to use additional barrier methods of contraception at their combination to Novinet during the entire period of therapy and 7 (for rifampicin – 28) days after their cancellation.

Decrease in tolerance to carbohydrates, increase in need for peroral antidiabetic means or insulin is possible.

Terms and storage conditions

To store at a temperature of 15-30 °C. To protect from children.

Period of validity – 3 years.