Regulon

Regulon – peroral monophase contraceptive means, possesses considerable anti-oestrogenic and gestagenny action, slight anabolic and androgenic activity.

Form of release and structure

Release form – tablets, film coated: a round biconvex form, almost white or white color, with marking of "RG" on one party and "P8" – on another (on 21 pieces in the blister, in a cardboard pack 1 or 3 blisters).

Content of active ingredients of Regulon in 1 tablet:

• Ethinylestradiol: 0,03 mg;
• Dezogestrel: 0,15 mg.

Auxiliary components: stearic acid, alpha tocopherol, lactoses monohydrate, povidone, magnesium stearate, potato starch, silicon dioxide colloid.

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

Indications to use

Regulon's use is shown for peroral contraception.

Contraindications

• Migraine with focal neurologic symptomatology (including the anamnesis);
• Average or heavy severity of arterial hypertension (the arterial pressure (AP) over 160 by 100 mm of a mercury column) and other expressed and/or multiple factors of risk of arterial or venous thrombosis;
• Venous or arterial thromboembolism or thrombosis, including a stroke, a myocardial infarction, an embolism of a pulmonary artery, a shin deep vein thrombosis (including in the anamnesis);
• Stenocardia, the tranzitorny ischemic attack and other harbingers of thrombosis (including the anamnesis);
• Pancreatitis (including the anamnesis) against the background of the expressed gipertriglitseridemiya;
• Diabetes mellitus with defeat of vessels (angiopatiya);
• Dislipidemiya;
• Jaundice at reception of glucocorticosteroids (GKS);
• Heavy pathologies of a liver, hepatitis, cholestatic jaundice (including at pregnancy) (including the anamnesis);
• Cholelithiasis (including the anamnesis);
• Liver tumors (including the anamnesis);
• Syndrome Cudgel Johnson, Gilbert's syndrome, Rotor syndrome;
• Hormonedependent malignant tumors of mammary glands and generative organs or suspicion on them;
• Existence of a severe itch, otosclerosis and its progressing during the previous pregnancy or against the background of reception of GKS;
• Smoking (over 15 cigarettes a day) is aged more senior than 35 years;
• Vaginal bleedings of an unspecified etiology;
• The period of pregnancy or suspicion on it;
• Breastfeeding;
• Individual intolerance of components of drug.

Because of the increased risk of development of an arterial or venous thromboembolism and thrombosis women should be careful at purpose of drug aged 35 years are more senior, during the smoking, the instruction in the family anamnesis on thromboembolisms and fibrinferments, at obesity (the index of body weight is higher than 30 kg on 1 ^sq.m), to patients with migraine, a dislipoproteinemiya, epilepsy, arterial hypertension, fibrillation of auricles, valve heart diseases, when carrying out extensive surgeries, a severe injury, in the period of a long immobilization, at surgical intervention on the lower extremities, superficial thrombophlebitis, varicosity, a diabetes mellitus without angiopatiya, acute and chronic diseases of a liver, existence of a heavy depression (including the anamnesis), change of biochemical indicators (a gipergomotsisteinemiya, deficit of antithrombin III, resistance of the activated protein of C, deficit of a protein of C or S, anti-phospholipidic antibodies, antibodies to cardiolipin, lupoid anticoagulant), a sickemia, a disease Krone, the system lupus erythematosus (SLE), ulcer colitis, a gipertriglitseridemiya (including the family anamnesis), in a puerperal period.

Route of administration and dosage

Pill is taken inside on 1 piece a day, it is desirable in at one time, within 21 days.

It is necessary to begin use in the first day of a menstrual cycle. After reception of the last tablet do a break within 7 days during which there comes menstrualnopodobny bleeding of the first blister. Reception of tablets from the following blister there begin weeks and time of day on the same day, as from the first packaging, after 7 days of a break, even against the background of the proceeding bleeding. At observance of all recommendations the contraceptive effect of drug remains also in the period of a break. This scheme of reception of tablets it is necessary to observe all the time while there is a need for contraception.

Reception of tablets from the first blister can be begun also from the second to the fifth day of periods, in this case in the first cycle during the first 7 days use of additional barrier methods of contraception is required. If menstrual bleeding lasts more than 5 days, the beginning of use of Regulon should be postponed until the following cycle.

After the delivery it is possible to begin reception in 21 days, previously having consulted with the doctor. If the woman had a sexual contact after the delivery, then reception should be postponed prior to the beginning of the following menstrual cycle to exclude conception. In case of the beginning of contraceptive therapy during later period after the delivery during the first 7 days of reception of tablets use of additional methods of contraception is required.

After abortion it is necessary to begin reception in day of operation (in the absence of contraindications) without use of additional contraceptives.

Upon transition from other oral contraceptive with a course 21 days it is necessary to take the first pill of Regulon next day after a seven-day break of the previous cycle. Upon transition from drug with a course of 28 days the first pill of Regulon is taken next day after reception of the last tablet from packaging of the previous means. At observance of the specified recommendations to apply additional methods of contraception does not follow.

Upon transition from hormonal oral contraceptives mini-drank (in structure only progestogen) the first pill should be taken in the first day of a menstrual cycle without additional use of barrier methods of contraception. If against the background of use mini-saw periods did not come, then only after an exception of pregnancy it is possible to begin Regulon's reception in any day of a cycle with use of additional contraceptives or abstention from sexual contacts during the first 7 days.

To delay menstrualnopodobny bleeding for the desirable period, it is necessary to continue reception of tablets from the new blister without seven-day break according to the usual scheme. During this period emergence of the smearing or breakthrough bleedings which are not influencing contraceptive effect of drug is possible. It is possible to recover regular reception after a usual break in reception.

At the accidental admission of reception of the next tablet at the scheduled time if delay does not exceed 12 hours, it should be accepted at once as soon as remembered and to continue reception in the usual mode. If delay made more than 12 hours (36 hours from the moment of reception of the previous tablet), reliability of contraception can be broken as it is considered the admission of one dose of drug. If the admission happened during the first or second week of a cycle, then it is necessary to take 2 pill at the same time and, continuing reception in the usual mode, until the end of a cycle to use additional barrier methods of contraception. If the accidental admission happened on the third week of a cycle, then after reception of a tablet it is necessary to continue regular use of drug until the end of the current blister and to begin reception from the following without seven-day break. The risk of bloody allocations or conception in this case increases therefore use of additional methods of contraception is required.

Developing of vomiting or diarrhea after reception of the next tablet can lead to defective absorption and break contraceptive effect of drug. If within 12 hours symptoms of an indisposition stopped, then after reception of an additional tablet continue contraception in accordance with the established procedure. At continuation of vomiting or diarrhea over 12 hours need for use of additional methods of contraception exists both in the period of vomiting or diarrhea, and during the next 7 days.

Side effects

Side effects at which drug withdrawal is required:

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

Besides, against the background of Regulon's use development of less heavy by-effects is possible, but they appear more often:

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

The decision on expediency of continuation of contraceptive therapy is made individually, after comparison of advantage of use and real risk.

Special instructions

It is not recommended to begin administration of drug without consultation of the gynecologist as Regulon it is possible to apply only on doctor's orders on the basis of results of preliminary all-medical and gynecologic survey. The doctor has to study in detail as the general condition of the woman (the family and personal anamnesis, indicators of laboratory researches, the ABP), and results of inspection of bodies of a small pelvis, mammary glands, the cytologic analysis of a cervical smear. The decision on hormonal peroral contraceptive therapy has to be weighed, taking into account all advantages and negative effects.

The woman needs to be warned about need regular (1 time in 6 months) preventive inspection during reception of tablets. At emergence or aggravation of diseases of system of a hemostasis, deviations in laboratory indicators of function of a liver, signs of the development of renal and/or cardiovascular failure, migraine, epilepsy which is not complicated by vascular disorders of a diabetes mellitus, a heavy depression, estrogenzavisimy tumors or gynecologic diseases the sickemia administration of drug needs to stop and use non-hormonal methods of contraception.

The risk of development of thromboembolic diseases against the background of reception of hormonal contraceptives exists, but it is not higher, than at pregnancy. Emergence of an arterial or venous thromboembolism of vessels of a retina or renal, hepatic, mezenterialny vessels is in rare instances possible. Their probability increases at women at intensive smoking, age 35 years, obesity are more senior, than the arterial hypertension complicated by hemodynamic disturbances pathologies of valves of heart, fibrillation of auricles, a dislipoproteinemiya, a long immobilization, the diabetes mellitus complicated by vascular defeats and also in the presence of thromboembolic diseases in the family anamnesis (parents, the sister, the brother).

Before planned lower extremity operation or extensive surgical intervention administration of drug should be stopped and resumed temporarily after a remobilization in 2 weeks.

The sudden stethalgia irradiating in the left hand, asthma, the severe headache which is followed by a diplopia, partial or total sudden loss of sight, dizziness, aphasia, a collapse, weakness, strong numbness of a half of a body, the focal epilepsy, an acute abdomen, disturbance of motive functions expressed by unilateral a gastrocnemius muscle pain belongs to symptoms of a thromboembolism.

The women predisposed to emergence of a hloazma should avoid influence of direct sunshine and ultraviolet radiation.

The accompanying therapy by other medicines can break efficiency of drug, in this case use of additional barrier methods of contraception is required.

In the presence of acyclic bloody allocations or absence of menstrualnopodobny bleeding after regular reception of tablets from two blisters, reception of tablets it is necessary to stop and conduct examination regarding a pregnancy exception.

Oestrogenic components of peroral contraceptives can exert impact on indicators of level of laboratory parameters of functional indicators of a thyroid gland, kidneys, adrenal glands, a hemostasis, a liver, the maintenance of transport proteins and lipoproteins.

Regulon's use for women with a menorrhagia considerably reduces losses of menstrual blood, normalizes a menstrual cycle, makes favorable impact on a condition of an integument, especially at vulgar eels.

At heavy pathologies of a liver, hepatitis, cholestatic jaundice purpose of drug is possible only in 3 months after recovery and preservation of normal laboratory and functional indicators.

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

Reception of tablets does not exert impact on ability of the woman to driving and other mechanisms.

Medicinal interaction

The risk of emergence of breakthrough bleedings increases against the background of a concomitant use of the drugs inducing liver enzymes including rifampicin, hydantoin, Primidonum, barbiturates, carbamazepine, фелбамат, топирамат, medicines of a St. John's Wort ordinary, griseofulvin, окскарбазепин. Besides the specified drugs reduce contraceptive efficiency of peroral contraceptives. It is necessary to consider that the maximum level of induction can proceed within 28 days after their cancellation.

In need of joint reception of Regulon with ampicillin and tetracycline it is required to use additional barrier methods of contraception during all course of treatment and 7 (for rifampicin – 28) days after their cancellation.

At patients with a diabetes mellitus drug can increase the need for hypoglycemic peroral means or insulin.

Terms and storage conditions

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

Period of validity – 3 years.