Structure of a cover: povidone 700 000, sucrose, macrogoal 6000, titanium dioxide, calcium carbonate, wax mountain glikoliyevy, глицерол, gland (II) oxide, talc (magnesium hydrosilicate).

Indications to use

Use of drug is shown to women with the androgenization phenomena as peroral contraception.

Besides, Diane-35 appoint for treatment of androgenozavisimy diseases at women: the expressed forms of eels which are followed by seborrhea, formation of inflammatory nodes including nodular and cystous eels, papular and pustular eels; easy forms of a hirsutism; androgenic alopecia.

Contraindications

Thromboembolisms and fibrinferments, including in the anamnesis (cerebrovascular disturbances, a deep vein thrombosis, a myocardial infarction, a thrombembolia of a pulmonary artery);
Existence of multiple or heavy signs of risk of arterial or venous thrombosis;
The stenocardia, the tranzitorny ischemic attacks and other states preceding thrombosis;
Liver tumors, including in the anamnesis;
Diseases of a liver or the expressed functional disturbances;
Pancreatitis, including in the anamnesis if it was followed by a heavy gipertriglitseridemiya;
The diabetes mellitus complicated by mikroangiopatiya;
Existence in the anamnesis of migraine which proceeded with focal neurologic symptomatology;
Uterine bleedings of unspecified genesis;
Hormonedependent malignant new growths, including tumors of generative organs or a mammary gland (including in the anamnesis);
Hypersensitivity to drug components.

Drug needs to be cancelled immediately if any of these pathologies develops for the first time against the background of use of Diane-35.

Drug is also contraindicated at suspicion on pregnancy, during incubation and breastfeeding.

Route of administration and dosage

Dragees accept inside, without chewing, washing down with a small amount of liquid, it is desirable right after a breakfast or a dinner.

Drug dosing – 1 dragee a day.

Reception is begun in the first day of a cycle, using from calendar packaging of a dragee of the corresponding day of the week, in time, convenient for the patient, on condition that the subsequent receptions will be surely carried out in this specific hour of days.

For each following reception use a dragee from a cell which the strelochka applied on a foil from previous indicates. Following the direction on calendar packaging, the woman accepts all 21 dragees and does a break lasting 7 days during which there passes bleeding similar to menstrual. One course of therapy lasts 28 days, from them 21 days – reception of a dragee and 7 days – a break. It is necessary to remember that reception should not be interrupted more than for 7 days and the first 7 days of reception of a dragee are required for achievement of the corresponding suppression of function гипоталамо - pituitary and ovarian system.

Day of administration of drug from the following packaging has to match a day of the week on calendar packaging of the previous course and begin in the 8th day after the beginning of a break in strictly determined time.

For transition from the combined oral contraceptives to use of Diane-35, reception needs to be begun next day after the last dragee from packaging with active agents of the previous means, for calendar packaging on 28 dragees and no later than 1 day after a 7-day break, for contraceptives with 21 dragees.

For transition from the drugs consisting only of gestagen ("mini-drank") reception of Diane-35 can be begun without interruption, with injection forms of contraception – from the date of the following injection, with an implant – in day of its removal. At each of the listed transitions it is in addition necessary to apply a barrier method of contraception during the first 7 days.

When performing abortion in 1 trimester of pregnancy peroral contraception is begun immediately, in this case additional methods of contraception are not required.

In the absence of sexual contacts after abortion in the II trimester of pregnancy or childbirth use of drug is recommended to be begun for the 21-28th day. If the woman began reception later, then during the first 7 days it is necessary to use a barrier method of contraception in parallel. Patients who led sex life in an interval between abortion or childbirth and the beginning of use of drug should wait for the first periods or to exclude pregnancy existence.

If the woman missed reception of a dragee at the scheduled time, it is necessary to accept it as soon as possible, and the following dragee – in usual time. Reliability of contraception is not broken at delay less, than for 12 hours.

In case from the moment of the last reception there passed more than 36 hours (delay more than 12 hours), the passed dragee should be accepted at once as soon as remembered even if it will be reception of two dragees at the same time, at the same time the following dose is accepted in usual time. If disturbance happened in the first or second week of use, it is necessary to use a barrier method of contraception the next 7 days. In case of delay more than for 12 hours during the third week of reception, upon termination of calendar packaging having rummaged in reception it is not necessary to do, it is necessary to continue reception from the following blister. During reception from the second packaging at the woman emergence of the bloody smearing allocations or breakthrough uterine bleeding is possible.

If the patient had a vomiting after reception of a dragee (in the first 3-4 hours), absorption of active ingredients can be broken and incomplete therefore it is necessary to use recommendations for a case at the admission of reception.

For a delay of the beginning of periods it is necessary to continue reception of a dragee from new calendar packaging, without doing a 7-day break. It is possible to accept a dragee from the second packaging up to its termination. It is necessary to know that during this period the patient can have smearing allocations or breakthrough bleedings. After 7 days of a break it is necessary to continue use of Diane-35 from new packaging.

To change day of the beginning of a menstrual cycle to other, next break it is necessary to reduce by the necessary number of days. Than the high probability of absence of bleeding of cancellation and existence of the smearing bloody allocations during reception of a dragee less days of a break, subjects.

Duration of administration of drug at treatment of hyper androgenic pathologies depends on weight of a state, after disappearance of symptoms of a disease reception of a dragee is recommended to be continued within 3-4 months. At emergence of a recurrence it is possible to repeat a therapy course.

Side effects

Use of drug can become the reason of side effects:

From a reproductive system: seldom – intermenstrual bleedings, change of a libido, disturbance of a vulval secret;
From the alimentary system: seldom – nausea and vomiting;
From a nervous system: seldom – migraine, decrease in mood, a headache;
From endocrine system: seldom – change of body weight, a nagrubaniye, increase, morbidity of mammary glands and allocation from them;
Others: very seldom – allergic reactions, bad portability of contact lenses, emergence on a face of a nevus pigmentosus (hloazm).

These side effects can be shown in the first months of administration of drug and gradually decrease, as a rule.

Special instructions

Use of Diane-35 can be begun only after performing all-medical examination, including a cytologic research of cervical slime, mammary glands, on an exception of disturbances from system of a blood coagulation and to pregnancy existence. At long administration of drug 1 time in half a year is recommended to conduct control examinations.

With risk factors the woman should make the decision on the forthcoming therapy, having carefully estimated potential risk and the expected advantage of administration of drug.

The woman has to be informed on possible development of arterial or venous thrombosis, and on need of the immediate address to the doctor in case of the first symptoms. They include: motive disturbances; hypostasis and/or unilateral scelalgia; a sharp stethalgia with irradiation in the left hand or without irradiation; unexpected asthma and/or fit of coughing; severe and long headache; increase in weight and frequency of migraine; sudden loss of sight (partial or full); diplopia; dizziness; inarticulate speech or aphasia; and others.

At emergence of persistent arterial hypertension administration of drug needs to be cancelled, after performing the corresponding hypotensive therapy and normalization of arterial pressure reception of a contraceptive can be continued.

Emergence of functional disturbances of a liver can demand temporary cancellation of reception of Diane-35 before normalization of laboratory indicators. At recurrent cholestatic jaundice it is necessary to stop reception of the combined oral contraceptives.

Patients with a diabetes mellitus have no need for correction of a dose of glucose-lowering drugs, but women of this category have to be under special observation of the doctor.

Patients with tendency to a hloazma are recommended to avoid impact of ultraviolet radiation and long stay on the sun.

Assessment of the irregular bleedings (the smearing allocations or breakthrough bleedings) arising against the background of use of Diane-35 in the first months of therapy should be carried out after the adaptation period which lasts three cycles.

Development of irregular bleedings after the previous systematic cycles, has to assume consideration of the non-hormonal reasons, holding diagnostic actions for an exception of pregnancy or malignant new growths, including a scraping.

When carrying out the differential diagnosis at women with a hirsutism, it is necessary to carry an androgenprodutsiruyushchy tumor, inborn dysfunction of bark of adrenal glands to the reasons of emergence or considerable strengthening of symptoms of a disease.

In case of absence of bleeding of cancellation in the period of a 7-day break after reception of two calendar packagings of drug it is in a row recommended to exclude pregnancy before continuation of reception.

Medicinal interaction

Contraceptive reliability of Diane-35 decreases at a concomitant use with tetracyclines and ampitsillina.

At a combination to inductors of microsomal liver enzymes, including barbiturates, hydantoins, Primidonum, rifampicin, carbamazepine, and, perhaps, with topiramaty, okskarbazepiny, felbamaty and griseofulvin occurs increase in clearance of active agents, it can cause breakthrough uterine bleedings and reduce reliability of contraception.