Klimen

Klimen – anticlimacteric means with anti-androgenic, gestagenny and anti-gonadotropic action.

Form of release and structure

Dosage form – a dragee of two types: white and pink color (in the blister of 11 pieces of white and 10 pieces of pink dragees, in a cardboard pack 1 blister).

Content of active ingredients is 1 dragees:

• White color: oestradiol valerate – 2 mg;
• Pink color: oestradiol valerate – 2 mg, a tsiproterona acetate – 1 mg.

Auxiliary components: calcium carbonate, starch corn, lactoses monohydrate, povidone 25 000 (K25), magnesium stearate, povidone 700 000 (K700), sucrose, macrogoal 6000, wax, talc.

In addition as a part of a dragee of pink color: глицерол 85%, ferrous oxide yellow, ferrous oxide red, titanium dioxide.

Indications to use

Klimen's use is shown to women for treatment and prevention of the pathologies connected with hormonal disturbances in an organism:

• Climacteric frustration, involutional changes of an urinogenital path and skin, symptoms of deficit of estrogen against the background of sterilization or primary dysfunction of ovaries (at an unextracted uterus), a hypogonadism or a natural menopause, depressions in a climacteric – in the form of replacement hormonal therapy;
• Irregular menstrual cycles;
• Amenorrhea (primary or secondary);
• Prevention of development of post-menopausal osteoporosis.

Contraindications

Klimen's use for replacement hormonal therapy is contraindicated to women with the following diseases and states:

• Vulval bleeding of unspecified genesis;
• The breast cancer (assumed or diagnosed);
• Malignant tumors or precancerous diseases of a hormonedependent etiology (the estimated diagnosis or confirmed);
• Severe forms of diseases of a liver;
• The benign or malignant tumors of a liver (specified in the anamnesis or now);
• Deep vein thrombosis (at an aggravation), the thromboembolism (specified in the anamnesis or now);
• Thrombembolia or acute arterial thrombosis, including myocardial infarction, stroke;
• The expressed gipertriglitseridemiya;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

In case of symptoms of the specified pathologies during treatment it is necessary to cancel reception of a dragee immediately.

With care women are recommended to appoint drug at arterial hypertension, a diabetes mellitus, an inborn hyperbilirubinemia (Gilbert's syndrome, the Rotor and Dabin-Johnson), cholestatic jaundice or a cholestatic itch during incubation, a hysteromyoma, endometriosis.

Route of administration and dosage

Dragees accept inside, without chewing, and wash down with a small amount of liquid. Drug is accepted 1 time a day in time, convenient for the patient, which is obligatory for reception of all subsequent dragees.

Women, with the proceeding periods, should begin administration of drug for the 5th day of menstrual bleeding.

At an amenorrhea, a postmenopause or very rare periods it is possible to begin reception at any time, on condition of a pregnancy existence exception.

It is necessary to begin treatment with a dragee of white color, on 1 dragee a day within 11 days, then on 1 dragee of pink color within 10 days. The course of one packaging is counted on 21-day reception after which the 7-day break follows. During a break at the woman for 2-3 day after reception of the last dragee, there comes menstrualnopodobny bleeding.

The first dragee from new packaging should be accepted after a 7-day break, week on the same day, as from the previous packaging.

If at the scheduled time the woman accidentally missed reception of the next dragee, it should be accepted during the near future (12-24 hours). At longer break between receptions, developing of vaginal bleeding is possible.

Side effects

Klimen's use can cause side effects:

• From reproductive system and mammary glands: morbidity, tension and/or increase in mammary glands, bloody intermenstrual allocations, breakthrough bleedings, changes of intensity and frequency of uterine bleedings (during therapy, usually, weakened), changes of vaginal allocations, a dysmenorrhea, the state similar to a premenstrual syndrome;
• From digestive tract: nausea, abdominal pain, vomiting, dyspepsia, abdominal distention, recurrence of cholestatic jaundice;
• From a nervous system: dizziness, headache, depression symptoms, uneasiness, migraine, increased fatigue;
• From skin and hypodermic cellulose: skin itch, skin rash, knotty erythema, hloazma;
• Others: increase in arterial pressure, cardiopalmus, thrombembolia and venous thrombosis, hypostases, muscular spasms, changes of a libido, change of body weight, intolerance of contact lenses, vision disorders, allergic reactions.

Special instructions

Use of drug is recommended only on doctor's orders, after careful all-medical and gynecologic examination, confirmation of lack of pregnancy and disturbances of system of a blood coagulation.

At purpose of drug to women aged, with genetic predisposition, heavy obesity it is necessary to weigh a ratio of risk and advantage of therapy.

Drug is not contraceptive and is not intended for use for the purpose of contraception.

In case of need contraceptions, to the woman it is necessary to recommend use of non-hormonal drugs. At pregnancy existence suspicion, administration of drug should be suspended until confirmation of its absence.

Against the background of zamenitelny hormonal therapy the probability of development of a venous thromboembolism, especially at patients with risk factors increases. In the period of a long immobilization or at extensive injuries it is recommended to stop reception of a dragee temporarily. In case of signs of trombotichesky disturbances Klimen's use should be cancelled.

Long oestrogenic monotherapy increases risk of development of a carcinoma or a hyperplasia of an endometria, presence of gestagen – reduces probability of cancer and hyperplasia of an endometria.

The relative risk of development of a breast cancer increases at the women accepting drug within several years.

Hormonal therapy increases density of mammary glands at a mammography research, in certain cases it can interfere with radiological detection of a breast cancer.

Against the background of use of sexual steroids, benign or malignant tumors of a liver, in some cases – with intra belly bleeding in rare instances take place. At the increased liver, pains in an upper part of a stomach or the diagnosed symptoms of intra belly bleeding it is necessary to consider a possibility of a tumor of a liver.

Estrogen exponentiates a bile litogennost, at predisposed women it leads to development of cholelithiasis against the background of reception of a dragee.

At emergence of very severe, frequent headaches or migrenepodobny states it is necessary to stop treatment and to be convinced that they are not symptoms of a trombotichesky stroke of a brain.

Use of hormonal drugs can cause slight increase of arterial pressure which has no clinical effects. At development of steady arterial hypertension administration of drug should be cancelled.

Replacement hormonal therapy at patients with the broken function of a liver should be carried out under regular observation of the doctor and carrying out periodic researches of function of a liver. In case of deterioration in the laboratory indicators or a recurrence of a cholestatic itch or jaundice for the first time observed during pregnancy or the previous hormonal therapy, Klimen's use should be stopped.

At patients with the moderate increased content of triglycerides reception of a dragee promotes growth of their level in blood and to risk of development of acute pancreatitis.

Use of hormonal means can cause uterine bleedings, at increase in their frequency and a profuseness it is necessary to conduct an endometria research.

In the absence of normalization of menstrual cycles at treatment of their irregularity, it is necessary to conduct additional examinations of the patient.

In case of an endometriosis recurrence, at increase in a hysteromyoma under the influence of estrogen their use should be stopped.

Treatment should be begun after an exception of existence of a prolaktinoma.

Hloazma is more often observed at patients with the instruction in the anamnesis on this disease. Women, inclined to its development, should avoid long ultraviolet radiation during reception of a dragee.

At emergence or aggravation against the background of therapy of a benign tumor of a mammary gland, epilepsy, bronchial asthma, a porphyria, migraine, a system lupus erythematosus, an otosclerosis, a hysterical chorea use of hormonal drugs has to take place under observation of the attending physician.

Klimen's reception can exert impact on results of laboratory researches – indicators of carbohydrate metabolism, a fibrinolysis, coagulation, biochemical indicators of function of adrenal glands, kidneys, a liver, a thyroid gland, contents level in a blood plasma of transport proteins.

Drug does not exert impact on ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

Contraindicated simultaneous use of Klimen with hormonal contraceptives.

Prolonged use of some antibiotics and anticonvulsants, including hydantoins, barbiturates, Primidonum, carbamazepine, rifampicin, and also presumably, окскарбазепин, топирамат, фелбамат and griseofulvin, is capable to induce liver enzymes, increasing clearance of sex hormones and reducing their clinical performance. Induction of enzymes reaches a maximum usually in 2-3 weeks of use of drug and can remain within 4 weeks after its cancellation.

Against the background of a concomitant use of antibiotics of tetracycline or penicillinic group, decrease in level of oestradiol is possible.

The paracetamol and other substances which are exposed to considerable extent of conjugation can increase bioavailability of oestradiol.

Drug influences tolerance to glucose, dose adjustment of at the same time accepted peroral antidiabetic means or insulin can be required.

The use of high doses of alcohol promotes increase in level of oestradiol in blood.

Terms and storage conditions

To store in the place, unavailable to children, at the room temperature.

Period of validity – 5 years.