Klimonorm

Klimonorm – the combined anticlimacteric means.

Form of release and structure

Dosage form – a dragee of two types: yellow and brown color, have the round form (in blisters on 9 yellow and 12 brown dragees, in a cardboard pack 1 or 3 blisters).

Content of active agents is 1 dragees:

• Yellow color: oestradiol valerate – 2 mg;
• Brown color: oestradiol valerate – 2 mg, levonorgestrel – 0,15 mg.

Auxiliary components: dextrose (glucose), calcium a carbonate, lactoses monohydrate, potato starch, magnesium stearate, K25 povidone, a macrogoal 35 000, sucrose, wax of karnaubskiya, talc, gelatin, titanium dioxide, the water purified.

In addition in structure:

• Yellow dragees: ferrous oxide yellow, magnesium carbonate the main;
• Brown dragees: ferrous oxide red, ferrous oxide brown, magnesium hydroxycarbonate the main.

Indications to use

• Gormonozamestitelny therapy of involutional changes of skin and urinogenital path, climacteric frustration and depressions in a climacteric, symptoms of deficit of estrogen against the background of sterilization, a hypogonadism or a natural menopause, and also primary dysfunction of ovaries at women with an unextracted uterus;
• Recovery of menstrual cycles at their irregularity;
• Treatment of an amenorrhea (primary and secondary);
• Prevention of postmenopauzny osteoporosis.

Contraindications

• Vulval bleeding of an unspecified etiology;
• The breast cancer (diagnosed or assumed);
• Period of pregnancy and breastfeeding;
• Malignant hormonedependent tumor or hormonedependent precancerous disease with the assumed or confirmed diagnosis;
• The expressed liver diseases;
• The benign or malignant tumors of a liver including specified in the anamnesis;
• Heavy gipertriglitseridemiya;
• Aggravation of a deep vein thrombosis, thromboembolism, including in the anamnesis;
• Acute arterial thrombosis, thromboembolism, including stroke, myocardial infarction;
• Hypersensitivity to drug components.

At emergence of the specified states during treatment Klimonorm's use should be cancelled immediately.

With care patients are recommended to make purpose of drug with an inborn hyperbilirubinemia (Gilbert's syndromes, the Rotor, Dabin-Johnson), a cholestatic itch or cholestatic jaundice at pregnancy, arterial hypertension, endometriosis, a diabetes mellitus, a hysteromyoma.

Route of administration and dosage

Klimonorm is intended for oral administration, the dragee is swallowed entirely and washed down with enough liquid. For administration of drug the woman chooses time of day, convenient for it, to which it is necessary to adhere strictly the entire period of treatment.

To patients with the kept menstrual cycle, it is necessary to accept the first dragee for the 5th day of menstrual bleeding.

At very rare periods or their absence treatment can be begun on condition of the confirmed lack of pregnancy at any time.

The drug dosing makes 1 dragee of 1 times a day, within 9 first days accept a dragee of yellow color, then 12 days – brown. After reception of all of 21 dragees the break within 7 days follows. For 2-3 day after drug withdrawal there comes menstrualnopodobny bleeding.

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

At the accidental admission of reception of a dragee at the scheduled time, the woman has to try to accept it as soon as possible (in the closest 12-24 h). At longer interruption of therapy approach of vaginal bleeding is possible.

Side effects

Klimonorm's use can become the reason of the following side effects:

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

Special instructions

Klimonorm it is impossible to apply for the purpose of contraception.

Purpose of drug is made by the doctor on the basis of clinical indications, careful all-medical, gynecologic examination, results of a research of mammary glands and cervical slime. Besides, it is necessary to confirm lack of pregnancy and disturbance of system of a blood coagulation.

Use of a dragee should be accompanied with periodic control inspections.

During treatment the woman has to use only non-hormonal contraceptive drugs. In case of suspicion on existence of pregnancy it is necessary to stop therapy till the moment until it is excluded.

Use of drug is accompanied by risk of development of a venous thromboembolism, with age it raises. At purpose of hormonal means the patient with genetic predisposition to a deep vein thrombosis or an embolism of a pulmonary artery, and patients with a gross obesity, it is necessary to weigh a ratio of potential risk and estimated advantage of therapy.

In case of a long immobilization during treatment or at emergence of the signs or suspicions indicating trombotichesky disturbances it is recommended to stop drug use.

In the first year of use increase of risk of a coronary disease and developing of a stroke is possible.

At long estrogenic monotherapy the risk of development of a carcinoma of an endometria or a hyperplasia increases, at a combination with addition of gestagen the probability of a hyperplasia of an endometria and cancer decreases.

The interrelation between hormonal therapy and development of a breast cancer is definitely not established. Data of researches demonstrate that at the women accepting hormonal drugs it more differentiated, than at other patients.

Treatment increases density of mammary glands at mammography inspections, it can negatively influence radiological detection of a breast cancer.

The increased risk of a breast cancer decreases to usual level in 5 years after completion of hormonal therapy.

Against the background of sexual steroids development of benign or malignant tumors of a liver is possible.

Klimonorm raises a bile litogennost that poses a threat of development of cholelithiasis.

Migrenepodobny or frequent and very severe headaches can be symptoms of a trombotichesky stroke of a brain therefore at their emergence it is necessary to stop reception of a dragee and to see a doctor.

In case of development of the steady expressed arterial hypertension it is recommended to consider a question of drug withdrawal.

Regular observation of the doctor is demanded by treatment of patients with abnormal liver functions, and at deterioration in indicators of function of a liver hormonal replacement therapy needs to be cancelled.

At emergence of a recurrence of cholestatic jaundice or cholestatic itch, for the first time observed during pregnancy or the previous reception of steroid sex hormones, it is necessary to stop treatment immediately.

Use of drug increases probability of development of acute pancreatitis in women with the increased level of triglycerides.

At frequent pathological uterine bleedings against the background of hormonal therapy carrying out a research of an endometria is recommended.

At increase in the size of a hysteromyoma, development of a recurrence of endometriosis under the influence of estrogen, therapy should be stopped.

To women inclined to a hloazma, or with the indication of a hloazma of pregnant women in the anamnesis, contraindicated long stay in the sun or under ultraviolet radiation.

In case of lack of clinical effect at treatment of irregular menstrual cycles carrying out the additional inspections directed to an exception of diseases of organic character is recommended.

Replacement hormonal therapy can become an origin or aggravation of the following states and diseases: benign tumor of a mammary gland, epilepsy, bronchial asthma, porphyria, migraine, otosclerosis, hysterical chorea, system lupus erythematosus.

Against the background of reception of sexual steroids there is a change of biochemical indicators of adrenal glands, kidneys, functions of a liver and a thyroid gland, contents in a blood plasma of transport proteins (kortikosteroidsvyazyvayushchy globulin, lipid or lipoprotein fractions), indicators of a fibrinolysis, coagulation, carbohydrate metabolism.

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

Medicinal interaction

Contraindicated simultaneous use with hormonal contraceptives.

Prolonged treatment by some anticonvulsant or antimicrobic drugs exponentiating induction of enzymes of a liver can increase clearance of sex hormones and reduce their action. Hydantoins, barbiturates, Primidonum, carbamazepine and rifampicin can induce liver enzymes, also existence of this feature is supposed at griseofulvin, an okskarbazepin, a felbamat and a topiramat. Induction of enzymes reaches a maximum usually after 2-3 weeks of reception of medicine and keeps stability still, at least, within 4 weeks after the termination.

The concomitant use of some antibiotics, including tetracycline and penicillinic groups, in rare instances leads to decrease in level of oestradiol. The paracetamol and other substances which are exposed to conjugation substantially can increase bioavailability of oestradiol.

Klimonorm influences tolerance to glucose, at a combination to peroral hypoglycemic means or insulin correction of their dose can be required.

Alcohol intake in high doses during hormonal therapy can promote increase in level of oestradiol in blood.

Terms and storage conditions

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

Period of validity – 5 years.