Climen

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Climen contains estrogen - estradiol valerate, which turns into a natural 17β- estradiol in the human body. Also Climen includes the progesterone derivative - cyproterone acetate with a gestagenic, antigonadotropic and antiandrogenic action.

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Climen

Dosage form, composition and packaging

Tablets of two kinds.

White tablets (11 tablets in a blister pack).

 

1 tablet

estradiol valerate

2 mg

Excipients: lactose monohydrate, maize starch, povidone 25000 (K25), talc, magnesium stearate, sucrose, povidone 700000 (K700), macrogol 6000, calcium carbonate, wax.

Pink tablets (10 tablets in a blister pack).

 

1 tablet

estradiol valerate

2 mg

cyproterone acetate

1 mg

Climen Pharmacological action

Climen contains estrogen - estradiol valerate, which turns into a natural 17β- estradiol in the human body. Also Climen includes the progesterone derivative - cyproterone acetate with a gestagenic, antigonadotropic and antiandrogenic action.

Due to the composition and cyclic regimen of Climen (receiving estrogen alone for 11 days, and then receiving a combination of estrogen and progestogen for 10 days, and finally a 7-day break) a menstrual cycle is set in women who did not have their uterus removed and who are regularly taking the drug.

During administration of Climen the ovulation is not suppressed, and production of hormones in the body remains virtually unchanged. Climen can be used by women of reproductive age to regulate the menstrual cycle, as well as by perimenopausal women to treat irregular uterine bleeding.

Estradiol replenishes estrogen deficiency in the female body after menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as "hot flashes", sweating, sleep disturbance, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, decreased libido, muscle and joint pain); involution of skin and mucous membranes, especially the mucous membranes of the genitourinary system (urinary incontinence, dryness and irritation of the vagina, pain during sexual intercourse).

Estradiol prevents bone loss caused by estrogen deficiency. This occurs mainly due to the suppression of osteoclast function and bone remodeling process shift toward the formation of bone. It has been proven that long-term use of hormone replacement therapy (HRT) can reduce the risk of peripheral bone fractures in women after menopause.

In addition, due to antiandrogenic properties of cyproterone acetate, Climen has a therapeutic effect on androgen-dependent diseases such as acne, seborrhea, androgenic alopecia.

Climen Indications

  • hormone replacement therapy (HRT) in case of menopausal disorders, involutional changes in the skin and urinary tract, depressed moods during the climacteric period, as well as symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian insufficiency in women who did not have their uterus removed;
  • prevention of postmenopausal osteoporosis;
  • normalization of irregular menstrual cycles;
  • treatment of primary or secondary amenorrhea.

Climen Contraindications

It is not recommended to start hormone replacement therapy (HRT) in the presence of any of the following conditions. If any of these conditions arise during HRT, one should stop using the product immediately.

  • pregnancy and lactation;
  • vaginal bleeding of unknown origin;
  • confirmed or presumptive diagnosis of breast cancer;
  • confirmed or presumptive diagnosis of hormone-dependent precancerous condition or hormone-dependent malignant tumors;
  • liver tumors at present or in history (benign or malignant);
  • severe liver diseases;
  • acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);
  • deep vein thrombosis in the acute stage, thromboembolism at present or in history;
  • severe hypertriglyceridemia;
  • hypersensitivity to the Climen drug.

Application Climen with caution: arterial hypertension, congenital hyperbilirubinemia (Gilbert’s syndrome, Dubin-Johnson syndrome and Rotor syndrome), cholestatic jaundice or cholestatic pruritus during pregnancy, endometriosis, uterine fibroid, diabetes.

Climen Overdose

No risk of serious side effects has been revealed if the drug has been accidentally taken in an amount many times greater than the daily therapeutic dose.

Symptoms that may occur in case of overdose: nausea, vomiting, vaginal bleeding.

Climen Treatment: there is no specific antidote, treatment is symptomatic.

Climen interactions

At the beginning of HRT one should stop using hormonal birth control methods. If necessary, the patient should be advised to use non-hormonal birth control methods.

Long-term treatment with drugs that induce liver enzymes (e.g., some anticonvulsants and antimicrobials) may increase the clearance of sex hormones and reduce their clinical efficacy. Similar ability to induce liver enzymes was found in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, the presence of this feature is also expected from oxcarbazepine, topiramate, felbamate and griseofulvin. Maximal induction of enzymes is usually observed no sooner than in 2-3 weeks, but then it can still be maintained at least for 4 weeks after discontinuation of the drug.

In rare cases with concurrent ingestion of certain antibiotics (e.g., penicillin and tetracycline groups) there was a decrease in estradiol levels.

Substances largely undergoing conjugation (e.g., paracetamol) may increase the bioavailability of estradiol due to competitive inhibition of conjugation system in the process of absorption.

Because of the effects of HRT on glucose tolerance in some cases the need for oral antidiabetic agents or insulin may change.

Alcohol interactions

Excessive alcohol consumption during HRT may lead to increased levels of circulating estradiol.

Pregnancy and lactation

HRT is not prescribed during pregnancy or breastfeeding.

Large-scale epidemiological studies of steroid hormones used for contraception or hormone replacement therapy found no increased risk of birth defects in children born to women who took such hormones before pregnancy, and teratogenic effects of hormones if they were accidentally taken during early pregnancy.

A small amount of sex hormones may be excreted into breast milk.

Climen Side effects

Reproductive system and breasts: changes in the frequency and intensity of uterine bleeding, breakthrough bleeding, intermenstrual spotting (usually decreases during therapy), dysmenorrhea, change in vaginal discharge, a condition similar to premenstrual syndrome; soreness, tension and/or breast enlargement.

Gastrointestinal tract: dyspepsia, bloating, nausea, vomiting, abdominal pain, recurrent cholestatic jaundice

Skin and subcutaneous tissue: skin rash, itching, chloasma, erythema nodosum

CNS: headache, migraine, dizziness, anxiety or depressive symptoms, fatigue

Miscellaneous: palpitations, edema, high blood pressure, venous thrombosis and thromboembolism, muscle cramps, changes in body weight, changes in libido, visual disturbances, intolerance to contact lenses, allergic reactions

Storage time and conditions

Climen should be stored out of children’s reach in normal conditions. Shelf life - 5 years.

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