OVIPOL KLIO CANDLES VAGINAL 0,5MG

Dosage and administration

Intravaginally, at bedtime.

At atrophy of the mucous membrane of the lower parts of the urogenital tract appoint 1 supp. (0.5 mg) daily for the first 2-3 weeks, then gradually reduce the dose, based on the symptoms, 1 supp. (0.5 mg) 2 times a week.

Pre- and postoperative therapy in postmenopausal women - 1 supp. (0.5 mg) within 2 weeks before or after surgery.

As a diagnostic tool - 1 supp. every other day for a week before taking the next smear.

If the next dose was missed, you should take it immediately. However, if it was found only on the day of the next dose, you should continue taking the drug in the usual way, without replenishing the missed dose. You can not use two doses in one day.

Side effect

Maybe: itching and irritation at the injection site, tension and tenderness of the mammary glands.

In combination with gestagens: benign and malignant estrogen-dependent tumors (including breast and endometrial cancer), venous thromboembolism (including deep veins of the leg and small pelvis, pulmonary veins), myocardial infarction, stroke, gallbladder disease, chloasma, erythema multiforme, erythema nodosum, hemorrhagic purpura, dementia at the onset of HRT in continuous use of the drug after 65 years, acyclic bleeding, "breakthrough" bleeding, increased libido.

Contraindications

- installed (incl.a history of) or suspected breast cancer;

- estrogen-dependent malignant neoplasms or suspicion of them (including endometrial cancer);

- undiagnosed genital bleeding;

- untreated endometrial hyperplasia;

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, thromboembolism of the pulmonary artery, myocardial infarction, stroke), cerebrovascular disorders;

- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history;

- multiple or severe risk factors for venous or arterial thrombosis (including complicated lesions of the cardiac valve apparatus, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled arterial hypertension, serious surgical intervention with prolonged immobilization, smoking after the age of 35 years );

- confirmed thrombophilia, hereditary or acquired factors predisposing to the development of venous and arterial thrombosis, such as: resistance to activated protein C, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, the presence of antibodies to phospholipids and others;

- deep vein thrombophlebitis (including history);

- severe hypertriglyceridemia;

- cholestatic jaundice;

- otosclerosis (including during a previous pregnancy or during treatment with sex hormones);

- acute liver disease or a history of liver disease until the liver function returns to normal;

- porphyria;

- pregnancy;

- lactation period;

- hypersensitivity to the drug.

WITH caution: leiomyoma or endometriosis, history of thromboembolism or risk factors for its development, risk factors for estrogen-dependent tumors, incl. 1st degree related to breast cancer in the family history, arterial hypertension, liver disease (including adenoma), diabetes mellitus with or without diabetic angiopathy, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, epilepsy, bronchial asthma, familial hyperlipoproteinemia, pancreatitis, cancer or endometrial hyperplasia in history, cardiac or renal failure, metabolic bone disorders, herpes during a previous pregnancy.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy and lactation.

Special notes

With prolonged treatment with estrogen, systematic medical examinations are indicated. Before the start of treatment and every 6 months of treatment, a thorough general medical and gynecological examination, including an examination of the mammary glands, should be carried out.

Hormone replacement therapy (HRT) in the treatment of menopausal symptoms is recommended to begin only if they adversely affect the patient's quality of life. In all other cases it is necessary to compare the ratio of benefits and risks.At a younger age, the ratio of benefits and risks is more favorable than that of older women. During treatment, you must inform the doctor about cases of vaginal bleeding, changes in the mammary glands, jaundice, and signs of thromboembolism (for example, painful swelling of limbs, sudden chest pain, shortness of breath). In all cases, patients require careful examination.

Reasons for immediate discontinuation of therapy:

- jaundice or abnormal liver function;

- increase in blood pressure;

- the occurrence of headaches like migraine;

- phlebitis.

Tumors

Long-term estrogen monotherapy increases the risk of endometrial hyperplasia or cancer, which is directly proportional to the dose of the drug and the duration of therapy.

The risk of developing breast cancer depends on the duration of HRT, but after a few years (most often 5 years), after cessation of therapy, it returns to normal. On the background of HRT, the density of breast tissue may increase, which complicates its radiological study.

Prolonged estrogen therapy (5–10 years) is also associated with an increased risk of ovarian cancer.

On the background of the use of sex hormones, benign or malignant tumors of the liver were rarely observed. In some cases, these tumors led to the development of life-threatening intra-abdominal bleeding. If there is pain in the upper abdomen, an enlarged liver or signs of intra-abdominal bleeding, differential diagnosis should take into account the presence of a liver tumor.

Cardiovascular diseases

HRT is associated with an increased risk of venous thromboembolism (VTE) 1.3-3 times and is more likely during the first year of the drug than at a later time. It is necessary to take into account all risk factors for VTE, and when prescribing a drug before surgery, it is necessary to carry out VTE prophylaxis, and it is also necessary to temporarily cancel HRT 4-6 weeks before surgery and resume treatment only after the woman begins to walk.

The risk of ischemic stroke especially increases in old age.

In the absence of VTE in history, but in the presence of thrombosis at a young age with immediate relatives, it is recommended to conduct a screening examination for the presence of thrombophilic disorders. If a thrombophilic defect is detected that is not identical to the disease in relatives, or the presence of a “severe” defect (for example, an antithrombin deficiency, protein S or protein C, or a combination of these defects), hormone therapy is contraindicated.

Women who receive treatment with anticoagulants, it is necessary to compare the ratio of benefits and risks.

Estrogens can cause fluid retention. Patients with renal or heart failure while receiving HRT should be under the supervision of a physician.

Other states

Estrogens increase the lithogenicity of bile, which increases the susceptibility of some patients to the development of cholelithiasis when using estrogens.

Estrogens are a weak gonadotropin antagonist and do not have significant effects on the endocrine system.

Cognitive function in the background of HRT is not improving. Data were obtained on the increased risk of dementia in women who began taking continuously combined HRT or estrogen monotherapy after 65 years of age.

If prolactinomas are detected, the patient should be under close medical supervision (including periodic assessment of prolactin concentration).

In women with hereditary factors for angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.

Influence on ability to drive motor transport and control mechanisms

Effect of the drug Ovipol Clio® on the ability to drive vehicles and mechanisms not identified.

Overdose

With intravaginal use overdose unlikely

Symptoms (for occasional ingestion): nausea, vomiting, withdrawal bleeding.

Treatment: symptomatic. There is no specific antidote.

Drug interaction

Inductors of microsomal oxidation (phenobarbital, Carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, efavirenz) increase estrogen metabolism; powerful inhibitors (ritonavir, nelfinavir) - significantly inhibit metabolism.

Hypericum perforatum drugs can induce estrogen metabolism.

Estriol enhances the action of hypolipidemic agents.

Weakens the effects of male sex hormones, anticoagulants, antidepressants, diuretic, hypotensive, hypoglycemic agents.

Pharmacy sales terms

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug should be stored in a dry, dark place, out of the reach of children, at a temperature of 15 ° to 25 ° C.