Ovipol Clio

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation.

Use for liver dysfunction

Contraindicated in patients with acute liver disease or a history of liver disease until liver function tests return to normal.

Use for renal impairment

Use the drug with caution in case of renal failure.

Use in elderly patients

Evidence has been obtained of an increased risk of developing dementia in women who began taking continuously combined HRT or estrogen monotherapy after 65 years of age.

special instructions

With long-term treatment with estrogen, systematic medical examinations are indicated. Before starting treatment and every 6 months of treatment, a thorough general medical and gynecological examination, including examination of the mammary glands, should be performed.

Hormone replacement therapy (HRT) in the treatment of menopausal symptoms is recommended to be started only if they adversely affect the patient’s quality of life. In all other cases, it is necessary to compare the balance of benefit and risk. At a younger age, the benefit-risk ratio is more favorable than in older women. During treatment, it is necessary to inform the doctor about cases of vaginal bleeding, changes in the mammary glands, the appearance of jaundice, as well as signs of thromboembolism (for example, painful swelling of the extremities, sudden chest pain, shortness of breath). In all cases, patients require careful examination.

Reasons for immediate discontinuation of therapy:

jaundice or liver dysfunction;
increased blood pressure;
the occurrence of migraine-type headaches;
phlebitis.

Tumors

With long-term estrogen monotherapy, the risk of developing endometrial hyperplasia or cancer increases, 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 stopping therapy it returns to normal. Against the background of HRT, the density of breast tissue may increase, which complicates its radiological examination.

Long-term estrogen therapy (5-10 years) is also associated with an increased risk of ovarian cancer.

Benign or malignant liver tumors have been observed in rare cases during the use of sex hormones. In some cases, these tumors have led to the development of life-threatening intra-abdominal bleeding. If pain appears in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, the presence of a liver tumor should be taken into account in the differential diagnosis.

Cardiovascular diseases

HRT is associated with a 1.3- to 3-fold increase in the risk of developing venous thromboembolism (VTE) and is most likely to occur during the first year of drug use than at a later date. All risk factors for VTE should be taken into account, and when prescribing the drug before surgery, it is necessary to carry out VTE prophylaxis, and it is also necessary to temporarily discontinue HRT 4-6 weeks before surgery and resume treatment only after the woman begins to walk.

The risk of ischemic stroke increases especially in old age.

In the absence of a history of VTE, but in the presence of thrombosis at a young age in close 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 if there is a severe defect (for example, deficiency of antithrombin, protein S or protein C, or a combination of these defects), HRT is contraindicated.

Women receiving anticoagulant treatment must weigh the benefits versus risks.

Estrogens can cause fluid retention. Patients with renal or heart failure should be under medical supervision while taking HRT.

Other states

Estrogens increase the lithogenicity of bile, which increases the susceptibility in 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 does not improve with HRT. Evidence has been obtained of an increased risk of developing dementia in women who began taking continuously combined HRT or estrogen monotherapy after 65 years of age.

If prolactinoma is detected, the patient should be under close medical supervision (including periodic assessment of prolactin concentrations).

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

Impact on the ability to drive vehicles and operate machinery

The effect of the drug Ovipol Clio® on the ability to drive vehicles and machines has not been identified.

Ovipol Clio supp vag 0.5 mg pack cont cell/pack card x15

Release form, composition and packaging Vaginal suppositories are white or white with a yellowish tint, cylindrical-conical in shape, an airy or funnel-shaped depression is allowed on the cut.

1 sup. estriol 500 mcg

Excipients: semi-synthetic glycerides (such as “Suppotsir”) - 1999.5 mg.

5 - contour cell packaging (3) - cardboard packs.

Clinical and pharmacological group: Anticlimacteric estrogen drug

Registration No.:

• vaginal suppositories. 500 mcg: 15 - LP-001598, 03/22/12. Active. DLO.

——————————————————————————— The description of the medicinal product OVIPOL CLIO® is based on the officially approved instructions for use of the drug OVIPOL CLIO® for specialists and approved by the company - manufacturer for the 2013 edition.

———————————————————————————

--------------------------- Pharmachologic effect

Estrogen synthesized in the human body. Once in the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, mammary gland, liver, hypothalamus, pituitary gland), stimulates the synthesis of DNA and proteins. It has a selective effect, mainly on the cervix, vagina, vulva, causes increased proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, promotes the restoration of the epithelium during its atrophic changes during premenopause and menopause, normalizes the pH of the vaginal environment, the microflora of the vagina, increases its resistance epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus. The effect on the endometrium is negligible (negligible risk of uterine bleeding).

It has a hypolipidemic effect, slightly increases the concentration of beta-lipoproteins in the blood, increases sensitivity to the action of insulin, improves glucose utilization, stimulates the liver's production of globulins that bind sex hormones, renin, HDL and blood clotting factors. Due to its participation in the implementation of positive and negative feedback in the hypothalamic-pituitary-ovarian system, estriol is able to cause moderately pronounced central effects and stimulates parasympathomimetic reactions.

Pharmacokinetics

Absorption is high. The time to reach the maximum concentration in blood plasma with intravaginal use is 1-2 hours. Binding with plasma albumin is 90%.

Excretion is carried out mainly by the kidneys in the form of metabolites (several hours after administration and continues up to 18 hours), 2% is excreted through the intestines unchanged.

Indications for use of the drug OVIPOL CLIO®

— hormone replacement therapy: atrophy of the mucous membrane of the lower parts of the urogenital tract associated with estrogen deficiency,

- pre- and postoperative therapy in postmenopausal women who are about to undergo or have undergone surgery via vaginal access,

— for diagnostic purposes in case of unclear results of a vaginal smear against the background of atrophic changes.

Dosage regimen

Intravaginally, before bedtime.

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

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

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

If the next dose of the drug has been missed, you should take it immediately. However, if this is discovered only on the day of taking the next dose, you should continue taking the drug as usual without making up for the missed dose. Do not use two doses in one day.

Side effect

Possible: itching and irritation at the injection site, tension and soreness 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 pelvis, pulmonary veins), myocardial infarction, stroke, gallbladder disease , chloasma, erythema multiforme, erythema nodosum, hemorrhagic purpura, dementia when starting HRT in continuous use of the drug after 65 years, acyclic spotting, breakthrough bleeding, increased libido.

Contraindications to the use of OVIPOL CLIO®

- established (including history) 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 currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders,

- conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history,

- multiple or severe risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral or coronary artery disease, uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years ),

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

— deep vein thrombophlebitis (including history),

- severe hypertriglyceridemia,

- cholestatic jaundice,

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

- acute liver disease or a history of liver disease until liver function tests return to normal,

- porphyria,

- pregnancy,

- lactation period,

- hypersensitivity to the components of the drug.

With caution: leiomyoma or endometriosis, a history of thromboembolism or risk factors for its development, risk factors for estrogen-dependent tumors, incl. 1st degree family history of breast cancer, 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, history of endometrial cancer or hyperplasia, heart or kidney failure, metabolic disorders of bone tissue, herpes during a previous pregnancy.

Use of the drug OVIPOL CLIO® during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation.

special instructions

Reasons for immediate discontinuation of therapy:

- jaundice or liver dysfunction,

- increased blood pressure,

- the occurrence of migraine-type headaches,

- phlebitis.

Tumors

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

Long-term estrogen therapy (5-10 years) is also associated with an increased risk of ovarian cancer.

Cardiovascular diseases

The risk of ischemic stroke increases especially in old age.

In the absence of a history of VTE, but in the presence of thrombosis at a young age in close 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, deficiency of antithrombin, protein S or protein C, or a combination of these defects), HRT is contraindicated.

Women receiving anticoagulant treatment must weigh the benefits versus risks.

Estrogens can cause fluid retention. Patients with renal or heart failure should be under medical supervision while taking HRT.

Other states

Estrogens increase the lithogenicity of bile, which increases the susceptibility in 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.

If prolactinoma is detected, the patient should be under close medical supervision (including periodic assessment of prolactin concentrations).

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

Impact on the ability to drive vehicles and operate machinery

The effect of the drug Ovipol Clio® on the ability to drive vehicles and machines has not been identified.

Overdose When used intravaginally, an overdose is unlikely. Symptoms (with accidental ingestion): nausea, vomiting, withdrawal bleeding. Treatment: symptomatic. There is no specific antidote.

Drug interactions Inducers of microsomal oxidation (phenobarbital, carbamazepine, phenytoin, rifampicin, rifabutin, nevirapine, efavirenz) increase estrogen metabolism, powerful inhibitors (ritonavir, nelfinavir) significantly inhibit metabolism.

St. John's wort preparations can induce estrogen metabolism.

Estriol enhances the effect of lipid-lowering drugs. Weakens the effects of male sex hormones, anticoagulants, antidepressants, diuretics, antihypertensives, hypoglycemic agents.

Conditions for dispensing from pharmacies The drug is approved for use as an over-the-counter product.

Conditions and periods of storage The drug should be stored in a dry place, protected from light, out of reach of children, at a temperature of 15° to 25°C. Shelf life: 3 years.

Indications for use

The reason for prescribing Ovipol Clio suppositories is:

Development of genitourinary syndrome during menopause. Symptoms: discomfort during sexual intercourse, dryness and burning in the vagina, frequent urge to urinate, urinary incontinence.
Amenorrhea (absence of menstruation) associated with temporary or permanent estrogen deficiency in women of reproductive age after cervical surgery.
Cervical canal stenosis.
Senile colpitis.
Preparation for gynecological surgery and the recovery period after it.
A questionable result of a cytological examination of the cervix with suspected oncology against the background of atrophy of the mucous membrane.

Ovipol Clio suppositories are administered once before bedtime. The duration of the course is prescribed by the attending gynecologist.

Contraindications

A prescription is not needed to purchase the drug, but be careful when reading the instructions for use - Ovipol Clio suppositories have contraindications for use:

thrombosis or thromboembolism;
problems with the cardiovascular system: angina pectoris, ischemia;
breast cancer;
genital bleeding;
pregnancy and breastfeeding;
estrogen-dependent tumors;
individual intolerance to the drug.

Treatment with Ovipol Clio suppositories is carried out under the strict supervision of the attending physician if you have been diagnosed with at least one of the following factors:

predisposition to the development of estrogen-dependent tumors;
diabetes;
tendency to edema;
migraine;
kidney pathologies.

pharmachologic effect

Ovipol Clio is produced by the company Pharmaprim, Moldova in the form of vaginal suppositories, packaged in a cardboard box of 15 pieces.

Manufacturer: FARMAPRIM, Republic of Moldova, Russia

Release form: vaginal suppositories

Active ingredient: estriol 0.5 mg; excipient Suppotsir - a mixture of solid fats from plant and synthetic components, 1999.5 mg.

Estriol is an estrogens that does not require control of the condition of the endometrium and mammary glands.

Glycerides, which make up 99% of the candle's mass, do not change the properties of estriol; they melt inside the body for 10-15 minutes, gradually releasing the active substance.

Ovipol Clio is not available in a dosage form in the form of a cream or ointment.

Estrogens are female sex hormones synthesized in the ovaries. Estriol is an estrogen with the least biological activity and selectively affects the urogenital tract. Normalizes the microflora and pH of vaginal contents, reduces the likelihood of infection of the genitourinary system, and prevents urinary incontinence.

Ovipol Klio®

Read the instructions for use carefully before you start using this drug, as they contain important information for you.

— Save the instructions, you may need them again.

— If you have any questions, consult your doctor.

— The medicine you are using is intended for you personally and should not be given to others as it may cause harm to them even if they have the same symptoms as you.

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

Reasons for immediate discontinuation of therapy:

- jaundice or liver dysfunction;

- increased blood pressure;

- the occurrence of migraine-type headaches;

- phlebitis.

Tumors

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

Long-term estrogen therapy (5-10 years) is also associated with an increased risk of ovarian cancer.

Cardiovascular diseases

The risk of ischemic stroke especially increases in old age (see section “Contraindications”),

In the absence of a history of VTE, but in the presence of thrombosis at a young age in close 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, deficiency of antithrombin, protein S or protein C, or a combination of these defects), HRT is contraindicated (see section “Contraindications”).

Women receiving anticoagulant treatment must weigh the benefits versus risks.

Estrogens can cause fluid retention. Patients with renal or heart failure should be under medical supervision while taking HRT.

Other states

Estrogens increase the lithogenicity of bile, which increases the susceptibility in 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.

If prolactinoma is detected, the patient should be under close medical supervision (including periodic assessment of prolactin concentrations). In women with hereditary factors for angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.