Ovipol Clio suppositories vaginas. 0.5mg 15 pc

Description

Composition
Active substance:
1 suppository contains estriol – 0.5 mg.
Excipients:
Semisynthetic glycerides (such as “Suppotsir”) – 1999.5 mg.
Description:
Suppositories are cylindrical-shaped white or white with a yellowish tinge. On the cut may be the presence of air or a funnel-shaped recess.
Product form:
Vaginal suppositories 0.5 mg.
5 suppositories in blisters. 3 blisters together with instructions for use in a stack of cardboard.
Contraindications
• installed sensitivity to the active agent or any of the excipients of the formulation; • installed with the disease or suspected breast cancer; • Diagnosed or suspected estrogen-dependent tumor to them (e.g., endometrial cancer); • Vaginal bleeding of unknown etiology; • Untreated endometrial hyperplasia; • hereditary or acquired predisposition to venous or arterial thrombosis (resistance to activated protein C deficiency of protein C, S, antithrombin III protein; hyperhomocysteinemia, antibodies to phospholipids); • thrombosis (venous and arterial) and thromboembolism currently or history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke..), Cerebrovascular disorders; state prior thrombosis (including transient ischemic attack, angina pectoris..) now or in the anamnesis; • Liver disease in the acute stage of the disease or a history of liver, after which liver function tests have not returned to normal; • porphyria; • Pregnancy; • The period of breastfeeding.
Carefully
Leiomyoma or endometriosis, risk factors for thromboembolic complications, risks of estrogen-dependent tumors, r. H. The presence of a family history of breast cancer among relatives 1st line relationship cancer, hypertension, benign liver tumors (e.g., adenoma of the liver), diabetes mellitus diabetic angiopathy or without cholelithiasis, migraine or severe headache, systemic lupus erythematosus, epilepsy, asthma, family hyperlipoproteinemia, pancreatitis, endometrial hyperplasia in history , Cardiac or renal failure.
Dosage
0.5 mg
Indications
Hormone replacement therapy: atrophy of the mucosa of the lower parts of the urogenital tract related to estrogen deficiency.
Pre- and post-operative therapy in postmenopausal women, who will be held or vaginal access operation.
For diagnostic purposes in unclear results of vaginal smear on the background of atrophic changes.
Interaction with other drugs
Inductors microsomal oxidation (phenobarbital, carbamazepine, phenytoin, rifampin, rifabutin, nevirapine, efavirenz) increase estrogen metabolism; potent inhibitors (ritonavir, nelfinavir) – significantly inhibit metabolism.
Preparations Hypericum perforatum may induce the metabolism of estrogens.
Estriol increases the effects of lipid-lowering drugs.
It reduces the effects of male sex hormones, anticoagulants, antidepressants, diuretics, antihypertensive, hypoglycemic agents.
If you apply the above or other medications (including over the counter) before using the product Ovipol Klio® consult your doctor.
Overdose
When intravaginal application overdose unlikely.
Symptoms (in case of accidental ingestion), nausea, vomiting, bleeding, “cancel”. Treatment is symptomatic. No specific antidote.
pharmachologic effect
Pharmacological group:
Estrogen.
Pharmacodynamics:
The drug Ovipol Klio® contains estriol – an analog of the natural female hormone. He makes up for deficiency of estrogen in postmenopausal women and reduces the symptoms of menopause. Estriol is most effective in the treatment of genitourinary disorders. In the case of mucosal atrophy lower parts of the urogenital tract estriol helps normalize epithelial urinary tract and promotes the restoration of the normal microflora and the physiological pH of the vagina. The resulting increased resistance of the epithelium of the urinary and reproductive tract to infection and inflammation, reduced mucosal dryness and itching of the vagina, pain during intercourse, the probability of occurrence of vaginal infections, urinary tract infections, and promotes the normalization of urinary prevents incontinence. In contrast to other estrogens estriol has a short duration of action, as in the nuclei of endometrial cells it is held for a short time. It is assumed that a single dose daily dose does not cause endometrial proliferation. Therefore, no cyclic administration of progestogen and no bleeding occurs “cancel.” In addition, it is shown that estriol does not increase mammographic density.
Pharmacokinetics:
Absorption
When administered intravaginal estriol ensures optimal bioavailability at the site of action. Estriol is also absorbed and enters the bloodstream, which is manifested a rapid increase in the concentration of unbound estriol in plasma. The maximum plasma concentration observed after 1-2 hours after administration.
Distribution
In plasma, 90% of estriol is bound to albumin and, unlike other estrogen hardly associated with binding globulin sex hormone.
Metabolism
Metabolism estriol is mainly in the transition in the conjugated and unconjugated state in enterohepatic circulation.
breeding
Estriol, being the end product of metabolism is mainly excreted by the kidneys in bound form. Only a small portion (± 2%) is output from the intestine, mainly in the form of unbound estriol. The half-life is approximately 6-9 hours.
Pregnancy and breast-feeding
Use of the drug during pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
Without recipe.
side effects
Itching and irritation at the injection site, stress and breast tenderness.
In combination with gestagens: benign and malignant estrogen-dependent tumors, incl breast cancer and endometrial venous thromboembolism, incl deep venous leg and pelvis, pulmonary veins, myocardial infarction, stroke, gallbladder disease, chloasma…. , erythema multiforme, erythema nodosum, hemorrhagic purpura, dementia at the start of HRT continuously taking the drug after 65 years, acyclic spotting, bleeding “breakthrough”, increased libido.
If you have marked side effects indicated in the instructions or they are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Carefully read the product instructions before first use of this drug, as it contains important information for you. • Keep the instructions, it may be necessary again. • If you have any questions, consult your doctor. • medicines that you are being treated, meant to you personally, and should not be transferred to other persons as it may harm them even if you have the same symptoms that you have.
With long-term estrogen therapy indicated for systematic medical examinations. Before the start of the reception and every 6 months. treatment should be thorough general medical and gynecological examination, including breast examination.
Hormone replacement therapy (HRT) for the treatment of menopausal symptoms is recommended to start only if they adversely affect the quality of patient life. In all other cases it is necessary to compare the ratio of benefits and risks. In the younger age benefit ratio favorable risk than older women. During treatment, you must inform the doctor about the cases of vaginal bleeding, changes in the mammary glands, the appearance of jaundice, as well as signs of thromboembolism (eg, painful swelling of the legs, sudden chest pain, shortness of breath). In all cases, patients require a thorough examination.
Reasons for immediate discontinuation: – jaundice or hepatic dysfunction; – increase in blood pressure; – renewal of the headache of migraine type; – phlebitis.
Tumors
During prolonged estrogen alone increases the risk of endometrial hyperplasia or cancer, which is directly proportional to the dose of the drug and duration of therapy.
The risk of developing breast cancer depends on the duration of HRT, but in a few years (usually 5 years) after discontinuation of therapy return to normal. HRT may increase the density of the breast tissue, which complicates its radiological examination.
Prolonged estrogen (5-10 years) therapy is also associated with an increased risk of developing ovarian cancer.
Against the background of sex hormones in rare cases benign or malignant tumors of the liver. In some cases, these tumors have led to the development of life-threatening intra-abdominal haemorrhage. When the pain in the upper abdomen, liver enlargement or signs of intraabdominal bleeding in the differential diagnosis should take into account the presence of liver tumor.
Cardiovascular diseases
HRT is associated with an increased risk of venous thromboembolism (VTE) in 1,3-3 times, and most likely in the first year of the drug than in later periods. Should take into account all the factors at risk for VTE, and in the appointment of the drug before surgical intervention is necessary to carry out prevention of VTE, as well as the need to temporarily cancel HRT 4-6 weeks before surgery and resume treatment only after the woman begins to walk.
The risk of ischemic stroke increased particularly in the elderly (see. Section “Contraindications”).
In the absence of VTE in history, but in the presence of thrombosis at a young age, the next of kin, it is recommended to carry out screening for thrombophilic disorders. In identifying thrombophilic defect not identical diseases in relatives, or the presence of “heavy” defect (e.g., Antithrombin deficiency, Protein S or Protein C, or a combination of these defects) HRT is contraindicated (see. The section “Contra ‘).
Women who receive anticoagulant treatment, it is necessary to compare the ratio of benefits and risks.
Estrogens can cause fluid retention. Patients with renal or heart failure while taking hormone replacement therapy should be under a doctor’s supervision.
other conditions
Estrogens increase the lithogenic bile, which increases the predisposition in some patients to the development of cholelithiasis when using estrogens.
Estrogens are weak antagonist of gonadotropin and has no significant effect on the endocrine system.
Cognitive function of HRT does not improve. There is evidence of an increased risk of dementia in women who start taking continuous combined HRT or estrogen monotherapy after 65 years.
In case of a prolactinoma, the patient must be under close medical supervision (including periodic evaluation prolactin concentration).
In women with hereditary angioedema exogenous factors estrogens may induce or worsen symptoms of angioedema.
Effect on the ability to drive mechanisms and
The drug does not affect the ability to drive vehicles or to engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In a dry, dark place at a temperature from 15 to 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Vaginally before bedtime.
When mucosal atrophy lower parts of the urogenital tract appoint 1 suppository (0.5 mg) daily for the first 2-3 weeks, and then gradually reduce the dose, based on symptoms, suppository 1 (0.5 mg), 2 times per week.
Pre- and postoperative therapy in postmenopausal women – 1 suppository (0.5 mg) for 2 weeks before or after surgery.
As a diagnostic tool – 1 suppository every other day for a week before taking the next smear.
If another dose has been missed, it should be taken immediately. However, if it is found only on the day of the next dose, you should continue taking the drug in the usual way, not make up the missed dose. You can not apply two doses in one day.
If after treatment there is no improvement or symptoms are aggravated, or there are new symptoms, you should consult with your doctor.
Use according to the drug only indications that the application and in those doses which are specified in the instruction.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist