Index of drugs

Hormone replacement therapy (HRT) for atrophic changes of the lower part of the urogenital tract caused by estrogen deficiency. Pre- and post-operative treatment of post-menopausal women undergoing vaginal surgery. As diagnostic aid in the case of a doubtful image of cytological smear from the cervix.

1 g of cream contains 1 mg of estriol. 1 vaginal globule contains 0.5 mg of estriol.

The product contains a natural female sex hormone - estriol. Estriol works for a short time, it can be used as a substitute for the loss of estrogen production in menopausal women and for the reduction of menopausal symptoms. It is particularly effective in the treatment of ailments related to the genitourinary system. In the case of atrophic lesions of the lower urogenital tract, estriol causes the normalization of the urogenital tract and helps to restore the normal microflora and physiological pH of the vagina. As a result, the resistance of uro-genital epithelial cells to infections and vaginal inflammatory processes such as dyspareunia, vaginal dryness, pruritus, urogenital infection, impaired urination, and mild incontinence are increased. Vaginal application of estriol provides optimal action at the site of administration. Estriol is also absorbed into the systemic circulation, as evidenced by the sudden increase in the concentration of free estriol in the plasma. The maximum concentration in plasma occurs after 1-2 h after administration. Almost all estriol (90%) binds to albumin, and to a small extent to globulin binding sex hormones. Estriol metabolism is mainly based on conjugation and deconjugation processes in the enterohepatic circulation. Estriol is excreted in the urine mainly in the conjugated form, and in a small part (2%) with faeces, mainly in unconjugated form.

Hypersensitivity to estriol or to any of the excipients. The presence or suspicion of breast cancer in the past or in the past. Currently occurring or suspected malignant neoplasms (eg endometrial cancer). Bleeding from the genital tract of unknown origin. Untreated endometrial hyperplasia. An earlier or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). Clotting disorders found (eg, protein C deficiency, protein S deficiency or antithrombin). Occurrence of occlusal thromboembolic events (eg angina pectoris, myocardial infarction). acute liver disease or liver disease in the past, until the liver parameters return to normal. Porphyria.

In the treatment of menopausal symptoms, HRT should be used only when they negatively affect the quality of life. The risk and benefits of HRT should be evaluated at least once a year. HRT should be continued as long as the benefits outweigh the risks. Before starting or restoring HRT, an accurate medical history should be collected, including family history. Physical examination (taking into account the pelvis and breasts) should be based on interview guidelines as well as contraindications and precautions. During the treatment, follow-up visits with frequency and character suited to the patient are recommended. Research, including appropriate imaging studies, such as mammography, should be performed in accordance with current screening practices adapted to the clinical requirements of individual patients. In the presence of the following conditions, their occurrence in the past and / or aggravation during pregnancy or previous hormonal treatment, the patient should remain under constant control (during the use of the preparation may recur or worsen the following conditions): leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic events; risk factors for estrogen-dependent cancers, eg breast cancer in first-degree relatives; hypertension; liver diseases (e.g. liver adenoma); diabetes with or without vascular changes; cholelithiasis; migraine or (severe) headache; systemic lupus erythematosus; endometrial hyperplasia; epilepsy; asthma; otosclerosis.Indications for immediate cessation of therapy: jaundice or liver dysfunction; significant increase in blood pressure; occurrencede novo migraine headache; pregnancy. Long-term oral administration of small doses of estriol may increase the risk of endometrial cancer. This does not apply to vaginal administration. This risk increases with the duration of treatment, and decreases within one year after discontinuation of therapy. Vaginal bleeding during treatment should be carefully examined. HRT may cause an increase in mammary tissue density in the mammogram image, which may impede the radiological detection of breast cancer. Estriol does not increase the density of mammary gland tissue in the mammogram image. Available data suggest an increased risk of breast cancer in women taking complex estrogen-progestagen estrogen and probably also estrogen-induced HRT; this risk depends on the duration of HRT. It is not known if the preparation carries such a risk. Before you start using HRT, you should consider the benefits of it and the risk of developing breast cancer. Long-term (at least 5-10 years) taking HRT containing only estrogen causes a small increase in the risk of ovarian cancer. Long-term intake of complex HRT may cause similar or slightly lower risk. It is not known whether long-term intake of low-dose estrogens (including the preparation) causes a different risk than other drugs containing only estrogen. HRT is associated with a 1.3-3-fold increase in the risk of venous thromboembolism (VTE), e.g. deep vein thrombosis or pulmonary embolism. The occurrence of the above episodes is more likely in the first year of use of HRT. It is not known whether the preparation carries with it the same level of risk. Patients with known thrombophilia have an increased risk of venous thromboembolism, and HRT may additionally increase this risk. Generally known risk factors for VTE include: estrogen intake, advanced age, major surgery, longer immobilization, obesity (WMC> 30 kg / m²), pregnancy / postpartum period, systemic lupus erythematosus (SLE) and cancer. There is no unambiguous position regarding the possible role of varicose veins in VTE. If after the elective surgery it will be necessary to immobilize longer, it is recommended to temporarily suspend HRT 4-6 weeks before surgery. Treatment should be resumed only after the patient is completely started. If the indication for the use of the preparation is "pre-operative and post-operative therapy", prophylactic anticoagulant therapy should be considered. Women with a history of venous thromboembolism who have a first-degree relative who has a thrombosis at an early age can be screened. HRT is contraindicated in the case of identification of thrombophilia, which is not associated with thrombosis in family members, or if the disorder is "serious" (eg, deficiency of antithrombin, protein S or protein C or combination of disorders). For women who already use anticoagulant therapy, the benefit and risk balance of HRT should be carefully considered. If VTE appears after the therapy has been implemented, the preparation should be discontinued. Patients should be advised to contact their physician immediately in case of potential symptoms of thromboembolism (eg painful swelling of the lower limb, sudden chest pain, shortness of breath). There is no evidence for protection against myocardial infarction in women with or without coronary artery disease who have taken estrogen-progestagen combined estrogen or HRT estrogen. The relative risk of coronary heart disease in the use of estrogen-progestagen combined HRT is slightly elevated. Data from clinical trials do not indicate an increased risk of coronary heart disease in women after hysterectomy taking estrogen HRT. Complex estrogen-progestagen HRT and estrogen-based HRT increases the risk of ischemic stroke even one and a half times. The total risk of stroke in women using HRT increases with age. Estrogens can cause fluid retention - patients with heart or kidney failure should remain under strict control. Estriol is a weak gonadotropin inhibitor without significant effects on the endocrine system. HRT does not improve cognitive function.There is some evidence to increase the risk of possible dementia in women who start using a continuous or oestrogenic HRT after 65 years.

The preparation is contraindicated in pregnant women. If the patient becomes pregnant while taking the preparation, the treatment should be stopped immediately. The results of epidemiological studies related to inadvertent exposure of the fetus to estrogen do not show teratogenic or toxic effects. The preparation is not indicated in women during lactation. Estriol is excreted with human food and may reduce its quantity.

The following may occur: irritation at the injection site, pruritus, discomfort and pain in the breast - these symptoms usually go away, but may also indicate too high a dose. Other side effects have been reported using estrogen therapy and combined estrogen-pre-estrogen therapy: estrogen-dependent benign and malignant tumors, e.g. endometrial cancer; heart attack and stroke; cholecystitis; subcutaneous and cutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura; probable dementia over the age of 65. The risk of breast cancer in women using complex estrogen-progestagen therapy for more than 5 years is increased by up to two times; in women using estrogen therapy it is significantly lower. The level of risk depends on the duration of therapy. Long-term intake of HRT estrogen and combined estrogen-progestagen HRT is associated with a small increase in the risk of ovarian cancer. HRT causes a 1.3-3-fold increase in the relative risk of venous thromboembolism (deep vein thrombosis or pulmonary embolism); the occurrence of such an event is more likely in the first year of hormone therapy. The risk of coronary heart disease is slightly elevated in women taking estrogen-progestagen HRT over the age of 60 years. The use of estrogen therapy and estrogen-progestagen therapy is associated with a nearly 1.5-fold higher relative risk of ischemic stroke; the risk of hemorrhagic stroke is not increased during HRT use. Relative risk is not dependent on age or duration of therapy, but due to the fact that the starting risk is strongly dependent on age, the overall risk of stroke in women taking HRT increases with age.

Vaginally. Atrophic changes of the lower part of the urogenital tract: 1 globule or 1 application of the cream daily for the first weeks, then the dose decreases depending on the symptom regression until the maintenance dose is obtained (eg 1 globule or 1 application of the cream twice a week) . Pre- and post-operative treatment in post-menopausal women undergoing vaginal surgery: 1 globule or 1 application of the cream daily for 2 weeks before the procedure; 1 globule or 1 application of cream 2 times a week for 2 weeks after the procedure. Diagnostic help in the case of a doubtful cervical smear image: 1 globule or 1 application of cream, every other day in the week preceding the Next swab. 1 application of the cream (applicator filled to a mark in the shape of a circle) contains 0.5 g of cream (0.5 mg of estriol). If a dose is missed, the preparation should be used as soon as possible; if the omission was noticed on the day of the next dose, skip the forgotten dose and use the next one according to the previously determined schedule; Do not use 2 doses in 1 day. In women who do not use HRT or women who want to replace the current continuous combined HRT, the preparation can be started at any time. In women using continuous sequential HRT, the preparation may be started one week after the end of the cycle. The preparation should be used vaginally before going to bed at night. Apply the cream with the enclosed calibrated applicator.