Estradiol valerate tablets/estradiol cyproterone acetate tablets combined packaging

This product is used in combination with progestins to establish an artificial menstrual cycle to supplement the estrogen deficiency mainly associated with natural or artificial menopause.

This product is a compound preparation, consisting of: 11 white sugar-coated tablets, each containing 2 mg of estradiol valerate; 10 light orange-red sugar-coated tablets, each containing 2 mg of estradiol valerate and 1 mg of cyproterone acetate.

This product is used in combination with progestins to establish an artificial menstrual cycle to supplement estrogen deficiency mainly related to natural or artificial menopause: vasomotor diseases (hot flashes), reproductive urinary tract nutritional diseases (vulvovaginal atrophy, dyspareunia, urinary incontinence) and mental diseases (sleep disorders, weakness). Prevent bone loss caused by primary or secondary estrogen deficiency.

The combined package of estradiol valerate tablets/estradiol cyproterone acetate tablets for oral administration is to be administered according to the following treatment regimen: * One tablet per day, without interruption, for 21 days, in the following order: 11 white tablets, 10 light orange-red tablets. * After this package is finished, there is a 7-day treatment break period. During the treatment period, withdrawal bleeding may occur. Treatment can be started on any day. However, when switching from other sequential hormone replacement therapies to the combined package of estradiol valerate tablets/estradiol cyproterone acetate tablets, it is recommended to start taking the medication after bleeding, i.e. a new sequential hormone replacement therapy starts on this day. For the prevention of osteoporosis in menopause, the course of treatment is several years. If the patient forgets to take a pill, the forgotten pill should be taken within 24 hours to avoid withdrawal bleeding. If intermittent bleeding occurs, continue to take the medication to avoid more severe bleeding. If bleeding persists, or recurs over several consecutive cycles, or if it is the first time bleeding occurs after long-term treatment with estradiol valerate tablets/estradiol cyproterone acetate combination pack, a comprehensive gynecological examination is necessary to exclude any organic cause. The risk-benefit balance should be reassessed regularly (every 6 months) so that the dosage can be adjusted or stopped if necessary: * throughout the treatment period of estradiol valerate tablets/estradiol cyproterone acetate combination pack, or * switching from other hormone therapy to estradiol valerate tablets/estradiol cyproterone acetate combination pack, or * as directed by your doctor.

In addition to the adverse reactions listed in the precautions, the following adverse reactions have been reported in users of oral HRT preparations. * Although the following serious adverse reactions are very rare, most of them have been observed. For the sake of caution, it is best to discontinue treatment if any of the following situations occur: 1. Cardiovascular accidents and embolism - cholestatic jaundice - benign breast disease, uterine tumors (such as increased fibroids) 2. Hepatic adenoma: may cause unexpected intra-abdominal bleeding 3. Galactorrhea: should be checked to exclude pituitary adenoma * Reproductive system and breast diseases Changes in vaginal bleeding pattern, abnormal bleeding or heavy bleeding, breakthrough bleeding, spotting (irregular bleeding usually improves during continuous treatment), dysmenorrhea, changes in vaginal discharge, premenstrual syndrome, breast pain, tenderness or enlargement. * Gastrointestinal diseases Indigestion, bloating, nausea, vomiting, abdominal pain. * Skin and subcutaneous tissue diseases Rashes and various skin diseases * Nervous system diseases Headache, migraine, dizziness, anxiety/depression symptoms, fatigue. *Others: Palpitations, edema, muscle cramps, weight changes, increased appetite, changes in libido, visual abnormalities, intolerance to contact lenses, allergic reactions.

Hormone replacement therapy (HRT) should not be started if any of the following conditions exist. If any of the following conditions occur during HRT, the drug should be discontinued immediately. * Pregnancy and breastfeeding * Undiagnosed vaginal bleeding * Known or suspected breast cancer * Known or suspected precancerous lesions or malignant tumors affected by sex hormones * Current or previous history of liver tumors (benign or malignant) * Severe liver disease * Acute arterial thromboembolic disease (such as myocardial infarction, stroke) * Active deep vein thrombosis, thromboembolic disease, or a documented history of these diseases * Severe hypertriglyceridemia * Known hypersensitivity to any of the ingredients in the combination package of estradiol valerate tablets/estradiol cyproterone acetate tablets Although coagulation factors will not change in the short term during treatment, this product should generally not be used in the following situations (as a precaution, because there is currently insufficient epidemiological data): * Heart disease that may cause embolism

Precautions during pregnancy and breastfeeding: HRT is not suitable for pregnant or breastfeeding women.

Please follow doctor's advice when taking with other medicines.

Store below 30℃.