देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DYDROGESTERONE; ESTRADIOL; ESTRADIOL
ABBOTT LABORATORIES (M) SDN. BHD.
DYDROGESTERONE; ESTRADIOL; ESTRADIOL
84 Tablet Tablets; 28 Tablet Tablets; 28Tablet Tablets
Abbott Biologicals B.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ FEMOSTON® 1/10 TABLET Estradiol (1mg), dydrogesterone (10mg) 1 WHAT IS IN THIS LEAFLET 1. What Femoston® is used for 2. How Femoston® works 3. Before you use Femoston® 4. How to use Femoston® 5. While you are using it 6. Side effects 7. Storage and disposal of Femoston® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT FEMOSTON® IS USED FOR Femoston® is used in postmenopausal women who still have a uterus (womb) as hormone replacement therapy. This product is not recommended for women older than 65 years. HOW FEMOSTON® WORKS Femoston® acts as a hormone replacement therapy by providing two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. BEFORE YOU USE FEMOSTON® _- When you must not use it_ Do not take Femoston®: • If you have or have ever had breast cancer, or if you are suspected of having it • if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it. • if you have or your doctor thinks you might have a tumor that is dependent on progestogens. An example is a tumor in the brain (meningioma). • if you have any unexplained vaginal bleeding • if you have excessive thickening of the womb lining that is not being treated • if you have or have ever had a blood clot in a vein such as in the legs or the lungs • if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) • if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, or angina • you have or have ever had a liver disease and your liver function tests have not returned to normal • if you have porphyria (a metabolic disorder) • if you are allergic (hypersensitive) to estradiol, dydrogesterone or to any of the other ingredients of Femoston®. If you are not sure, talk to your doctor or pharmacist before taking Femoston पूरा दस्तावेज़ पढ़ें
1. NAME OF THE MEDICINAL Femoston 1/10 film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 14 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 14 tablets, each containing 1 mg 17β- estradiol (as hemihydrate) and 10 mg dydrogesterone. 3. PHARMACEUTICAL FORM Film-coated tablet, Round, biconvex tablets marked 379 on one side. White 1 mg tablets and grey 1/10 mg tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy for women with disorders due to natural or surgically induced menopause with intact uterus. Elderly population The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use th One tablet, containing 1mg estradiol, daily during 14 consecutive days per cycle of 28 days on one tablet, containing 1mg estradiol and 10mg dydrogesterone, daily during the remaining 14 days has to be taken immediately after a 28 day cycle, the next treatment cycle is to be started. Patients should take one tablet a day orally, according to the sequence indicated on the package. Medication is to be continued without interruption. If the patient is still menstruating, it is recommended to begin treatment on the first day after onset of menstruation. If the patient is menstruating infrequently it is advisable to begin treatment after 10-14days monotherapy of progesteogen (“chemical curettage”). In patients who had their last period more than approximately 12 months ago treatment can be started at any time. Femoston 1/10 can be taken irrespective of food intake. Paediatric population: There is no relevant indication for the use of Femoston 1/10 in the paediatric population. 4.3 CONTRAINDICATIONS • Known past or suspected breast cancer • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) • Known or suspected progestogen-dependent neoplasms (e.g meningioma) • Undiagnosed genital bleeding • Untreated endometrial hyperplasia • Previous or current venous thromboembolism (de पूरा दस्तावेज़ पढ़ें