国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ESTRADIOL, DYDROGESTERONE
BGP Products Ltd
G03FA14
ESTRADIOL, DYDROGESTERONE
1mg/5mg Milligram
Film Coated Tablet
Oral use
packs of 28, 84 (3 x 28) or 280 (10 x 28) tablets
Product subject to prescription which may not be renewed (A)
: Genito urinary system and sex hormones, progestogens and oestrogens, fixed combinations
Progestogens and estrogens, fixed combinations
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 months since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis
Authorised
2015-03-27
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ _FEMOSTON-CONTI 1MG/5MG _FILM-COATED TABLETS Active substances: estradiol/dydrogesterone The full name of your medicine is Femoston-conti 1mg/5mg. In this leaflet the shorter name Femoston is used. WHAT IS IN THIS LEAFLET: 1. What Femoston is and what it is used for 2. What you need to know before you take Femoston 3. How to take Femoston 4. Possible side effects 5. How to store Femoston 6. Contents of the pack and other information 1. WHAT FEMOSTON IS AND WHAT IT IS USED FOR Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in postmenopausal women with at least 12 months since their last natural period. FEMOSTON IS USED FOR RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Femoston alleviates these symptoms after menopause. You will only be prescribed Femoston if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Femoston to prevent osteoporosis after menopause. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medi 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femoston-conti 1 mg/5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 28 tablets, each containing 1 mg 17 -estradiol (as hemihydrate) and 5 mg dydrogesterone. Excipient(s) with known effect: lactose monohydrate 114.7mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Round, biconvex marked 379 on one side (7mm) Salmon coloured 1/5 mg tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 months since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also section 4.4) The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Femoston conti ® 1mg /5mg is a continuous combined HRT for oral use. The oestrogen and the progestogen are given every day without interruption. The dosage is one tablet per day for a 28 day cycle. Femoston conti ® 1mg /5mg should be taken continuously without a break between packs. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. Continuous combined treatment may be started with Femoston conti ® 1mg /5mg depending on the time since menopause and severity of symptoms. Women experiencing a natural menopause should commence treatment with Femoston conti ® 1mg /5mg 12 months after their last natural menstrual bleed. For surgically induced menopause, treatment may start immediately. Depending on the clinic 完全なドキュメントを読む