Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
DYDROGESTERONE; ESTRADIOL
Mylan Products Limited
G03FB08
DYDROGESTERONE; ESTRADIOL
FILM-COATED TABLET
DYDROGESTERONE 10 mg; ESTRADIOL 1 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER Active substances: oestradiol hemihydrate and Dydrogesterone 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 or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 and a progestogen. HRT is used in woman who require oestrogen replacement and who have not had their womb removed (hysterectomy). Femoston is used in postmenopausal women at least 6 months since last menses. Femoston is used for: Relief of symptoms occurring after menopause During the menopause, the amount of 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. 2. BEFORE YOU TAKE FEMOSTON Medical history and regular check-ups The use of HRT carries risks which ne Perskaitykite visą dokumentą
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Femoston® 1/10 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg oestradiol (as hemihydrate) or a combination of 1 mg oestradiol (as hemihydrate) and 10 mg dydrogesterone. Excipient with known effect: lactose monohydrate For the full list of excipients see 6.1 3. PHARMACEUTICAL FORM Film-coated tablets. Oestradiol only tablets: Round, biconvex, white film-coated tablets with inscription '379'. Oestradiol/dydrogesterone combination tablets: Round, biconvex, grey film-coated tablets with inscription '379'. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 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 1/10 and Femoston 2/10, are continuous sequential hormone replacement therapies. 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. Page 2 of 18 In general, treatment should start with Femoston 1/10. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to oestrogen deficiency are not ameliorated the dosage can be increased by using Femoston 2/10 Starting Femoston In women who are not taking hormone replacement therapy and who are amenorrhoeic, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior re Perskaitykite visą dokumentą