Страна: Малта
Език: английски
Източник: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
G03FB08
ESTRADIOL 1 mg DYDROGESTERONE 10 mg
FILM-COATED TABLET
ESTRADIOL 1 mg DYDROGESTERONE 10 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2008-04-07
Package Leaflet: Information for the user FEMOSTON 1/10MG FILM-COATED TABLETS estradiol / 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, 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, 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 estrogen called estradiol • A progestogen called dydrogesterone. Femoston is used in postmenopausal women with at least 6 months since their last natural period. Femoston is used for: • RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE. During the menopause, the amount of the estrogen 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. What you need to know before you take Femoston MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be co Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Femoston 1/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This product contains estradiol hemihydrate equivalent to 1mg estradiol per tablet for the first 14 days of a 28 day cycle (white tablets). For the second 14 days one tablet contains estradiol hemihydrate equivalent to 1 mg estradiol and 10 mg dydrogesterone (grey tablets). Excipient(s) with known effect: Each white tablet contains 119.1 mg of lactose monohydrate. Each grey tablet contains 110.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet (Tablet) Estradiol only tablets: Round, biconvex, white, film-coated tablet with inscription ‘379’ on one side. Estradiol/dydrogesterone combination tablets: Round, biconvex, grey, film-coated tablet with inscription ‘379’ on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women at least 6 months since the 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) Elderly population The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Femoston 1/10 is a continuous sequential HRT. 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 estrogen deficiency are not ameliorated the dosage can be increased by using Femoston 2/10. Treatment commences with one white tablet containing estradiol taken daily for the first 14 days during a 28-cycle, during the following 14 days one grey tablet containing estradiol and dydrogesterone is taken daily, as directed on the 28 day calendar pack. After a cycle of 2 Прочетете целия документ