Страна: Мальта
мова: англійська
Джерело: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
G03CA03
ESTRADIOL 1 mg
FILM-COATED TABLET
ESTRADIOL 1 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2024-02-29
Page 1 of 7 Package leaflet: Information for the patient FEMATAB 1MG FILM-COATED TABLETS estradiol 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fematab is and what it is used for 2. What you need to know before you take Fematab 3. How to take Fematab 4. Possible side effects 5. How to store Fematab 6. Contents of the pack and other information 1. What Fematab is and what it is used for WHAT FEMATAB IS The name of your medicine is Fematab. It belongs to a group of medicines called Hormone Replacement Therapy (HRT). Fematab contains a form of the female oestrogen hormone called estradiol. WHAT FEMATAB IS USED FOR Fematab is used in postmenopausal women with at least 6 months since their last natural period. • FOR THE RELIEF OF THE 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”). Fematab alleviates these symptoms after menopause. You will only be prescribed Fematab if your symptoms seriously hinder your daily life. • TO PREVENT THINNING OF THE BONES (OSTEOPOROSIS) IN POST MENOPAUSAL WOMEN 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 Fematab to prevent osteoporosis after menopause. Fematab is suitable for postmenopau Прочитайте повний документ
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fematab 1 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains estradiol hemihydrate equivalent to 1 mg estradiol per tablet. Excipients - Contains Lactose Monohydrate 119.1mg For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Round, biconvex, white film-coated tablet with inscription “379” on one side. 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) Older people The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet daily to be taken orally. The initial daily dosage is 1 mg. The dosage may be increased to 2 mg if required. 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. Treatment of hysterectomised women and postmenopausal women may be started on any convenient day. If the patient is menstruating, treatment is started on day one of bleeding. In women with a uterus, a progestagen should be added to Fematab for 12-14 days each month/28 day cycle. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. Page 2 of 14 If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. Method of administration For oral use. Fematab can be taken with or without food. Paedi Прочитайте повний документ