ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
ESTRADIOL AS HEMIHYDRATE
NOVO NORDISK LTD., ISRAEL
G03CA03
FILM COATED TABLETS
ESTRADIOL AS HEMIHYDRATE 1 MG
PER OS
Required
NOVO NORDISK A/S, DENMARK
ESTRADIOL
ESTRADIOL
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of , or contraindicated for other medicinal products approved for the prevention of osteoporosis. Estrofem is particularly for women who have been hysterectomized and therefore do not require combined estrogen/progestagen therapy.The experience treating women older than 65 years is limited.
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY ESTROFEM 1 MG ESTROFEM 2 MG FILM-COATED TABLETS FILM-COATED TABLETS ACTIVE INGREDIENT: ESTRADIOL AS HEMIHYDRATE 1 MG ESTRADIOL AS HEMIHYDRATE 2 MG Inactive ingredients and allergens in this medicine: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? • Estrofem is a hormone replacement therapy (HRT) that is used to treat symptoms of estrogen deficiency in postmenopausal women. • Estrofem is used to prevent osteoporosis (bone thinning) in postmenopausal women who are at high risk of future fractures and who cannot be treated with other medicines for this condition. Estrofem is used in women who have had their womb removed and therefore do not require combined estrogen-progestagen therapy. There is only limited experience of treating women older than 65 years with Estrofem. THERAPEUTIC GROUP: natural and semi-synthetic estrogens. When a woman’s period stops during menopause, the amount of estrogen produced by her body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Estrofem alleviates these symptoms after menopause. Only take Estrofem if your symptoms seriously hinder your daily life. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are SENSITIVE (allergic) to ESTRADIOL or to any of the other ingredients in this medicine (listed in section 6 ‘Additional information’) • you have or have ever had BREAST CANCER, or if อ่านเอกสารฉบับเต็ม
Estrofem IL SPC Dec23- Notification 1 1 NAME OF THE MEDICINAL PRODUCT Estrofem ® 1 mg Estrofem ® 2 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains estradiol 1 mg or 2 mg (as estradiol hemihydrate). Excipient with known effect: Estrofem 1 mg: Each film-coated tablet contains lactose monohydrate 37.3 mg. Estrofem 2 mg: Each film-coated tablet contains lacotse monohydrate 36.8 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Estrofem 1 mg: Red, film-coated, round, biconvex tablets, engraved with NOVO 282. Diameter 6 mm. Estrofem 2 mg: Blue, film-coated, round, biconvex tablets, engraved with NOVO 280. Diameter 6 mm. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of, or contraindicated for other medicinal products approved for the prevention of osteoporosis. Estrofem is particularly for women who have been hysterectomised and therefore do not require combined oestrogen/progestagen therapy. The experience treating women older than 65 years is limited. 4.2 Posology and method of administration Estrofem is an oestrogen-only product for hormonal replacement. Estrofem is administered orally, one tablet daily without interruption. For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. Estrofem IL SPC Dec23- Notification 2 A switch to a higher dose or a lower dose of Estrofem could be indicated if the response after three months is insufficient for satisfactory symptom relief or if the tolerability is not satisfactory. In women without a uterus, Estrofem may be started on any convenient day. In women with a uterus who present amenorrhoea and are being transferred from a sequential HRT, Estrofem may be initiated on day 5 of bleeding and only in co อ่านเอกสารฉบับเต็ม