Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 1.03 mg (Equivalent: estradiol, Qty 1 mg)
Novo Nordisk Pharmaceuticals Pty Ltd
estradiol hemihydrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; maize starch; purified talc; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide red; propylene glycol
Oral
28 tablets
(S4) Prescription Only Medicine
Short term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. In women with intact uteri, use of opposed therapy must be considered.
Visual Identification: red tablets, 6 millimetres in diameter, stamped with 'Novo 282'; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-11-17
Estrofem ® tablets Page 1 of 6 Estrofem cmi-v10 ESTROFEM ® 1 MG TABLETS ESTROFEM ® 2 MG TABLETS _Estradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT ESTROFEM ® IS USED FOR ........ 1 BEFORE YOU TAKE ESTROFEM ® ......... 1 HOW TO TAKE ESTROFEM ® ................ 4 WHILE YOU ARE TAKING ESTROFEM ® 4 SIDE EFFECTS .................................... 4 STORAGE .......................................... 5 PRODUCT DESCRIPTION .................... 5 USER INSTRUCTIONS .......................... 6 This leaflet answers some common questions about Estrofem ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Estrofem ® against the benefits they expect it will have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. Estrofem ® is available only by prescription at pharmacies. WHAT ESTROFEM ® IS USED FOR Estrofem ® is a hormone replacement therapy (HRT) that is used for the short-term symptomatic treatment of women who have had their womb surgically removed (which is called hysterectomy) and who have signs and symptoms of estrogen deficiency. A woman’s last menstrual period is called the menopause and usually occurs between the ages of 45 and 55 years. Around the time of the menopause, the body slowly stops producing the two sex hormones called estrogen and progesterone. Periods become irregular until they finally stop. If a woman has surgical or natural menopause the production of these hormones is diminished or stopped. Estrofem ® replaces the hormone called estrogen which your body stops making after surgical or natural menopause. The falling or reduced hormone levels may cause you to experience uncomfortable symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, urinary problems, headaches, mood swings, lack of conce Læs hele dokumentet
Estrofem-pi-v13 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION ESTROFEM ® ESTRADIOL (AS HEMIHYDRATE) 1 MG TABLET DIAL DISPENSER PACK ESTROFEM ® ESTRADIOL (AS HEMIHYDRATE) 2 MG TABLET DIAL DISPENSER PACK 1. NAME OF THE MEDICINE Estradiol hemihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Estrofem is an estrogen preparation comprising 28 tablets. Each tablet contains 1 mg or 2 mg estradiol (as hemihydrate). The estrogen component of Estrofem substitutes for the loss of endogenous estrogen production due to natural or surgical menopause in hysterectomised women. Excipient with known effect: lactose monohydrate. For the full list of excipients, see ‘Section 6.1 List of Excipients.’ 3. PHARMACEUTICAL FORM Film coated tablet. Estrofem 1 mg are red tablets marked NOVO 282 on one side, blank on the other side, with a diameter of 6 mm. Estrofem 2 mg are blue tablets marked NOVO 280 on one side, blank on the other side, with a diameter of 6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term symptomatic treatment of estrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women (see ‘Section 4.2 Dose and Method of Administration’ and ‘Section 5.1 Pharmacodynamic Properties’ - ‘Clinical trials’). In women with intact uteri, use of opposed therapy must be considered. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage The initial dose for relief of symptoms of estrogen deficiency is 1 mg or 2 mg daily. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. In postmenopausal women with normal uteri Estrofem should be given with a progestagen for at least 10 consecutive days of the 28 day cycle. This will usually induce a withdrawal bleed. Estrofem-pi-v13 Page 2 of 17 In hysterectomised post-menopausal women Estrofem may be started on any convenient day. In oligomenorrhoea, treatment should be started on day 5 of bleeding. If symptoms such as hot flushes have ceased, consideration of transferring t Læs hele dokumentet