البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ESTRADIOL
Besins Healthcare S.A.
G03CA03
ESTRADIOL
0.06 %w/w
Gel
Product subject to prescription which may be renewed (B)
estradiol
Not Marketed
1997-12-11
PACKAGE LEAFLET: INFORMATION FOR THE USER OESTROGEL 750 MICROGRAMS / METERED DOSE GEL PUMP-PACK ESTRADIOL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Oestrogel is and what it is used for 2. What you need to know before you use Oestrogel 3. How to use Oestrogel 4. Possible side effects 5. How to store Oestrogel 6. Contents of the pack and other information 1. WHAT OESTROGEL IS AND WHAT IT IS USED FOR The full name of your medicine is Oestrogel Pump-Pack. It is called Oestrogel in this leaflet. Oestrogel is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Oestrogel is used in postmenopausal women. OESTROGEL IS USED FOR RELIEF OF 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 check (“hot flushes”). Oestrogel alleviates these symptoms after menopause. You will only be prescribed Oestrogel 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 Oestrogel to prevent osteoporosis after menopause. HOW OESTROGEL WORKS Oestrogel works by replacing the oestrogen in your body. This is so that you have a similar amount of oestrogen as before your menopause. 2. WHAT YOU اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oestrogel 750 micrograms/metered dose Gel Pump-Pack. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of 1.25 g of gel (1 pump) contains 750 micrograms Estradiol (as hemihydrate) 0.06% w/w. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal gel. A clear, colourless gel with an odour of alcohol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women considered at risk of developing fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (see section 4.4). Oestrogel is indicated for women with or without a uterus. Advice on the addition of a progestogen is given in section 4.2 for women with a uterus. The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Oestrogel is an oestrogen-only product indicated only for women without a uterus. Oestrogel should be administered daily on a continuous basis. In women with an intact uterus it is recommended to add a progestogen (e.g. a progesterone) for at least 12 days of each month, in accordance with the manufacturers recommendations. _MENOPAUSAL AND POSTMENOPAUSAL SYMPTOMS:_ Each metered dose (1 pump actuation) from the dispenser is 1.25g of Oestrogel. Two pumps (2.5g) of Oestrogel once daily (1.5mg 17ß-oestradiol) is the usual starting dose, which in the majority of women will provide effective relief of symptoms. If after one month's treatment effective relief is not obtained, the dosage may be increased accordingly to a maximum of four pumps (5g) of Oestrogel daily (3.0mg 17ß-oestradiol). The lowest effective dose should be used for maintenance therapy. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4. اقرأ الوثيقة كاملة