País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Novartis Pharmaceuticals UK Ltd
G03CA03
ESTRADIOL HEMIHYDRATE
50 Microgram/day
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Natural and semisynthetic estrogens, plain
Authorised
2002-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESTRADOT 25 MICROGRAMS/24 HOURS TRANSDERMAL PATCH ESTRADOT 37.5 MICROGRAMS/24 HOURS TRANSDERMAL PATCH ESTRADOT 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH ESTRADOT 75 MICROGRAMS/24 HOURS TRANSDERMAL PATCH ESTRADOT 100 MICROGRAMS/24 HOURS TRANSDERMAL PATCH (Estradiol (as hemihydrate)) 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 ESTRADOT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRADOT 3. HOW TO USE ESTRADOT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ESTRADOT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ESTRADOT IS AND WHAT IT IS USED FOR Estradot is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Estradot is used in postmenopausal women with at least 12 months since their last natural period. Estradot comes as a patch that is applied to the skin. Estradot is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Estra dot alleviates these symptoms after menopause. You will only be prescribed Estradot if your symptoms seriously hinder your Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estradot 50 micrograms/24 hours, transdermal patch. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5 cm 2 patch containing 0.78 mg estradiol (as hemihydrate) with a release rate of 50 micrograms estradiol per 24 hours. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Rectangular patch with rounded corners, comprising a pressure-sensitive adhesive layer containing estradiol, with a translucent polymeric backing on one side and a protective liner on the other. 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 intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (for Estradot 50, 75 and 100 only). The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage The transdermal patch is applied twice weekly, i.e. every three to four days. _Oestrogen deficiency symptoms:_ Estradot is available in five strengths: 25, 37.5, 50, 75 and 100. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (_see also section 4.4, Special_ _warnings and precautions for use) _should be used. Depending on the clinical response the dose can then be adjusted to the patient’s individual needs. If, after three months, there is insufficient response in the form of alleviated symptoms, the dose can be increased. If symptoms of overdose arise (e.g. tender breasts) the dose must be decreased. _Prevention of postmenopausal osteoporosis:_ Estradot is available Leia o documento completo