País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol
Sandoz Ltd
G03CA03
Estradiol
50microgram/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5010678905205
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"). Estradot alleviates these symptoms after menopause. You will only be prescribed Estradot if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS (for Estradot 50, 75 and 100 only) 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 Leia o documento completo
OBJECT 1 ESTRADOT 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH Summary of Product Characteristics Updated 01-Jun-2016 | Novartis Pharmaceuticals UK Ltd 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) 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 in three strengths: 50, 75 and 100. Treatment must be initiated with an Estradot 50 microgram/24 hours patch. Adjustments can be made by using Estradot 50, 75 a Leia o documento completo