देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol
Norgine Pharmaceuticals Ltd
G03CA03
Estradiol
50microgram/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5010678539103 5010678547801
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESTRADERM ® MX 25, 50, 75 AND 100 (OESTRADIOL (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 ESTRADERM MX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRADERM MX 3. HOW TO USE ESTRADERM MX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ESTRADERM MX 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ESTRADERM MX IS AND WHAT IT IS USED FOR Estraderm MX is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Estraderm MX is used in postmenopausal women with at least 12 months since their last natural period. Estraderm MX is a patch that is applied to the skin. The patch contains a supply of oestradiol which is released from the patch and absorbed through the skin into your blood stream. This is called a transdermal patch. Estraderm MX is used for: RELIEF OF SYMPTOMS OCCURING 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 chest (hot flushes). Estraderm MX alleviates these symptoms after menopause. You will only be prescribed Estraderm MX if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS (FOR ESTRADERM MX 50 AND 75 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 not suitable f पूरा दस्तावेज़ पढ़ें
OBJECT 1 ESTRADERM MX 50 Summary of Product Characteristics Updated 17-Oct-2016 | Merus Labs Luxco S.a.R.L. 1. Name of the medicinal product Estraderm MX ® 50 2. Qualitative and quantitative composition The active ingredient is estra-1, 3,5(10)-triene-3,17ß-diol (oestradiol hemihydrate). Patches contain 1.50 mg active substance corresponding to a surface area of 22cm². For a full list of excipients, see section 6.1. 3. Pharmaceutical form Estraderm MX is a square-shaped, self-adhesive, transparent, transdermal patch for application to the skin surface. Each patch comprises an impermeable polyester backing film, an adhesive matrix containing oestradiol and an oversized protective liner which is removed prior to application of the patch to the skin. Estraderm MX releases oestradiol into the circulation via intact skin at a low rate for up to 4 days. _Cross section:_ DOSAGE STRENGTHS ESTRADERM MX 50 Nominal rate of estradiol release 50 micrograms /day Oestradiol content 1.50mg Drug-releasing area 22 cm² Imprint (on backing film) Product logo CG GSG 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 (See also section 4.4). The experience treating women older than 65 years is limited. 4.2 Posology and method of administration Estraderm MX 50 is an oestrogen only patch. In women with an intact uterus oestrogen should be supplemented by sequential administration of a progestagen (e.g. medroxyprogesterone acetate 10mg, norethisterone 5mg, norethisterone acetate 1-5mg or dydrogesterone 20mg per day) to be taken at least on the last 12 days of each 4-week treatment cycle. Withdrawal bleeding usually occurs following 12 days or more of progesterone administration. Unless there is a previous diagnosis of endometriosis, it is not rec पूरा दस्तावेज़ पढ़ें