Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol
Bayer Plc
G03CA03
Estradiol
50microgram/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5016703003663
v019_0 Page 1 of 11 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. PACKAGE BOOKLET: INFORMATION FOR THE USER PROGYNOVA TS 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH Estradiol READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this booklet. 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 BOOKLET 1. WHAT PROGYNOVA TS 50 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROGYNOVA TS 50………………………… MEDICAL HISTORY AND REGULAR CHECK-UPS ........................................................................................................ DO NOT USE PROGYNOVA TS 50 ......................................................................................................................... WARNINGS AND PRECAUTIONS ............................................................................................................................ HRT AND CANCER……………………………………………………………………………………………………... EFFECTS OF HRT ON HEART AND CIRCULATION………………………………………………………………………… OTHER CONDITIONS ...................................................................................................................................... Przeczytaj cały dokument
OBJECT 1 PROGYNOVA TS 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH Summary of Product Characteristics Updated 28-Sep-2017 | Bayer plc 1. Name of the medicinal product Progynova® TS 50 micrograms/24 hours Transdermal Patch 2. Qualitative and quantitative composition Each 12.5 cm 2 patch contains 3.8 mg estradiol (formed from 3.9 mg estradiol hemihydrate), releasing a nominal 50 micrograms of estradiol per 24 hours. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch. Oval transdermal patch with a translucent homogenous matrix on a transparent carrier film. 4. Clinical particulars 4.1 Therapeutic indications • Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause. • 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) 4.2 Posology and method of administration Posology Progynova TS 50 is an oestrogen-only patch applied to the skin once weekly. 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. Treatment to control menopausal symptoms should be initiated with the lowest Progynova TS patch dose. If considered necessary, a higher dosed patch should be used. Once treatment is established the lowest effective dose patch necessary for relief of symptoms should be used. For prevention of postmenopausal osteoporosis Progynova TS 50 is recommended. Women receiving Progynova TS 100 for postmenopausal symptoms can continue at this dose. In women with an intact uterus, a progestogen should be added to Progynova TS 50 for at least 12-14 days each month. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. _For continuous use: _ The patches should be applied once weekly on a conti Przeczytaj cały dokument