Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Estradiol
Bayer Limited
G03CA; G03CA03
Estradiol
100 microgram(s)/24 hours
Transdermal patch
Product subject to prescription which may not be renewed (A)
Natural and semisynthetic estrogens, plain; estradiol
Not marketed
1996-07-25
BP23029_REC31756 1 PACKAGE LEAFLET: INFORMATION FOR THE USER CLIMARA FORTE 100 micrograms / 24 hour transdermal patch 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 CLIMARA FORTE IS AND WHAT IT IS USED FOR ................................................................................... 2 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLIMARA FORTE ..................................................................... 2 Medical history and regular check-ups ................................................................................................... 2 Do not use Climara Forte ........................................................................................................................ 2 Warnings and precautions ....................................................................................................................... 3 HRT and cancer ....................................................................................................................................... 4 Effects of HRT on heart and circulation ................................................................................................. 5 Other conditions ...................................................................................................................................... 6 Other medicines and Climara Forte ....................................................................................................... 6 Laboratory tests .................................................... Citiți documentul complet
Health Products Regulatory Authority 06 March 2024 CRN00DXT7 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Climara Forte 100 micrograms/24 hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 cm 2 patch contains 7.6 mg estradiol (formed from 7.8 mg estradiol hemihydrate), releasing a nominal 100 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 estrogen 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 Climara is an estrogen-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 Climara 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 Climara 50 is recommended. Women receiving Climara 100 for postmenopausal symptoms can continue at this dose. In women with an intact uterus, a progestogen should be added to Climara 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 continuous basis, each used patch being removed after 7 days an Citiți documentul complet