Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Estradiol hemihydrate
Theramex Ireland Limited
G03CA; G03CA03
Estradiol hemihydrate
50 microgram(s)/24 hours
Transdermal patch
Natural and semisynthetic estrogens, plain; estradiol
Marketed
– 1 – PACKAGE LEAFLET – 2 – PACKAGE LEAFLET: INFORMATION FOR THE USER EVOREL® 50 MICROGRAMS PER 24 HOURS TRANSDERMAL PATCH Estradiol hemihydrate Evorel is a registered trademark 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 Evorel is and what it is used for 2. What you need to know before you use Evorel 3. How to use Evorel 4. Possible side effects 5. How to store Evorel 6. Contents of the pack and other information 1. WHAT EVOREL IS AND WHAT IT IS USED FOR The name of your medicine is Evorel 50 micrograms per 24 hours Transdermal Patch. It is called Evorel in this leaflet. Evorel is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Evorel is used in postmenopausal women with at least 18 months since their last natural period. Evorel comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight patches. The hormone is spread evenly in each patch. It passes slowly into your body through the skin. EVOREL IS USED FOR: RELIEF OF SYMPTOMS OCCURRING 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"). Evorel alleviates these symptoms after menopause. You will only be prescribed Evorel if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with yo Læs hele dokumentet
Health Products Regulatory Authority 20 February 2024 CRN00DZHM Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Evorel 50 micrograms per 24 hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3.2 mg estradiol hemihydrate per patch, releasing a nominal 50 micrograms (μg) estradiol per 24 hours. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch Evorel is a matrix type transdermal patch. Description of Product Patches are square with rounded corners and are 0.1 mm thick.Patches are made of a flat, two-layer laminate.The outer layer is a flexible, translucent and nearly colourless backing film.The inner layer is a monolayer adhesive film (matrix) composed of acrylic adhesive and guar gum, which contains the active ingredients.This adhesive layer is protected by a polyester foil release liner, which is removed prior to application of the patch to the skin.The polyester foil used is coated with silicone on both sides.It has an S-shaped incision to facilitate its removal prior to use.Each patch is individually enclosed in a protective, hermetically sealed, labelled pouch. Evorel 50 is marked on the outer side with ‘CE50’ and has a surface area of 16 cm 2 . 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For treatment of post-menopausal symptoms, the lowest effective dose should be used. 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. Adults - _Treatment of oestrogen deficiency symptoms_ For women with an intact uterus, a progestogen must be added to Evorel for the prevention of adverse Læs hele dokumentet