Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
ESTRIOL
Besins Healthcare (UK) Ltd
G03CA04
ESTRIOL
0.03 Milligram
Pessary
Product subject to prescription which may not be renewed (A)
Natural and semisynthetic estrogens, plain
Authorised
2018-03-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ESTRIOL 0.03 MG PESSARY Estriol 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, please 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 Estriol is and what it is used for 2. What you need to know before you use Estriol 3. How to use Estriol 4. Possible side effects 5. How to store Estriol 6. Contents of the pack and other information 1. WHAT ESTRIOL IS AND WHAT IT IS USED FOR Estriol contains a female sex hormone (oestrogen) for the vaginal use which is suitable for the treatment of local complaints. Estriol is used for local treatment of disorders caused by estrogen deficiency in the vaginal region in women after their last regular menstrual period (menopause). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRIOL DO NOT USE ESTRIOL if any of the following applies to you. If you are not sure about any of the points below, TALK TO YOUR DOCTOR before using Estriol. Do not use Estriol if you have or have had BREAST CANCER, or if you are suspected to having it if you have CANCER WHICH IS SENSITIVE TO OESTROGENS, such as cancer of the womb lining (Endometrium), or if you are suspected of having it if you have EXCESSIVE THICKENING OF THE WOMB LINING (endometrial hyperplasia) that is not being treated if you have any UNEXPLAINED VAGINAL BLEEDING if you have or have ever had a BLOOD CLOT IN A VEIN (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) if you have a BLOOD CLOTTING DISORDER (such as protein C, protein S, or antithrombin deficiency) Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estriol 0.03 mg pessary 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pessary contains 0.03 mg estriol. Excipient with known effect: butylhydroxytoluene For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Pessary White, homogenous pessaries. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local treatment of vaginal symptoms of estrogen deficiency in postmenopausal women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology During the first 3 weeks of treatment one pessary is administered daily. Thereafter a maintenance dose of 1 pessary twice a week is recommended. Method of administration and duration of treatment The pessary should be introduced deeply into the vagina, preferably in the evening before going to bed. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see also section 4.4). Missed dose during daily use within the first 3 weeks of treatment: If a missed dose is not realized before the next day, it should not be replaced. In that case the usual dosing schedule should be resumed. during twice-weekly use: If the administration of the medicinal product has been forgotten at a scheduled date during the twice-weekly maintenance treatment, the missed dose should be administered as soon as possible. 4.3 CONTRAINDICATIONS Known, past or suspected breast cancer, known or suspected estrogen-dependent malignant tumours (e. g. endometrial cancer), untreated endometrial hyperplasia, undiagnosed genital bleeding, previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lire le document complet