País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
TAMSULOSIN HYDROCHLORIDE
Teva Pharma B.V.
G04CA02
TAMSULOSIN HYDROCHLORIDE
400 Microgram
Capsules Modified Release
Product subject to prescription which may be renewed (B)
tamsulosin
Authorised
2016-02-12
PACKAGE LEAFLET: INFORMATION FOR THE USER TAMSULOSIN TEVA 400 MICROGRAMS MODIFIED-RELEASE CAPSULES (Tamsulosin hydrochloride) The name of your medicine is TAMSULOSIN TEVA 400 MICROGRAMS MODIFIED-RELEASE CAPSULES which will be referred to as Tamsulosin throughout this leaflet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Tamsulosin is and what it is used for 2. What you need to know before you take Tamsulosin 3. How to take Tamsulosin 4. Possible side effects 5. How to store Tamsulosin 6. Contents of the pack and other information 1. WHAT TAMSULOSIN IS AND WHAT IT IS USED FOR The active ingredient in your capsules, tamsulosin hydrochloride, belongs to a group of medicines known as alpha-IA-adrenoceptor blockers. The capsules are used to treat the symptoms of Benign Prostatic Hyperplasia (BPH) which is caused by enlargement of the prostate gland in men which can cause difficulty in passing urine and/or frequent passing of urine. Tamsulosin works by relaxing muscle around the bladder and prostate gland so urine can be passed more easily. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN DO NOT TAKE TAMSULOSIN - If you are allergic (hypersensitive) to tamsulosin hydrochloride or any of the other ingredients of this medicine(listed in section 6). - Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamsulosin Teva 400 micrograms Modified-release Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 0.4 mg of tamsulosin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsule, hard. Orange/olive-green capsule, with a black printed mark ‘TSL 0.4’ and with a black stripe at both ends. The capsules contain white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section 4.3 Contraindications). Paediatric population There is no relevant indication for use of tamsulosin in children. The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described in section 5.1 4.3 CONTRAINDICATIONS Hypersensitivity to tamsulosin, including drug-induced angio-oedema, or to any of the excipients. Orthostatic hypotension observed earlier (history of orthostatic hypotension). Severe hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other 1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin as a result of which, rarely, syncope Leer el documento completo