Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
Imbat Limited
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; tamsulosin
Authorised
2007-09-14
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER OMNEXEL ® 400 MICROGRAMS PROLONGED RELEASE TABLETS, FILM-COATED (tamsulosin hydrochloride) Your medicine is available using the name Omnexel 400 micrograms, prolonged-release tablets, film-coated but will be referred to as Omnexel throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Omnexel is and what it is used for 2. Before you take Omnexel 3. How to take Omnexel 4. Possible side effects 5. How to store Omnexel 6. Further information 1. WHAT OMNEXEL IS AND WHAT IT IS USED FOR The active ingredient in Omnexel is tamsulosin. This is a selective alpha 1A/1D -adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge. Omnexel is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia). These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day. 2. BEFORE YOU TAKE OMNEXEL DO NOT USE OMNEXEL if you are allergic (hypersensitive) to tamsulosin or to any of the other ingredients in Omnexel. Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema). if you suffer from severe liver problems. if you suffer fro Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omnexel, 400 micrograms, prolonged release tablets, film-coated 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release film-coated tablet contains 400 micrograms tamsulosin hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged release tablet. (Oral Controlled Absorption System, OCAS). _Product imported from The Netherlands, Poland, and the United Kingdom:_ Round, bi-convex, yellow, film-coated and debossed with the code '04' on one side and plain on the other. 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 Oral use. One tablet daily. Omnexel can be taken independently of food. The tablet must be swallowed whole and not be crunched or chewed as this interferes with the prolonged release of the active substance. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3. Contraindications). Paediatric population There is no relevant indication for use of Omnexel, 400 micrograms, 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 hydrochloride, including drug-induced angioedema or to any of the excipients. A history of orthostatic hypotension. Severe hepatic insufficiency. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Læs hele dokumentet