Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
Astellas Pharma Co. Limited
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; tamsulosin
Marketed
2005-03-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OMNEXEL 400 MICROGRAMS PROLONGED RELEASE TABLETS (FILM-COATED) tamsulosin hydrochloride 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 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 Omnexel is and what it is used for 2 What you need to know before you take Omnexel 3 How to take Omnexel 4 Possible side effects 5 How to store Omnexel 6 Contents of the pack and other information 1. W HAT O MNEXEL 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMNEXEL DO NOT TAKE 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 from fainting due to reduced blood pressure when changing posture (going Leggi il documento completo
Health Products Regulatory Authority 08 February 2023 CRN00DC2R Page 1 of 6 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 0.4 mg tamsulosin hydrochloride. Excipients: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged release tablet. (Oral Controlled Absorption System, OCAS). Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated and debossed with the code ‘04’. 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 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. Health Products Regulatory Authority 08 February 2023 CRN00DC2R Page 2 of 6 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other α 1 ‑adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Omnexel as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Be Leggi il documento completo