Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
TAMSULOSIN HYDROCHLORIDE
B & S Healthcare
G04CA02
TAMSULOSIN HYDROCHLORIDE
400 Microgram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
tamsulosin
Authorised
2009-04-24
PATIENT INFORMATION LEAFLET OMNEXEL 400MICROGRAMS PROLONGED RELEASE TABLETS FILM COATED (tamsulosin hydrochloride) 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 from fainting due to reduced blood pressure when changing posture (going to sit or stand up). TAKE SPECIAL CARE WITH OMNEXEL Periodic medical examinations are necessary to monitor the development of the condition you are being treated for. Rarely, fainting can occur during the use of Omnexel, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disapp Прочитать полный документ
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. Excipients: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged release tablets. (Oral Controlled Absorption System, OCAS). _Product sourced from France:_ Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated and debossed with the code '04'. 4 CLINICAL PARTICULARS As per PA 1241/006/001 5 PHARMACOLOGICAL PROPERTIES As per PA 1241/006/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Macrogol 7,000,000 Macrogol 8,000 Magnesium stearate (E470b) Butylhydroxytoluene (E321) Colloidal anhydrous silica (E551) Tablet coat: Macrogol 8,000 Hypromellose (E464) Iron oxide yellow (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/11/2014_ _CRN 2146767_ _page number: 1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package. This medicinal product does not require any special temperature storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium/aluminium foil blister packs containing 30 tablets in an over labelled outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER B&S Healthcare Unit 4 Bradfield Road Ruislip Middlesex HA4 0NU United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBE Прочитать полный документ