Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
PCO Manufacturing Ltd.
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; tamsulosin
Authorised
2005-11-18
_ _ _ _ _ _ _ _ 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 your 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. 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. WHAT YOU NEED TO KNOW 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 bloo Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 09 September 2022 CRN00D54J Page 1 of 2 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. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged release tablet _Product imported from the Netherlands, Hungary, France, Spain, Greece and Poland_ Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated and debossed with the code '04'. 4 CLINICAL PARTICULARS As per PA1241/006/001. 5 PHARMACOLOGICAL PROPERTIES As per PA1241/006/001. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from France, Spain, Greece, Poland and the Netherlands:_ Macrogol 7,000,000 Macrogol 8,000 Magnesium stearate (E470b) Butylhydroxytoluene (E321) Colloidal anhydrous silica (E551) Hypromellose (E464) Iron oxide yellow (E172) _Product imported from the UK:_ Macrogol Butylhydroxytoluene Hypromellose Magnesium stearate Yellow iron oxide _Product imported from Hungary:_ Magnesium stearate Macrogol 7,000,000 Macrogol 8,000 _Film-coating:_ Opadry yellow O3F22733 (Hypromellose, macrogol 8000, Iron oxide yellow (E172)) 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 09 September 2022 CRN00D54J Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 30 tablets contained in an overlabelled outer cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Busines Lesen Sie das vollständige Dokument