Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
IMED Healthcare 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
2009-08-28
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. WHAT OMNEXEL IS AND WHAT IT IS USED FOR The active ingredient in Omnexel is tamsulosin. This is a selective alpha1A/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 read_full_document
Health Products Regulatory Authority 03 March 2023 CRN00DDND 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 0.4mg 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) _Product imported from Poland:_ Approximately 9mm 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 Macrogol Magnesium stearate (E470b) Butylhydroxytoluene (E321) Colloidal silica anhydrous (E551) Hypromellose (E464) Iron oxide yellow (E172) 6.2 INCOMPATIBILITIES Not applicable. 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 This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium foil blister strips in an overlabelled cardboard carton containing 30 tablets. Health Products Regulatory Authority 03 March 2023 CRN00DDND Page 2 of 2 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 IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/025/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28th August 2009 10 DATE OF REVISION OF THE TEXT March 2023 read_full_document