Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Trospium chloride
Imbat Limited
A03DA; A03DA06
Trospium chloride
20 milligram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
Synthetic anticholinergic agents in combination with analgesics; trospium and analgesics
Authorised
2007-11-23
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER REGURIN ® 20MG COATED TABLETS (trospium chloride) Your medicine is available using the name Regurin 20mg coated Tablets but will be referred to as Regurin throughout this leaflet. 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 any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. 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. IN THIS LEAFLET: 1. What Regurin is and what it is used for 2. What you need to know before you take Regurin 3. How to take Regurin 4. Possible side effects 5. How to store Regurin 6. Contents of the pack and further information 1. WHAT REGURIN IS AND WHAT IT IS USED FOR Regurin is a medicine used for the relaxation of the bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REGURIN DO NOT TAKE REGURIN If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath). For the list of ingredients in Regurin, please see section 6. If you suffer from any of the following: urinary retention, i.e. blockage of the urinary tract, the eye condition narrow-angle glaucoma, abnormal/faster than normal heart beats, myasthenia gravis (a disorder that causes muscle fatigue), a severe gastro-inte Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Regurin 20mg coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is trospium chloride. Each coated tablet contains 20 mg trospium chloride. Excipients: includes lactose monohydrate, sucrose and wheat starch per coated tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet _Product imported from France and UK:_ Brownish-yellow, glossy coated, biconvex tablets with no markings 4 CLINICAL PARTICULARS As per PA1288/001/001 5 PHARMACOLOGICAL PROPERTIES As per PA1288/001/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Wheat starch Microcrystalline cellulose Lactose monohydrate Povidone Croscarmellose sodium Stearic acid Colloidal anhydrous silica Talc Tablet coat: Sucrose Carmellose sodium Talc Colloidal anhydrous silica Calcium carbonate (E170) Macrogol 8000 Titanium dioxide (E171) Iron oxide hydrate yellow (E172) Beeswax white H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _1_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _7_ _4_ _6_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Carnauba wax Note for diabetics: 1 coated tablet corresponds to 0.06g carbohydrate (equivalent to 0.005 bread units). 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 carton of the product on the market in the country of origin. 6.4 Read the complete document