Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE
Imbat Limited
N02BE; N02BE51
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE
500/30 milligram(s)
Tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Authorised
2009-07-31
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER NON-DROWSY SINUTAB ® TABLETS (Paracetamol 500mg Pseudoephedrine hydrochloride 30mg) Your medicine is available using the above name but will be referred to as 'Sinutab' throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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._ You must talk to a doctor if you do not feel better or if you feel worse after 5 days WHAT IS IN THIS LEAFLET 1. What Sinutab is and what it is used for 2. What you need to know before you use Sinutab 3. How to use Sinutab 4. Possible side-effects 5. How to store Sinutab 6. Contents of the pack and other information 1. WHAT SINUTAB IS AND WHAT IT IS USED FOR Sinutab relieves the symptoms of colds and flus including aches, pains, fever, nasal and sinus congestion. The tablets contain paracetamol, an analgesic and antipyretic to relieve pain and fever, and pseudoephedrine, a decongestant to clear nasal congestion and blocked sinuses. This medicine is for use in adults and children aged 12 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SINUTAB This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE... If you have ever had a BAD REACTION (ALLERGIC REACTION) to PARACETAMOL or PSEUDOEPHEDRINE or any of the other ingredients (_listed in section 6_). If you have HIGH BLOOD PRESSURE or HEART DISEASE. If you have DIABETES. If you have a PHAEOCHROMOCYTOMA (a tumour which affects your heart rate and blood pressure). If you have an OVERACTIVE THYROID. Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Non-drowsy Sinutab Tablets Paracetamol 500mg Pseudoephedrine hydrochloride 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg Pseudoephedrine hydrochloride and 500 mg Paracetamol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets _Tablets imported from the UK:_ White, round, biconvex tablets, plain on both sides. 4 CLINICAL PARTICULARS As per PA0823/005/001 5 PHARMACOLOGICAL PROPERTIES As per PA0823/005/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Pregelatinised maize starch Crospovidone Sodium starch glycolate (Type A) Povidone Stearic acid Magnesium stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Store in the original packaging. 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_ _6_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _7_ _6_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Over-labelled carton containing blister strip. Pack size: 15 tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2 North Ring Business Park Santry Dublin 9 8 PARALLEL PRODUCT AUT Lesen Sie das vollständige Dokument