Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Diphenhydramine; Pseudoephedrine; Paracetamol
Imbat Limited
N02BE; N02BE51
Diphenhydramine; Pseudoephedrine; Paracetamol
500 12.5 22.5 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Authorised
2009-09-25
Page 1 of 2 PATIENT INFORMATION LEAFLET BENYLIN FOUR FLU ® FILM-COATED TABLETS (paracetamol 500mg / diphenhydramine hydrochloride 12.5mg / pseudoephedrine hydrochloride 22.5mg) Your medicine is available using the above name but will be referred to as Benylin Four Flu throughout the leaflet. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to take Benylin Four Flu carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please consult your doctor or pharmacist. IN THIS LEAFLET 1. What Benylin Four Flu is and what it is used for. 2. Before you take Benylin Four Flu. 3. How to take Benylin Four Flu. 4. Possible side effects. 5. How to store Benylin Four Flu. 6. Contents of the pack and other information. 7. Information about treating cough and cold in children 1. WHAT BENYLIN FOUR FLU IS AND WHAT IT IS USED FOR Benylin Four Flu is used to help relieve cold and flu symptoms. The tablets contain paracetamol which helps to relieve aches and pains and fever (high temperature), diphenhydramine, which is an antihistamine that helps relieve coughing, sneezing and runny nose and pseudoephedrine, which is a decongestant that helps unblock stuffy noses. The medicine is for use in adults and children aged 10 years and over. 2. BEFORE TAKING BENYLIN FOUR FLU 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 are taking any other medicines containing PARACETAMOL. If you have ever had an ALLERGIC (HYPERSENSITIVITY) REACTION to any of the ingredients. If you have HEART DISEASE or HIGH BLOOD PRESSURE. If you h Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine Hydrochloride 22.5mg Excipients:Contains Sunset yellowing colouring (E110) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets _Product imported from_ the UK: Orange, biconvex, film coated tablets with no markings 4 CLINICAL PARTICULARS As per PA0823/034/002 5 PHARMACOLOGICAL PROPERTIES As per PA0823/034/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Pregelatinized maize starch Povidone Crospovidone Stearic acid Microcrystalline cellulose Croscarmellose sodium Magnesium Stearate Film-coating materials Hypromellose Macrogol 6000 Talc Titanium Dioxide (E171) Sunset Yellow (E110) Quinoline Yellow (E104) 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_ _9_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _0_ _8_ _1_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister strip and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 ° C Store in the original package. Keep container in the outer cart Aqra d-dokument sħiħ