Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
PCO Manufacturing
N02BE51
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
500, 12.5 & 22.5 Milligram
Film Coated Tablet
Oral use
24 tablets (two strips of 12 tablets)
Product not subject to medical prescription
PCO Manufacturing
Analgesics and antipyretics
For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing, fever, headache, muscular aches and pains.
Authorised
2015-07-01
BENYLIN 4FLU FILM-COATED TABLETS PARACETAMOL 500MG DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG PSEUDOEPHEDRINE HYDROCHLORIDE 22.5MG 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 4 Flu tablets 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 the leaflet, please consult your doctor or pharmacist. IN THIS LEAFLET: 1. What Benylin 4 Flu tablets are and what they are used for 2. Before you take Benylin 4 Flu tablets 3. How to take Benylin 4 Flu tablets 4. Possible side effects 5. How to store Benylin 4 Flu tablets 6. Further information 1. WHAT BENYLIN 4 FLU TABLETS ARE AND WHAT THEY ARE USED FOR Benylin 4 Flu Tablets are 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 6 years and over. 2. BEFORE TAKING BENYLIN 4 FLU TABLETS 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 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 500 mg Diphenhydramine hydrochloride 12.5 mg Pseudoephedrine hydrochloride 22.5 mg Also contains: Sunset yellow E110 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from the UK:_ Orange, oval, biconvex, film coated tablets 4 CLINICAL PARTICULARS As per PA0823/034/002 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sunset yellow (E110) may cause allergic reactions. 5 PHARMACOLOGICAL PROPERTIES As per PA0823/034/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Pregelatinized maize starch Povidone Crospovidone Macrogol 6000 Croscarmellose Sodium Stearic acid Magnesium stearate Hypromellose Titanium dioxide (E171) Quinoline yellow (E104) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/08/2016_ _CRN 2182039_ _page number: 1_ Sunset yellow (E110) Talc 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 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 carton. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 24 tablets (two strips of 12 tablets). 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Aqra d-dokument sħiħ