Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
N02BE51
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
500/12.5/22.5 Milligram
Film Coated Tablet
Product not subject to medical prescription
Analgesics and antipyretics
Authorised
1998-06-02
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: Diphenhydramine hydrochloride 12.5 mg Paracetamol 500 mg Pseudoephedrine hydrochloride 22.5 mg Also contains: Sunset yellow E110 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orange, oval, biconvex, film coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER: Two tablets, up to four times daily, as required. Do not take more frequently than every four hours. CHILDREN 10 TO 15 YEARS One tablet, up to four times daily, as required. Do not take more frequently than every four hours. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment. CHILDREN UNDER 10 YEARS Benylin Four Flu Tablets are contraindicated in children under the age of 10 years (see section 4.3). Do not exceed the stated dose. 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 Soma hati kamili