Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE
Procter & Gamble (Health & Beauty Care) Limited
N02BE51
PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE
1000/12.2 Milligram
Powder for Oral Solution
Product not subject to medical prescription
Analgesics and antipyretics
Authorised
2011-12-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for oral solution, Lemon flavour Paracetamol 1000mg, Phenylephrine HCl 12.2mg Powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet contains: 1000mg Paracetamol 12.2mg Phenylephrine hydrochloride (equivalent to 10mg phenylephrine base) Excipients Sucrose 1936mg Aspartame 25mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution, sachet Yellow powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief of symptoms of colds and influenza, including the relief of headaches, aches and pains, sore throat, nasal congestion and lowering of temperature. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Dissolve the contents of one sachet in a standard mug of hot, but not boiling, water (approx. 250ml). Allow to cool to a drinkable temperature. Posology Adults: One sachet May be repeated every 4-6 hours as required Adolescents aged 16 years of age and over: One sachet May be repeated every 6 hours as required Maximum of 4 doses (4 sachets) in 24 hours _Paediatric population_ Paracetamol 1000mg, Phenylephrine hydrochloride 12.2mg, Powder for oral solution, Lemon flavour is indicated in adults and adolescents aged 16 and over. Elderly: No special dosage modifications are required. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, phenylephrine or any of the excipients Severe ischaemic heart disease 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ