Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PARACETAMOL
PCO Manufacturing
PARACETAMOL
120 MG/5ml
Oral Suspension
Withdrawn
2009-12-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calpol 120 mg/5 ml Sugar Free Infant Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 120mg of paracetamol. Excipients: Maltitol Sorbitol Carmoisine Ethyl hydroxybenzoate Propyl hydroxybenzoate Methyl hydroxybenzoate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension _Product imported from the UK:_ A pink suspension with a strawberry colour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CALPOL Sugar Free Infant Suspension is indicated for the treatment of pain (including teething pain), and as an antipyretic. Calpol Sugar Free Infant Suspension is indicated for the relief of headache, migraine, neuralgia, toothache and teething pains, sore throat, rheumatic aches and pains, influenza, feverishness and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _CHILDREN AGED 6 YEARS TO 12 YEARS:_ Oral. 10 to 20 ml (240 mg to 480 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. _CHILDREN AGED 1 TO UNDER 6 YEARS:_ Oral. 5 to 10ml (120 mg to 240 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2009_ _CRN 2065009_ _page number: 1_ _INFANTS 3 MONTHS TO UNDER 1 YEAR:_ Oral. 2.5 to 5 ml (60 mg to 120 mg paracetamol). Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. _INFANTS 2-3 MONTHS (>3KG BODY WEIGHT)_ Oral 2.5ml (60mg paracetamol) Repeat every 4 hours, if necessary, up to a maximum of 4 doses per 24 hours. Do not use for more than 2 days without medical supervision. _UNDER 2 MO Läs hela dokumentet