Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Cupal Limited
PARACETAMOL
120 mg/5 m %v/v
Oral Suspension
Product not subject to medical prescription
Authorised
0000-00-00
Package Leaflet: Information for the user MEDINOL UNDER 6 120 MG/5 ML ORAL SUSPENSION PARACETAMOL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAS TOLD YOU. • Keep this leaflet, you may wish to read it again. • Ask your doctor or pharmacist if you need more information or advice. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. WHAT THIS MEDICINE IS AND WHAT IS IT USED FOR? 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE 3. HOW TO TAKE THIS MEDICINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE THIS MEDICINE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT THIS MEDICINE IS AND WHAT IS IT USED FOR? Medinol for Children is specifically formulated for children under 6 years and is used for the relief of mild to moderate pain and fever. Paracetamol is used to treat high temperatures and provide pain relief. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE Do not take… • If your child is allergic to any of the ingredients in this product. • See 'What this suspension contains' for the full list of ingredients. • At the same time as taking other medicines containing paracetamol. • If your child has an inherited intolerance to fructose, speak to your doctor before giving this medicine. The body can make some fructose from the ingredient maltitol. Speak to Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medinol Under 6 Paracetamol Oral Suspension 120mg/5ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml suspension contains 120mg Paracetamol. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral Suspension. A grey/white viscous thixotropic liquid oral suspension with a strawberry odour and taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic for the treatment of mild to moderate pain and as an anti-pyretic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION Oral. AGE DOSE FOR POST-VACCINATION FEVER FOR BABIES AGED BETWEEN 2 – 3 MONTHS ONE 2.5 ML SPOONFUL (SMALL END) IF NECESSARY, AFTER 4-6 HOURS, GIVE A SECOND 2.5 ML DOSE • Do not give to babies less than 2 months of age • Do not give more than 2 doses • Leave at least 4 hours between doses • If further doses are needed, talk to your doctor or pharmacist CHILD’S AGE HOW MUCH HOW OFTEN (IN 24 HOURS) 3 – 6 MONTHS ONE 2.5 ML SPOONFUL (SMALL END) 4 TIMES 6 – 24 MONTHS ONE 5 ML SPOONFUL (LARGE END) 4 TIMES 2 – 4 YEARS ONE 5.0 ML SPOONFUL (LARGE END) AND ONE 2.5 ML SPOONFUL (SMALL END) 4 TIMES 4 – 6 YEARS TWO 5 ML SPOONFULS (LARGE END) 4 TIMES • Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/12/2013_ _CRN 2112619_ _page number: 1_ 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and/or other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The following medical advice should be given: • It Lire le document complet