Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Paracetamol
McNeil Healthcare (Ireland) Ltd
N02BE; N02BE01
Paracetamol
250 mg/5ml
Oral suspension
Medicinal product not subject to medical prescription
Anilides; paracetamol
Marketed
1994-10-14
Package leaflet: Information for the user Read all of this leaflet carefully before you start using 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 have told you. ■ Keep this leaflet. You may need to read it again. ■ Ask your pharmacist if you need more information or advice. ■ If your child gets any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4. ■ You must talk to a doctor if your child does not feel better or feels worse after 3 days. What is in this leaflet 1. What CALPOL ® is and what it is used for 2. What you need to know before you use CALPOL ® 3. How to use CALPOL ® 4. Possible side-effects 5. How to store CALPOL ® 6. Contents of the pack and other information 1 What Calpol ® is and what it is used for The paracetamol in CALPOL SIXPLUS ® Sugar/Colour Free Suspension is used to relieve pain such as tooth pain, headache, sore throat and aches and pains that come with colds and flu. It also brings down fever (high temperature). 2 WHAT YOU NEED TO KNOW BEFORE YOU USE Calpol ® DO NOT GIVE YOUR CHILD THIS MEDICINE… ■ If s/he is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). ■ IF S/HE HAS EVER HAD A BAD REACTION to any of the ingredients. ■ IF S/HE IS TAKING ANYTHING ELSE WITH PARACETAMOL IN IT. If any of these applies, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING CALPOL ® . WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist… ■ IF YOUR CHILD HAS SERIOUS KIDNEY OR LIVER PROBLEMS. ■ IF YOUR CHILD HAS AN INHERITED INTOLERANCE TO FRUCTOSE or been diagnosed with an INTOLERANCE TO SOME OTHER SUGARS. OTHER MEDICINES AND CALPOL ® Tell your doctor or pharmacist if your child is taking any other medicines including: ■ _metoclopramide_ or _domperidone_ (used to treat NAUSEA AND VOMITING) ■ _colestyramine_ (used to treat HIGH CHOLES Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calpol Six Plus 250mg/5ml Sugar/Colour Free Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CALPOL SIX PLUS SUGAR/COLOUR FREE SUSPENSION contains Paracetamol 250 mg per 5 ml. Excipients with known effect: Maltitol 2040mg per 5ml Sorbitol 1400mg per 5ml Methyl parahydroxybenzoate 5.0mg per 5ml Propyl parahydroxybenzoate 1.0mg per 5ml For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Suspension An off-white oral suspension with an odour of strawberries. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calpol products are indicated for the treatment of mild to moderate pain and as antipyretics. Calpol is indicated for the symptomatic relief of headache, migraine, neuralgia, toothache and teething pains, sore throat, influenza, feverishness and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration 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_ _ _ _1_ _5_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _4_ _8_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ CHILDREN AGED 6 YEARS – 12 YEARS: CHILDREN AGED 12 – 16 YEARS: Two – three 5ml spoonfuls (large end) up to 4 times a day. ADULTS AND CHILDREN OVER 16 YEARS: Two – four 5ml spoonfuls (large end) up to 4 times a day. CHILDREN UNDER 6 YEARS: Not suitable for administration to children under 6years of age. [See Section 4.3] HEPATIC/RENAL DYSFUNCTION: Caution should be exer Citiți documentul complet