Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Paracetamol
McNeil Healthcare (Ireland) Ltd
N02BE; N02BE01
Paracetamol
120 mg/5ml
Oral suspension
Product not subject to medical prescription
Anilides; paracetamol
Not marketed
2010-11-12
PARACETAMOL _120 mg/5 ml_ _INFANT ORAL SUSPENSION _ _Contains Paracetamol_ 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 Paracetamol Infant Oral Suspension is and what it is used for 2. What you need to know before you use Paracetamol Infant Oral Suspension 3. How to use Paracetamol Infant Oral Suspension 4. Possible side-effects 5. How to store Paracetamol Infant Oral Suspension 6. Contents of the pack and other information 1 WHAT PARACETAMOL INFANT ORAL SUSPENSION IS AND WHAT IT IS USED FOR The paracetamol in Paracetamol Infant Oral 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 PARACETAMOL INFANT ORAL SUSPENSION DO NOT GIVE YOUR CHILD THIS MEDICINE… IF S/HE HAS EVER HAD A BAD REACTION TO paracetamoL or any of the other ingredients in this medicine (see Section 6). IF S/HE IS TAKING ANYTHING ELSE WITH PARACETAMOL IN IT. IF S/HE WEIGHS LESS THAN 4 KG. If any of these applies, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING PARACETAMOL INFANT ORAL SUSPENSION. 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. If your child has GILBERT’S SYNDROME (familial non- haem Baca dokumen lengkapnya
Health Products Regulatory Authority 07 April 2022 CRN00CSYN Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PARACETAMOL 120mg/ 5ml Infant Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PARACETAMOL Infant Suspension contains 120 mg Paracetamol in each 5 ml. Excipients with known effect (per 5ml): Sucrose 2202.48 mg Sorbitol Liquid (E420) 451.5 mg Ethyl parahydroxybenzoate (E214) 2.0 mg Methyl parahydroxybenzoate (E218) 5.0 mg Propyl parahydroxybenzoate (E216) 1.0 mg Carmoisine (E122) 75 microgram For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Oral Suspension. A viscous, pink coloured suspension with a strawberry odour and taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PARACETAMOL Infant120mg/5ml Oral Suspension is indicated for the treatment of pain (including teething pain), and as an antipyretic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION INFANTS AGED 2-3 MONTHS: AGE: 2 – 3 MONTHS DOSE 1. POST-VACCINATION FEVER 2.5 ml If necessary, after 4-6 hours, give a second 2.5 ml dose 2. OTHER CAUSES OF PAIN AND FEVER - if your babyweighs over 4 kg and was born after 37 weeks Do not give to babies less than 2 months of age. Do not give more than 2 doses unless your doctor or nurse has advised otherwise Leave at least 4 hours between doses. If further doses are needed, talk to your doctor or pharmacist. It is important to SHAKE THE BOTTLE for at least 10 seconds before use. CHILDREN AGED 3 MONTHS – 6 YEARS: CHILD'S AGE HOW MUCH HOW OFTEN (IN 24 HOURS) 3 – 6 months 2.5 ml 4 times 6 – 24 months 5 ml 4 times 2 – 4 years 7.5ml (5 ml + 2.5 ml) 4 times 4 – 6 years 10ml (5 ml + 5 ml) 4 times Do not give more than 4 doses in any 24 hour period Leave at least 4 hours between doses Health Products Regulatory Authority 07 April 2022 CRN00CSYN Page 2 of 8 Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist RENAL IMPAIRMENT: It is recommended, when giving Baca dokumen lengkapnya