Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
McNeil Products Ltd
N02BE01
Paracetamol
50mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5010123667320 5010123730642 3574660435221
■ This medicine brings down high temperatures (also called fever) and relieves pain. ■ The medicine is OK for most children over 6 years. ■ Do not give it to children on this list: ■ Not to children taking some other medicines. _See section 2_ ■ Not to anyone who is allergic to the ingredients. _See section 6_ ■ Follow the dosage instructions carefully. Children of different ages need different amounts. These are shown in the tables. _See section 3_ ■ Speak to your doctor if anything in this list applies: ■ If a child is not getting better, or needs more medicine than shown in the table. _See section 3_ ■ If a child gets a rash, breathing problems, diarrhoea or gets very tired. _See section 3_ Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again. 1 What the medicine is for The paracetamol in CALPOL SIXPLUS ® Suspension Sugar Free is used to relieve pain and / or bring down fever (high temperature) in many conditions including cold and flu, headache, toothache, earache, post immunisation fever, sore throat and other aches and pains. 2 Before giving the medicine to your child This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. Do not give your child this medicine… ■ 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 ® . 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 is taking any other medicines including: ■ _metoclopramide_ or _domperidone_ (used to treat nausea and vomiting) ■ _colestyramine_ (used to treat high cholesterol) ■ _anticoagulants _(drugs that thin the blood, such as warfarin) ■ _anticonvulsants Baca dokumen lengkap
OBJECT 1 CALPOL SIX PLUS SUSPENSION SUGAR FREE 80ML BOTTLE (GSL) Summary of Product Characteristics Updated 08-Sep-2016 | McNeil Products Ltd 1. Name of the medicinal product Calpol Six Plus Suspension Sugar Free 2. Qualitative and quantitative composition Calpol Six Plus Suspension Sugar Free contains 250 mg Paracetamol in each 5 ml. Excipients: maltitol liquid (contain 2.04 g of maltitol per 5 ml), sorbitol liquid (E420), glycerol, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). See section 4.4 for further information. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Suspension. 4. Clinical particulars 4.1 Therapeutic indications Calpol Six Plus Suspension Sugar Free is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever. 4.2 Posology and method of administration 4.2.1 POSOLOGY CHILDREN AGED 6 TO 12 YEARS: CHILD'S AGE HOW MUCH HOW OFTEN (IN 24 HOURS)* Under 6 years Not recommended N/A 6 8 years 5 ml 4 times 8 10 years 7.5 ml (5ml + 2.5 ml) 4 times 10 12 years 10 ml (5ml + 5ml) 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 CHILDREN AGED 12-16 YEARS: 10 15 ml (Two to three 5 ml doses) up to 4 times a day ADULTS AND CHILDREN OVER 16 YEARS: 10 20 ml (Two to four 5 ml doses) up to 4 times a day. It is important to SHAKE THE BOTTLE for at least 10 seconds before use. THE ELDERLY: In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults. 4.3 Contraindications Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Taking more than the recom Baca dokumen lengkap