Страна: Великобритания
Язык: английский
Источник: 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: 5010123731717
■ This medicine brings down high temperatures (also called fever) and relieves pain. ■ This medicine is intended 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. What is in this leaflet 1. What this medicine is used for 2. What you need to know before you use this medicine 3. How to use this medicine 4. Possible side-effects 5. How to store this medicine 6. Contents of the pack and other information 1 What the medicine is for The paracetamol in CALPOL SIXPLUS ® Sugar Free Suspension is used to relieve mild/moderate 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 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 giving your child this medicine if: ■ Your child Прочитать полный документ
OBJECT 1 CALPOL SIX PLUS SUGAR FREE SUSPENSION (P) Summary of Product Characteristics Updated 15-Aug-2016 | McNeil Products Ltd 1. Name of the medicinal product Calpol Six Plus Sugar Free Suspension 2. Qualitative and quantitative composition Calpol Six Plus Sugar Free Suspension contains 250 mg Paracetamol in each 5 ml. Excipients: Also contains maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). 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 Sugar Free Suspension 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.It is important to MASSAGE THE SACHET before use. Прочитать полный документTHE 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 recommended d