Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Reckitt Benckiser Healthcare (UK) Ltd
M01AE01
Ibuprofen
20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5000158069770
Package Leaflet: Information for the user Contains Ibuprofen This leaflet is valid for Nurofen for Children Cold, Pain and Fever Orange flavour or for Nurofen for Children Cold, Pain and Fever Strawberry flavour. The only difference between both products is the flavour. To know the flavour of the medicine you are using, please refer to the carton or label. Read all of this leaflet carefully before you use this medicine, because it contains important information for you. Keep this leaflet: you might need it again. Ask your doctor or pharmacist if you need more information or advice. • This medicine is designed to help bring down a high temperature (fever and post-immunisation fever), relieve the symptoms of cold and flu and relieve pain from headaches, sore throats, minor aches and sprains, teething and toothache. • This medicine is suitable for most babies over 3 months of age, children and adults. • Follow the dose instructions carefully. Section 3 shows the different amount that children need. • Speak to your doctor if your child: suffers from any of the conditions listed in Section 2 of the leaflet is taking aspirin at a dose above 75 mg a day. See Section 2 is taking other medicines. See Section 2. is not getting better, or feeling worse, or you feel at all concerned. See Section 3 develops a rash, breathing problems or diarrhoea and gets very tired. See Section 3. gets any side effects. See Section 4. This includes any possible side effects not listed in this leaflet. • Do not use this medicine and speak to your doctor if you are pregnant, think you may be pregnant or trying to get pregnant or are breast feeding. See Section 2. In this leaflet: 1. What Nurofen for Children is and what it is used for 2. What you need to know before giving Nurofen for Children to your child 3. How to use Nurofen for Children 4. Possible side effects 5. How to store Nurofen for Children 6. Contents of pack and other information 1. What Nurofen for Children is and what it is used for The active ingredient (which makes Lugege kogu dokumenti
OBJECT 1 NUROFEN FOR CHILDREN COLD, PAIN AND FEVER ORANGE FLAVOUR 100MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 07-Jun-2018 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Nurofen for Children Orange Nurofen for Children Orange Baby Nurofen for Children 3 months to 9 years Orange Nurofen for Children Cold, Pain and Fever Orange Flavour 100mg/5mL Oral Suspension 2. Qualitative and quantitative composition Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v). Excipients with known effect: Maltitol Liquid For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral suspension. An off-white, orange-flavoured, syrupy suspension. 4. Clinical particulars 4.1 Therapeutic indications Prescription and OTC: For the fast and effective reduction of fever, including post immunisation pyrexia and the fast and effective relief of the symptoms of colds and influenza and mild to moderate pain, such as a sore throat, teething pain, toothache, headache, minor aches and sprains. 4.2 Posology and method of administration Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). For short term use only. The recommended daily dose of the product is 20 – 30 mg per kg of body weight, divided into equal doses, with dosing intervals of 6 to 8 hours. Leave at least 4 hours between doses and do not take more than the recommended dose in 24 hours. The recommended dose should not be exceeded. Using the spoon or syringe dosing device provided this can be achieved as follows: Age Body weight (kg) Recommended Dosage Infants 3-6 months weighing more than 5 kg 5-7.6 one 2.5ml dose may be taken 3 times in 24 hours Infants 6-12 months 7.7-9 one 2.5ml dose may be taken 3 to 4 times in 24 hours Children 1-3 years 10-16 one 5ml dose may be taken 3 times in 24 hours Children 4-6 years 17-20 7.5ml (5ml +2.5ml spoonful) may be taken 3 times in 24 hours Children 7-9 years 21-30 two 5ml doses may be take Lugege kogu dokumenti