Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Ibuprofen
Rowa Pharmaceuticals Limited
M01AE01
Ibuprofen
Oral suspension
ibuprofen
Marketed
2022-03-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRUPRO FOR CHILDREN 100 MG/5 ML ORAL SUSPENSION ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you or your child get 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 YOU OR YOUR CHILD DO NOT FEEL BETTER OR IF YOU OR YOUR CHILD FEEL WORSE AFTER 3 DAYS (NOT LATER THAN 24 HOURS IN CASE OF INFANTS 3 TO 5 MONTHS OF AGE). WHAT IS IN THIS LEAFLET 1. What Brupro for Children is and what it is used for 2. What you need to know before you use Brupro for Children 3. How to use Brupro for Children 4. Possible side effects 5. How to store Brupro for Children 6. Contents of the pack and other information 1. WHAT BRUPRO FOR CHILDREN IS AND WHAT IT IS USED FOR The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidal-anti- inflammatory (NSAID) painkiller. Ibuprofen is used as an analgesic (painkiller) for the relief of teething and toothache pain, earache, headache, muscular minor aches and sprains, sore throats and cold and flu symptoms. Brupro for Children also reduces a high temperature (fever). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRUPRO FOR CHILDREN DO NOT GIVE BRUPRO FOR CHILDREN TO CHILDREN WHO: • ARE LESS THAN 3 MONTHS OLD OR WEIGH LESS THAN 5 KG. • are ALLERGIC TO IBUPROFEN OR OTHER SIMILAR PAINKILLERS (NSAIDS) or to any of the other ingredients of this medicine (listed in section 6) • have ever suffered from shortness of breath, asthma, a runny nose, swelling on their face and/or hands or hives after using acetylsalicylic acid (ASPIRIN) or OTHER SIMILAR PAINKILLERS (NSAIDS) • have ever had GASTROIN Đọc toàn bộ tài liệu
Health Products Regulatory Authority 26 February 2024 CRN00DZC8 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brupro for Children 100 mg/5 ml oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml oral suspension contains 100 mg ibuprofen. Excipients with known effect Each 5 ml oral suspension contains 140 mg sorbitol, 50 mg propylene glycol, 10 mg sodium benzoate and 5.25 mg ethanol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension White or almost white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of fever and relief of mild to moderate pain, such as cold and flu symptoms, teething pain, headache, sprains and strains and to ease the pain of sore throats and earache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For short term use only. The maximum daily dosage of Brupro for Children is 30 mg of ibuprofen/kg bodyweight administered in divided doses. The symptomatic treatment of mild to moderate pain, and/or fever in children and adolescents depends on body weight and age respectively – in general with 7 to 10 mg/kg body weight as single dosage. This can be achieved as follows: Age and/or bodyweight can be used as a guide to select the correct dose. AGE BODY WEIGHT (KG) RECOMMENDED DOSAGE 3 to 6 months 5-7.6 2.5ml, 3 times a day 6 to 12 months 7.7-9 2.5ml, 3 times a day 1 to 3 years 10-16 5 ml, 3 times a day 4 to 6 years 17-20 7.5 ml, 3 times a day 7 to 9 years 21-30 10 ml, (two 5ml spoonfuls) 3 times a day 10 to 12 years 31-40 15 ml, (three 5ml spoonfuls) 3 times a day This product should only be given to infants aged 3-6 months who weigh more than 5kg. Do not dose more frequently than at 6 hourly intervals. The recommended dose should not be exceeded. For short term use only. For infants aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist. Health Products Regulatory Authority 26 February 2024 CRN00DZC8 Page 2 of 12 If in children a Đọc toàn bộ tài liệu