Country: Malta
Language: English
Source: Medicines Authority
Vale Pharmaceuticals Limited 3 Anglesea Street, Clonmel, Co. Tipperary, E91 D6C5, Ireland
N02BE51
PARACETAMOL 32 mg IBUPROFEN 9,6 mg
ORAL SUSPENSION
PARACETAMOL 32 mg IBUPROFEN 9,6 mg
POM
ANALGESICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-02-27
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PARAIBUCOMB 32 MG/ML + 9.6 MG/ML ORAL SUSPENSION paracetamol/ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Paraibucomb is and what it is used for 2. What you need to know before you take Paraibucomb 3. How to take Paraibucomb 4. Possible side effects 5. How to store Paraibucomb 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR Paraibucomb contains paracetamol and ibuprofen. Paracetamol is an active substance that relieves pain. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness or soreness). Paraibucomb is used for short-term management of mild to moderate acute pain which is not considered to be relieved by paracetamol or ibuprofen (alone) in children 2-12 years of age with body weight of 12 kg and above. Ask your doctor or pharmacist if you have any questions about this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT USE PARAIBUCOMB: - if your child is allergic to paracetamol, ibuprofen or any of the other ingredients of this medicine (listed in section 6); - if your child has a peptic ulcer (i.e. stomach or duodenal ulcer) or bleeding, or has had two or more episodes of an ulcer or bleeding in the stomach or small intestine in the past; - if your child has ever had bleeding or perforation in the stomach or intestine associated with previous treatment with NSAIDs - Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paraibucomb 32 mg/ml + 9.6 mg/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 32 mg paracetamol and 9.6 mg ibuprofen. Excipients with known effect Maltitol liquid (E965) 250 mg/ml Propylene glycol (E1520) 9.6 mg/ml Sodium benzoate (E211) 1 mg/ml Sodium 1.23 mg/ml Glycerol (E422) 150 mg/ml For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. A viscous pink suspension, free from foreign substances and with characteristic strawberry flavour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paraibucomb is indicated for the short-term management of mild to moderate acute pain which is not considered to be relieved by paracetamol or ibuprofen (alone) in children 2-12 years of age with body weight of 12 kg and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For oral administration and short term use only (not more than 3 days). The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Paediatric population _ Paraibucomb is intended for use in children aged between 2 years and 12 years. Paraibucomb is not intended for use in children under 2 years of age and in children with body weight under 12 kg. 2 Doses should be given every 6 hours as necessary, with no more than 4 doses in 24 hours. In children up to 10 years of age it is essential to respect the posology on the basis of body weight and not age, which is approximate and reported only for information. BODY WEIGHT AGE (APPROXIMATE) DOSE (ML) MAXIMUM DAILY DOSE (ML) 12 - <14kg 2 years 4.5 18 14 - <16kg 3 years 5.5 22 16 - <18kg 4 years 6 24 18 - <20kg 5 years 7 28 20 - <22kg 6 years 7.5 30 22 - <25kg 7 years 8.5 34 25 - <28kg 8 years 9.5 38 28 - <31kg 9 years 10.5 42 31 - <33kg 10 years 11.5 46 33-<40 kg* 11-12 years 12.5 50 * In children over 10 years of age, the relationship between weight and age is no longer homogeneous due to pubertal development which has Read the complete document