Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Thornton & Ross Ltd
M01AE01
Ibuprofen
20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5011309400816
FRONT FACE TOP MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 100ml 92767231802 338 x 148mm Flat (29 x 148mm folded) 1 19.02.2018 Care Ibuprofen for Children Oral Suspension Yes A GKE 930145 14746 Update in line with PSUSA/10345/201702 Helvetica 9pt 16pt Process Black Keyline (Non-Printing) 2767231802 Datamatrix: VERIFIED POINT SIZES USED MIN MAX MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 100ml 92767231802 338 x 148mm Flat (29 x 148mm folded) 1 19.02.2018 Care Ibuprofen for Children Oral Suspension Yes A GKE 930145 14746 Update in line with PSUSA/10345/201702 Helvetica 9pt 16pt Process Black Keyline (Non-Printing) 2767231802 Datamatrix: VERIFIED POINT SIZES USED MIN MAX CARE IBUPROFEN FOR CHILDREN ORAL SUSPENSION (Ibuprofen 100mg/5ml) IMPORTANT INFORMATION ABOUT IBUPROFEN FOR CHILDREN • This medicine reduces fever and relieves mild to moderate pain in infants and children between 6 months and 12 years old. • Follow the dosage instructions carefully. Children of different ages need different amounts. See section 3. DO NOT GIVE…. • For longer than 3 days. • To infants under 6 months old. • To anyone who is allergic to the ingredients. See section 6. • To anyone who is allergic to aspirin. TALK TO YOUR DOCTOR…. • If your child is taking or is allergic to any other painkiller. • If your child has asthma. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If any of the side effects gets serious, or if y Lesen Sie das vollständige Dokument
OBJECT 1 CARE IBUPROFEN FOR CHILDREN ORAL SUSPENSION Summary of Product Characteristics Updated 08-Mar-2018 | Thornton & Ross Ltd 1. Name of the medicinal product Care Ibuprofen for Children Oral Suspension 2. Qualitative and quantitative composition Ibuprofen 100 mg / 5ml 3. Pharmaceutical form Oral Suspension A white, opaque smooth suspension. 4. Clinical particulars 4.1 Therapeutic indications For reduction of fever (including post immunisation fever) and relief of mild to moderate pain such as headache, sore throat, teething pain and toothache, cold and flu symptoms, minor aches and sprains. 4.2 Posology and method of administration To be taken with or after food. For oral administration and short term use only. Children 8 to 12 years: 10ml three to four times daily. Children 3 to 7 years: 5ml three to four times daily. Children 1 to 2 years: 2.5ml three to four times daily. Infants 6 to 12 months: 2.5ml three times daily. If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Not to be given to children under six months of age except on the advice of a doctor. For post immunisation fever: 2.5ml followed by one further 2.5ml 6 hours later, if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult your doctor. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 4.3 Contraindications Patients with a known hypersensitivity to Ibuprofen, Aspirin or any of the product's constituents. Patients with a history of bronchospasm, rhinitis or urticaria particularly associated with therapy with aspirin or other anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4). Last trimester of p Lesen Sie das vollständige Dokument