Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen; Codeine phosphate
Reckitt Benckiser Healthcare (UK) Ltd
N02AJ08
Ibuprofen; Codeine phosphate
200mg ; 12.8mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 10010100; GTIN: 5000167016642 5000167016635 5000167094305 5000158101043
CUSTOMER INFO: Minimum Point Size = 10.00pt N/A N/A N/A N/A N/A N/A N/A N/A BARCODE INFO BARCODE TYPE: BARCODE NUMBER: MAGNIFICATION: TRUNCATED BY: FULL HEIGHT: BAR HEIGHT (SMALLEST BAR) : BWR: ENCODED DATA: TRIDENT REFERENCE NO: ZEN REF: ACTION: BRAND: CATEGORY: SEGMENT GROUP: SEGMENT: PACK SIZE: MARKET/COUNTRY: DATE: COMPONENT CODE (2D IF APPLICABLE) : PARENT TECHNICAL PACKAGING SPECIFICATION: FINISHED GOODS CODE: SUPPLY POINT: PHARMACODE NO/NE: EDGEMARK POSITION: CAD CAM REF: PRINTER: SUBSTRATE: N/A RB Nottingham N/A 00000000 Nurofen Adult Stronger Pain Plus 24 / 32Capsule RB307491 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. PLEASE NOTE THAT ANY LOW RESOLUTION PAPER CANON COLOUR COPIES ASSOCIATED WITH THIS JOB SHOULD BE REFERRED TO FOR CONTENT, LAYOUT AND COLOUR SEPARATION ONLY. STUDIO USE ONLY V2.0 SM•ART CHECK RESULTS: CUTTER GUIDES TECHNICAL & NON PRINTING ITEMS CUTTER 2 (IF APPLICABLE) GUIDES 2 (IF APPLICABLE) Generic RB N-Lft-FB-D0069114-296x192-Lge-Reel TR1346702 Paper White UK 01/05/18 D RYAN REILLY 000000 G=2; O=0; R=0; - RR - 01/05/18 13:37:15 RB ARTWORK AND PRINT SPECIFICATION Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 APPROVED BY SONOCO TRIDENT ON BEHALF OF RECKITT BENCKISER SIGNED: DATE: NOT APPROVED FOR COLOUR ARTWORK APPROVAL D0069114 ARTWORK TYPE: IDM SUBMISSION 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 1 LTH PROCESS BLACK COLOURS (LEAFLET) RBH CONTACT: Mathilde Capart 000000 000000 • IF YOU HAVE HEART PROBLEMS, HAVE HAD A STROKE OR THINK THAT YOU MIGHT BE AT RISK OF THESE CONDITIONS (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist. • Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affec Lees het volledige document
OBJECT 1 NUROFEN PLUS Summary of Product Characteristics Updated 22-May-2018 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Nurofen Plus 2. Qualitative and quantitative composition Active constituents: Ibuprofen Ph Eur 200.0 mg Codeine phosphate Ph Eur 12.8 mg 3. Pharmaceutical form Tablet 4. Clinical particulars 4.1 Therapeutic indications Nurofen Plus (which contains codeine) is indicated in patients older than 12 years of age for the short term treatment of acute, moderate pain (such as rheumatic and muscular pain, backache, migraine, headache, neuralgia, period pain and dental pain) which is not considered to be relieved by other analgesics such as paracetamol, ibuprofen or aspirin alone. 4.2 Posology and method of administration POSOLOGY: Recommended dosage: _ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE: _ One or two tablets every four to six hours. _CHILDREN AGED 12-18 YEARS:_ One or two tablets every four to six hours. _CHILDREN UNDER 12 YEARS:_ Nurofen plus (which contains Codeine) should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). _ELDERLY:_ No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Do not take more than 6 tablets in 24 hours. Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. For short term use only. Codeine should be used at the lowest effective dose for the shortest period of time necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days. METHOD OF ADMINISTRATION For oral administration 4.3 Contraindic Lees het volledige document