Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen; Pseudoephedrine hydrochloride
Reckitt Benckiser Healthcare (UK) Ltd
M01AE51
Ibuprofen; Pseudoephedrine hydrochloride
200mg ; 30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5000158106246
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 Sinus Pain Relief 24Tablets RB313380 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-D0069118-190x295mm LST Flat TR1361832 Paper White UK 01/05/18 D SAMANTHA KEYWORTH 0000000 G=2; O=0; R=0; - SK - 01/05/18 12:42:02 RB ARTWORK AND PRINT SPECIFICATION Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 D0069118 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 1 LTH PROCESS BLACK COLOURS (LEAFLET) RBH CONTACT: Mathilde Capart CUSTOMER INFO: Minimum Point Size = _(Refers to the text within the_ _Nurofen bullet, main body copy is_ _at 11.5pt)._ 9.05pt Continued overleaf Sinus Pressure & Headache Relief 200mg/30mg tablets Contains Ibuprofen and Pseudoephedrine Hydrochloride OTHER WARNINGS • Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets belong to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant. • Anti-inflammatory/pain-killer Прочетете целия документ
OBJECT 1 NUROFEN SINUS PRESSURE & HEADACHE RELIEF 200MG/30MG TABLETS Summary of Product Characteristics Updated 22-May-2018 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Nurofen Sinus Pressure & Headache Relief 200mg/30mg Tablets 2. Qualitative and quantitative composition Active ingredients Quantity Ibuprofen BP 200mg Pseudoephedrine Hydrochloride 30mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Yellow film coated tablet. Printed in black with an identifying motif. 4. Clinical particulars 4.1 Therapeutic indications For the relief of symptoms cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses. 4.2 Posology and method of administration For oral administration and short-term use only. Adults, the elderly and children over 12 years: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Take 1 or 2 tablets with water, up to three times a day as required. Leave at least 4 hours between doses. Do not take more than 6 tablets in any 24 hour period. Not to be given to children under 12 years. 4.3 Contraindications Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/hemorrhage (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 pregnancy (see section 4.6) Patients with serious cardiovascular disease, tachycardia, hypertension, angina pect Прочетете целия документ