Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
RECKITT BENCKISER (NEAR EAST) LTD
M01AE51
TABLETS
IBUPROFEN 200 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG
PER OS
Not required
RECKITT BENCKISER HEALTHCARE (LTD), UK
IBUPROFEN, COMBINATIONS
IBUPROFEN, COMBINATIONS
Relief of symptoms of cold and flu in the presence of fever or pain with associated congestion.
2021-06-30
CUSTOMER INFO: Minimum Point Size = 7.00pt 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) : 2 nd Component Code (if applicable) : Parent Technical Packaging Specification: Finished Goods Code: Supply Point: 3rd Party Code Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: 0000001001(1032) NA RB Nottingham NA 3128009 Nurofen Adult Cold & Flu Ibuprofen & Pseudoephedrine 24Pack RB472692 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) Westrock MPS (Tewkesbury, UK) N-Lft-D0351021-248x670mm TR2187047 Paper White Israel 10/02/22 J Ayyanar Vengatesan 3199401 N/A G=0; O=2; R=4; - AV - 10/02/22 11:29:54 RB Artwork and Print Specification D0351021 Artwork Type: BW Commercial 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: Bar Yaron Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. .مﺪﻟا ﻂﻐﺿ عﺎﻔﺗرﻻ رﺎﻄﺘﺧا كﺎﻨﻫ نﻷ ,ﻦﻴﺳﻮﺘﻴﺴﻛوأ • .ﻦﻳرﺪﻓاوﺪﻴﺴﭘ ﻞﻤﻋ ﺔﻘﻳﺮﻃ ﻰﻠﻋ ﺮﺛﺆﺗ ﺪﻗ ﺎﻬﻧﻷ .ﻦﻴﻟﻮﻜﻠﻟ ةدﺎﻀﻣ ﺔﻳودأ • ةرﺎﺸﺘﺳا ﺐﺠﯾ ﺎﻣ ئاد .اﺰﻧﻮﻠﻔﻧﻹاو ﺢﺷﺮﻠﻟ ﻦ ِ ﻓورﻮﻨﺑ جﻼﻌﻟا ﻦﻣ ﺮﺛﺄﺘﺗ وأ ىﺮﺧأ ﺔﻨﯿﻌﻣ ﺔﯾودأ ﺮﺛﺆﺗ ﺪﻗ .ىﺮﺧأ Przeczytaj cały dokument
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Cold and Flu 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients Quantity Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A yellow, round, biconvex film-coated tablet with an identifying logo in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms cold and flu accompanied by pains, fever and nasal congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. POSOLOGY Adults and children 12 years of age and over: Take 1 tablet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 tablet, 2 tablets may be used. Do not use more than 6 tablets in any 24-hour period unless directed by a doctor. METHOD OF ADMINISTRATION: For oral administration with water. PAEDIATRIC POPULATION: Nurofen Cold and Flu is not indicated for children under 12 years old. Page 2 of 13 4.3 CONTRAINDICATIONS Hypersensitivity to ibuprofen, pseudoephedrine 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 acetylsalicylic acid (aspirin) or other non-steroidal 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 coronary heart disease and cardiovascular disorders. Severe hypertension. Severe heart failure, renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy (see section 4.6) Not to be used in children under the age of 12 years. Monoamine oxidase inhibitors (MAOIs), or Przeczytaj cały dokument