Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
IBUPROFEN
RECKITT BENCKISER (NEAR EAST) LTD
M01AE01
TABLETS
IBUPROFEN 200 MG
PER OS
Not required
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD, UK
IBUPROFEN
IBUPROFEN
Relief of mild to moderate pain such as headache, toothache, menstrual pain, backache, muscular pain, anti-inflammatory for rheumatic diseases, reduction of fever.
2015-01-31
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS), 1986 This medicine is sold without a doctor's prescription. NUROFEN TABLETS 200 MG ACTIVE INGREDIENT AND ITS QUANTITY: Ibuprofen 200 mg For list of inactive ingredients, please see section 6. See also section “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE”. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, ask your doctor or pharmacist. This medicine is intended for adults and children over 12 years of age. Under this age, refer to the doctor. Use this medicine in accordance with the dosage instructions in this leaflet. Consult a pharmacist if you need additional information. You must refer to a doctor if the signs of the illness (symptoms) worsen or do not improve after 3 days in children and adolescents between 12 and 18 years of age, and after 10 days in adults. 1. WHAT IS THIS MEDICINE INTENDED FOR? Nurofen Tablets 200 mg contains ibuprofen which belongs to a group of medicines known as non- steroidal anti-inflammatories. These medicines act by altering the body's response to pain, swelling and high temperature. Nurofen Tablets 200 mg is intended for relief of mild to moderate pain such as headache, toothache, menstrual pain, back and muscular pain, anti-inflammatory for rheumatic diseases and for fever reduction. THERAPEUTIC GROUP: Non-steroidal anti-inflammatories (NSAIDs). 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: - You are sensitive (allergic) to ibuprofen or to any of the additional ingredients this medicine contains (see section 6). - You suffer or have suffered in the past from an ulcer/gastrointestinal bleeding (two separate confirmed incidents or more of ulcers or bleeding). - You have suffered from hemorrhage or perforation in the digestive system in the past as a result of previous treatment with non-steroidal anti-inflammatories. - You have suffered from Pročitajte cijeli dokument
Page 1 of 9 PHYSICIAN'S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT NUROFEN ® TABLETS 200mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Ibuprofen 200 mg Excipient(s) with known effect: Sucrose Sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated Tablet. A white to off-white, biconvex, round, sugar coated tablet printed 'Nurofen' in black on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults and children over 12 years: Relief of mild to moderate pain such as headache, toothache, menstrual pain, backache, muscular pain, anti-inflammatory for rheumatic diseases, reduction of fever. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor. Adults and children and adolescents between 12 and 18 years: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor. _ _ CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS:_ _ Take 1 or 2 tablets with water up to three times a day as required. ADULTS: Take 1 or 2 tablets with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 6 tablets in any 24 hour period. Not for use by children under 12 years of age. Page 2 of 9 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/haemorrhage (two or more distinct Pročitajte cijeli dokument