Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen lysine
Reckitt Benckiser Healthcare (UK) Ltd
M01AE01
Ibuprofen lysine
684mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5000158101074
INFORMATION FOR THE USER Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nurofen Maximum Strength Migraine Pain 684mg Caplets carefully to get the best results from it. Nurofen Maximum Strength Migraine Pain 684mg Caplets will be referred to as this medicine throughout this leaflet. Keep this leaflet. You may want to read it again. If you have any further questions after you have read it, ask your doctor or pharmacist. YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 3 DAYS FOR CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS AND AFTER 10 DAYS FOR ADULTS. If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What this medicine is and what it is used for 2.Before you take this medicine 3.How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Further Information 1.WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature. This medicine is used for the relief of: • HEADACHES AND MIGRAINE PAIN 2. BEFORE TAKING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF YOU: • are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers • have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding • have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines • have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs) • are taking other NSAID painkillers or more than 75mg aspirin a day • have severe live Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Maximum Strength Migraine Pain 684mg Caplets Nurofen Express 684mg Caplets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen Lysine 684mg/tablet (equivalent to 400mg ibuprofen) For excipients, see 6.1 3 PHARMACEUTICAL FORM Coated tablet A white, film-coated, capsule-shaped tablet, printed with an identifying logo in black on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of headache and migraine 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). Adults, the elderly and children and adolescents between 12 and 18 years: If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take 1 caplet with water, up to three times a day as required. ADULTS: Take 1 caplet with water, up to three times a day as required. Leave at least 4 hours between doses. Do not take more than 3 caplets in any 24 hour period. 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 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). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Undesirable effects may be minimised by using the lowest effe Aqra d-dokument sħiħ