País: Malta
Idioma: inglés
Fuente: Medicines Authority
CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN
Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland
N02AJ
CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg
FILM-COATED TABLET
CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg
OTC
ANALGESICS
Authorised
2006-02-28
NUROFEN PLUS TABLETS Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg ADVANCE DUAL ACTION POWEFUL RELIEF READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you will still need to take Nurofen Plus Tablets carefully to get the best results from them. - Keep this leaflet. You may need to read it again. - Ask you pharmacist if you need more information or advice - You must contact a doctor if your symptoms worsen or do not improve after 3 days. - If any of the side-effects gets serious, or if you notice any side-effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1.What Nurofen Plus Tablets are and what are they used for? 2.What you need to know before you take Nurofen Plus Tablets 3. How to take Nurofen Plus Tablets 4. Possible side-effects 5. How to store Nurofen Plus Tablets 6. Further Information 1.WHAT NUROFEN PLUS TABLETS ARE AND WHAT ARE THEY USED FOR? Nurofen Plus Tablets contains two active ingredients – each tackles pain in a different way: Ibuprofen belongs to a group of medicines known as non steroidal anti-inflammatory drugs (NSAIDs) and works to relieve inflammation and pain at source. The product also contains Codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Together they change the body’s response to pain and swelling to provide relief. Nurofen Plus Tablets have been specially formulated for use when you need pain relief for example RHEUMATIC AND MUSCULAR PAIN, MIGRAINE, CRAMPING PERIOD PAIN, DENTAL PAIN, BACKACHE, FEVER AND SYMPTOMS OF COLD & FLU. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUROFEN PLUS TABLETS Do not take Nurofen Plus Tablets if you: - Are allergic to ibuprofen, codeine, or any of the ingredients of Nurofen Plus listed in Section 6 - Have experienced shortness of breath, worsening of asthma, allergic rash or Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200.0 mg and Codeine Phosphate Hemihydrate 12.8 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated Tablet (Tablet) Nurofen Plus is a white film coated, biconvex capsule-shaped tablet embossed with the logo ‘N+’ on one side. 4. CLINICAL PARTICULARS 4.1.THERAPEUTIC INDICATIONS For the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu. This product is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. 4.2.POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken up to 4 times daily at intervals of not less than 6 hours. The maximum daily dose should not exceed 6 tablets in 24 hours. 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. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). Adults, the elderly and children over 12 years; Initially two tablets, then if necessary one or two tablets every 6 hours. Paediatric population: Children aged less than 12 years: Ibuprofen + Codeine combination solid dose strength products 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 & 4.4). Nurofen Plus is contraindicated in children below the age of 12 years for the symptomatic treatment of cough and/or cold (see section 4.3 Leer el documento completo