Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Codeine phosphate hemihydrate; Ibuprofen
Imbat Limited
N02AJ; N02AJ08
Codeine phosphate hemihydrate; Ibuprofen
200 mg/12.8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Opioids in combination with non-opioid analgesics; codeine and ibuprofen
Authorised
2009-10-30
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER NUROFEN ® PLUS TABLETS IBUPROFEN 200MG CODEINE PHOSPHATE HEMIHYDRATE 12.8MG Your medicine is available using the above name, but will be referred to as ‘Nurofen Plus Tablets’ throughout this leaflet. ADVANCED DUAL ACTION FOR POWERFUL 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. Contents of the pack and other information 1. WHAT NUROFEN PLUS TABLETS ARE AND WHAT ARE THEY USED FOR Nurofen Plus Tablets contain 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 TABL Прочетете целия документ
Health Products Regulatory Authority 30 July 2019 CRN0091PH Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200mg and Codeine Phosphate Hemihydrate 12.8mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet (Tablet) _Product imported from the UK:_ Nurofen Plus are white, film-coated torpedo-shaped tablets embossed with ‘N+’ on one side and plain on the other. 4 CLINICAL PARTICULARS As per PA0979/034/001 5 PHARMACOLOGICAL PROPERTIES As per PA0979/034/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Sodium starch glycolate Hypromellose Pregelatinised starch Talc Opaspray white M-1-7111B 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25˚C. Store in the original package in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Rebox containing blister strips of 12 or 24 tablets. Pack size: 12 or 24 tablets. Not all pack sizes may be marketed. Health Products Regulatory Authority 30 July 2019 CRN0091PH Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2 North Ring Business Park Santry Dublin 9 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1151/126/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 th October 2009 10 DATE OF REVISION OF THE TEXT November 2015 Прочетете целия документ