Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Ibuprofen; Codeine phosphate hemihydrate
PCO Manufacturing Ltd.
N02AJ; N02AJ08
Ibuprofen; Codeine phosphate hemihydrate
200/12.8 milligram(s)
Film-coated tablet
Oral use
Blister packs containing 12 or 24 tablets
Product not subject to medical prescription
Reckitt Benckiser Healthcare International Ltd
NSAID
Opioids in combination with non-opioid analgesics; codeine and ibuprofen
For the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu.
Authorised
2015-05-29
_ _ _ _ _ _ _ _ _ _ _ _ _ _ TABLETS IBUPROFEN 200 MG CODEINE PHOSPHATE HEMIHYDRATE 12.8 MG ADVANCED DUAL ACTION 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 your 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, wor Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 06 December 2023 CRN00DXS9 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet (Tablet) _Product imported from Poland_ Nurofen Plus is a white film-coated, biconvex capsule-shaped tablet embossed with the logo ‘N+’ on one side. 4 CLINICAL PARTICULARS As per PA0979/034/001 5 PHARMACOLOGICAL PROPERTIES As per PA0979/034/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Product imported from the UK Tablet core: Microcrystalline cellulose Sodium starch glycolate Starch Pregelatinised Hypromellose Film coating: Hypromellose Opaspray white M-1-7111B Talc Product imported from Poland Tablet core Microcrystalline cellulose Sodium starch glycollate Starch Pregelatinised Hypromellose Tablet coating Hypromellose Talc Opaspray white M-1-7111B (containing: hypromellose and titanium dioxide (E171),) 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 06 December 2023 CRN00DXS9 Page 2 of 2 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container 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 Blister packs containing 12 or 24 tablets in a cardboard carton (OTC pack sizes). Not all pack sizes may be marketed. 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 PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODU Olvassa el a teljes dokumentumot