国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Codeine phosphate hemihydrate; Paracetamol
Imbat Limited
N02AJ; N02AJ06
Codeine phosphate hemihydrate; Paracetamol
500/30 milligram(s)
Effervescent tablet
Product subject to prescription which may not be renewed (A)
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Authorised
2014-02-28
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SOLPADOL ® 500MG/30MG EFFERVESCENT TABLETS (paracetamol / codeine phosphate hemihydrate) THIS PRODUCT IS AVAILABLE AS ‘CO-CODAMOL 30/500 EFFERVESCENT TABLETS’ IN OTHER JURISDICTIONS. Solpadol is available as Solpadol Caplets 500mg/30mg Tablets and Solpadol 500mg/30mg Effervescent Tablets. This leaflet applies to Solpadol 500mg/30mg Effervescent Tablets which will be referred to as Solpadol throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any 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 Solpadol is and what it is used for 2. Before you take Solpadol 3. How to take Solpadol 4. Possible side effects 5. How to store Solpadol 6. Contents of the pack and other information 1. WHAT SOLPADOL IS AND WHAT IT IS USED FOR Solpadol belongs to a group of medicines called analgesics (painkillers) and is used to treat severe pain. Solpadol can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. This product 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. 2. BEFORE YOU USE SOLPADOL DO NOT TAKE SOLPADOL: For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome If you know that you metabolise very rapidly codeine into morphine If you are pregnant or are breast-feeding If you are allergic to 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpadol 500mg/30mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol 500.0 mg Codeine Phosphate Hemihydrate 30.0 mg Excipients of known effect: sorbitol (E420) and sodium For a full list of excipeints see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablet. _Product imported from: UK_ A white bevelled-edge tablet scored on one face and plain on the reverse. 4 CLINICAL PARTICULARS As per PA0540/159/003 5 PHARMACOLOGICAL PROPERTIES As per PA0540/159/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Citric Acid Anhydrous Saccharin Sodium Povidone Sodium Bicarbonate Sodium Carbonate Anhydrous Sorbitol Powder (E420) Sodium Laurilsulfate Dimeticone 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the laminate 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 moisture. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _8_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _3_ _2_ _9_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Strips of 10 tablets in a cardboard outer carton. Pack size: 100 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUC 阅读完整的文件