Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate
Imbat Limited
N02AJ; N02AJ06
Paracetamol; Codeine phosphate hemihydrate
500 mg/30 milligram(s)
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 ® CAPLETS 500MG/30MG TABLETS (paracetamol / codeine phosphate hemihydrate) THIS PRODUCT IS AVAILABLE AS ‘CO-CODAMOL 30/500 TABLETS’ IN OTHER JURISDICTIONS. Solpadol is available as Solpadol Caplets 500mg/30mg Tablets and Solpadol 500mg/30mg Effervescent Tablets. This leaflet applies to Solpadol Caplets 500mg/30mg 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. What you need to know 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 The name of this medicine is Solpadol Caplets 500mg/30mg Tablets. 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 codein Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 11 October 2019 CRN008Z15 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpadol Caplets 500mg/30mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol 500.0 mg Codeine Phosphate Hemihydrate 30.0 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from: UK_ White to off-white, capsule-shaped tablets with flat sides, marked ‘SOLPADOL’ on one side and blank on the reverse. 4 CLINICAL PARTICULARS As per PA0540/159/001 5 PHARMACOLOGICAL PROPERTIES As per PA0540/159/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Pregelatinised starch Maize starch Povidone Potassium sorbate Microcrystalline cellulose Stearic acid Talc Magnesium sterate Croscarmellose sodium (Type A) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blisters 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. 6.5 NATURE AND CONTENTS OF CONTAINER Health Products Regulatory Authority 11 October 2019 CRN008Z15 Page 2 of 2 Blisters in a cardboard outer carton. Pack size: 100 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 PPA1151/191/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 th February 2014 10 DATE OF REVISION OF THE TEXT October 2019 Lesen Sie das vollständige Dokument