Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate
Opella Healthcare France SAS T/A Sanofi
N02AJ; N02AJ06
Paracetamol; Codeine phosphate hemihydrate
500/30 milligram(s)
Tablet
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Marketed
1991-06-26
SOLPADOL® CAPLETS 500MG/30MG TABLETS _Paracetamol _ _Codeine Phosphate Hemihydrate _ _ _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP. 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 codeine into morphine • If you are pregnant or are breastfeeding • If you are allergic to codeine, paracetamol or any of the other ingredients • If you have asthma or severe breathing problems • If you have recently had a head injury • If you have recently had gall bladder surgery or a similar operatio Läs hela dokumentet
Health Products Regulatory Authority 26 September 2022 CRN00CN3D Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpadol Caplets 500 mg/30 mg 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. White to off‐white capsule‐shaped tablet with flat sides marked ‘SOLPADOL’ on one side and blank on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of severe pain. Solpadol 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 Solpadol should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg. 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. Adults (18 years and over): Two tablets every 4‐6 hours to a maximum of four doses in any 24 hours. Do not exceed eight tablets in 24 hours. Elderly: The initial dosage should be reduced to half the recommended dosage and should be titrated to the individuals need and overall medical condition. Paediatric Population Children aged 16 to 18 years: One to two tablets every 6 hours to a maximum of four doses in any 24 hours. Do not exceed 8 tablets in 24 hours. Children (12-15 years): One tablet every 6 hours to a maximum of four doses in any 24 hours. Do not exceed 4 tablets in 24 hours. Health Products Regulatory Authority 26 September 2022 CRN00CN3D Page 2 of 10 Children aged less than 12 years: Solpadol should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the Läs hela dokumentet