Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate; Paracetamol
Galen Ltd
N02AJ06
Codeine phosphate; Paracetamol
15mg ; 500mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070100; GTIN: 5016298200423
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-CODAMOL 15MG/500MG TABLETS (Codeine Phosphate Hemihydrate and Paracetamol) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Co-codamol 15mg/500mg Tablets are and what they are used for 2. What you need to know before you take Co-codamol 15mg/500mg Tablets 3. How to take Co-codamol 15mg/500mg Tablets 4. Possible side effects 5. How to store Co-codamol 15mg/500mg Tablets 6. Contents of the pack and other information 1. WHAT CO-CODAMOL 15MG/500MG TABLETS ARE AND WHAT THEY ARE USED FOR Co-codamol 15mg/500mg Tablets contain codeine, an opioid analgesic, in combination with paracetamol. Co-codamol 15mg/500mg Tablets are one of a group of medicines called analgesics or painkillers. They are used to relieve moderate pain. Codeine 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL 15MG/500MG TABLETS DO NOT TAKE CO-CODAMOL 15MG/500MG TABLETS: • if you are allergic to codeine phosphate hemihydrate, paracetamol or any of the other ingredients of this medicine (listed in section 6). • if you are suffering from increased pressure on the brain or a head injury. • if you have been told by your doctor that you have a severe breathing difficulty called respiratory depression. • if you are having (or have recently had) a severe but short-lasting asthma attack (acute asthma) Read the complete document
OBJECT 1 CO-CODAMOL 15MG/500MG TABLETS (CODEINE PHOSPHATE HEMIHYDRATE AND PARACETAMOL) Summary of Product Characteristics Updated 13-Feb-2018 | Galen Limited 1. Name of the medicinal product Co-codamol 15mg/500mg Tablets 2. Qualitative and quantitative composition Per tablet Paracetamol 500mg Codeine Phosphate Hemihydrate 15mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. Oblong, white uncoated tablets marked 'K1' both sides of a score line on one side, the other side is plain and unmarked. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications For the relief of moderate pain. Codeine 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 Posology _Adults:_ Two tablets to be taken every four hours as required, up to a maximum of eight tablets in any 24-hour period. _Paediatric population:_ CHILDREN AGED 16 AND OVER: Two tablets to be taken every six hours as required, up to a maximum of eight tablets in any 24-hour period. CHILDREN AGED 12 TO 15 YEARS: One tablet to be taken every six hours as required, up to a maximum of four tablets in any 24-hour period. CHILDREN AGED LESS THAN 12 YEARS: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). _Elderly:_ The adult dose is appropriate (please refer to section 4.4 for additional information on elderly patients). The duration of treatment should be limited to three days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Method of administration For oral use. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excip Read the complete document