PRESCRIBING INFORMATION
Presentation: Each capsule contains codeine phosphate hemihydrate 15mg and paracetamol 500mg. Each effervescent tablet contains codeine phosphate hemihydrate 15mg and paracetamol 500mg. Excipients in the effervescent tablets include 389mg sorbitol and 379mg sodium. Indications: Codipar Capsules and Effervescent Tablets: For the relief of mild to severe acute pain in adults. Codeine is indicated for the treatment of acute moderate pain which is not relieved by other analgesics such as paracetamol or ibuprofen alone. Dosage and Administration: For oral administration. Swallow the capsules whole with a glass of water or dissolve the tablets in a glass of water and drink immediately. Adults: Usual dosage is 2 capsules or effervescent tablets every 6 hours as needed. Codeine should be used at the lowest effective dose for the shortest period of time. Maximum daily dose should not exceed 8 capsules or 8 tablets in a day. The duration of treatment should be limited to 3 days. Elderly: Reduced dosage may be necessary. Children: Codipar capsules and tablets are not recommended below the age of 18 years. Contraindications: Hypersensitivity to either paracetamol or codeine, or any of the excipients. Moderate to severe renal or hepatic impairment. In all paediatric patients (0-18 years of age). In conditions where morphine and opioids are contraindicated e.g. those with acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, after biliary surgery or diarrhoea of any cause. In patients who have taken MAO inhibitors within 14 days. In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers and in women during breast-feeding. Precautions and warnings: Caution in patients with inflammatory or obstructive bowel disorders or with acute abdominal conditions, increased intracranial pressure or those taking CNS depressants, the elderly, debilitated, hypothyroidism, Addison’s disease, impaired hepatic or renal function, prostatic hypertrophy and urethral stricture. Codeine is metabolised by the liver enzyme CYP2D6 into morphine. Caution is advised in patients who are CYP2D6 ultra-rapid metabolisers as there is increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. Symptoms include confusion, shallow breathing, small pupils, nausea, vomiting, constipation, lack of appetite and somnolence. Risk of paracetamol overdose is greater in those with alcoholic liver disease. Other products containing paracetamol or opiate derivatives should not be taken while on Codipar. Tolerance to codeine dependence (psychological and/physical), abuse, as well as withdrawal can develop with continued use and the incidence of unwanted effects is dose related. Long term use for headache treatment can make them worse. High doses can cause respiratory depression, cough suppression or impaired mental and physical abilities. Dose should be reduced in liver and kidney disease. Immediate medical advice should be taken after overdose especially when liver disease co-exists. Patients should not drive, operate machinery or perform hazardous tasks if Codipar causes dizziness, sedation or visual disturbance. Interactions: Antihypertensive agents, diuretics, quinine, quinidine, mexilitine, CNS depressants (anxiolytics, hypnotics, antidepressants, antipsychotics, alcohol), MAOIs or tricyclic antidepressants, anticholinergics, antidiarrhoeal agents, antimuscarinic drugs, metoclopramide, domperidone, cholestyramine, cimetidine, warfarin and other coumarins (with long term use of paracetamol), enzyme-inducing antiepileptics (carbamazepine, phenytoin, and phenobarbital) as well as CYP2D6 inhibitors (quinidine, some SSRIs, some neuroleptics and ritonavir). Opioids may interfere with results of some laboratory tests and codeine may interfere with tests for gastrointestinal function. Pregnancy and lactation: Not recommended. Undesirable effects: Common: Dizziness, light-headedness, sedation, headache, nausea, vomiting, constipation, abdominal pain, dysphoria, euphoria, shortness of breath, pruritus, rash or urticaria. Codeine can cause respiratory depression in patients with respiratory problems or with pre-existing lung disorders or in overdose situations. Paracetamol may cause liver damage. Most often this is with chronic alcohol use. Paracetamol containing products may also rarely cause blood dyscrasias (including thrombocytopenia and agranulocytosis). Addiction and withdrawal are also possible and headaches can worsen with chronic use. (Please refer to the Summary of Product Characteristics for detailed information) Overdose: Over 5g ingestion of paracetamol can cause liver damage if patient has risk factors (like taking drugs that induce liver enzymes, excessive alcohol intake, glutathione depletion, eating disorders, starvation, cystic fibrosis, HIV, cachexia) or over 10g intake otherwise. Codeine overdose may produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur from respiratory failure. Codeine overdose is potentiated with alcohol and psychotropic drugs. Legal Category: POM. Pack sizes: Codipar Capsules: 1 x 100; Codipar Effervescent Tablets: 1 x 100. Marketing Authorisation Numbers: Codipar Capsules: PA 0899/033/002; Codipar Effervescent Tablets: PA 899/33/1. PCRS reimbursed. Marketing Authorisation Holder: Amdipharm Mercury Company Limited (AMCo), 1st Floor, Capital House, 85 King William Street, London, EC4N 7BL. Date of preparation: August 2012. Date of revision: April 2015
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Adverse events should be reported to the local regulatory authority. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Amdipharm Mercury Medical Information via telephone on 1890 25 24 73 or via e-mail at medicalinformation@amcolimited.com. |
Reference:
- ACC Review 50. Preventing Chronic Pain:Pharmacological treatment of sprains, strains and other minor,painful injuries. ACC 6338, March 2012.
- A Gordon Macleod, Ashford B et al. 2002. Paracetamol versus paracetamol-codeine in the treatment of post-operative dental pain: A randomized, double-blind, prospective trial. Australian Dental Journal. Volume 47, issues 3, pages 147-151.
IRE/COD/ADV/787/2015 May 2015