CO-CODAMOL

For oral administration only. The tablets should be dissolved in at least half a tumbler of water before taking. Adults and children over 15 years One to two tablets dissolved in water every 4 to 6 hours as required, to a maximum of 8 tablets daily.

Children 12 to 15 years One tablet dissolved in water every 4 to 6 hours when necessary to a maximum of 4 tablets in 24 hours. Not recommend to children under 12 years of age Elderly There is no current evidence for the alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.

Duration of treatment Do not take more than 3 days continuously without medical review. The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.

Treatment goals and discontinuation Before initiating treatment with Co-codamol effervescent tablets, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4).

Co-codamol effervescent tablets are generally well tolerated but hypersensitivity reactions including skin rashes may occur. Rare cases of anaphylaxis, angioedema, urticaria, pruritus and fixed drug eruption have been reported with medications containing paracetamol and/or codeine.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to Co- codamol. High anion gap metabolic acidosis has been reported at an unknown frequency.

Codeine may sometimes cause typical opioid effects such as vomiting, constipation, nausea, light-headedness, dizziness, confusion, drowsiness and urinary retention. The frequency and severity of these effects are determined by dosage, duration of treatment and individual sensitivity.

Tolerance and dependence can occur, especially with prolonged high dosage of codeine. There have been rare reports of acute pancreatitis in patients taking codeine or codeine/paracetamol combinations. • Regular prolonged use of codeine is known to lead to addiction and tolerance.

Symptoms of restlessness and irritability may result when treatment is then stopped. • Prolonged use of a painkiller for headaches can make them worse. The information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Drug dependence Repeated use of Co-codamol Effervescent Tablets can lead to drug dependence, even at therapeutic doses. 4).

Reporting of suspected adverse reactions:

Other paracetamol containing medication should be avoided when taking co- codamol effervescent tablets. This medicinal product contains 438mg sodium per dose, equivalent to 22% of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 175% of the WHO recommended maximum daily intake for sodium. Co- codamol Effervescent Tablets are considered high in sodium. This sodium be particularly taken into account for those on a low salt diet.

The tablets contain aspartame and so should not be taken by patients with phenylketonuria. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Care should be observed in administering the product to any patient, whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.

Care should also be observed if prolonged therapy is contemplated. Care should be taken when prescribing these tablets to patients with liver or renal impairment. The hazards of paracetamol overdose are greater in those with non- cirrhotic alcoholic liver disease.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

The label will state:

g. acute alcoholism and where risk of paralytic ileus, acute respiratory depression, raised intracranial pressure or head injury (affects pupillary responses vital for neurological assessment). Sensitivity to codeine or paracetamol or any of the constituents of the tablets.

4). 6). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.