CO-CODAMOL

Route of administration:

Oral To be taken every three or four hours when needed. Adults and Children over 15 years of age One or two tablets – Maximum of eight tablets per 24 hours Children 6 – 15 years Age Recommended Paracetamol Dose Co-codamol tablet dose How Often 6-8 years 240-250mg Half Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours 8-10 years 360-375mg Half – three quarters Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours 10-12 years 480-500mg One Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours 12-15 years 480-750mg One – One & half Every 4-6 hours when necessary to a maximum of 4 doses in Not suitable for children under six years of age.

Do not take more than 3 days continuously without medical review.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Codeine can cause constipation, nausea, drowsiness and confusion. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when the treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Do not exceed the recommended dose Contains paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advise should be sought in the event of an overdose, because of the risk of delayed serious liver damage.

If symptoms persist, consult your doctor. If you are pregnant consult your doctor before taking this product. Keep out of the reach of children. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of 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.

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.

For product in packs of 32 tablets or fewer the label and leaflet will state:

Patient Information Leaflet (in ‘before taking’ section) If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.

1 . Impaired kidney or liver function. Monoamine oxidase inhibitor therapy, concurrent or within 14 days.