PARACETAMOL & CODEINE

For oral administration Adults One to two capsules, if necessary, three or four times daily at intervals of not less than four hours, up to maximum of eight capsules in 24 hours. Children aged 16 to 18 years One or two capsules every 6 hours when necessary up to a maximum of eight capsules in 24 hours.

Children aged 12 to 15 years One capsule every 6 hours when necessary up to a maximum of four capsules in 24 hours. 4). Elderly In the elderly, the rate and extent of paracetamol absorption is normal, but plasma half-life is longer, and paracetamol clearance is lower than in young adults.

Elderly patients may require a reduced dose or frequency of dosing. Treatment goals and discontinuation Before initiating treatment with Paracetamol & Codeine Capsules, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines.

Duration of treatment Do not take for 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.

Codeine The most common side effects are nausea, vomiting, constipation, dry mouth, sweating, skin rashes and other allergic reactions. Dizziness, drowsiness and pruritus may occur with frequency not known. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse. Gastrointestinal disorders Frequency “Not known” (cannot be estimated from the available data): • Pancreatitis. Hepatobiliary disorders Frequency “Not known” (cannot be estimated from the available data): • Sphincter of Oddi dysfunction.

Paracetamol Very rare cases of serious skin reactions have been reported. Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Hepatobiliary disorders Frequency “Not known” (cannot be estimated from the available data): • Hepatic dysfunction Metabolism and nutrition disorders Frequency “Not known” (cannot be estimated from the available data): • High anion gap metabolic acidosis.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Drug dependence Repeated use of Paracetamol & Codeine Capsules can lead to drug dependence, even at therapeutic doses. 4). 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.

Should be taken with caution by patients with impaired kidney or liver function. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Do not give to children under 12 years. Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Keep all medicines out of the reach of children.

The label will state:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. 1 of the SPC • If you need to take this medicine continuously for more than 3 days you must speak to your doctor or pharmacist for advice • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days.

If you take this medicine for headaches for more than 3 days it can make them worse The leaflet (or combined label/leaflet) will state: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

(indications) • You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days.

1 of the SPC “Before you take this medicine” section • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it • If you take a painkiller for headaches for more than 3 days it can make them worse “How to take this medicine” section • Do not take for more than 3 days.

Hypersensitivity to any of the ingredients. Severe liver disease. 4). 6). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. In patients with respiratory depression, chronic constipation or raised intracranial pressure.