PARACETAMOL AND CODEINE

Adults Two tablets up to 4 times a day. This dose should not be repeated more frequently than every 4 hours, and not more than 4 doses (8 tablets) should be taken in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Paediatric population:

Children aged 16 years to 18 years One to Two tablets up to 4 times a day. This dose should not be repeated more frequently than every 6 hours, and not more than 4 doses (8 tablets) should be taken in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Children aged 12 years to 15 years One tablet up to 4 times a day. This dose should not be repeated more frequently than every 6 hours and not more than 4 doses (4 tablets) should be taken in any in 24 hours period. Do not take for more than 3 days without consulting a doctor.

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.

For oral administration only. 8 mg Tablets, 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.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system.

The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100 to, <1/10), uncommon (≥1/1,000, to <1/100), rare (≥1/10,000 to, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Paracetamol Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Not known Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes and angioedema.

Not known Skin and subcutaneous tissue disorders Serious skin reactions Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Not known Hepatobiliary disorders Hepatic dysfunction Not known Metabolism and nutrition disorders High anion gap metabolic acidosis** Not known * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Codeine Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. 8 mg Tablets 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.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the stated dose. Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol or codeine-containing products concurrently. If symptoms persist consult your doctor. Keep out of the reach and sight of children. Patients with inflammatory or obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.

Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. Not recommended for use in children in whom respiratory function might be compromised as this may worsen the symptoms of morphine toxicity.

The label will state:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Keep all medicines out of the sight and reach of children.

Do not take anything else containing paracetamol while taking this medicine. Front of pack • Can cause addiction • Contains opioid • For three days use only Back of pack • This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.

Wait at least four hours after taking any other painkiller before you take this medicine. 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.

Hypersensitivity to paracetamol, codeine, opioid analgesics or any of the other constituents. 4). 6). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 4) In patients with respiratory depression, chronic constipation or raised intracranial pressure.