Composition:
Each tablet contains
Paracetamol 500mg
Codeine Phosphate Hemihydrate 8mg
Mode of Action:
Paracetamol is an effective analgesic, possessing a remarkably low level of side effects. Paracetamol is well tolerated having a bland effect on gastric mucosa, it neither exacerbates symptoms of peptic ulcer nor precipitates bleeding. Codeine has been widely used for a number of years as a powerful analgesic. In addition the compound exhibits well-defined anti-tussive activity. Fortifying paracetamol with Codeine provides an effective combination of drugs for the treatment of severe pain.
Indication:
For the relief of mild to moderately severe pain. In addition the compound exhibits well-defined anti-tussive activity.
Dosage:
Dosage should be adjusted according to severity of pain and response of the patient. Tablet should, if possible, be taken during or after meals.
Children under 12 years: not recommended.
Adults and children over 12 years: 1 - 2 tablets not more frequently than every 4 hours, up to a maximum of 8 tablets in any 24 hour period.
Elderly: A reduced dose may be required.
Do not exceed the recommended dose.
Patients should be advised not to take other paracetamol containing products concurrently.
It should be kept in mind however, that the tolerance to codeine can develop with continued use.
Side effects:
It should be kept in mind that the incidence of unwanted effects is dose related constipation, if it occurs, is readily treated with a mild laxative.
Other side-effects of codeine which may occur in few patients are nausea, vomiting, headache, vertigo, giddiness, urinary retention, pruritus, sedation, euphoria, hallucinations and allergic reactions including skin rashes.
Adverse effects of Paracetamol are rare but hypersensitivity reactions including skin rash, blood dyscrasias and acute pancreatitis have been reported.
Contra-indications:
Respiratory depression, obstructive airways disease, hypersensitivity to paracetamol or codeine. The drug should not be administered to patients who have previously exhibited hypersensitivity to either paracetamol or codeine, or to any of its excipients, in case of respiratory depression or obstructive airways disease.
Drug interactions:
-Codeine should be used with caution in patients taking monoamine oxidase inhibitors and should be avoided in those patients with raised intracranial pressure or head injury.
-Use with caution in patients with prostatic hypertrophy since codeine may cause urinary retention.
-Additive CNS central nervous system depression may occur with alcohol, and other CNS depressants such as anxiolytics, antidepressants, hypnotics and anti-psychotics.
-The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption of paracetamol may be reduced by cholestyramine.
-The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding.
Precautions:
- It should be given with caution in patients with allergic disorders and should not be given during an attack of asthma.
- Caution should also be observed if there is marked impairment of liver function, advanced kidney disease and in chronic alcoholics.
- Patients should be advised not to take other paracetamol-containing products concurrently.
- Dosage should be reduced in the elderly, hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis.
Use in pregnancy or lactation:
Pregnancy: For paracetamol not known to be harmful. Codeine avoids or reduce dose. Studies in human pregnancy have shown no effects due to paracetamol or codeine. However, it should be avoided during pregnancy unless considered essential by physician.
Lactation: It is not recommended during lactation since safety has not been established.
Effects on ability to drive and use machines:
Codeine may cause drowsiness and if affected, patients should not drive or operate machinery.
Pharmacokinetic properties:
Codeine is well absorbed from the gastro-intestinal tract. Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion.