PHARMACOLOGICAL CLASSIFICATION A 2.8 Central nervous system depressants. Combination analgesics.
PHARMACOLOGICAL ACTION Analgesic and antipyretic.
INDICATIONS For the relief of mild to moderate pain and fever.
CONTRA-INDICATIONS Hypersensitivity to any of the active ingredients.
Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Patients taking monamine oxidase inhibitors or within 14 days of stopping such treatment.
WARNING Dosages of paracetamol in excess of those recommended may cause severe liver damage.
DOSAGE AND DIRECTIONS FOR USE
1 - 2 tablets, repeated 6 hourly if necessary
Children 7 - 12 years:
½ - 1 tablet, repeated 6 hourly if necessary
Children under 6 years:
DO NOT EXCEED THE STATED DOSE. DO NOT USE CONTINUOUSLY FOR LONGER THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Side-effects Paracetamol Sensitivity reactions resulting in reversible skin rash or blood disorders may occur but these are rare.
May cause constipation and may delay the absorption of other medicines administered concomitantly.
Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than ten days without consulting your doctor. Store in a safe place, out of reach of children. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Codeine phosphate Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
The prolonged use of high doses of codeine has produced dependence.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Paracetamol overdosage symptoms include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Codeine phosphate overdosage symptoms include narcosis followed sometimes by a feeling of exhilaration and then convulsions, nausea and vomiting. Contracted pupils. Increased pulse. Respiratory depression. Treatment In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.