EMPACOD is indicated for the relief of mild to moderate pain and fever .COMPOSITION: Each tablet contains:
PHARMACOLOGICAL CLASSIFICATION: A2.8 (Analgesic Combinations) PHARMACOLOGICAL ACTION:
EMPACOD has analgesic and antipyretic effects INDICATIONS:
EMPACOD is indicated for the relief of mild to moderate pain and fever. CONTRA-INDICATIONS:
EMPACOD should not be used in the presence of:
EMPACOD should not be taken by the chronically constipated. EMPACOD is not for use in children under 12 years. During pregnancy, particularly the first trimester, and during the lactation period, EMPACOD should only be taken under a doctor's supervision. WARNINGS:
||impaired kidney or liver function
||hypersensitivity to either paracetamol or codeine
||acute alcoholism, head injuries and conditions in which intracranial pressure is raised during an attack of bronchial asthma, heart failure secondary to chronic lung disease
||patients taking monoamine oxidase inhibitors or within 10 days of stopping such treatment
||after operations on the biliary tract.
Dosages in excess of those recommended may cause severe liver damage. Administer cautiously to pre-psychotic patients who may form a dependence on codeine phosphate. DOSAGE AND DIRECTIONS FOR USE:
Adults and adolescents over 12 years only. Unless otherwise directed, 1 tablet should be taken four times daily between meals with sufficient fluid. The tablet can first be dissolved in a little water. SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PARACETAMOL: Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. CODEINE: Side-effects may be constipation, nausea, vomiting, dizziness and drowsiness. Skin rashes may occur in patients hypersensitive to codeine. Codeine may delay the absorption of other medicines administered concomitantly. INTERACTIONS WITH OTHER DRUGS: The depressant effects of codeine are enhanced by the concurrent administration of depressants of the central nervous system such as sedatives, tranquillizers, hypnotics, anaesthetics, phenothiazines and alcohol. Paracetamol may enhance the activity of coumarin anticoagulants. With concomitant use of certain drugs which increase the metabolism of paracetamol in the liver, (eg. hypnotics of the barbiturate type, anti-epileptics, rifampicin), liver damage can be induced by normal doses of paracetamol. This also applies to alcohol abuse. 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. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
PARACETAMOL: Symptoms of overdosage include nausea and vomiting, gastrointestinal haemorrhage, cerebral oedema, hyperglycaemia and hypoglycaemia have been reported. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication. CODEINE: Poisoning with codeine produces central stimulation with exhilaration, and in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis and coma, Naloxone may be used to counteract respiratory depression and coma. 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. CONDITIONS OF REGISTRATION:
Flat, white tablet 13 mm in diameter and approximately 5,0 - 5,2 mm in thickness. Embossed on one side with the trade name 'EMPACOD'. PRESENTATION:
EMPACOD is available in packs of 20 tablets. STORAGE INSTRUCTIONS:
Store at room temperature (below 25°C) Protect from light. Keep out of reach of children.
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