(and dosage form):
Each tablet contains:
A 2.8 Analgesic combinations
MEGAPYN-tablets have analgesic and skeletal muscle-relaxing properties.
Pain and pain associated with tension.
Hypersensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of MEGAPYN during pregnancy should be avoided. Asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, acute alcoholism, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with this product. Paracetamol administration in excess of the recommended dosage may cause severe liver damage. MEGAPYN-tablets contain tartrazine which may cause allergic-type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low, it is however, frequently seen in patients who also have aspirin sensitivity.
DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children, under the age of 12 years.
Adults: Two tablets every 6 to 8 hours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in skin rash or blood disorders may occur.
Caffeine may cause headache, nausea, insomnia, restlessness, excitement and muscle tremor. Caffeine increases gastric secretion and may cause gastric ulceration.
Meprobamate may cause drowsiness, nausea, vomiting, diarrhoea, paraesthesia, hypotension, tachycardia, cardiac arrhythmias, weakness and central effects such as headache, excitement, dizziness, ataxia and disturbances of vision. Hypersensitivity reactions such as skin rashes, urticaria and purpura may occur or may be more severe with angioneurotic oedema, bronchospasm or anuria.
Erythema multiforme and exfoliative or bullous dermatitis have been reported. Blood disorders such as agranulocytosis, eosinophilia leucopenia, thrombocytopenia and aplastic anaemia have been reported.
Symptoms of porphyria may be exacerbated. Meprobamate may lower tolerance to alcohol and other central nervous system depressants. It may induce the hepatic microsomal enzymes involved in drug metabolism.
Due to the dependence potential, meprobamate should be gradually withdrawn after long-term treatment.
Codeine may cause respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening come, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo, flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm, and an antiduiretic effect.
Codeine should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock.
It should be used with caution or in reduced dosis in patients with adrenocortical insufficiency and hypothyroidism.
Dosages should be reduced in debilitated and in elderly patients.
Codeine may affect the activity of other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.
Meprobamate may lower the tolerance to alcohol and other central nervous system depressants.
Meprobamate may enhance the metabolism of oral contraceptives, corticosteroids, phenytoin, phenothiazines and tricyclic antidepressants.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include the following: nausea, vomiting, restlessness, sensory disturbances, muscle tremor, diuresis, palpitations stupor, shock, central stimulation with exhilaration, convulsions, drowsiness respiratory depression, hypotension with circulatory failure, respiratory collapse, cyanosis and coma. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.
Treatment is symptomatic and supportive.
Green, round, biconvex tablet, bisected on the one side.
Packaged in push-through blister packs of 10 tablets in containers of 20 and 100 tablets and bottles of 1000 tablets.
Store in a dry place below 25°C. Protect from strong light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Compu Pharmaceutical Products Limited
476 Kings Highway
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 December 1989.
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