COMPOSITION: Each tablet contains metoclopramide monohydrochloride monohydrate equivalent to 10 mg metoclopramide monohydrochloride.
PHARMACOLOGICAL CLASSIFICATION: A 5.7.2 Anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION: ACUMET acts peripherally to enhance the action of acetylcholine at the muscarinic, synapses, thereby increasing the motility and tone of the stomach and intestine, relaxing the sphincters and stimulating gastric secretion.
Digestive disorders: ACUMET is indicated in conditions associated with gastric stasis or hypomotility.
Anti-emetic use: ACUMET is used in the control of nausea in the following conditions: Drug-induced vomiting and gastrointestinal disorders.
CONTRA-INDICATIONS: In patients where gastrointestinal conditions might be adversely affected as in intestinal obstruction or immediately after surgery.
In patients with suspected or confirmed phaeochromocytoma, because this medicine may cause a hypertensive crisis. In patients with known hypersensitivity to the medicine. Safety in pregnancy and lactation has not been established.
WARNINGS: Dystonic reactions resembling tetanus has been reported, especially in young patients. Tardive dyskinesia have been reported during prolonged therapy and long-term treatment should be regularly reviewed, especially when used in elderly patients for long periods.
DOSAGE AND DIRECTIONS FOR USE:
One tablet three times daily
Children (5 to 15 years):
Half a tablet three times daily
The total daily dose in children and young adults should not exceed 0,5 mg/kg body mass.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Metoclopramide may cause extrapyramidal side-effects, such as feelings of restlessness, involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech or trismus.
Side-effects of metoclopramide include depression, lassitude, insomnia, headache, constipation, diarrhoea, nausea, oedema of tongue, periorbital oedema and skin rashes.
Other adverse effects include bowel upsets, drowsiness and fatigue, dizziness, restlessness and anxiety. Galactorrhoea, gynaecomastia, breast engorgement, amenorrhoea and impotence have been reported.
Hypertensive crisis have occurred in patients with phaeochromocytomas given metoclopramide. Metoclopramide should be used with care in children and young patients. Care should be exercised when concomitant medication that can also cause extrapyramidal side-effects such as the phenothiazines, are taken. Anticholinergic agents antagonise the effects of metoclopramide; narcotic analgesics may act similarly. Metoclopramide may affect the absorption of other medicines by either diminishing absorption from the stomach or by enhancing absorption from the small intestine. The effects of central nervous system depressants may be enhanced. Care should be taken when using metoclopramide in patients with parkinsonism. Increases in plasma aldosterone concentrations have been observed.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Refer to side-effects for symptoms to be expected in the event of overdosage.
Further treatment is symptomatic and supportive.
IDENTIFICATION: Round, biconvex white scored tablets.
PRESENTATION: Boxes containing two or ten blister strips of 10 tablets each. Securitainers containing 500 tablets.
STORAGE INSTRUCTIONS: Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 27/5.7.2/0054
NAME AND BUSINESS ADDRESS OF THE APPLICANT: ACUPHARM (PTY) LTD
43 Richards Drive
Halfway House, 1685