INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CONTROMET TABLETS
CONTROMET SYRUP

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CONTROMET TABLETS
CONTROMET SYRUP

COMPOSITION:
Metoclopramide monohydrochloride         10 mg per tablet
Metoclopramide monohydrochloride         5 mg per 5 mL syrup
Alcohol 7,0% v/v
Preservatives: 
Propylparaben 0,04% m/v
Methylparaben 0,2% m/v

PHARMACOLOGICAL CLASSIFICATION:
A.11.2 Medicines acting on gastro-intestinal tract: Gastro-intestinal antispasmodics and cholinolytics (anti-cholinergics).

PHARMACOLOGICAL ACTION:
Metoclopramide acts on the chemoreceptor trigger zone to produce an anti-emetic effect. It also has a peripheral action which alters upper gut motility, increasing stomach peristalsis and emptying, as well as relaxing the pyloric antrum and duodenal cap. Gastric secretion is unaffected. The direct effects on the gut are antagonized by atropine and other anticholinergics.
Metoclopramide causes a marked increase in the amplitude, frequency and duration of gastric contractions. The action of metociopramide is not affected by vagotomy.
Metoclopramide is well absorbed following oral and rectal administration.

INDICATIONS:
CONTROMET
is used as an adjunct to the X-ray examination of the stomach and duodenum and post-operative hypotonia (postvagotomy syndrome).
It is also used as an anti-emetic for the prevention and treatment of irradiation sickness, post-operative vomiting, and drug-induced nausea and vomiting.

CONTRA-INDICATIONS:
CONTROMET
should not be used where gastro-intestinal conditions might be adversely affected as in intestinal obstruction or immediately after surgery.
Patients with phaeochromocytoma, or convulsive disorders.

WARNINGS:
The use of metoclopramide throughout the duration of pregnancy is considered unsafe as teratogenicity has been demonstrated in animal studies.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
The average adult dose is 10 mg eight hourly.
In diagnostic radiology and duodenal intubation: 20 mg before the barium meal.
Children:
5-14 years: 2,5 - 5 mg three times daily.
3-5 years: 2 mg two to three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
CONTROMET
may cause extrapyramidal symptoms which usually occur as dystonic reactions, especially in young patients. Parkinsonism and/or tardive dyskenia may occur, usually during prolonged treatment in elderly patients.
Bowel upsets such as diarrhoea or constipation, drowsiness and fatigue, dizziness, restlessness and anxiety, galactorrhoea and gynaecomastia may also occur. Transient increases in plasma aldosterone concentrations have been reported. Hypertensive crises have occurred in patients with phaeochromocytoma.
Children, young patients and the elderly should be treated with care. Patients on prolonged therapy should be reviewed regularly. Care should also be taken when CONTROMET is administered to patients with those at risk of fluid retention as in hepatic impairment or to thse at risk of fluid retention as in hepatic impairment.
care should be exercised when using CONTROMET in patients taking other drugs can also cause extrapyramidal reactions, such as the phenothiazines. The effect of central nervous system depressants may be enhanced. Anticholinergic agents antagonise the effects of CONTROMET; narcotic analgesics may act similarly.
CONTROMET may effect the absorption of other drugs either by diminishing absorption from the stomach or by enhancing absorption from the small intestine. CONTROMET may also increase prolactin blood concentrations and therefore interfere with drugs which have a hypoprolactinaemic effect and with some diagnostic tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms as under Side-effects. Treatment is symptomatic and supportive.

CONDITIONS OF REGISTRATION:
Advertising to the medical professions only.

IDENTIFICATION:
Tablet: Round, white, normal convex, bisected tablet, 6,35 mm in diameter.
Syrup: Cerise coloured mobile liquid with a cherry flavour and odour.

PRESENTATION:
Tablets: Containers holding 100 and 500 tablets.
Syrup: Bottles of 50 mL.

STORAGE INSTRUCTIONS:
Store below 25°C out of direct sunlight. Keep out of the reach of children.

REGISTRATION NUMBER:
Tablet:         K/11.2/49
Syrup:         K/11.2/50

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69,Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9/12/1977

New addition to this site: April 2004
Source: Pharmaceutical Industry

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