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

Logo CLOPAMON®-T TABLETS
CLOPAMON®-S SYRUP
CLOPAMON® SUPPOSITORIES 5 mg
CLOPAMON® SUPPOSITORIES 10 mg

SCHDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLOPAMON®-T TABLETS
CLOPAMON®-S SYRUP
CLOPAMON® SUPPOSITORIES 5 mg
CLOPAMON® SUPPOSITORIES 10 mg

COMPOSITION:
Tablets
  Contains 10 mg metoclopramide monohydrochloride.
Syrup
  Contains 5 mg/5 mL metoclopramide monohydrochloride
  Preservatives:
  Methyl p-hydroxybenzoate B.P. 0,08 % m/v.
  Propyl p-hydroxybenzoate B.P. 0,02 % m/v.
Suppositories:
  Contains 5 mg or 10 mg metoclopramide free base.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.2. Anti-emetics and antivertigo preparations.

PHARMACOLOGICAL ACTION:
Gastro-intestinal Action:
Metoclopramide increases the number, mean strength and total activity of gastric antral contractions and also produces a significant increase in the strength of duodenal contractions, which decreases intestinal transit time. These changes would all tend to increase the speed of gastric emptying, which has been observed radiologically and by other methods. Metoclopramide has no effect on gastric secretion or on the cardiovascular system.
Metoclopramide has an effect on the gastro-oesophageal junction of the stomach, producing an increase in cardiac sphincter pressure. The increase in pressure seen, after metoclopramide is administered, is directly proportional to the initial resting pressure, and minimal or absent in those with very low resting pressures.
The action of metoclopramide on the gastro-intestinal tract is antagonised by atropine and other anticholinergic medicines if they are administered in the previous 3 hours.
Anti-Emetic Action:
Metoclopramide acts on the chemo-emetic trigger zone to produce a central anti-emetic effect. The anti-emetic action of metoclopramide is not affected by atropine and other anticholinergic medicines.
Other Action:
Metoclopramide stimulates prolactin secretion.

INDICATIONS:
Digestive Disorders:
Metoclopramide is of particular value in any condition associated with gastric stasis or hypomotility. It is therefore useful in the management of postvagotomy syndrome.
Nausea and Vomiting:
Metoclopramide is an effective anti-emetic agent in the control of nausea and vomiting associated with the following conditions:
medicine-induced nausea and vomiting, uraemic conditions, malignant disease, gastro-intestinal disorder and post-anaesthetic vomiting.
Diagnostic Radiology:
Metoclopramide speeds up gastric emptying and dilates the duodenal bulb. It is, therefore, particularly useful in the following situations:
(a) Where barium meal studies are delayed by spasm of the duodenal cap, making examination for the presence of an ulcer difficult.
(b) to facilitate examination of the hypotonic stomach with delayed emptying (gastric stasis and pyloric canal syndrome).
(c) to control or prevent nausea and vomiting of barium which occurs in a small minority of patients undergoing barium meal examination.
Duodenal Intubation:
The action of metoclopramide in promoting stomach emptying, combined with its anti-emetic effect, has proved a very useful aid to gastro-intestinal intubation procedures.

CONTRA-INDICATIONS:
Metoclopramide should not be given to patients being treated with phenothiazines. There have been reports of hypertensive crises in patients with phaeochromocytoma, who were given metoclopramide. Until further evaluation, metoclopramide should therefore not be given to patients with suspected or confirmed phaechromocytoma.
The use of metoclopramide throughout the duration of pregnancy is considered unsafe as teratogenicity has been demonstrated in animal studies.
Should not be used in intestinal obstruction or immediately after surgery.

WARNINGS:
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 metoclopramide is administered to patients with significant renal impairment or to those at risk of fluid retention as in hepatic impairment.
It is recommended that metoclopramide should not be given to patients with convulsive disorders. Caution should be observed when using metoclopramide in patients taking other medicines that can also cause extrapyramidal reactions, such as the phenothiazines. The effects of central nervous system depressants may be enhanced. Antimuscarinic agents and opioid analgesics antagonise the effects of metoclopramide. Metoclopramide has been found to be transferred to breast milk. It should therefore not be taken while breast feeding.
The safe use of metoclopramide is contentious in patients with porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Tablets or Syrup:
Adults and children over 14 years Take 10 mg (one tablet or 2 medicine measuresful of syrup) 3 times a day.
Children 5 - 14 years Take 5 mg (half a tablet or 1 medicine measureful of syrup) three times a day.
Children 3 - 5 years Take 2,5 mg (half a medicine measureful of syrup) 3 times a day.
Suppository:
Adults and children over 14 years 10 mg: Insert one 10 mg suppository per rectum 1 to 3 times a day.
Children 5 - 14 years 5 mg: Insert one 5 mg suppository per rectum 1 to 3 times a day.
Children under 5 years No suitable preparation available.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Metoclopramide may cause extrapyramidal symptoms which usually occur as acute dystonic reactions especially in young patients; the findings include spasm of facial and/or extra-ocular muscles, trismus, a bulbar type of speech and unnatural positioning of the head and shoulders. There may be a general increase in muscle tone.
Parkinsonism and/or tardive dyskinesia have occasionally occurred, usually during prolonged treatment in elderly patients. Other adverse effects include restlessness, drowsiness, dizziness, and bowel upsets such as diarrhoea or constipation. The hyperprolactinaemia which metoclopramide produces may result in breast engorgement and galactorrhoea or related disorders. The conditions return to normal after withdrawal of the medicine.
As both metoclopramide and the phenothiazines may cause transient dystonia, care should be exercised in the event of both medicines being prescribed concurrently.
Transient increases in plasma aldosterone concentrations have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of metoclopramide could give rise to dyskinetic reactions manifested as motor restlessness, agitation, irritability, spasm of facial and neck muscles and the muscles of the tongue. In severe cases opisthotonus can result. Anti-parkinson medication, e.g. procyclidine, will usually control these reactions.

IDENTIFICATION:
Tablets
Small white, uncoated, scored tablets, engraved with the Lennon logo on the other side.
Syrup Pale yellow liquid in amber-coloured bottle.
Suppositories Off-white torpedo-shaped suppositories.

PRESENTATION:
Tablets
Containers containing 20, 100 or 500 tablets.
Syrup Bottles containing 100 mL syrup.
Suppositories Cartons containing 5 suppositories of either 5 mg or 10 mg.

STORAGE INSTRUCTIONS:
Tablets
Store below 25°C and protect from light and against moisture.
Syrup Store below 25°C and protect from light.
Suppositories Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Tablets
L/5.7.2/322.
Syrup L/5.7.2/319.
5 mg Suppositories M/5.7.2/190.
10 mg Suppositories M/5.7.2/191.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/12/1985
               
G398B
        KOHLER C&P P.E

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