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

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

GELACID SUSPENSION

COMPOSITION:

Each 10 mL contains:	Sodium Bicarbonate	267 mg
	Sodium Alginate	500 mg
	Calcium Carbonate	160 mg
Preservatives:	Methyl Hydroxybenzoate	0,4% m/v
	Propyl Hydroxybenzoate	0,0 6% m/v
Total sodium content:	6,052 mmol/10 mL

PHARMACOLOGICAL CLASSIFICATION:
A 11.10 Drugs acting on gastro-intestinal tract (special combinations).

PHARMACOLOGICAL ACTION:
GELACID protects the mucosa and mechanically impairs reflux by forming a viscous layer on the surface of the gastric contents.

INDICATIONS:
GELACID is indicated for gastric reflux, mild to moderate reflux oesophagitis, heartburn and hiatus hernia.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. GELACID should not be administered to patients with metabolic or respiratory alkalosis, hypercalcaemia and hypochlorhydria.

WARNINGS:
Do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. Do not use this product if you are on a sodium restricted diet, or suffering from hypertension or heart failure, except under the supervision of a doctor.

DOSAGE AND DIRECTIONS FOR USE:

Adults and children over 12 years:	Take two to four medicine measurefuls (10-20 mL), after meals and at bedtime. 80 mL (16 medicine measurefuls) should be the maximum dosage per day (24 hour period).
Children under 12 years:	Take two medicine measurefuls (10 mL) after meals and at bedtime. 40 mL (8 medicine measurefuls) should be the maximum dosage per day. (24 hour period).
Children under 2 years:	The use of GELACID is not usually recommended except where a doctor considers its use necessary where one medicine measureful (5 mL) should be the maximum dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
GELACID should be administered with caution to patients with congestive cardiac failure, oedema, renal impairment, cirrhosis of the liver, hypotension and to patients receiving corticosteroids.
GELACID can cause stomach cramps and flatulence.
Hypercalcaemia and alkalosis can occur following high doses of calcium carbonate.
Large doses of GELACID may interfere with the absorption of some medicines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
A feeling of abdominal distention may occur with very large doses of GELACID.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A pink liquid with a fennel flavour.

PRESENTATION:
200 mL and 500 mL amber coloured glass or plastic bottles.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
Keep out of reach of children.

REGISTRATION NUMBER:
33/11.10/0046

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd.
Units 8-11 Glen Park Industrial
1 Highdale Road
Glen Anil
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 2001

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