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

Logo GELACID TABLETS
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

GELACID TABLETS

COMPOSITION:
Each tablet contains: Alginic Acid 500 mg
  Magnesium Trisilicate 25 mg
  Aluminium Hydroxide Gel 100 mg
  Sodium Bicarbonate 170 mg

PHARMACOLOGICAL CLASSIFICATION:
A 11.4 Antacids

PHARMACOLOGICAL ACTION:
GELACID has antacid and demulcent properties. It decreases acid reflux and increases esophageal clearance of acid. This compound has no demonstrable effect on lower oesophageal sphincter pressure and is not a potent antacid. The alginate component may protect the mucosa and mechanically impair reflux by forming a viscous layer on the surface of the gastric contents.

INDICATIONS:
GELACID tablets is indicated for the relief of gastroesophageal reflux, mild to moderate reflux, oesophagitis, heartburn and dyspepsia.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Obstructive disease of the gastro-intestinal tract, impaired renal function. Heart failure, hypertension, cirrhosis.
Safety in pregnancy and lactation has not been established.

WARNINGS:
Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor. Hypermagnesaemia, aluminium encephalopathy and central nervous system depression with dementia may occur in patients with kidney function failure or gastro-intestinal atony or obstruction. Do not take this medicine if you are presently taking a prescription antibiotic containing any form of tetracycline.

DOSAGE AND DIRECTIONS FOR USE:
GELACID tablets should be chewed thoroughly or broken into pieces and swallowed with water or milk.
Adults and children over 12 years: One to two tablets after meals and at bedtime.
Children 6 to 12 years: One tablet after meals and at bedtime.
Children under 6 years: As directed by the physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
The use of this medication may have the following side-effects:
Magnesium containing antacids may cause gastro-intestinal irritation and watery diarrhoea. Chronic diarrhoea due to long-term use of antacids, may result in electrolyte imbalance. Hypermagnesaemia may occur in patients suffering from impaired renal function. Symptoms of hypermagnesaemia may include loss of deep tendon reflexes and respiratory depression. Other symptoms may include nausea, vomiting, flushing of the skin, drowsiness, confusion, thirst, hypotension, muscle weakness, bradycardia, cardiac arrest and coma.
Aluminium containing antacids may cause constipation. Aluminium encephalopathy and osteomalacia have been associated with aluminium accumulation in patients suffering from renal failure. Excessive doses of aluminium hydroxide or even normal doses in patients on low phosphate diets may lead to phosphate depletion accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia.
Excessive administration of sodium bicarbonate may lead to hyperkalaemia and metabolic acidosis, especially in patients with impaired renal function. Symptoms may include muscle weakness, shortness of breath, tiredness, mood changes and irregular heartbeat. Stomach cramps, belching and flatulence have been reported. Congestive heart failure may occur due to excessive sodium absorption.
Special precautions
Patients suffering from renal impairment should avoid the prolonged and excessive use of antacids. Aluminium containing antacids should be given with caution to patients suffering from chronic renal failure, especially in children. Sodium containing antacids should be administered extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, eclampsia or aldosteronism.
Interaction
The absorption of tetracyclines, digoxin and oral iron preparations, may be decreased by the concurrent use of magnesium containing antacids. Administration should be separated by a number of hours.
Citrate containing preparations, including many effervescent or dispersible tablets, are best avoided by patients with renal failure, taking aluminium containing antacids.
Sodium containing antacids may increase the renal clearance of acidic drugs such as salicylates and barbiturates.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects and special precautions.
A feeling of abdominal distension may occur with very large doses of GELACID tablets.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Round chewable off-white tablet scored on one side.

PRESENTATION:
20 Tablets packed into a plastic tube.

STORAGE INSTRUCTIONS:
Store in an airtight container below 25°C.
Keep out of reach of children.
Keep well closed.

REGISTRATION NUMBER:
33/11.4/0383

NAME AND BUSINESS ADDRESS OF 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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