PHARMACOLOGICAL ACTION: Gelusil-S is a combination of two antacids, aluminium hydroxide and magnesium hydroxide plus a defoaming agent, simethicone. This component breaks down barriers of foaming mucus thereby providing effective anti-flatulent action.
INDICATIONS: For the relief of hyperacidity and flatulence associated with heartburn, gastritis and acid indigestion, and as adjunctive treatment in peptic ulcers.
CONTRA-INDICATIONS: Sensitivity to any of the ingredients. Impaired renal function.
DOSAGE AND DIRECTIONS FOR USE:
Adults: One or two tablets chewed or allowed to disintegrate in the mouth 4 to 8 times a day, preferably between meals, or as directed by a doctor. Do not take more than 16 tablets in a 24 hour period. Do not use the maximum dosage of this product for more than 2 weeks, except under the advice or supervision of a doctor.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Aluminium hydroxide may cause nausea, vomiting and constipation. Large doses can cause intestinal obstruction. Aluminium hydroxide in patients with low-phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia.
Osteomalacia, and also encephalopathy and dementia, have occurred in patients with chronic renal failure who received relatively high doses of aluminium hydroxide as a phosphate-binding agent.
Magnesium may cause diarrhoea. Although magnesium is poorly absorbed following oral administration, hypermagnesaemia has occurred after the excessive use of magnesium-containing antacids and especially in renal insufficiency. Symptoms may include flushing of the skin, thirst, hypotension due to peripheral vasodilatation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and cardiac arrest. Interactions: Gelusil-S used concurrently with oral tetracyclines, digoxin, oral iron preparations, anticholinergic drugs, barbiturates, quinines, quinidine, warfarin, vitamins, H2-receptor antagonists, oral isoniazid, sucralfate, sodium fluoride, ketoconazole, phenytoin, phenothiazines and methenamine may reduce the absorption of these agents.
In general, patients should be advised not to take any oral medication within at least 2 hours of taking antacids.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See Side-effects and Special precautions. Treatment: Symptomatic and supportive
IDENTIFICATION: A white, round, bevel-edged tablet with a lemon-spearmint odour and taste.
PRESENTATION: Blisters of 24 tablets.
STORAGE INSTRUCTIONS: Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: E/11.4.1/633
NAME AND BUSINESS ADDRESS OF APPLICANT: Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 24 March 1993.
Updated on this site: May 2003 Source: Pharmaceutical Industry
GELUSIL-S