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ACIBAN (TABLET)ACIBAN (TABLET)

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

ACIBAN (TABLET)

COMPOSITION:
Each tablet contains:

Aluminium hydroxide dried gel 250 mg
Magnesium trisilicate 500 mg

(Magnesium content: 3,3 mmol per tablet)
Sugar        ۴۰۰ mg

PHARMACOLOGICAL CLASSIFICATION:
A: 11.4.1 Antacids – Acid neutralisers.

PHARMACOLOGICAL ACTION:
ACIBAN has acid-neutralising properties.

INDICATIONS:
For the relief of hyperacidity and gastritis, and in the management of peptic ulcer, heartburn and acid indigestion.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. Impaired renal function.

WARNING:
Do not use this product if you have kidney disease, except under the advice and supervision of a doctor.

INTERACTIONS:
ACIBAN 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.

DOSAGE AND DIRECTIONS FOR USE:
Adults: One or two tablets chewed or allowed to disintegrate in the mouth up to 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 hours 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.
Excessive doses of aluminium hydroxide, or even normal doses in patients with low-phosphate diets, may lead to phosphate depletion accompanied by increased bone resorption and hypercalciura with the risk of osteomalacia. Care is necessary in patients with chronic renal impairment, since osteomalacia or adynamic bone disease, encephalopathy, dementia, and microcytic anaemia, have been associated with aluminium accumulation in patients with chronic renal failure who received large doses of aluminium hydroxide as a phosphate-binding agent.
Magnesium may cause diarrhoea and gastro-intestinal irritation. Release of carbon dioxide may cause discomfort. 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 nausea, vomiting, flushing of the skin, thirst, hypotension due to peripheral vasodilatation, drowsiness, confusion, loss of tendon reflexes and respiratory depression, both due to neuromuscular blockade, muscle weakness, bradycardia, coma, and cardiac arrest.
ACIBAN may alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT’S TREATMENT:
See Side-effects and specail precautions.
Treatment: Symptomatic and supportive.

IDENTIFICATION:
A white, round, biconvex, bevel-edged tablet, with a diameter of 16mm, and a characteristic peppermint odour and taste.

PRESENTATION:
500 tablets in an amber PVC container and a white HDPE jar.
Cartons containing 10 aluminium foil strips packs of 10 tablets each. ie. 100 tablets.
96 tablets in a white polypropylene securitainer.
Patient ready packs.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Keep containers well-closed.
KEEP OUT OF REACH OF CHILDREN.

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