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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 400 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.

ACUGEL SUSPENSION

SCHEDULING STATUS:

S2

PROPRIETARY NAME

(and dosage form):

ACUGEL SUSPENSION

COMPOSITION:

Each 10 mL of suspension contains:

Dicyclomine hydrochloride 5 mg

Compressed aluminium hydroxide gel equivalent to dried aluminium hydroxide 400 mg

Light magnesium oxide 200 mg

Preservatives:

Nipastat 0,2% (m/v)

Chloroform 0,2% (v/v)

Benzyl alcohol 0,3% (v/v)

PHARMACOLOGICAL CLASSIFICATION:

A 11.4.2 Acid neutralisers with antispasmodic.

PHARMACOLOGICAL ACTION:

ACUGEL has antacid properties.

INDICATIONS:

ACUGEL is indicated as an antacid.

CONTRA-INDICATIONS:

Prostatic enlargement, paralytic ileus or pyloric stenosis where it’s use may lead to obstruction, severe ulcerative colitis, myasthenia gravis, glaucoma.

Patients with renal failure. Obstructive uropathy, thyrotoxicosis, cardiac failure.

Sensitivity to any of the ingredients.

WARNINGS:

ACUGEL should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis and cardiac insufficiency or cardiac failure.

DOSAGE AND DIRECTIONS FOR USE:

Adults: Two to four medicine measures (10-20 mL) three to four times daily.

Children over 2 years of age: One to two medicine measures (5-10 mL) three to four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Side-effects that may occur due to dicyclomine include dry mouth, blurred vision, flushing and dryness of skin, tachycardia with palpitations and arrhythmias, urinary retention and constipation.

It’s effect may be enhanced by other drugs with anticholinergic properties. Fatigue, sedation, rash, thirst, nausea and vomiting, headache and dizziness have been reported.

Preparations containing dicyclomine should be used with caution in elderly men. 5-10% of magnesium is absorbed, and retention in patients with impaired renal function may lead to neurological, neuromuscular and cardiovascular impairment. The urine of normal persons may become alkaline which decreases excretion of drugs that are weak bases.

Magnesium may cause diarrhoea and mucosal irritation.

Aluminium hydroxide absorbs phosphates and excessive doses or normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or osteomalacia. Use with care in patients with hiatal hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.

ACUGEL may interfere with or reduce the absorption of anticholinergic medicines, barbiturates, digoxin, quinine, warfarin, tetracyclines and vitamins.

The effects of dicyclomine hydrochloride may be enhanced by the concomitant administration of anticholinergic medicines such as antihistamines, amantadine, butyrophenones, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Toxic doses of dicyclomine cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with hypertension or circulatory failure and respiratory depression. See further under “Side-Effects and Special Precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:

A white suspension with peppermint odour and a sweet aromatic taste.

PRESENTATION:

Round plastic bottles of 200 mL and 350 mL, and rectangular plastic containers of 2,5 litres.

STORAGE INSTRUCTIONS:

Store in a cool place below 25°C.

KEEP OUT OF REACH OF CHILDREN.

ALUKON GEL

SCHEDULING STATUS:

Not scheduled

PROPRIETARY NAME

(and dosage form):

ALUKON GEL

COMPOSITION:

Each 15 mL of suspension contains:

Compressed Aluminium Hydroxide Gel equivalent to Aluminium Oxide

630 mg

Preservatives:

Sodium Benzoate 0,5 % m/v

Chloramine T 0,04% m/v

PHARMACOLOGICAL CLASSIFICATION:

A 11.4.1 Acid Neutralisers.

PHARMACOLOGICAL ACTION:

ALUKON GEL has antacid properties.

INDICATIONS:

ALUKON GEL is indicated as an antacid.

CONTRA-INDICATIONS:

Patients with renal failure. Sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:

Adults: 5 to 15 mL three to four times daily in half a glass of water or milk, or when required.

SHAKE WELL BEFORE USE.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Aluminium hydroxide absorbs phosphates and excessive doses or normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or osteomalacia (a disease characterised by a gradual and painful softening and bending of the bones). ALUKON GEL may interfere with or reduce the absorption of anticholinergic medicines, barbiturates, digoxin, quinine, quinidine, warfarin, tetracyclines and vitamins.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Constipation, intestinal obstruction, renal rickets and osteomalacia (a disease characterised by a gradual and painful softening and bending of the bones). See further under “Side-effects and Special Precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:

A white homogenous suspension with a slight peppermint flavour.

PRESENTATION:

200 mL amber glass bottles.

STORAGE INSTRUCTIONS:

Store in a cool place, below 25°C. Protect from light.

KEEP OUT OF REACH OF CHILDREN.

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