sanofi-aventis

Maalox 225mg/200mg per 5ml Oral Suspension

Each 5ml of the suspension contains:

200mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste)

225mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel)

Excipients: Each 5ml also contains 2.5mg propyl parahydroxybenzoate (E216), 5mg methyl parahydroxybenzoate (E218), 49.47mg sorbitol (E420) and 1.59mg sodium.

For a full list of excipients, see section 6.1.

Oral Suspension.

White, viscous, aqueous oral suspension with a peppermint odour and taste.

For the relief of the symptoms of dyspepsia.

The route of administration is oral.

Recommended Dosage

Adults: One to Two x 5ml spoonfuls taken 20 minutes to one hour after meals and at night as required or as directed by the physician.

Use in severely debilitated patients or in those suffering from kidney failure.

Use in patients who are allergic to any of the ingredients in Maalox Oral Suspension.

Aluminium hydroxide may cause constipation due to its astringent action, this effect may be balanced by the cathartic effect of the magnesium salts.

Aluminium hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet e.g. malnutrition.

Magnesium salts may cause central nervous depression in the presence of renal insufficiency and should be used with caution in patients with advance renal disease.

In patients with renal impairment, plasma levels of both aluminium and magnesium increase. In these patients, a long-term exposure to high doses of aluminium and magnesium salts may lead to encephalopathy, dementia, microcytic anemia or worsen dialysis- induced osteomalacia.

The prolonged use of antacids in patients with renal failure should be avoided.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis because it has been shown that aluminium may be involved in porphyrin metabolism abnormalities.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Aluminium hydroxide may form complexes with certain drugs, e.g. tetracyclines, digoxin and vitamins, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered.

Concomitant use with quinidines may increase the serum levels of quinidine and lead to quinidine overdosage.

Aluminium-containing antacids may prevent the proper absorption of H2 antagonists, atenolol, chloroquine, cyclines, diflunisal, digoxin, diphosphonates, ethambutol, fluoroquinolones, sodium fluorure, glucocorticoids, indometacine, isoniazide, kaylexalate, ketoconazole, lincosamides, metoprolol, nueroleptics phenothiazines, penicillamine, propranolol, iron salts.

Staggering the administration times of the interacting drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones) will often help avoid undesirable drug interactions.

Aluminium hydroxide and citrates may result in increased aluminium levels, especially in patients with renal impairment.

The product should not be used during pregnancy unless considered essential by the physician.

None

Gastrointestinal side- effects are uncommon.

Occasionally high doses of antacids may cause diarrhoea or constipation.

Serious symptoms are unlikely following overdosage.

Maalox is a balanced mixture of two antacids: aluminium hydroxide is a slow acting antacid and magnesium hydroxide is a fast acting one. The two are frequently combined in antacid mixtures. Aluminium hydroxide on its own is astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in common with other magnesium salts, may cause diarrhoea.

The absorption of aluminium and magnesium from antacids is small. Aluminium hydroxide is slowly converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occurs in the gastro intestinal tract with urinary excretion. Any absorbed magnesium is likewise excreted in the urine.

Not Relevant

Not applicable.

As packaged for sale: 2 years.

After first opening the container: The product should be used within 4 weeks of opening.

Do not store above 25°C.

White HDPE bottles with plastic screw cap: 100ml, 300ml, and 500ml.

Not all pack sizes are marketed.

No special requirements.

sanofi-aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

PA 540/110/1

30 January 1991/ 1^st October 2009.

April 2010.