sanofi-aventis

Maalox 400mg/400mg Chewable Tablets

Excipients: Each tablet contains 192 mg confectioners sugar (containing no less than 97% sucrose) 125 mg sorbitol (E420) and 59.2mg Sucrose.

For a full list of excipients, see section 6.1.

Chewable Tablet.

Flat, circular, bevel-edged white chewable tablet of diameter 1.4 cm with the monogram “Mx” on both sides and having an odour of peppermint.

For the relief of the symptoms of dyspepsia.

The route of administration is oral.

Recommended Dosage

Adults: 1-2 tablets chewed 4 times daily, taken 20 minutes to 1 hour after meals and at bedtime, or as directed by the physician. A maximum of 8 tablets in a 24 hour period should not be exceeded, nor should the maximum dose continue for more than 2 weeks except under the direction of 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 Chewable Tablets.

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 antacid in patients with renal failure should be avoided.

Care should be observed if used by diabetics because of the sugar content of the tablet.

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, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product 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 quindines may increase the serum levels of quinidine and lead to quinidine overdosage.

Aluminium-containing antacids may prevent the proper adsorption of H2 antagonists, atenolol, chloroquine, cyclines, difunisal, digoxin, diphosphonates, ethambutol, fluroquinolones, sodium fluorure, glucocorticoids, indometacine, isoniazide, kayexalate, ketoconazole, lincosamides, metoprolol, neuroleptics 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.

Mannitol E421

Confectioners Sugar (contains starch and maize starch)

Sucrose

Saccharin Sodium

Sorbitol E420

Peppermint Flavour powder

Magnesium Stearate

Not applicable.

3 years.

Store in the original package.

Tablets are packed in PVC/aluminium blister strips 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 80, 84, 90, 96 and 100 tablets in a cardboard outer.

Not all pack sizes are marketed.

No special requirements.

sanofi-aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

PA 540/110/4

30^th January 1991/1^st October 2009.

January 2011.