sanofi-aventis

Maalox Plus Chewable Tablets 200mg/200mg/25mg.

Each tablet contains:

200 mg of Magnesium Hydroxide (as magnesium hydroxide paste)

200mg of Hydrated Aluminium Oxide

25mg of Dimeticone (as simeticone)

For a full list of excipients, see section 6.1.

Chewable Tablet.

Bi-layered, white/yellow tablets engraved with “Maalox” on one side.

In the treatment of heartburn, indigestion, flatulence and dyspepsia.

The route of administration is oral.

Recommended Dosage

Adults: One to two tablets four times a day (after meals and at bedtime) or as required.

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 Plus 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 extreme caution in patients with kidney 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.

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

Sulphur dioxide (E220) may rarely cause hypersensitivity reactions and bronchospasm.

Maalox Plus contains small amounts of ethanol (alcohol), less than 100mg per dose.

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 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, glucorticoids, 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 use of Maalox Plus should be avoided during the first trimester of pregnancy.

None

Gastrointestinal side-effects are uncommon

Side effects are uncommon at recommended doses. Occasional diarrhoea or constipation may occur if use if excessive.

Serious symptoms are unlikely following overdosage.

Maalox Plus is a balanced mixture of two antacids and simethicone: aluminium hydroxide is a slow-acting antacid and magnesium hydroxide is a fast-acting one. The two are frequently combined in antacids 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. Simethicone is a surface-active agent included to disperse form. This reduces gastrooesophageal reflux. It does not have antacid properties.

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.

Sucrose

Mannitol

Sorbitol liquid non-crystallising

Sorbitol

Saccharin sodium

Magnesium stearate

Talc

Pregelatinised maize starch

Maize starch

Citric acid, anhydrous

Glucose, anhydrous

Lemon flavour (contains sulphur dioxide)

Swiss cream flavour (contains sulphur dioxide and ethanol)

Iron oxide yellow (E172)

Not applicable.

3 years.

Do not store above 25°C. Store in the original package in order to protect from moisture.

PVC/aluminium blister packs in outer carton: 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 80, 84, 90, 96 and 100 tablets.

Not all pack sizes are marketed.

No special requirements.

sanofi-aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

PA 540/109/2

10^th November 1985/ 1^st October 2009.

November 2011.