sanofi-aventis

Maalox Plus 225mg/200mg/25mg Oral Suspension

Each 5ml of the suspension contains:

225mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel)

200mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste).

25mg of Simeticone

Excipients: Each 5ml also contains 1.5mg propyl parahydroxybenzoate (E216), 8.5mg methyl parahydroxybenzoate (E218), 224.85mg sorbitol (E420), 1.66mg sodium, 3.667mg ethanol, 3ppm sulphur dioxide (E220).

For a full list of excipients, see section 6.1.

Oral suspension.

A white lemon flavoured oral suspension.

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

The route of administration is oral.

Recommended Dosage

Adults: One to Two x 5ml spoonfuls 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 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 extreme caution in patients with kidney disease.

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

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.

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, kayexalate, ketoconalzole, lincosamides, metoprolol, neuroleptics phenothiazines, pencillamine, propranolol, iron salts.

Staggering the administration times of the interacting drug and the antacid by at least 2 hours (4 hours of 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 is excessive.

Serious symptoms are unlikely following overdosage.

Maalox 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 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. Simethicone is a surface-active agent included to disperse form. This reduces gastroesophageal 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.

None.

None known.

3 years.

Do not store above 25°C. Do not freeze. Keep bottle tightly closed.

White HDPE bottles with plastic screw cap: 200ml, 355ml, and 500ml.

Not all pack sizes may be marketed.

No special requirements.

sanofi-aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

PA 540/109/1

10 November 1985/ 01 October 2009.

April 2010