Maalox Suspension

Dried aluminium hydroxide gel BP 220 mg, and Magnesium hydroxide BP 195 mg per 5 ml.

Suspension.

Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn and gastric hyperacidity.

Adults (including the elderly):

10 – 20 ml taken 20 minutes to one hour after meals and at bedtime or as required. Maalox can be taken with water or milk if required.

Children:

Not recommended for children under 14 years.

Oral administration.

Maalox should not be used in patients who are severely debilitated or suffering from renal insufficiency, or if there is severe abdominal pain and/or the possibility of bowel obstruction.

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 dementia, microcytic anemia.

Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.

Antacids are known to interfere with the absorption of certain drugs including tetracyclines, vitamins, ciprofloxacin, ketoconazole, hydroxychloroquine, chloroquine, chlorpromazine and rifampicin.

Aluminum hydroxide and citrates may result in increased aluminum levels, especially in patients with renal impairment.

No clinical data on exposed pregnancies are available. Use of antacids should be avoided in the first trimester of pregnancy. Caution should be exercised when prescribing to pregnant and lactating women.

Magnesium is considered as compatible with lactation

None stated.

Gastrointestinal side effects are uncommon. However, occasional diarrhoea or constipation may occur if use is excessive.

Serious symptoms are unlikely following overdose. Discontinue medication and correct fluid deficiency if necessary.

Treatment of magnesium overdose: consider administration of IV Calcium Gluconate, rehydration and forced diuresis. In case of renal deficiency, haemodialysis or peritoneal dialysis is necessary.

Maalox is a balanced mixture of two antacids; aluminium hydroxide is a slow-acting antacid and magnesium hydroxide is a quick-acting one. The two are frequently combined in antacid mixtures. Aluminium hydroxide on its own is an 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. Gastro-intestinal side effects are thus rare with Maalox and this makes it especially suitable when long term therapy is necessary.

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. Aluminium containing antacids should not be administered to patients with renal impairment where increased plasma concentration may occur.

No relevant data.

Methylparaben (E218), propylparaben (E216), citric acid (anhydrous), sodium saccharin (granular), sorbitol solution 70% (E420), mannitol powder (E421), hydrogen peroxide solution 35%, hydrochloric acid, peppermint oil and purified water.

None stated.

Unopened: 24 months.

After opening: 28 days.

Protect from freezing. Store away from direct sunlight.

White plastic bottles/alternative polypropylene closure containing 500 ml.

Maalox can be taken with milk or water if required.

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0378

23 January 2009

11 January 2010

GSL