Maalox Plus

The active components of Maalox Plus are:

Suspension

The symptomatic relief of:

1. Dyspepsia.

2. Heartburn.

3. Flatulence.

For oral administration:

Adults

Children

As an appropriate proportion of the adult dose.

Children under 5 years

Elderly

The normal adult dose is appropriate.

Should not be used in patients who are hypersensitive to any of the active or other ingredients, are severely debilitated or suffering from kidney failure, or hypophosphataemia.

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.

Maalox Plus should not be taken simultaneously with other medicines as they may interfere with their absorption if taken within 1 hour.

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

The safety of Maalox Plus (Suspension) in pregnancy has not been established.

Magnesium is considered as compatible with lactation

None stated.

Gastrointestinal side-effects are uncommon.

Serious symptoms are unlikely following overdosage.

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 Plus is a balanced mixture of two antacids and an antiflatulent/antifoaming agent simeticone. The two antacids are magnesium hydroxide which is fast acting and aluminium hydroxide which is a slow acting antacid. The combination produces a fast onset of action and an increase in total buffering time. Aluminium hydroxide on its own is an astringent and may cause constipation. This effect is balanced by the effect of the magnesium hydroxide which is in common with other magnesium salts may cause diarrhoea.

None stated.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

Methylparaben (E218), Propylparaben (E216), Microcrystalline cellulose and sodium carboxymethyl cellulose (dispersible cellulose), Hydroxpropyl cellulose, Hydrogen peroxide solution 35%, Citric acid, Sodium saccharin, Sorbitol solution 70% (E420), Methyl cellulose, Natural lemon concentrate NO 1355, Swiss creme flavour No 11546, Sanitized water.

None stated.

48 months.

Keep from freezing.

White HDPE plastic bottles and security caps or alternative polypropylene closure: 500mls.

None.

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0382

27 January 2009

11 January 2010

GSL