MAALOX Oral suspension Ref.[50870] Active ingredients: Aluminium hydroxide Magnesium hydroxide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

4.1. Therapeutic indications

For the relief of the symptoms of dyspepsia.

4.2. Posology and method of administration

The route of administration is oral.

Recommended Dosage

Adults

One to Two x 5 ml spoonfuls taken 20 minutes to one hour after meals and at night as required or as directed by the physician.

Children

Not recommended.

4.9. Overdose

SIGNS AND SYMPTOMS

Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhea, abdominal pain, vomiting. Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see Section 4.4 Special warnings and precautions for use).

MANAGEMENT

Aluminium and magnesium are eliminated through urinary route; treatment of acute overdose consists of rehydration, forced diuresis. In case of renal function deficiency, haemodialysis or peritoneal dialysis is necessary.

Serious symptoms are unlikely following overdosage.

6.3. Shelf life

As packaged for sale: 3 years.

After first opening the container: this product should be used within 6 months of first opening the bottle.

6.4. Special precautions for storage

Do not store above 25ยบC.

6.5. Nature and contents of container

White PET bottles with plastic screw cap: 250 ml and 355 ml.

Not all pack sizes are marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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