MAALOX PLUS Oral suspension Ref.[50847] Active ingredients: Aluminium hydroxide Magnesium hydroxide Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

4.1. Therapeutic indications

The symptomatic relief of:

  1. Dyspepsia.
  2. Heartburn.
  3. Flatulence.

4.2. Posology and method of administration

For oral administration:

Adults

5-10ml taken 20 minutes to 1 hour after meals and at bedtime or as required.

Children

As an appropriate proportion of the adult dose.

Children under 5 years

Maximum of 5ml t.d.s.

Elderly

The normal adult dose is appropriate.

4.9. Overdose

Serious symptoms are unlikely following overdosage.

Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhoea, abdominal pain, vomiting.

Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4)

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

6.3. Shelf life

Unopened: 2 years.

After opening: 6 months.

6.4. Special precautions for storage

Store below 30°C.

Do not refrigerate or freeze.

6.5. Nature and contents of container

White polyethylene terephthalate (PET) bottles with polypropylene (PP) closure and polyethylene (PE/LDPE) liner: 250ml and 355ml.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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