Indigestion Relief Tablets, Double Action Indigestion Tablets, Antacid Plus Tablets, Gastricalm Tablets, Boots Wind Relief Tablets

Tablet.

For relief from discomfort of painful wind, indigestion, heartburn and excess acidity.

For oral administration.

Adults and children over 12 years: One or two tablets to be sucked or chewed after meals, at bedtime or whenever discomfort is felt.

Children 5 to 12 years: One tablet to be sucked or chewed after meals, at bedtime or whenever discomfort is felt.

Children under 5 years: Not recommended.

Elderly: There is no need for dosage reduction in the elderly.

Hypersensitivity to any of the ingredients.

Hypophosphataemia.

This product should be used with caution in patients with impaired renal function.

If symptoms persist for more than 5 days, consult your doctor.

Keep all medicines out of the reach of children.

This product may interfere with the absorption of tetracyclines, chloroquine, penicillamine, phenothiazines and quinolone antibacterials, when these are given concomitantly.

There are no adequate human data from the use of aluminium hydroxide and magnesium hydroxide in pregnant women. Studies in animals have not been done. No data are available to suggest any harmful effects in pregnant women, associated with simethicone. Caution should therefore be exercised when taken by pregnant women.

Although some aluminium and magnesium may be secreted in breast mild, the concentration is too small to be harmful. Secretion of simethicone in the breast milk of nursing mothers has not been established but would be most unlikely

No adverse effects known.

May occasionally cause diarrhoea or constipation, although the combination of magnesium and aluminium salts minimises these gastrointestinal effects.

Symptoms of overdosage include nausea, vomiting, gastrointestinal irritation, diarrhoea/constipation. Treatment should be symptomatic and supportive.

Aluminium hydroxide and magnesium hydroxide have antacid properties and are used to neutralise gastric acid. Activated methylpolysiloxane (simethicone) has anti-foaming/deflatulent activity by virtue of its ability to change the surface tension of gas bubbles, thereby causing them to coalesce.

Magnesium hydroxide reacts with hydrochloric acid in the stomach to produce magnesium chloride. Small amounts of magnesium salts may be absorbed and excreted in the urine, otherwise excretion if via the faeces.

Aluminium hydroxide reacts with hydrochloric acid in the stomach to form aluminium chloride, some of which is absorbed. Absorbed aluminium is eliminated in the urine. The majority of aluminium remains in the gastrointestinal tract and forms insoluble poorly absorbed aluminium salts including hydroxide, phosphate, carbonate and fatty acid derivatives, which are excreted in the faeces.

There is no date availability on the pharmacokinetics of activated methylpolysiloxane.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Sorbitol pdr

Maize starch pdr

Povidone

Isopropyl alcohol

Icing sugar

Magnesium stearate

Peppermint oil Black leaf

Microcrystalline cellulose

Purified water

Not applicable

36 months

None

PVC/PVDC blister heat sealed to aluminium foil.

Pack sizes: 12, 24, 36, 48

Not applicable

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0287

Date of first authorisation: 15 October 1982

Date of last renewal: 15 December 1992

February 2004