SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient    Quantity/Unit    dose

Dried Aluminium Hydroxide Gel EP    351 mg

(equivalent to 170mg aluminium oxide)

Magnesium hydroxide EP    164 mg

Simethicone HSE or Silicone Antifoam M HSE    25 mg

(activated methylpolysiloxane)

3    PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

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.

4.3    Contraindications

Hypersensitivity to any of the ingredients.

Hypophosphataemia.

4.4    Special warnings and precautions for use

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.

4.5    Interaction with other medicinal products and other forms of interaction

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

4.6    Pregnancy and lactation

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 milk, 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.

4.7    Effects on ability to drive and use machines

No adverse effects known.

4.8    Undesirable effects

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

4.9    Overdose

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

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic    properties

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.

5.2    Pharmacokinetic properties

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 are no data availability on the pharmacokinetics of activated methylpolysiloxane.

5.3    Preclinical safety data

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sorbitol pdr Maize starch pdr Povidone Isopropyl alcohol Icing sugar Magnesium stearate Peppermint oil Black leaf Microcrystalline cellulose Purified water

6.2    Incompatibilities

Not applicable

6.3    Shelf life

36 months

6.4    Special precautions for storage

None

6.5    Nature and contents of container

PVC/PVDC blister heat sealed to aluminium foil.

Pack sizes: 12, 24, 36 & 48

6.6 Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8    MARKETING AUTHORISATION NUMBER(S)

PL 00014/0287

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/10/1982 / 23/02/2004

10 DATE OF REVISION OF THE TEXT

03/02/2005