This information is intended for use by health professionals
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 (equivalent to 170mg aluminium oxide)||351 mg|
|Magnesium hydroxide EP||164 mg|
|Simethicone HSE or Silicone Antifoam M HSE (activated methylpolysiloxane)||25 mg|
3. Pharmaceutical form
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.
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.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
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 is 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 pdrMaize starch pdrPovidoneIsopropyl alcoholIcing sugarMagnesium stearatePeppermint oil Black leafMicrocrystalline cellulosePurified water
6.3 Shelf life
6.4 Special precautions for storage
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 and other handling
7. Marketing authorisation holder
The Boots Company PLC1 Thane Road WestNottingham NG2 3AA
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 15 October 1982Date of last renewal: 15 December 1992
10. Date of revision of the text
1 September 2015