MAALOX

Main information

  • Trade name:
  • MAALOX Tablets Chewable 400/400 Milligram
  • Available from:
  • Sanofi-Aventis Ireland Limited
  • Dosage:
  • 400/400 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine type:
  • Human

Documents

Localization

  • Available in:
  • MAALOX Tablets Chewable 400/400 Milligram
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • IMB
  • Authorization date:
  • 30-01-2001
  • Last update:
  • 23-04-2015

Summary of Product characteristics


Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Maalox 400mg/400mg Chewable Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

400 mg of Aluminium oxide, hydrated

400 mg of Magnesium Hydroxide.

Excipients: Each tablet contains 192mg confectioners sugar (containing no less than 97% sucrose), 125mg sorbitol

(E420) and 59.2 mg sucrose

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable Tablet

Flat, circular, bevel-edged white chewable tablet of diameter 1.4 cm with 'Mx' engraved on both sides and having an

odour of peppermint.

4 CLINICAL PARTICULARS

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: 1-2 tablets chewed 4 times daily, taken 20 minutes to 1 hour after meals and at bedtime, or as directed by the

physician. A maximum of 8 tablets in a 24 hour period should not be exceeded, nor should the maximum dose continue

for more than 2 weeks except under the direction of the physician.

4.3 Contraindications

Use in severely debilitated patients or in those suffering from kidney failure.

Use in patients who are allergic to any of the ingredients in Maalox Chewable Tablets.

4.4 Special warnings and precautions for use

Aluminium hydroxide may cause constipation due to its astringent action, this effect may be balanced by the cathartic

effect of the magnesium salts.

Aluminium hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet e.g.

malnutrition.

Magnesium salts may cause central nervous depression in the presence of renal insufficiency and should be used with

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In patients with renal impairment, plasma levels of both aluminium and magnesium increase. In these patients, a long-

term exposure to high doses of aluminium and magnesium salts may lead to encephalopathy, dementia microcytis

anemia or worsen dialysis-induced osteomalacia.

The prolonged use of antacids in patients with renal failure should be avoided.

Care should be observed if used by diabetics because of the sugar content in the tablet.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis because it has been shown

that aluminium may be involved in porphyrin metabolism normalities.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase

insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

This product may form complexes with certain drugs, e.g. tetracyclines, digoxin and vitamins, resulting in decreased

absorption. This should be borne in mind when concomitant administration is considered.

Concomitant use with quinidines may increase the serum levels of quinidine and lead to quinidine overdosage.

Aluminium-containing antacids may prevent the proper absorption of H2 antagonists, atenolol, chloroquine, cyclines,

diflunisal, digoxin, diphosphonates, ethambutol, fluoroquinolones, sodium fluorure, glucocorticoids, indometacine,

isoniazide, kayexalate, ketoconazole, lincosamides, metoprolol, neuroleptics phenothiazines, penicillamine,

propranolol, iron salts. Staggering the administration times of the interacting drug and the antacid by at least 2 hours (4

hours for the fluoroquinolones) will often help avoid undesirable drug interactions.

Aluminium hydroxide and sitrates may result in increased aluminium levels, especially in patients with renal

impairment.

4.6 Fertility, pregnancy and lactation

The product should not be used during pregnancy unless considered essential by the physician.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Gastrointestinal side-effects are uncommon.

Occasionally high doses of antacids may cause diarrhoea or constipation.

4.9 Overdose

Serious symptoms are unlikely following overdosage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Maalox is a balanced mixture of two antacids: aluminium hydroxide is a slow acting antacid and magnesium

hydroxide is a fast acting one. The two are frequently combined in antacid mixtures. Aluminium hydroxide on its own

is astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in

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5.2 Pharmacokinetic properties

The absorption of aluminium and magnesium form antacids is small. Aluminium hydroxide is slowly converted to

aluminium chloride in the stomach. Some absorption of soluble aluminium salts occurs in the gastro intestinal tract

with urinary excretion. Any absorbed magnesium is likewise excreted in the urine.

5.3 Preclinical safety data

Not relevant.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol (E421)

Confectioners sugar (Contains Sucrose and maize starch)

Saccharin sodium

Sorbitol (E420)

Sucrose

Peppermint flavour powder

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store in the original package.

6.5 Nature and contents of container

Tablets are packed in PVC/aluminium blister strips 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 80, 84, 90, 96 and 100

tablets in a cardboard outer.

Not all pack sizes are marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

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7 MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland.

8 MARKETING AUTHORISATION NUMBER

PA 540/110/4

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 April 1982

Date of last renewal: 01 October 2009

10 DATE OF REVISION OF THE TEXT

Irish Medicines Board

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There are no safety alerts related to this product.

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