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sanofi-aventis

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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Summary of Product Characteristics last updated on the eMC: 24/01/2011

SPC	Maalox Plus Tablets

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
LEGAL STATUS

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1. NAME OF THE MEDICINAL PRODUCT

Maalox Plus Tablets

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Aluminium hydroxide gel (dried)

Magnesium hydroxide

Simeticone

200mg

25mg

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3. PHARMACEUTICAL FORM

Tablet.

Bi-layered white and yellow tablets, 16mm in diameter, with 'Maalox' embossed on one side.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

The symptomatic relief of:

a. Dyspepsia

b. Heartburn

c. Flatulence

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4.2 Posology and method of administration

Route of administration: Oral

Adults (including elderly persons): 1-2 tablets well chewed, four times a day, taken twenty minutes to one hour after meals and at bedtime, or as required.

Children: Not recommended

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4.3 Contraindications

Should not be used in patients who are severely debilitated or suffering from kidney failure.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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4.4 Special warnings and precautions for use

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 dementia, microcytic anemia.

Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.

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4.5 Interaction with other medicinal products and other forms of interaction

Maalox Plus should not be taken simultaneously with other medicines as they may interfere with their absorption if taken within 1 hour.

Aluminum hydroxide and citrates may result in increased aluminum levels, especially in patients with renal impairment.

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4.6 Pregnancy and lactation

The safety of Maalox Plus Tablets in pregnancy has not been established..

Magnesium is considered as compatible with lactation

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4.7 Effects on ability to drive and use machines

None stated.

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4.8 Undesirable effects

Gastrointestinal side effects are uncommon.

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4.9 Overdose

Serious symptoms are unlikely following overdosage.

Treatment of magnesium overdose: consider administration of IV Calcium Gluconate, rehydration and forced diuresis. In case of renal deficiency, haemodialysis or peritoneal dialysis is necessary.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Dried aluminium hydroxide gel - antacid

Magnesium hydroxide - antacid

Simeticone - Antifoaming agent/antiflatulent

The antacids are balanced such that gastrointestinal side effects (constipation and diarrhoea) are minimal.

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5.2 Pharmacokinetic properties

None stated

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