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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 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 25/02/2010

SPC	Maalox Plus suspension

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

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

The active components of Maalox Plus are:

Aluminium Hydroxide mixture		220mg
Magnesium Hydroxide		195mg
Simeticone		25mg

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3. PHARMACEUTICAL FORM

Suspension

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

The symptomatic relief of:

1. Dyspepsia.

2. Heartburn.

3. Flatulence.

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4.2 Posology and method of administration

For oral administration:

Adults

5-10ml taken 20 minutes to 1 hour after meals and at bedtime or as required.

Children

As an appropriate proportion of the adult dose.

Children under 5 years

Maximum of 5ml t.d.s.

Elderly

The normal adult dose is appropriate.

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4.3 Contraindications

Should not be used in patients who are hypersensitive to any of the active or other ingredients, are severely debilitated or suffering from kidney failure, or hypophosphataemia.

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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 (Suspension) 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

Maalox Plus is a balanced mixture of two antacids and an antiflatulent/antifoaming agent simeticone. The two antacids are magnesium hydroxide which is fast acting and aluminium hydroxide which is a slow acting antacid. The combination produces a fast onset of action and an increase in total buffering time. Aluminium hydroxide on its own is an astringent and may cause constipation. This effect is balanced by the effect of the magnesium hydroxide which is in common with other magnesium salts may cause diarrhoea.

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5.2 Pharmacokinetic properties

None stated.

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5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Methylparaben (E218), Propylparaben (E216), Microcrystalline cellulose and sodium carboxymethyl cellulose (dispersible cellulose), Hydroxpropyl cellulose, Hydrogen peroxide solution 35%, Citric acid, Sodium saccharin, Sorbitol solution 70% (E420), Methyl cellulose, Natural lemon concentrate NO 1355, Swiss creme flavour No 11546, Sanitized water.

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6.2 Incompatibilities

None stated.

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6.3 Shelf life

48 months.

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6.4 Special precautions for storage

Keep from freezing.

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6.5 Nature and contents of container

White HDPE plastic bottles and security caps or alternative polypropylene closure: 500mls.