Maalox Plus Tablets

1. Name Of The Medicinal Product

Maalox Plus Tablets

2. Qualitative And Quantitative Composition

Aluminium hydroxide gel (dried)	BP	200mg
Magnesium hydroxide	BP	200mg
Simeticone		25mg

3. Pharmaceutical Form

Tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of:

a. Dyspepsia

b. Heartburn

c. Flatulence

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

4.3 Contraindications

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

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.

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.

4.6 Pregnancy And Lactation

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

Magnesium is considered as compatible with lactation

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Gastrointestinal side effects are uncommon.

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.

5. Pharmacological Properties

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.

5.2 Pharmacokinetic Properties

None stated

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Swiss creme powder 13773

Lemon flavour S260, spray dried

Magnesium stearate

Talc

Citric acid, anhydrous

Dextrose, anhydrous

Saccharin sodium

Sorbitol crystalline powder

Sorbitol solution

Yellow lake blend LB737

Instant corn starch

Maize starch

Confectioners sugar

Mannitol powder

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None stated.

6.5 Nature And Contents Of Container

Plastic/aluminium strip packs packed in cardboard boxes

Packs of 40 tablets are available

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

PL 04425/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

23 January 2009

10. Date Of Revision Of The Text

11 January 2010

LEGAL STATUS

GSL