1. Name Of The Medicinal Product
Maalox Plus
2. Qualitative And Quantitative Composition
The active components of Maalox Plus are:
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3. Pharmaceutical Form
Suspension
4. Clinical Particulars
4.1 Therapeutic Indications
The symptomatic relief of:
1. Dyspepsia.
2. Heartburn.
3. Flatulence.
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.
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.
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 (Suspension) 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
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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.
5.2 Pharmacokinetic Properties
None stated.
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.
6. Pharmaceutical Particulars
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.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
48 months.
6.4 Special Precautions For Storage
Keep from freezing.
6.5 Nature And Contents Of Container
White HDPE plastic bottles and security caps or alternative polypropylene closure: 500mls.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. Marketing Authorisation Number(S)
PL 04425/0382
9. Date Of First Authorisation/Renewal Of The Authorisation
27 January 2009
10. Date Of Revision Of The Text
11 January 2010
LEGAL STATUS
GSL
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