MAALOX PLUS Oral suspension Ref.[50847] Active ingredients: Aluminium hydroxide Magnesium hydroxide Simethicone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Product name and form

Maalox Plus.

Pharmaceutical Form

Oral suspension.

White suspension, homogenous after shaking, with the odour and taste of lemon.

Qualitative and quantitative composition

The active components of Maalox Plus are:

Dried Aluminium Hydroxide Gel: 230mg/5ml
Magnesium Hydroxide: 200mg/5ml
Simeticone: 25mg/5ml

Also contains 224mg of sorbitol (E420), per 5ml.

For a full list of excipients, see section 6.1

Active Ingredient Description
Aluminium hydroxide

Aluminium hydroxide is a slow-acting antacid. It is used to provide symptomatic relief in gastric hyperacidity. In addition, the antipeptic and demulcent activity of aluminium hydroxide helps to protect inflamed gastric mucosa against further irritation by gastric secretions.

Magnesium hydroxide

Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is almost equal to that of sodium bicarbonate. When the dose is in excess of that required to neutralise the acid the intragastric pH may reach pH 8 or 9. Acid rebound following magnesium hydroxide is clinically insignificant. Magnesium hydroxide has an indirect cathartic effect resulting from water retention in the intestinal lumen.

Simethicone

Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

List of Excipients

Domiphen bromide
Microcrystalline cellulose and carmellose sodium
Hydroxpropylcellulose
Hydrogen peroxide 30%
Citric acid monohydrate
Sodium saccharin
Sorbitol liquid 70% (non-crystallising) (E420)
Methylcellulose
Lemon flavour
Swiss cream flavour
Purified water

Pack sizes and marketing

White polyethylene terephthalate (PET) bottles with polypropylene (PP) closure and polyethylene (PE/LDPE) liner: 250ml and 355ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Marketing authorization dates and numbers

PL 53886/0041

Date of first authorisation: 08/09/1989

Drugs

Drug Countries
MAALOX PLUS Cyprus, Hong Kong, Ireland, Israel, Malta, United Kingdom, South Africa

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