ACIDEX Oral suspension Ref.[50687] Active ingredients: Alginic acid Calcium carbonate Sodium bicarbonate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product name and form

Acidex.

Pharmaceutical Form

Oral Suspension.

Aniseed flavoured pink suspension.

Qualitative and quantitative composition

Each 10 ml dose contains:

Sodium Alginate 500 mg
Sodium Bicarbonate 267 mg
Calcium Carbonate 160 mg

Excipients with known effect:

Each 10 ml dose contains 143 mg sodium, 15.0 mg ethyl parahydroxybenzoate (E214), 5.50 mg propyl parahydroxybenzoate (E216) and 2.5 mg butyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alginic acid

Alginic acid is a polysaccharide distributed widely in the cell walls of brown algae which is hydrophilic and forms a viscous gum when hydrated. Its salts with metals such as sodium and calcium are known as alginates. It is a significant component of the biofilms produced by the bacterium Pseudomonas aeruginosa, a major pathogen found in the lungs of some people who have cystic fibrosis. The biofilm and P. aeruginosa have a high resistance to antibiotics and are susceptible to inhibition by macrophages.

Calcium carbonate

Calcium carbonate releases, in a pH-dependent manner, calcium ions in the stomach. Calcium carbonate is widely used as antacid and extensively used as a dietary supplement.

Sodium bicarbonate

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

List of Excipients

Carbomer
Sodium Hydroxide (E524) (For pH adjustment)
Saccharin Sodium (E954)
Ethyl parahydroxybenzoate (E214)
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
Isopropyl Alcohol
Erythrosine Colour (E127)
Star Anise Oil
Purified Water

Pack sizes and marketing

Type III amber glass bottles with pilfer proof caps and tamper evident screw caps, in pack sizes of 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PA0281/075/001

Date of first authorisation: 26 June 1998
Date of last renewal: 26 June 2008

Drugs

Drug Countries
ACIDEX Ireland, Malta, New Zealand, United Kingdom

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