1. Name Of The Medicinal Product
Acidex, Compound Alginate Oral Suspension, Heartburn and Indigestion Liquid
Compound Alginate, Oral Suspension, Heartburn and Indigestion Liquid
Brunel Healthcare Heartburn and Indigestion Liquid
Superdrug Acid Indigestion and Heartburn Relief Liquid
Heartburn and Indigestion Relief
SETLERS Heartburn and Indigestion Liquid
Coalgicarb Suspension
Lloydspharmacy Heartburn and Indigestion Liquid
Raft-Eze Liquid
Boots Heartburn Relief Aniseed Flavour
Co-op Heartburn and Indigestion Liquid
Entrocalm Heartburn and Indigestion Relief
Morrisons Heartburn and Indigestion Liquid
Peptac Liquid (Ivax Pharmaceuticals UK)
Asda Heartburn and Indigestion Liquid
Numark Heartburn and Indigestion Liquid
Wilkinson Heartburn and Indigestion Liquid
Sainsbury's Heartburn and Indigestion Liquid
2. Qualitative And Quantitative Composition
Each 5ml contains:
Sodium Bicarbonate BP - 133.5mg
Sodium Alginate BP - 250mg
Calcium Carbonate - 80mg
3. Pharmaceutical Form
Aniseed flavoured pink suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid alleviates the painful conditions resulting from the reflux of gastric acid and bile into the oesophagus by suppressing the reflux itself. It is indicated in heartburn, including heartburn of pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2 Posology And Method Of Administration
For oral use
Adults and children over 12 years: Two to four 5 ml spoonfuls.
Children 6 - 12 years: One to two 5 ml spoonfuls
Not recommended in children under six years of age.
Doses should be taken after meals and at bedtime.
4.3 Contraindications
There are no specific contraindications.
4.4 Special Warnings And Precautions For Use
1 Each 10 ml dose of Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid contains about 6 mmoles of sodium and therefore care should be exercised in patients on a sodium restricted diet.
2. Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid should not be taken within 1 to 2 hours of taking other medicines by mouth, or for more than 2 weeks if symptoms persist.
3. Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid should not be used by patients allergic to any of its constituents.
4. Parahydroxybenzoates (E214 and E216): may cause allergic reactions (possibly delayed).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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4.6 Pregnancy And Lactation
Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid is indicated for heartburn of pregnancy and may be used during lactation.
For Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. To date, no other relevant epidemiological data are available.
Caution should be exercised when prescribing to pregnant women.
4.7 Effects On Ability To Drive And Use Machines
There are no effects on ability to drive or operate machinery.
4.8 Undesirable Effects
Constipation, flatulence, stomach cramps or belching may occasionally occur.
4.9 Overdose
As Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid mode of action is physical, overdosage in terms of the alginate content is virtually no hazard. The only consequence is abdominal distension which is best treated conservatively. The relatively low concentrations of sodium and calcium carbonate in Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid would also make serious consequences from overdosage very unlikely.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
When taken after a meal Sodium Alginate forms a rigid raft of alginic acid in the stomach reducing gastric reflux. This raft formed is maintained in the stomach for two hours. Sodium bicarbonate reacts with gastric acid to produce carbon dioxide which is retained in the gel and allows the raft to rise to the surface of the gastric contents. Calcium ions from calcium carbonate link the alginic acid molecules and strengthen the raft.
5.2 Pharmacokinetic Properties
Alginic acid is not absorbed into the systemic circulation.
5.3 Preclinical Safety Data
There is no Preclinical Safety Data.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Carbomer (Carbopol 974P)
Sodium Hydroxide
Saccharin Sodium
Ethyl parahydroxybenzoate (E214)
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
Isopropyl Alcohol
Erythrosine Colour (E127)
Aniseed Oil
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months - amber glass bottles
18 months - HDPE bottles
15 months – PET bottles
6.4 Special Precautions For Storage
Do not store above 25°C. Do not refrigerate.
6.5 Nature And Contents Of Container
Pharmaceutical Grade III amber glass bottles with pilfer proof caps.
High density polyethylene bottles with tamper evident screw caps.
PET bottle with tamper evident screw caps.
Pack sizes: 50ml, 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.
50ml (PET)
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Pinewood Laboratories Limited,
Ballymacarbry,
Clonmel,
Co. Tipperary.
8. Marketing Authorisation Number(S)
PL 4917/0021
9. Date Of First Authorisation/Renewal Of The Authorisation
25/03/1998
10. Date Of Revision Of The Text
19/04/2011
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