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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 08/06/2011

SPC	Boots Heartburn Relief Aniseed Flavour

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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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

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Sodium Bicarbonate BP - 133.5mg

Sodium Alginate BP - 250mg

Calcium Carbonate - 80mg

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3. PHARMACEUTICAL FORM

Aniseed flavoured pink suspension.

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4. CLINICAL PARTICULARS

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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.

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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.

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4.3 Contraindications

There are no specific contraindications.

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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).

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4.5 Interaction with other medicinal products and other forms of interaction

1.	Antacids may interact with other drugs as they alter the gastric pH which may affect dissolution, solubility or ionization of the other drug. Antacids reduce the absorption of certain drugs from the following groups: ACE Inhibitors, Analgesics, Antibacterials, Antiepileptics, Antifungals, Antimalarials, Antipsychotics, Bisphosphonates, Penicillamine.
2.	Antacids may increase the pH of the urine and affect the rate of drug elimination. Excretion of basic drugs is decreased whereas acidic drugs are eliminated more rapidly.
3.	Due to effects at the renal level sodium bicarbonate may reduce plasma lithium levels and increase plasma quinidine levels.

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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.

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4.7 Effects on ability to drive and use machines

There are no effects on ability to drive or operate machinery.

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4.8 Undesirable effects

Constipation, flatulence, stomach cramps or belching may occasionally occur.

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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.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Alginic acid is not absorbed into the systemic circulation.

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5.3 Preclinical safety data

There is no Preclinical Safety Data.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Carbomer (Carbopol 974P)

Sodium Hydroxide