SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

1. Name of the Medicinal Product

Acidex, Compound Alginate Oral Suspension Heartburn

Asda Heartburn and Indigestion Liquid

Boots Heartburn Relief Aniseed Flavour

Galpharm Heartburn and Indigestion Relief Oral Suspension

LloydsPharmacy Heartburn and Indigestion Liquid

Peptac Liquid, Heartburn and Indigestion Liquid

Heartburn and Indigestion relief

Sainsbury's Heartburn and Indigestion Liquid

Superdrug Acid Indigestion and Heartburn Relief Suspension

Wilkinson Heartburn and Indigestion Liquid

Essential Waitrose Heartburn and Indigestion Oral Suspension

Morrisons Heartburn and Indigestion Oral Suspension

Numark Heartburn and Indigestion Oral Suspension

Healthpoint Heartburn and Indigestion Oral Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Sodium Bicarbonate BP - 133.5mg Sodium Alginate BP - 250mg Calcium Carbonate - 80mg

Also contains parahydroxybenzoates. For a full list of excipients, see section

6.1

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

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.

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. Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website :www.mhra.gov.uk/yellowcard

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.

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. Pre-clinical 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)

Star Anise Oil Purified Water

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 and tamper evident screw 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. Instructions for use/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 AUTHORISATION

25/03/1998

10 DATE OF REVISION OF THE TEXT

09/03/2016