SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

1. Name of the Medicinal Product

Acidex Liquid - peppermint flavour

LloydsPharmacy Heartburn and Indigestion Liquid Peppermint Flavoured

Boots Heartburn Relief Peppermint Flavour

Peptac Peppermint Liquid

Tesco Heartburn & Indigestion relief

Heartburn and Indigestion Oral Suspension Peppermint Flavour Healthpoint Heartburn and Indigestion Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

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

3 PHARMACEUTICAL FORM

Oral Suspension

Peppermint Flavoured White Suspension Gluten and Sugar free

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Acidex 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 5ml spoonfuls

Children 6 -12 years:    One to two 5ml spoonfuls

Not recommended in children under six years of age.

Doses should be taken after meals and at bedtime.

4.3    Contraindications

Hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

1.    Each 10ml dose of Acidex Liquid contains about 6 mmoles of sodium and therefore care should be exercised in patients on a sodium restricted diet.

2.    Acidex 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 Liquid should not be used by patients allergic to any of its constituents.

4.    Parahydroxybenzoates (E214, 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 ionisation of the other drug. Antacids reduce the absorption of certain drugs from the following groups; ACE Inhibitors, Analgesics, Antibacterials, Antiepileptics, Antifungals, Antimalarials, Antipsychotics, Biphosphonates, Lithium and 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    Fertility, pregnancy and lactation

Acidex Liquid is indicated for heartburn of pregnancy and may be used during

lactation.

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 at www.mhra.gov.uk/yellowcard.

4.9    Overdose

As Acidex Liquid's mode of action is physical, overdose 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 Liquid would also make serious consequences from overdose 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. The 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 are no preclinical data of relevance to the prescriber in addition to that included in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Carbomer

Sodium Hydroxide

Saccharin Sodium

Ethyl parahydroxybenzoate (E214)

Propyl parahydroxybenzoate (E216)

Butyl parahydroxybenzoate Isopropyl Alcohol

Peppermint Oil Purified Water

6.2    Incompatibilities

None known.

6.3    Shelf life

24 months - amber glass bottles 18 months - HDPE bottles 12 months - PET bottles

6.4    Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

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 bottles with tamper evident screw caps.

Pack sizes: 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8    MARKETING AUTHORISATION NUMBER(S)

PL 04917/0027

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/07/2002 / 26/03/2009

10 DATE OF REVISION OF THE TEXT

16/03/2016