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

Each 5 ml contains:

Oral Suspension

Peppermint Flavoured White Suspension

Gluten and Sugar free.

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.

For oral use

Not recommended in children under six years of age.

Doses should be taken after meals and at bedtime.

Hypersensitivity to any of the ingredients.

1. Each 10 ml 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).

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, Bisphosphonates, 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.

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

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

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

As Acidex Liquids 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 Liquid would also make serious consequences from overdosage very unlikely.

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.

Alginic acid is not absorbed into the systemic circulation.

There are no preclinical data of relevance to the prescriber in addition to that included in other sections of the SmPC.

Carbomer

Sodium Hydroxide

Saccharin Sodium

Ethyl parahydroxybenzoate (E214)

Propyl parahydroxybenzoate (E216)

Butyl parahydroxybenzoate

Isopropyl Alcohol

Peppermint Oil

Purified Water

None known.

24 months - amber glass bottles

18 months - HDPE bottles

12 months - PET bottles

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

Pharmaceutical Grade III amber glass bottles with pilfer proof 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.

Not applicable.

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland.

PL 4917/0027

26/03/2009

26/04/2011