SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Acidex Max Strength Heartburn Relief Oral Suspension (Peppermint Flavour)

Peptac Max Strength Heartburn Relief Oral Suspension (Peppermint Flavour)

Boots Max Strength Heartburn Relief Oral Suspension (Peppermint Flavour)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 10 ml contains Sodium Alginate Sodium Bicarbonate Calcium Carbonate

Excipients include:

Ethyl parahydroxybenzoate (E214)

Propyl parahydroxybenzoate (E216)

Butyl parahydroxybenzoate

For a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Oral Suspension,

Peppermint flavoured white or cream coloured suspension

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Alleviation of the symptoms of gastro-oesophageal reflux by suppressing the reflux itself. It is indicated for the treatment of dyspepsia and heartburn due to gastric reflux associated with hiatus hernia, pregnancy and reflux oesophagitis

4.2 Posology and method of administration

For oral use

Adults and children over 12 years and the Elderly:	5 - 10 ml
Children under 12 years:	only under medical supervision

Doses should be taken after meals and at bedtime.

4.3 Contraindications

Hypersensitivity to any of the ingredients of this medicinal product, including the esters of hydroxybenzoates (Parabens) (see section 6.1).

4.4 Special warnings and precautions for use

1.    Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

2.    This medicinal product contains about 7.5 mmol of sodium per 10ml dose. To be taken into consideration by patients on a controlled sodium diet e.g. in cases of cardiac failure and renal impairment.

3.    Each 10ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

4.    Compound Alginate Oral suspensions should not be taken within 1 to 2 hours of taking other medicines by mouth, or for more than 7 days if symptoms persist.

5.    Parahydroxybenzoates (E214, E216) may cause allergic reactions (possibly delayed)

6.    If symptoms do not improve after seven days, medical advice should be sought.

7.    There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

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, 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

An open, uncontrolled study in 146 pregnant women did not demonstrate any significant adverse effects of this product on the course of pregnancy or on the health of the fetus/new-born child.

No effects during pregnancy are anticipated, since systemic exposure to this product is negligible. This product can be used during pregnancy. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to this product is negligible.

Based on this and previous experience this product may be used during pregnancy and lactation, however it is recommended to limit the treatment duration as much as possible.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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

Very rarely, in less than one in ten-thousand cases, patients sensitive to the ingredients develop allergic manifestations such as bronchospasm, urticaria, and anaphylaxis.

4.9 Overdose

As Compound Alginate Oral suspensions 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 this product would also make serious consequences from overdosage very unlikely.

5.1 Pharmacodynamic properties

ATC Code: A02BX13

Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux

When taken after a meal Sodium Alginate forms a 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

The mode of action of the product is physical and does not depend on absorption 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

Incompatibilities

None known.

6.3    Shelf life

24 months

Use within 3 months of opening

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 Type III amber glass bottles with white polypropylene caps that have a Low density Polyethylene (LDPE) liner

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

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Shake bottle well before use

7    MARKETING AUTHORISATION HOLDER

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland.

MARKETING AUTHORISATION NUMBER(S)

PL 04917/0114

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/02/2012

10    DATE OF REVISION OF THE TEXT

24/02/2012