1.

Gaviscon Extra Strength 500 Peppermint Tablets.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains sodium alginate 500mg, sodium bicarbonate 267mg and calcium carbonate 160mg.

For excipients, see Section 6.1.

3.    PHARMACEUTICAL FORM

Chewable tablet.

An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and acid indigestion, for example, following meals or during    pregnancy.

4.2.    Posology and method of administration

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over: One to two tablets after meals and at bedtime. Children under 12 years: Should be given only on medical advice.

Elderly: No dose modifications necessary for this age group.

4.3    Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

If symptoms do not improve after seven days, the clinical situation should be reviewed.

The sodium content of a two-tablet dose is 246 mg (10.6 mmol). This should be taken into account when a highly restricted salt diet is recommended. e.g. in some cases of congestive cardiac failure and renal impairment.

Each two-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Due to its aspartame content this product should not be given to patients with phenylketonuria.

4.5 Interaction with other medicinal products and other forms of interaction

A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, biphosphonates and estramustine. See also 4.4.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.

Breast feeding:

No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.

Fertility:

Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.

Clinical data do not suggest that Gaviscon has an effect on human fertility.

4.7. Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

System Organ Class	Frequency	Adverse Event
Immune System Disorders	Very rare	Anaphylactic and anaphylactoid reactions.

		Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and Mediastinal Disorders	Very rare	Respiratory effects such as bronchospasm.

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 national reporting system. 4.9. Overdose

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic classification: A02BX 13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

On ingestion Gaviscon Extra Strength 500 Peppermint Tablets react rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.

5.2. Pharmacokinetic properties

The mode of action of Gaviscon Extra Strength 500 Peppermint Tablets is physical and does not depend on absorption into the systemic circulation.

5.3. Preclinical safety data

No preclinical findings of relevance to the prescriber have been reported.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Lemon flavour no. 1

Marcrogol 20,000 Mannitol (E421)

Copovidone Aspartame (E951)

Acesulfame potassium (E950) Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Two years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package.

6.5. Nature and contents of container

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blister trays into cartons.

Blister tray containing six or ight individually sealed tablets. Two, four, six or eight blister trays in a carton.

Not all pack sizes may be marketed

6.6. Instruction for use and handling (, and disposal) No special instructions.

No Data Held

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS United Kingdom.

MARKETING AUTHORISATION NUMBER

PL 00063/0138

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

7 October 2003

10 DATE OF REVISION OF THE TEXT

24/09/2014