SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gaviscon Cool Mint Liquid

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each 10 ml dose contains sodium alginate 500 mg, sodium hydrogen carbonate 267 mg and calcium carbonate 160 mg.

Excipients: methyl parahydroxybenzoate (E218) 40 mg/10 ml and propylparahydroxybenzoate (E216) 6 mg/10 ml.

For full list of excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Oral suspension.

An off-white suspension 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 indigestion, for example, following meals or during pregnancy.

4.2    Posology and method of administration

Posology

Adults and children 12 years and over: 10-20 ml after meals and at bedtime (up to four times a day).

Children under 12 years: Should be given only on medical advice.

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

Special Patient groups

Elderly: No dose modifications necessary for this age group.

Hepatic impairment: No modifications necessary.

Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).

Method of administration

For oral administration

4.3 Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium bicarbonate and calcium carbonate, or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).

4.4 Special warnings and precautions for use

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

Each 10 ml dose has a sodium content of 141 mg (6.2 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

For children below 12 years, please see section 4.2

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, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and bisphosphonates (diphosphonates). See section 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 breastfeeding.

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

Gaviscon has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions have been ranked under headings of frequency using the following convention: Very rare: <1/10,000.

System Organ Class	Frequency	Adverse Event
Immune System Disorders	Very rare	Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and	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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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: A02BX13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents in 3 minutes, effectively impeding gastro-oesophageal reflux for up to 4 hours. 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 the medicinal product is physical and does not depend on absorption into the systemic circulation.

5.3    Preclinical safety data

No pre-clinical findings of any relevance to the prescriber have been reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer 974P

Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Saccharin sodium Mint flavour no. 4

Mint flavour no. 5 Sodium hydroxide Purified water

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Two years.

6.4    Special precautions for storage

Do not store above 30°C. Do not refrigerate or freeze.

6.5    Nature and contents of container

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5 ml, 10 ml, 15 ml, and 20 ml graduations, or a measuring spoon (crystal poltstyrene) containing 2.5 ml and 5 ml measure, and containing 100, 150, 200, 300, 500 or 600 ml.

Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.

6.6 Special precautions for disposal

None required.

7    MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0158.

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13/11/2008

10 DATE OF REVISION OF THE TEXT

13/11/2014