SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gaviscon Liquid Sachets Mint Flavour

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Gaviscon contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate per 10 ml dose.

Excipients:    methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl

parahydroxybenzoate (E216) 6 mg/10 ml.

For a full list of excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Oral suspension in sachets.

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 related to reflux, for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

4.2    Posology and method of administration

For oral administration.

Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a day).

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, 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.

Sodium content of a 10 ml, one sachet dose is 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 10 ml, one sachet 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).

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, biphosphonates (diphosphonates) 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 postmarketing 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 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 quickly and 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 Natural mint flavour 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 25°C and store in the original package. Do not freeze or refrigerate.

6.5 Nature and contents of container

A cardboard outer carton containing unit dose stick pack style sachets.

Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.

Not all pack sizes may be marketed.

The sachets are composed of polyester, aluminium and polyethylene.

Each sachet contains 10 ml of Gaviscon.

6.6 Special precautions for disposal

No special requirement.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0628

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/07/2011

10    DATE OF REVISION OF THE TEXT

19/11/2014