SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gaviscon Advance Oral suspension.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20 mg.

Excipients: methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

For a full list of excipients, see Section 6.1.

3.    PHARMACEUTICAL FORM

Oral suspension Off-white, viscous suspension.

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

Posology

Adults and children 12 years and over: 5-10 ml after meals and at bedtime.

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 modification is required 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 use.

Shake well before use. Check that the cap seal is unbroken before first taking the product.

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 special 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 106 mg (4.6 mmol) and a potassium content of 78 mg (2.0 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 or when taking drugs which can increase plasma potassium levels.

Each 10 ml 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.

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): 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

None known.

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.

Breastfeeding

No known effect on breastfed infants. Gaviscon can be used during breastfeeding.

Fertility:

No known 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 or use machines.

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 www.mhra.gov.uk/yellowcard.

4.9. Overdose

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

PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Pharmacotherapeutic classification: A02E AO1 Anti-regurgitant

On ingestion the suspension reacts with gastric acid to form a raft of alginic acid gel having a near-neutral pH and which floats on the stomach contents effectively (up to 4 hours) 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 this product is physical and does not depend on absorption into the systemic circulation.

5.3.    Pre-clinical Safety Data

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

6 PHARMACEUTICAL PARTICULARS

6.1.    List of excipients

Calcium carbonate Carbomer 974P

Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Saccharin sodium Fennel flavour

Sodium hydroxide (for pH adjustment) Purified water

Ingredients of fennel flavour:

Fennel anethol Benzyl alcohol

6.2.    Incompatibilities

Not applicable.

Shelf-life

Shelf life: 2 years.

Shelf life after opening: 6 months.

6.4. Special Precautions for Storage

Do not refrigerate.

6.5. Nature and contents of container

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

Or

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane,

Hull,

HU8 7DS,

United Kingdom

8.    MARKETING AUTHORIZATION NUMBER(S)

PL 00063/0097

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/09/2006

10    DATE OF REVISION OF THE TEXT

06/11/2014