It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 21/7/2015

Gaviscon Advance Tablets

1. NAME OF THE MEDICINAL PRODUCT

Gaviscon Advance Chewable Tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains sodium alginate 500 mg and potassium bicarbonate 100 mg.

Excipient with known effect: Aspartame (E951) 4.5mg in 1 tablet.

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. Each tablet is imprinted with a "Sword and Circle" on one side and "GA 500" on the reverse.

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: One to two tablets 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 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 after being thoroughly chewed.

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 103 mg (4.5 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 two-tablet dose 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.

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

May cause central nervous depression in the presence of renal insufficiency and should not be used in patients with renal failure.

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 rarely (1/10,000) and not known (cannot be estimated from the available data)..

System Organ Class

Frequency

Adverse Event

Immune System Disorders

Very Rare

Anaphlyactic and anaphlyactoid reactions. Hypersensitivity reactions such as urticarial.

Respiratory, Thoracic and Medistinal 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 Pharmacovigilance Section, Health Product Regulatory Authority, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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

On ingestion Gaviscon Advance 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 Advance Tablets 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

Calcium carbonate

Macrogol 20,000

Mannitol (E421)

Aspartame (E951)

Copovidone

Mint flavour no. 3

Magnesium stearate

Acesulfame potassium

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

White, rigid, injection-moulded, polypropylene cylinder with snap-bead neck finish.

Container containing 20 or 60 tablets. Pack sizes are comprised of either three 20-tablet containers packed into a carton or one 60-tablet container. For some markets the 60-tablet container will be packed into a carton.

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

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

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited,

7 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland.

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/11/8.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10th February 2006

Date of last renewal: 05th January 2010

10. DATE OF REVISION OF THE TEXT

December 2014

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.