SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gaviscon Strawberry Flavour Chewable Tablets.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg and calcium carbonate 80 mg.

Excipient with known effect: Aspartame (E951) 8.8 mg per tablet.

For the full list of excipients, see Section 6.1.

3.    PHARMACEUTICAL FORM

Chewable tablet.

Pale pink, circular, flat with beveled edges with the odour and flavour of strawberry

The tablets are embossed with a sword and circle on one side, and GS250 on the reverse side.

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: Two to four tablets after meals and at bedtime (up to four times per day).

Children under 12: 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 use, after being thoroughly chewed.

4.3. Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate 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 four-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 four-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 medicinal product should not be given to patients with phenylketonuria.

Paediatric population: For children below 12 years please see section 4.2.

4.5.    Interactions 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 biphosphonates (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 breast-feeding.

Fertility:

Clinical experiences have shown that at therapeutic doses no effects on human fertility are anticipated.

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 Mediastinal Disorders	Very rare	Respiratory effects such as broncospasm.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 national reporting system.

4.9. Overdose

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

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ATC code: A02BX.

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 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 mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.

5.3. Pre-clinical safety data

There are no non-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SmPC.

6.1. List of excipients

Macrogol 20,000 Mannitol (E421)

Aspartame (E951)

Magnesium stearate

Xylitol and Carmellose sodium

Red iron oxide E172

Strawberry cream flavour

Ingredients of the strawberry cream flavour:

Maltodextrin Modified starch E1450 Vegetable oil Propylene glycol E1520 6.2. Incompatibilities

Not applicable.

6.3. Shelf-life

2 years.

Polypropylene container only: Use within 6 months of opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

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

Blister pack containing 4, 6 or 8 individually sealed tablets.

Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.

Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets

Coloured, opaque, injection-moulded, polypropylene container with a hinged fliptop lid containing 8, 12, 16, 18, 20, 22 or 24 tablets.

Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into cartons.

Single packs 8, 12, 16, 18, 20, 22 or 24 tablets will be packed into cartons.

Pack sizes 8, 12, 16, 18, 20, 22 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited Dansom Lane

Hull

HU8 7DS United Kingdom.

8. MARKETING AUTHORISATION NUMBER

PL 00063/0135

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/10/2008

10    DATE OF REVISION OF THE TEXT

09/04/2015