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Gaviscon Strawberry Flavour Chewable Tablets

Document: label-leaflet MAH BRAND_PL 00063-0135 change

PROPOSED LEAFLET TEXT (HANDY PACK PRESENTATION)

GAVISCON STRAWBERRY FLAVOUR CHEWABLE TABLETS

Sodium alginate

Sodium hydrogen carbonate

Calcium carbonate

These tablets bring relief from the pain and discomfort of heartburn and acid indigestion, which for example, can occur after meals or during pregnancy. This product belongs to a group of medicines called “reflux suppressants”, which form a protective layer on top of the stomach contents to prevent stomach acid escaping from the stomach where it works into the food pipe causing pain and discomfort.

BEFORE TAKING THIS PRODUCT: Do not take if you know that you are allergic to any of the

ingredients (see further information for a full list).

Each four tablet dose contains 10.6 mmol of sodium and 3.2 mmol of calcium. If you have been advised to follow a diet restricted in either of these salts please consult your doctor before taking this product. Please also talk to your doctor regarding these salt contents if you suffer or have suffered from significant kidney or heart disease, as certain salts could interfere with these diseases.

If you have phenylketonuria, note that the product is sweetened with aspartame a source of phenylalanine.

You can take this product if you are pregnant or breast-feeding.

DOSAGE: For oral administration. Chew thoroughly before swallowing.

Adults, including the elderly and children 12 years and over: When symptoms occur take two to four tablets after meals and at bedtime.

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

If you forget a dose do not double the dose next time, just carry on taking as before. If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist.

Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines.

AFTER TAKING THIS PRODUCT: If symptoms persist after 7 days consult your doctor. POSSIBLE SIDE EFFECTS: Very rare (less than 1 in 10,000) chance of an allergic reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately.

FURTHER INFORMATION: These tablets are pale pink, circular, flat with bevelled 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. Each chewable tablet contains 250 mg sodium alginate, 133.5 mg sodium hydrogen carbonate and 80 mg calcium carbonate as the active ingredients. The other ingredients are mannitol (E421), macrogol 20 000, aspartame (E951), strawberry flavouring (maltodextrin, modified starch E1450, vegetable oil, propylene glycol E1520), magnesium stearate, red iron oxide, xylitol and carmellose sodium.

These tablets do not contain sugar or gluten.

Do not store above 25oC.

Do not use after the expiry date shown. Use within 6 months of opening Keep out of the reach and sight of children.

Last revised: May 2015