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Gaviscon Strawberry Flavour Chewable Tablets

Document: leaflet MAH BRAND_PL 00063-0135 change

PROPOSED LEAFLET TEXT (BLISTERS OR HANDYPACKS IN A CARTON) Package leaflet: Information for the user GAVISCON STRAWBERRY FLAVOUR CHEWABLE TABLETS 500mg/267mg/160mg Chewable Tablets

Sodium alginate/ Sodium hydrogen carbonate/ Calcium carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.    What are Gaviscon Strawberry Flavour Chewable Tablets and what are they used for

2.    What you need to know before you take Gaviscon Strawberry Flavour Chewable Tablets

3.    How to take this Gaviscon Strawberry Flavour Chewable Tablets

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

1.    What are Gaviscon Strawberry Flavour Chewable Tablets and what are they used for?

Gaviscon Strawberry Flavour Chewable Tablets belong 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.

Gaviscon Strawberry Flavour Chewable Tablets are used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), which may occur, for example, following meals or during pregnancy, and in patients with symptoms related to oesophagitis.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2.    What you need to know before you take Gaviscon Strawberry Flavour Chewable Tablets Do not take this product if:

-    you know that you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occurred (see section 6 for a full list).

Warnings and precautions:

This medicine contains sodium (10.6 mmol per four tablet dose) and calcium (3.2 mmol per four tablet dose).

-    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.

This medicine contains aspartame: If you have phenylketonuria, note that this product is sweetened with aspartame, a source of phenylalanine.

Taking other medicines:

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.

Pregnancy and breast-feeding:

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

3. How to take Gaviscon Strawberry Flavour Chewable Tablets:

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, it is not necessary to double the dose next time, just carry on taking as before.

If you take more than you should you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist.

4.    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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store this medicine:

Do not use this product after the expiry date (EXP: month/year) shown.

<Handypack only>Use within 6 months of opening.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25oC.

6.    Contents of the pack and other information What this medicine contains

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), red iron oxide, xylitol and carmellose sodium, magnesium stearate.

These tablets do not contain sugar or gluten.

What this medicine looks like and contents of the pack

Gaviscon Strawberry Flavour Chewable 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

Gaviscon Strawberry Flavour Chewable Tablets are available in 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.

Marketing Authorisation Holder and Manufacturer

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU87DS United Kingdom.

This medicinal product is authorised in the Member States of the EEA under the following names

Gaviscon Strawberry Flavour Chewable Tablets This leaflet was last revised in May 2015