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Gaviscon Peppermint Tablets

Document: leaflet MAH BRAND_PL 00063-0134 change

LEAFLET TEXT

GAVISCON PEPPERMINT TABLETS Sodium alginate Sodium hydrogen carbonate Calcium carbonate

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take this medicine carefully to get the best results from it.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve after 7 days.

•    If any of the side-effects gets serious, or if you notice any side-effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What are Gaviscon Peppermint Tablets and what are they used for?

2.    Before you take Gaviscon Peppermint Tablets.

3.    How to take Gaviscon Peppermint Tablets.

4.    Possible side effects.

5.    How to store Gaviscon Peppermint Tablets.

6.    Further information.

1.    WHAT ARE GAVISCON PEPPERMINT TABLETS AND WHAT ARE THEY USED FOR?

Gaviscon Peppermint Tablets form a protective layer which floats above the contents of the stomach. This layer prevents stomach acid escaping from the stomach into the food pipe, thus relieving the burning feeling of heartburn and the feeling of discomfort in the throat and mouth. Heartburn may occur following meals (e.g. when eating fatty or spicy food) or during pregnancy, or in patients with symptoms related to an inflammation in the wall of the food pipe (e.g. difficult and/or painful swallowing, mouth sores, vomiting).

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

2.    BEFORE YOU TAKE GAVISCON PEPPERMINT TABLETS:

Do not take Gaviscon Peppermint Tablets:

-    if you know that you are allergic (hypersensitive) to any of the ingredients of Gaviscon Peppermint Tablets as very rarely difficulty in breathing and skin rashes have occurred (see further information for a full list).

Take special care with Gaviscon Peppermint Tablets:

This medicine contains sodium (5.3 mmol per two tablet dose) and calcium (1.6 mmol per two 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.

If symptoms persist after 7 days please consult your doctor.

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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.

Pregnancy and breast-feeding:

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

Important information about some of the ingredients of Gaviscon Peppermint Tablets If you have phenylketonuria, note that the product is sweetened with aspartame, a source of phenylalanine.

3.    HOW TO TAKE GAVISCON PEPPERMINT 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, up to four times a day.

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

If you take more Gaviscon Peppermint Tablets than you should

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.

If you forget to take Gaviscon Peppermint Tablets

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Gaviscon Peppermint Tablets can cause side effects, although not everybody gets them.

If you experience these side-effects-stop taking the product and consult your doctor immediately. 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.

Reporting side effects

If you get any side effects please talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 GAVISCON PEPPERMINT TABLETS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not use Gaviscon Peppermint Tablets after the expiry date which is stated on the blister and carton {EXP: month/year}. The expiry date refers to the last day of that month.

Do not store above 30oC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Gaviscon Peppermint Tablets contain

The active substances in each chewable tablet are 250 mg sodium alginate, 133.5 mg sodium hydrogen carbonate and 80 mg calcium carbonate. The other ingredients are mannitol (E421), macrogol 20,000, copovidone, aspartame (E951), peppermint flavouring, magnesium stearate and acesulfame potassium.

These tablets do not contain sugar or gluten.

What Gaviscon Peppermint Tablets look like and contents of the pack

Gaviscon Peppermint Tablets are circular tablets with an off white to cream, slightly mottled

appearance.

8 chewable tablets.

16 chewable tablets.

20 chewable tablets.

24 chewable tablets.

32 chewable tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS,

United Kingdom

This medicinal product is authorised in the member states of the EA under the following names:

Gaviscon Peppermint Tablets

This leaflet was last approved in

February 2015