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Gaviscon Cool Mint Liquid

Document: leaflet MAH BRAND_PL 00063-0158 change

LEAFLET TEXT

Gaviscon Cool Mint Liquid.

Sodium alginate, sodium hydrogen carbonate and 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 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.

In this leaflet:

1.    What is Gaviscon Cool Mint Liquid and what is it used for?

2.    Before you take Gaviscon Cool Mint Liquid.

3.    How to take Gaviscon Cool Mint Liquid.

4.    Possible side effects.

5.    How to store Gaviscon Cool Mint Liquid.

6.    Further information.

1.    WHAT IS GAVISCON COOL MINT LIQUID AND WHAT IS IT USED FOR?

Gaviscon Cool Mint Liquid 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.

This medicine is 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, or in patients with symptoms related to reflux oesophagitis.

2.    BEFORE YOU TAKE GAVISCON COOL MINT LIQUID Do not take Gaviscon Cool Mint Liquid

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

Take special care with Cool Mint Liquid

This medicine contains small amounts of sodium (6.2 mmol per 10 ml) and calcium (1.6 mmol per 10 ml).

-    If you have been advised to follow a diet restricted in any of these please consult your doctor.

-    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 Cool Mint Liquid

This product contains methyl (E218) and propyl (E216) para-hydroxybenzoates which may cause allergic reactions (possibly delayed).

3. HOW TO TAKE GAVISCON COOL MINT LIQUID

For oral administration.

Shake well before use.

Adults, including the elderly and children 12 years and over: 10-20 ml after meals and at bedtime (up to four times a day).

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

If you take more Gaviscon Cool Mint Liquid than you should

If you take too much of this product it is unlikely to cause you any harm. However, you may feel bloated. Consult your doctor if this doesn’t go away.

If you forget to take Gaviscon Cool Mint Liquid

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 Cool Mint Liquid 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, 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 COOL MINT LIQUID

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Do not use Gaviscon Cool Mint Liquid after the expiry date which is stated on the label {EXP: month/year}. The expiry date refers to the last day of that month.

Do not store above 30oC. Do not freeze or refrigerate

Check that the cap seal is unbroken before first using this product.

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 Cool Mint Liquid contains

The active substances in each 10 ml of oral suspension contains 500 mg sodium alginate, 267 mg sodium hydrogen carbonate and 160 mg calcium carbonate as the active ingredients. The other ingredients are carbomer, methyl (E218) and propyl (E216) parahydroxy-benzoates, saccharin sodium, sodium hydroxide, mint flavour no. 4, mint flavour no. 5 and purified water. This product does not contain sugar or gluten.

What Gaviscon Cool Mint Liquid looks like and contents of the pack

Gaviscon Cool Mint Liquid is an off-white suspension with the odour and flavour of peppermint.

Gaviscon Cool Mint Liquid is available in bottles of 150 ml or 300 ml.

Marketing Authorisation Holder and Manufacturer

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

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

Gaviscon Cool Mint Liquid.

This leaflet was last approved in

November, 2014.