iMedi.co.uk

Gaviscon Advance Tablets

Informations for option: Gaviscon Advance Tablets, show other option

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON


1. NAME OF THE MEDICINAL PRODUCT


Gaviscon Advance Chewable Tablets Peppermint Flavour


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Each chewable tablet contains 500 mg sodium alginate and 100mg potassium bicarbonate as the active ingredients.


3. LIST OF EXCIPIENTS


Contains aspartame (E951), sodium and calcium. See leaflet for further information


4. PHARMACEUTICAL FORM AND CONTENTS


12 Chewable Tablets 24 Chewable Tablets


5. METHOD AND ROUTE(S) OF ADMINISTRATION


For oral administration. Chew thoroughly before swallowing. Read the package leaflet before use.


6.    SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN


Keep out of the sight and reach of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


If symptoms persist after 7 days consult your doctor.


8. EXPIRY DATE


MM/YYYY.

9. SPECIAL STORAGE CONDITIONS


Do not store above 30oC. Store in original package.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


Not applicable

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS. 12. MARKETING AUTHORISATION NUMBER(S)

PL 00063/0144

13. BATCH NUMBER


BN


14. GENERAL CLASSIFICATION FOR SUPPLY


GSL

15. INSTRUCTIONS ON USE


Adults, including the elderly and children 12 years and over. When symptoms occur take one to two tablets after meals and at bedtime, or as directed. Children under 12 years: Should only be taken on medical advice.

16.


INFORMATION IN BRAILLE


Gaviscon Advance Chewable Tablets Peppermint Flavour

Sodium alginate Potassium bicarbonate

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told 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 Gaviscon Advance Chewable Tablets are and are they used for

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

3.    How to take Gaviscon Advance Chewable Tablets

4.    Possible side effects

5.    How to store Gaviscon Advance Chewable Tablets

6.    Contents of the pack and other information

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

Gaviscon Advance Chewable Tablets Peppermint Flavour bring fast, soothing and long lasting relief from the pain and discomfort of heartburn and acid indigestion. They can also be used to treat the symptoms of conditions such as hiatus hernia and reflux oesophagitis (inflamed food pipe). They 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 where it hurts.

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

Do not take Gaviscon Advance Chewable Tablets: if you know you are allergic to any of the

ingredients as skin rashes and difficulty in breathing have been reported. See section 6 for a full list of ingredients.

If symptoms persist after 7 days consult your doctor.

Talk to your doctor or pharmacist before taking:

-    Each two-tablet dose contains 4.5 mmol of sodium, 2.0 mmol of potassium and 2.0 mmol of calcium. If you have been advised to follow a diet restricted in any of these please consult your doctor before taking this product.

-    May cause central nervous system depression in the presence of renal insufficiency and should not be used in patients with renal failure.

This product contains aspartame (E951). If you have phenylketonuria, note that the product is sweetened with aspartame (E951), a source of phenylalanine.

Other medicines and Gaviscon Advance Chewable Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

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

3. How to take Gaviscon Advance Chewable Tablets

For oral administration. Chew thoroughly before swallowing.

Adults, including the elderly and children 12 years and over. When symptoms occur take one to two tablets after meals and at bedtime, or as directed.

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

If you take more Gaviscon Advance Chewable Tablets than you should 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 Advance Chewable Tablets it is not necessary to double the dose next time, just carry on taking as before.

4.    Possible side effects

Like all medicines, this medicine 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 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 via the yellow card scheme 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 Advance Chewable Tablets

Do not use this medicine after the expiry date (EXP: month/year) shown. Keep out of the sight and reach of children. Do not store above 30oC. Store in original package.

6.    Contents of the pack and other information What Gaviscon Advance Chewable Tablets contains

Each chewable tablet contains 500 mg sodium alginate and 100mg potassium bicarbonate as the active ingredients. The tablets also contain mannitol (E421), calcium carbonate, macrogol 20,000, copovidone, magnesium stearate, aspartame (E951), acesulfame potassium and mint flavour.

What Gaviscon Advance Chewable Tablets looks like and contents of the pack

An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint. Blister tray containing six individually sealed tablets. Two or four blister trays in a carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer: Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU8 7DS

This leaflet was last revised in 02/2014.