GAVISCON ADVANCE TABLETS

Active substance: SODIUM ALGINATE

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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

Package leaflet
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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