Gaviscon Extra Mixed Berries Flavour Chewable Tablets Sodium alginate 250 mg Sodium hydrogen carbonate 106.5 mg Calcium carbonate 187.5 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate

Pharmaceutical form:

Chewable tablet

Therapeutic area:

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid

Authorization status:

Not marketed

Authorization date:

2023-10-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GAVISCON EXTRA MIXED BERRIES CHEWABLE TABLETS
SODIUM ALGINATE 250 MG, SODIUM HYDROGEN CARBONATE 106.5 MG, CALCIUM
CARBONATE 187.5 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use 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 are Gaviscon Extra Mixed Berries Chewable Tablets and what are
they used for?
2.
What you need to know before taking Gaviscon Extra Mixed Berries
Chewable Tablets.
3.
How to take Gaviscon Extra Mixed Berries Chewable Tablets.
4.
Possible side-effects.
5.
How to store Gaviscon Extra Mixed Berries Chewable Tablets.
6.
Contents of the pack and further information.
1.
WHAT ARE GAVISCON EXTRA MIXED BERRIES CHEWABLE TABLETS AND
WHAT ARE THEY USED FOR?
Gaviscon Extra Mixed Berries Chewable Tablets are a combination of an
alginate and two
antacids (calcium carbonate and
sodium hydrogen carbonate) which works in two ways:
1.
Forming a protective barrier over the stomach contents to soothe the
burning pain in
your chest which may last for up to 4 hours.
2.
Neutralising excess stomach acid to relieve the pain and discomfort.
This medicinal product is used for the treatment of acid related
symptoms of gastro-
oesophageal reflux
such as heartburn, acid regurgitation and indigestion, for example
following
meals, or during pregnancy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON EXTRA MIXED
BERRIES CHEWABLE TABLETS
DO NOT TAKE THIS MEDICINE IF:
-
you know you are allergic to any of the ingredients of this medicine
(listed in section 6).
WAR

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2024
CRN00F39C
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Extra Mixed Berries Flavour Chewable Tablets Sodium alginate
250 mg Sodium hydrogen carbonate 106.5 mg
Calcium carbonate 187.5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 250 mg sodium alginate, 106.5 mg sodium
hydrogen carbonate and 187.5 mg calcium
carbonate.
Excipient(s) with known effect:
Aspartame (E951) 5.86 mg per chewable tablet
Carmoisine Lake (E122) 0.375 mg per chewable tablet
Sucrose 1.59 mg per chewable tablet
Sodium 55.936 mg per chewable tablet
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
A 15 mm flat, circular, bi-layer chewable tablet with bevelled edges.
One layer of the chewable tablet is pink and slightly
mottled with GDB surface markings, and the other white with sword and
circle surface markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acid related symptoms of gastro-oesophageal reflux such
as heartburn, acid regurgitation and indigestion, for
example following meals or during pregnancy.
The product is indicated in adults and children aged 12 years and
over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults and children 12 years and over: Two to four chewable tablets
after meals and at bedtime, up to four times per day.
PAEDIATRIC:
Children under 12 years: Treatment of children younger than 12 years
of age is not recommended.
ELDERLY:
No dose modifications necessary for this age group.
HEPATIC IMPAIRMENT:
No modifications necessary
RENAL INSUFFICIENCY:
Caution if highly restricted salt diet is necessary (see section 4.4).
METHOD OF ADMINISTRATION:
For oral administration after being thoroughly chewed.
DURATION OF TREATMENT:
Health Products Regulatory Authority
31 January 2024
CRN00F39C
Page 2 of 5
The recommended maximum duration of use without medical intervention
is 7 days. If symptoms do not improve after 7 days,
the clinical situation