Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium bicarbonate; Sodium alginate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Potassium bicarbonate; Sodium alginate

Dosage:

500/100 milligram(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2006-02-10

Patient Information leaflet

LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USE
Gaviscon Advance Chewable Tablets
Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you will
still need to take this medicine
carefully to get the best results from it.
Always us this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse 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, pharmacist or nurse.
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 what they are used for
2.
What you need to know before taking 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 GAVISCON ADVANCE CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
Gaviscon Advance Chewable Tablets belong to a group of medicines
called “reflux suppressants”. This
product forms a protective layer that floats on top of the stomach
contents. This layer prevents reflux and
keeps the stomach contents away from the lining of the food pipe to
relieve the symptoms of heartburn
and acid indigestion.
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.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON

Summary of Product characteristics

Health Products Regulatory Authority
09 February 2023
CRN00DC3L
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium
hydrogen carbonate 100 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 500 mg and potassium hydrogen
carbonate 100 mg.
Excipient with known effect:
Aspartame (E951) (4.5mg per tablet).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, circular, flat with bevelled edges tablet with
the odour and flavour of
peppermint. Each tablet is imprinted with a Sword and Circle on one
side and GA 500
on the reverse
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and children 12 years and over: One to two tablets after meals
and at bedtime.
Children under 12 years: Should be given only on medical advice.
Duration of treatment:
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
Special Patient Groups:
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.
4.3 CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected hypersensitivity to the active substances or to
any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
09 February 2023
CRN00DC3L
Page 2 of 4
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
Each tablet contains 1.0