Gaviscon Extra Chewable TabletsSodium alginate 250mgSodium bicarbonate 106.5mgCalcium carbonate 187.5mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Dosage:

250 mg/106.5 mg/187.50 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:

2010-10-01

Patient Information leaflet

PATIENT LEAFLET INFORMATION FOR THE USER
GAVISCON DOUBLE ACTION TABLETS
Sodium alginate, Sodium bicarbonate and calcium carbonate.
Please read this leaflet carefully before you take 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 you feel worse
after
7 days.
What is in this leaflet:
1.
What are Gaviscon Double Action Tablets and what are they used for?
2.
What do you need to know before taking
Gaviscon Double Action
Tablets
3.
How to take Gaviscon Double Action Tablets
4.
Possible side-effects
5.
How to store Gaviscon Double Action Tablets
6.
Contents of the pack and further information.
1.
WHAT ARE GAVISCON DOUBLE ACTION TABLETS
AND
WHAT ARE THEY USED FOR?
Gaviscon Double Action Tablets are a combination of two antacids
(calcium
carbonate and sodium bicarbonate) and an alginate which works in two
ways:
1.
Neutralising excess stomach acid to relieve the pain and discomfort.
2.
Forming a protective barrier over the stomach contents to soothe the
burning pain in your chest which may last for up to 4 hours.
Reckitt Benckiser
0025 NL H 4534 001 GI Jane
1.3.1 Package Leaflet clean
Gaviscon Double Action MRP Peppermint Tablets 0041116
Page 1
This medicine is used for the treatment of acid related symptoms of
gastro-
oesophageal reflux such as acid regurgitation, heartburn and
indigestion which
may occur, for example, following meals, or during pregnancy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON
DOUBLE ACTION TABLETS
:
DO NOT TAKE GAVISCON DOUBLE ACTION TABLETS
:
If you are allergic to any of the ingredients of this medicine (listed
in section 4).
TALK TO YOUR DOCTOR

Summary of Product characteristics

Health Products Regulatory Authority
09 April 2020
CRN009K2L
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Extra Chewable TabletsSodium alginate 250mgSodium bicarbonate
106.5mgCalcium carbonate 187.5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5
mg and calcium carbonate 187.5 mg.
Excipients:
Aspartame (E951) 5.863mg per tablet
Carmoisine Lake (E122) 0.375mg per tablet
Sucrose 0.5 mg per tablet
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of
the tablet is pink and slightly mottled, and the other white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acid related symptoms of gastro-oesophageal reflux such
as acid regurgitation, heartburn and indigestion, for
example following meals or during pregnancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
If symptoms do not improve after seven days, the clinical situation
should be reviewed. Prolonged use should be avoided.
POSOLOGY
Adults and children 12 years and over: Two to four tablets after meals
and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
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
Each tablet dose contains 75 mg (1.88 mmol) of calcium. Care needs to
be taken in treating patients with hypercalcaemia,
nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains 55.89 mg sodium per tablet, equivalent
to 2.80% of the WHO recommended maximum daily
intake for sodium.
The maximum daily dose of this product is equivalent t