Gaviscon Extra Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 213 mg Calcium carbonate 325 mg

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:

500 mg+213 mg+325 milligram(s)

Pharmaceutical form:

Oral suspension

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

PEEL & REVEAL LABEL TEXT
Gaviscon Extra Oral Suspension
Sodium Alginate 500mg
Sodium bicarbonate 213mg
Calcium carbonate 325mg
150ml
300ml
600ml
Mint Flavour
Each 10ml contains sodium alginate 500mg, sodium bicarbonate 213mg and
calcium carbonate 325mg.
Also contains methyl (E218) and propyl (E216) parahydroxybenzoates,
sodium and calcium.
See leaflet for further information
Consult your doctor if you are over 40 years and have never suffered
with heartburn and indigestion before.
High in sodium – see leaflet for further details. Contains calcium.
If you have been advised to follow a diet
restricted in either of these please consult your doctor before taking
this product.
DOSAGE:
For oral use. Shake well before use.
Read the package leaflet before use.
KEEP OUT OF THE REACH & SIGHT OF CHILDREN
ADULTS INCLUDING THE ELDERLY AND CHILDREN 12 YEARS AND OVER: 10 to 20
mls after meals or at bedtime, or as
directed up to four times a day.
CHILDREN UNDER 12 YEARS OLD: Should only be taken on medical advice.
If symptoms persist after 7 days consult your doctor.
Do not store above 30
o
C and store in the original package.
Do not freeze or refrigerate.
Do not use after the expiry date (EXP: month/year) shown.
Use within 6 months of opening.
PA 979/15/11
PA Holder: Reckitt Benckiser Ireland Ltd, Dublin 24.
LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Extra Oral Suspension
Sodium alginate 500mg
Sodium bicarbonate 213mg
Calcium carbonate 325mg
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
wor

Summary of Product characteristics

Health Products Regulatory Authority
11 May 2021
CRN00C4M4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Extra Oral Suspension Sodium alginate 500 mg Sodium
bicarbonate 213 mg Calcium carbonate 325 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate
213 mg and calcium carbonate 325 mg.
Excipients:
Methyl parahydroxybenzoate (E218) 40mg/10ml
Propyl parahydroxybenzoate (E216) 6mg/10ml
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
An off-white suspension with the odour and flavour of peppermint.
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
For oral administration.
Adults and children 12 years and over: 10-20 ml 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.
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
This medicinal product contains 255.76mg sodium per 20ml dose,
equivalent to 12.79% of the WHO recommended maximum
daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% of the
WHO recommended daily maximum intake for sodium.
This product is considered high in sodium and this should be taken
into account by those who have been advised to follow a
low salt diet by their doctor e.g in some cases of congestive cardiac
failure and renal impairment.
Each 10 ml contains 130 mg (3.25 mmol) of calcium. Care needs to be
taken in treating patients with hypercalcaemia,
nephrocalcinosis and recurrent calcium containing renal