Gaviscon Oral Suspension 500mg/10ml Sodium Alginate 267mg/10ml Sodium Bicarbonate 160mg/10ml Calcium Carbonate

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium bicarbonate; Calcium carbonate; Sodium alginate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02AX; A02AX13

INN (International Name):

Sodium bicarbonate; Calcium carbonate; Sodium alginate

Dosage:

500mg/10 ml+267mg/10ml+160 milligram/ 10 millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antacids, other combinations; Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)

Authorization status:

Marketed

Authorization date:

1978-05-03

Patient Information leaflet

LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Liquid Aniseed Flavour Oral Suspension
Sodium alginate 500mg/10ml, Sodium bicarbonate 267mg/10ml, Calcium
carbonate 160mg/10ml
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 still
need to take this medicine carefully to
get the best results from it.
Always use 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 is Gaviscon Liquid and what is it used for?
2.
What you need to know before taking Gaviscon Liquid
3.
How to take Gaviscon Liquid
4.
Possible side-effects
5.
How to store Gaviscon Liquid
6.
Contents of the pack and other information.
1.
WHAT GAVISCON LIQUID IS AND WHAT IT IS USED FOR?
Gaviscon Liquid belongs 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.
2.
WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON LIQUID
DO NOT TAKE GAVISCON LIQUID:

If you know you are allergic (hypersensitive) to any of the
ingredients in this product (see “further
information” for

Summary of Product characteristics

Health Products Regulatory Authority
04 May 2021
CRN00C7ZY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Oral Suspension 500mg/10ml Sodium Alginate 267mg/10ml Sodium
Bicarbonate 160mg/10ml Calcium Carbonate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS MG/10ML
Sodium alginate 500
Sodium bicarbonate 267
Calcium carbonate 160
Excipients with known effect:
Sodium 142.6mg (6.2 mmol) / 10ml. Total maximum daily dose (MDD) is
1140.8mg (49.6 mmol)
Benzyl alcohol 1.1mg / 10ml, present in fennel flavour
Methyl parahydroxybenzoate (E218) 40mg / 10 ml
Propyl parahydroxybenzoate (E216) 6mg / 10 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
An opaque, pink, viscous oral suspension with an odour of fennel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of gastric reflux, reflux oesophagitis, hiatus
hernia, heartburn (including heartburn of pregnancy) and
similar gastric distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN OVER 12 YEARS: 10-20 ml(two to four 5 ml
spoonfuls) after meals and before retiring.
CHILDREN UNDER 12 YEARS: Should only be given on medical advice.
CHILDREN 6-12 YEARS: 5-10 ml (one to two 5 ml spoonfuls) after meals
and before retiring.
SPECIAL PATIENT GROUPS ELDERLY: No dosage modification is required in 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.
Health Products Regulatory Authority
04 May 2021
CRN00C7ZY
Page 2 of 5 DURATION OF TREATMENT If symptoms do not improve after seven days, the clinical situation
should be reviewed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1, including methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all medicine