Gaviscon Advance Peppermint Oral Suspension Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alginate; Potassium hydrogen carbonate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Sodium alginate; Potassium hydrogen carbonate

Dosage:

1000/200 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:

Not marketed

Authorization date:

2004-03-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Advance Peppermint Oral Suspension
Sodium alginate 500 mg
Potassium hydrogen carbonate 100 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take 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 Gaviscon Advance is and what it is used for
2.
What you need to know before you take Gaviscon Advance
3.
How to take Gaviscon Advance
4.
Possible side effect
5.
How to store Gaviscon Advance
6.
Contents of the pack and other information
1.
WHAT GAVISCON ADVANCE IS AND WHAT IT IS USED FOR
This product 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, 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 ADVANCE
DO NOT TAKE GAVISCON ADVANCE:
•
if you know you are allergic to any of the ingredients of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
THIS MEDICINE CONTAINS 57.85 MG SODIUM
(main component of cooking/table salt) in each 5 ml dose.
This is the equivalent of 2.9

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 Peppermint Oral Suspension Sodium alginate 500 mg,
Potassium hydrogen carbonate 100 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains sodium alginate 500 mg and potassium hydrogen
carbonate 100 mg.
Excipients with known effect:
Methylparahydroxybenzoate (E218) (20 mg / 5 ml)
Propylparahydroxybenzoate (E216) (3 mg / 5 ml)
Sodium (57.85 mg / 5 ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Off-white viscous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of symptoms of gastro-oesophageal refluxsuch as acid
regurgitation, heartburn and indigestion (related to reflux),
forexample, following meals, or during pregnancy, or in patients with
symptomsrelated to reflux oesophagitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and children 12 years and over: 5-10 ml 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 modification is required 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 use.
Shake well before use. Check that the cap seal is unbroken before
first taking the product.
Health Products Regulatory Authority
09 February 2023
CRN00DC3L
Page 2 of 4
4.3 CONTRAINDICATIONS
The 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, including methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) (see section 4.4).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after seven da