Gaviscon Advance Peppermint Oral Suspension Sachets Sodium Alginate 500mg, Potassium hydrogen carbonate 100 mg Oral suspension.

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 PATIENT
Gaviscon Advance Peppermint Oral Suspension Sachets
sodium alginate 500 mg
potassium hydrogen carbonate 100 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
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 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 Sachets are and what they are used for
2.
What you need to know before you take Gaviscon Advance Sachets
3.
How to take Gaviscon Advance Sachets
4.
Possible side effect
5.
How to store Gaviscon Advance Sachets
6.
Contents of the pack and other information
1.
WHAT GAVISCON ADVANCE SACHETS ARE AND WHAT THEY ARE 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, 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 ADVANCE SACHETS
DO NOT TAKE GAVISCON ADVANCE SACHETS:
•
if you know you are allergic to any of the ingredients (listed in
section 6).
WARNINGS AND PRECAUTIONS
THIS MEDICINE CONTAINS 57.85 MG SODIUM

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 Sachets Sodium Alginate
500mg, Potassium hydrogen carbonate 100 mg Oral
suspension.
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 in sachets.
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: 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.
Any unused solution should be discarded.
Health Products Regulatory Authority
09 February 2023
CRN00DC3L
Page 2 of 4
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 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 days, the clinic