Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate 160mg

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+267 mg+160 milligram(s)

Pharmaceutical form:

Oral suspension in sachet

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:

2010-10-01

Patient Information leaflet

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Liquid Sachets Oral Suspension
Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate
160mg
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 will
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 THE LEAFLET
1. What are Gaviscon Liquid Sachets and what are they used for?
2. What you need to know before taking Gaviscon Liquid Sachets
3. How to take Gaviscon Liquid Sachets
4. Possible side-effects
5. How to store Gaviscon Liquid Sachets
6. Contents of the pack and other information.
1. WHAT ARE GAVISCON EXTRA LIQUID SACHETS AND WHAT THEY ARE USED FOR?
Gaviscon Liquid Sachets belongs to a group of medicines called
“reflux suppressants”, which
act rapidly (in 3 minutes) to form a protective layer on top of the
stomach contents for up to 4
hours to prevent stomach acid escaping from the stomach where it works
into the food pipe
causing pain and discomfort.
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
oesophatitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON LIQUID SACHETS
DO NOT TAKE GAVISCON LIQUID SACHETS:
If you know that you are allergic (hypersensitive) to any of the
ingredients of
Gaviscon Liquid Sachet

Summary of Product characteristics

Health Products Regulatory Authority
19 July 2022
CRN00CZ9Q
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium
bicarbonate 267mg, Calcium carbonate 160mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon contains 500mg sodiumalginate, 267mg sodium bicarbonate and
160mg calcium carbonate per 10 ml dose.
Excipients: methyl parahydroxybenzoate (E218) 40 mg/10ml and propyl
parahydroxybenzoate
(E216) 6 mg/10 ml.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension in sachets.
An off-white suspension with the odour and flavour of peppermint.
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: One to two sachets after meals
and at bedtime (up to four times a day).
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 modifications necessary 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 administration
4.3 CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected hypersensitivity to sodium alginate, sodium
bicarbonate, and calcium carbonate,or to any of the excipients listed
ins ection 6.1, including methylparahydroxybenzoate
(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 clinical situation
should be reviewed.
This medicin