Gaviscon Extra Liquid Sachets Peppermint Flavour Oral SuspensionSodium Alginate 500 mg/10 ml Sodium Bicarbonate 213 mg/10 ml Calcium Carbonate 325 mg/10 ml

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Disponible depuis:

Reckitt Benckiser Ireland Ltd

Code ATC:

A02BX; A02BX13

DCI (Dénomination commune internationale):

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Dosage:

500 mg/10 ml + 213 mg/10 ml + 325 milligram/ 10 millilitre

forme pharmaceutique:

Oral suspension in sachet

Type d'ordonnance:

Product not subject to medical prescription

Domaine thérapeutique:

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid

Statut de autorisation:

Not marketed

Date de l'autorisation:

2012-12-14

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Extra Liquid Sachets
Peppermint Flavour Oral Suspension
Sodium Alginate 500 mg / 10 ml, Sodium Bicarbonate 213 mg / 10 ml
Calcium Carbonate 325 mg / 10 ml
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 any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist.
•
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 Extra Liquid Sachets Peppermint Flavour and what are
they used for?
2.
What you need to know before you take Gaviscon Extra Liquid Sachets
Peppermint Flavour
3.
How to take Gaviscon Extra Liquid Sachets Peppermint Flavour
4.
Possible side-effects.
5.
How to store Gaviscon Extra Liquid Sachets Peppermint Flavour
6.
Contents of the pack and other information.
1.
WHAT ARE GAVISCON EXTRA LIQUID SACHETS PEPPERMINT FLAVOUR AND WHAT
THEY ARE USED FOR?
Gaviscon Extra Liquid Sachets Peppermint Flavour is a combination of
two antacids (calcium carbonate
and sodium bicarbonate) and an alginate which works in two ways:
1.
Neutralising excess stomach acid to relieve the pain and discomfort.
2.
Forming a protective barrier over the stomach contents to soothe the
burning pain in your chest
which may last for up to 4 hours.
This medicine is used for the treatment of acid related symptoms of
gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion, for example following meals
or during pregnancy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON EXTRA LIQUID SACHETS
PEPPERMINT FLAVOUR
DO NOT TAKE GAVISCON EXTRA LIQUID SACHETS PEPPERMINT FLAVOUR IF YOU
know you are ALLERGIC
(hypersensitive

Résumé des caractéristiques du produit

Health Products Regulatory Authority
10 September 2020
CRN009J21
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Extra Liquid Sachets Peppermint Flavour Oral SuspensionSodium
Alginate 500 mg/10 ml Sodium Bicarbonate 213
mg/10 ml Calcium Carbonate 325 mg/10 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose (sachet) contains sodium alginate 500 mg, sodium
bicarbonate 213 mg and calcium carbonate 325 mg.
Excipients with known effects:
Methyl parahydroxybenzoate (E218) 40 mg
Propyl parahydroxybenzoate (E216) 6 mg
Sodium 127.88 mg
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension in sachet.
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 (1 to 2 sachets) 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 127.88 mg sodium per 10 ml / 1 sachet
dose, equivalent to 6.39% 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 maximum daily intake for sodium.
This product is considered high in sodium. This should be taken into
account when a highly restricted salt diet is
recommended, e.g. in some cases of congestive cardiac failure and
renal impairment.
Each 10 ml (sachet) contains 130 mg (3.25 mmol) of calcium. C