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

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Potassium hydrogen carbonate; Sodium alginate

Доступно од:

Reckitt Benckiser Ireland Ltd

АТЦ код:

A02BX

INN (Међународно име):

Potassium hydrogen carbonate; Sodium alginate

Дозирање:

500mg/ 5 ml+100 mg/5ml

Фармацеутски облик:

Oral suspension

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

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

Статус ауторизације:

Marketed

Датум одобрења:

1998-08-14

Информативни летак

LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Advance Oral Suspension
Sodium alginate 500mg, Potassium hydrogen carbonate 100mg.
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 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 effects
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
Gaviscon Advance 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
DO NOT TAKE GAVISCON ADVANCE:
-
if you know you are allergic to any of the ingredients in 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

Карактеристике производа

Health Products Regulatory Authority
09 February 2023
CRN00DC3L
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance 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.
Excipient(s) with known effect:
Methylparahydroxybenzoate (E218) (20 mg per 5 ml)
Propylparahydroxybenzoate (E216) (3 mg per 5 ml)
Sodium (57.85 mg per 5 ml)
Benzyl alcohol (0.525 mg per 5 ml) present in fennel flavour
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 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.
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 5
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
(E218) and propyl parahydroxybenzoate (E216) (see