Gaviscon Advance

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

POTASSIUM HYDROGEN, CARBONATE, SODIUM ALGINATE

Commercializzato da:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

Codice ATC:

A02BX

INN (Nome Internazionale):

POTASSIUM HYDROGEN CARBONATE 20 mg/ml SODIUM ALGINATE 100 mg/ml

Forma farmaceutica:

ORAL SUSPENSION

Composizione:

POTASSIUM HYDROGEN CARBONATE 20 mg/ml SODIUM ALGINATE 100 mg/ml

Tipo di ricetta:

OTC

Area terapeutica:

DRUGS FOR ACID RELATED DISORDERS

Stato dell'autorizzazione:

Invalid

Data dell'autorizzazione:

2006-04-24

Foglio illustrativo

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Scheda tecnica

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Aniseed Suspension.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/10ML
Sodium alginate
1000.0
Potassium bicarbonate
200.0
3
PHARMACEUTICAL FORM
Oral suspension.
An off-white, viscous suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms resulting from the reflux of acid, bile and
pepsin into
the oesophagus such as acid regurgitation, heartburn, indigestion
(occurring
due to the reflux of stomach contents), for instance, after gastric
surgery, as a
result of hiatus hernia, during pregnancy, accompanying reflux
oesophagitis,
including symptoms of laryngopharyngeal reflux such as hoarseness and
other
voice
disorders,
sore
throats
and
cough.
Can
also
be
used
to
treat
the
symptoms of gastro-oesophageal reflux during concomitant treatment
with or
following withdrawal of acid suppressing therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: 5-10ml after meals and at
bedtime
Children under 12 years: Should be given only on medical advice
Elderly: No dose modification is required for this age group.
Page 2 of 5
4.3
CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected
hypersensitivity to any of the ingredients, or 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 clinical situation
should be
reviewed.
Each 10 ml dose has a sodium content of 106 mg (4.6 mmol) and a
potassium
content of 78 mg (2.0 mmol). 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 or when taking drugs which can
increase
plasma potassium levels.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs
to
be
taken
in
treating
patie