Gaviscon Advance Mint chewable tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Potassium bicarbonate; Sodium alginate

Disponibil de la:

Reckitt Benckiser Healthcare (UK) Ltd

INN (nume internaţional):

Potassium bicarbonate; Sodium alginate

Dozare:

100mg ; 500mg

Forma farmaceutică:

Chewable tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 01010201; GTIN: 5000158067745 5000158067752 5000158066366

Prospect

PATIENT INFORMATION LEAFLET
GAVISCON ADVANCE MINT CHEWABLE TABLETS
SODIUM ALGINATE
POTASSIUM BICARBONATE
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE. IF
YOU ARE NOT SURE ABOUT ANYTHING ASK YOUR PHARMACIST OR DOCTOR.
WHAT ARE GAVISCON ADVANCE MINT CHEWABLE TABLETS?
Gaviscon Advance Mint Chewable Tablets belong to a group of
medicines called ‘reflux suppressants’, which form a protective
layer
on top of the stomach contents to prevent stomach acid escaping from
the stomach where it works into the food pipe causing pain and
discomfort.
WHAT ARE GAVISCON ADVANCE MINT CHEWABLE TABLETS USED FOR?
Gaviscon Advance Mint Chewable Tablets are used for the treatment
of symptoms of gastro-oesophageal reflux such as acid regurgitation,
heartburn and indigestion, which may occur, for example, following
meals or during pregnancy, and in patients with symptoms related to
oesophagitis.
It can also be used to relieve the symptoms of conditions such as
hiatus hernia (protrusion of muscle through a muscle wall), symptoms
of hoarseness and other voice disorders, sore throat and cough
associated with reflux. It can be taken to control heartburn symptoms
which may occur while taking, or following withdrawal of medication
to reduce stomach acid such as Proton Pump Inhibitors (PPI’s) or H2
Antagonists.
BEFORE USING GAVISCON ADVANCE MINT CHEWABLE TABLETS:
DO NOT TAKE THIS PRODUCT IF:
•
You know you are allergic to any of the ingredients as very rarely
difficulty in breathing and skin rashes have occurred (see further
information for a full list of ingredients).
TAKE SPECIAL CARE BEFORE TREATMENT WITH GAVISCON ADVANCE MINT
CHEWABLE TABLETS:
This medicine contains calcium (1.0 mmol per tablet dose).
This medicine contains 1.01 mmol (39.43 mg) potassium per tablet.
To be taken into consideration by patients with reduced kidney
function or patients on a controlled potassium diet.
This medicine contains 53.22 mg sodium (main component of
cooking/table salt) in each tablet.
This is equivalent to 2.7 % of the
recommen

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Mint Chewable Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 500 mg and potassium bicarbonate
100 mg.
Excipient(s) with known effect:
Sodium 53.22 mg (2.314 mmol)/tablet
Aspartame (E 951) 4.5 mg/tablet
Potassium 39.43 mg/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, circular, flat with bevelled edges tablet with
the odour
and flavour of peppermint. Each tablet is imprinted with a "Sword and
Circle"
on one side and "GA500" on the reverse.
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. It 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
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: One to two tablets after meals
and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see section
4.4).
4.3
CONTRINDICATIONS
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
If symptoms do not improve after 7 days, the clinical situation should
be rev