GUARDIUM ACID REFLUX RELIEF esomeprazole 20 mg (as esomeprazole magnesium) enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium, Quantity: 20.7 mg (Equivalent: esomeprazole magnesium, Qty 20 mg; Equivalent: esomeprazole, Qty 20 mg)

Available from:

Reckitt Benckiser Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: hyprolose; purified talc; macrogol 4000; crospovidone; macrogol 400; macrogol 6000; microcrystalline cellulose; povidone; diethyl phthalate; hypromellose phthalate; sodium stearylfumarate; maize starch; sucrose; titanium dioxide; hypromellose; iron oxide red

Administration route:

Oral

Units in package:

14, 7

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

For the symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastroesophageal reflux disease (GORD).

Product summary:

Visual Identification: Light brick red to brown, oval, biconvex, film-coated tablets with 'E5' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-05-25

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
GUARDIUM ACID REFLUX RELIEF
(ESOMEPRAZOLE MAGNESIUM)
1.
NAME OF THE MEDICINE
Esomeprazole magnesium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole magnesium 20.7 mg (equivalent to Esomeprazole 20 mg).
Esomeprazole magnesium is a substituted benzimidazole. Esomeprazole is
the S-isomer of
omeprazole. It is optically stable in vivo, with negligible conversion
to the R-isomer.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Enteric-coated tablets.
Each enteric-coated tablet comprises enteric-coated pellets with
esomeprazole magnesium equivalent
to esomeprazole 20 mg.
Guardium Acid Reflux Relief are light brick-red to brown, oval,
biconvex, enteric-coated tablets with
‘E5’ debossed on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Guardium Acid Reflux Relief is indicated for the symptomatic relief of
frequent heartburn, acid
regurgitation and other symptoms associated with gastroesophageal
reflux disease (GORD).
4.2.
DOSE AND METHOD OF ADMINISTRATION
Guardium Acid Reflux Relief should be swallowed whole with liquid. The
tablets should not be chewed
or crushed.
If required, the tablets can also be dispersed in half a glass of
non-carbonated water (mineral water is
not suitable). No other liquids should be used. Stir until the tablets
disintegrate and drink the liquid
with the pellets immediately or within 30 minutes. Rinse the glass
with half a glass of water and drink.
The pellets must not be chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in
non-carbonated water and
administered via a large syringe through a gastric tube. To ensure
appropriate dosing and to avoid
clogging, the gastric tube should be flushed with non-carbonated water
following administration.
ADULTS
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Symptomatic Treatment of gastroesophageal reflux oesophagitis (GORD)
Once daily for at least 7 days, and up to 14 days.
Patients should be referred to thei