NEXIUM 24HR ONCE DAILY DOSING esomeprazole 20 mg (as magnesium trihydrate) tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

esomeprazole magnesium trihydrate, Quantity: 22.3 mg

Boleh didapati daripada:

Haleon Australia Pty Ltd

INN (Nama Antarabangsa):

esomeprazole magnesium trihydrate

Borang farmaseutikal:

Tablet, enteric coated

Komposisi:

Excipient Ingredients: methacrylic acid copolymer; titanium dioxide; sodium stearylfumarate; triethyl citrate; macrogol 6000; glyceryl monostearate; microcrystalline cellulose; hyprolose; crospovidone; polysorbate 80; magnesium stearate; iron oxide red; purified talc; iron oxide yellow; synthetic paraffin; hypromellose; sucrose; hydrolysed maize starch

Laluan pentadbiran:

Oral

Unit dalam pakej:

14, 7

Jenis preskripsi:

(S2) Pharmacy Medicine

Tanda-tanda terapeutik:

NEXIUM 24HR ONCE DAILY DOSING is indicated for the symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (GORD).

Ringkasan produk:

Visual Identification: A light pink, oblong, biconvex, film-coated tablet engraved ?20mG? on one side and ? A/EH? on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2014-12-04

Ciri produk

Nexium 24HR Once Daily Dosing Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
NEXIUM
® 24HR ONCE DAILY DOSING
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule or tablet of NEXIUM 24HR Once Daily Dosing (referred as
NEXIUM
24HR elsewhere in this Product Information) contains esomeprazole
magnesium
trihydrate 22.3 mg (equivalent to esomeprazole 20 mg) as
enteric-coated pellets.
Esomeprazole is the S-isomer of omeprazole. It is optically stable
_in vivo_
, with
negligible conversion to the R-isomer.
EXCIPIENT(S) WITH KNOWN EFFECT:
Sucrose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
NEXIUM 24HR 20 mg capsules are approximately 11 x 5 mm with a clear
body, and
an amethyst cap imprinted with “NEXIUM 20 MG” in white. The
capsule has a yellow
centre band, and contains yellow and purple enteric coated pellets.
NEXIUM 24HR 20 mg tablets are light pink, oblong, biconvex,
film-coated tablet
engraved “20 mg” on one side and “A/EH” on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NEXIUM 24HR is indicated for the symptomatic relief of frequent
heartburn, acid
regurgitation and other symptoms associated with gastro-oesophageal
reflux disease
(GORD).
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
For symptomatic treatment of gastro-oesophageal reflux disease (GORD),
take 1
capsule (20 mg) or tablet (20 mg) once daily for at least 7 days, and
up to 14 days.
Patients should be referred to their doctor if symptoms persist or
worsen while taking
this course, or if symptoms persist or recur within two weeks of
completing the course.
Nexium 24HR Once Daily Dosing Page 2 of 16
_CHILDREN BELOW THE AGE OF 18 YEARS: _
NEXIUM 24HR is not intended for use in children under the age of 18.
METHOD OF ADMINISTRATION
NEXIUM 24HR capsules or tablets should be swallowed whole with liquid.
The
capsules or tablets must not be chewed, crushed or opened.
If require