Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium trihydrate, Quantity: 22.3 mg (Equivalent: esomeprazole, Qty 20 mg)
Haleon Australia Pty Ltd
Capsule, hard
Excipient Ingredients: hypromellose; propylene glycol; indigo carmine aluminium lake; carmine; magnesium stearate; Gelatin; purified talc; methacrylic acid copolymer; titanium dioxide; erythrosine; iron oxide yellow; indigo carmine; povidone; Shellac; triethyl citrate; sodium hydroxide; allura red AC; glyceryl monostearate; polysorbate 80; hyprolose; sucrose; hydrolysed maize starch
Oral
14
(S2) Pharmacy Medicine
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).
Visual Identification: A hard capsule with a clear amethyst cap and clear body. The capsule is sealed with a yellow band in radial format that covers the joined portions of the body and cap. Additionally, the cap is marked "NEXIUM 20 MG" printed in white in radial format.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-04-15
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 Izlasiet visu dokumentu