NEXIUM esomeprazole 10 mg (as magnesium trihydrate) enteric coated granules for oral suspension sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium trihydrate, Quantity: 11.1 mg (Equivalent: esomeprazole, Qty 10 mg)

Available from:

AstraZeneca Pty Ltd

INN (International Name):

esomeprazole magnesium trihydrate

Pharmaceutical form:

Granules, enteric-coated

Composition:

Excipient Ingredients: crospovidone; xanthan gum; polysorbate 80; hyprolose; triethyl citrate; hypromellose; iron oxide yellow; magnesium stearate; citric acid; purified talc; glucose; glyceryl monostearate; methacrylic acid copolymer; maize starch; sucrose; hydrolysed maize starch

Administration route:

Oral

Units in package:

30 sachets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NEXIUM is indicated for: Gastro-Oesophageal Reflux Disease (GORD) -Treatment of erosive reflux oesophagitis -Long-term management of patients with healed oesophagitis to prevent relapse -Symptomatic treatment of gastro-oesophageal reflux disease (GORD) Patients requiring NSAID therapy: -Short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. -Healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. -Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk. Prevention of rebleeding of gastric or duodenal ulcers following treatment with NEXIUM IV solution by intravenous infusion. Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. In combination with appropriate antibiotics for: -Healing of duodenal ulcer associated with Helicobacter pylori. -Eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Product summary:

Visual Identification: Pale yellow fine granules. Brownish granules may be visible.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-05-15

Patient Information leaflet

NEXIUM
®
_Esomeprazole magnesium trihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
NEXIUM. It does not contain all the
information that is known about
NEXIUM.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
NEXIUM against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NEXIUM IS USED
FOR
_REFLUX OESOPHAGITIS_
NEXIUM is taken to treat reflux
oesophagitis. This can be caused by
"washing back" (reflux) of food and
acid from the stomach into the food
pipe (oesophagus).
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
NEXIUM is also taken to help stop
reflux oesophagitis coming back or
relapsing.
_UPPER GASTROINTESTINAL_
_SYMPTOMS ASSOCIATED WITH_
_NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS_
_(NSAIDS) THERAPY_
NEXIUM is taken to treat the
symptoms of pain or discomfort, in
the stomach caused by NSAIDs, a
type of medicine for pain or
inflammation.
NEXIUM is also taken to help heal
and prevent ulcers caused by
NSAIDs.
_PEPTIC ULCERS ASSOCIATED_
_WITH HELICOBACTER PYLORI_
_INFECTION_
Most people who have a peptic
(gastric and duodenal) ulcer also
have a bacterium called Helicobacter
pylori in their stomach.
Depending on the position of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach. A duodenal ulcer occurs in
the duodenum which is the tube
leading out from the stomach.
If you have a peptic ulcer, your
doctor will prescribe NEXIUM with
antibiotics. When NEXIUM and
antibiotics are taken together, they
work to kill the bacterium and let
your ulcer heal. You may need
further treatment with antibiotics.
_ZOLLINGER-ELLISON SYNDROME_
NEXIUM is also used to treat a rare
condition called Zolli

Summary of Product characteristics

NEXIUM
®
Product Information
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AUSTRALIAN PRODUCT INFORMATION
NEXIUM
®
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
MULTIPLE UNIT PELLET SYSTEM
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NEXIUM is esomeprazole magnesium trihydrate,
a
substituted benzimidazole.
The NEXIUM 20 mg and 40 mg tablets are comprised of enteric coated
pellets
containing esomeprazole (as magnesium trihydrate). Contains sugars.
NEXIUM 10 mg granules for oral suspension are comprised of enteric
coated pellets
containing esomeprazole (as magnesium trihydrate). Contains sugars.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
NEXIUM 20 MG TABLETS are a light pink, oblong, biconvex, film-coated
tablet
engraved 20 mg on one side and A/EH on the other side. Each tablet
contains
esomeprazole magnesium trihydrate 22.3 mg as enteric-coated pellets.
NEXIUM 40 MG TABLETS are a pink, oblong, biconvex, film-coated tablet
engraved 40
mg on one side and A/EI on the other side. Each tablet contains
esomeprazole
magnesium trihydrate 44.5 mg as enteric-coated pellets.
NEXIUM 10 MG GRANULES FOR ORAL SUSPENSION are pale yellow fine
granules
(brownish granules may be visible) in a unit dose sachet. Each sachet
contains
esomeprazole magnesium trihydrate 11.1 mg as enteric-coated pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEXIUM is indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
•
treatment of erosive reflux oesophagitis
NEXIUM
®
Product Information
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•
long-term management of patients with healed oesophagitis to prevent
relapse
•
symptomatic treatment of gastro-oesophageal reflux disease (GORD)
PATIENTS REQUIRING NSAID THERAPY
•
short-term treatment of upper gastrointestinal symptoms associated
with
non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2
selective) therapy.
•
healing of gastric ulcers associated with non-steroidal
anti-inflam