NOUMED ESOMEPRAZOLE esomeprazole 40 mg enteric-coated tablets blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

esomeprazole magnesium, Quantity: 41.4 mg (Equivalent: esomeprazole, Qty 40 mg)

थमां उपलब्ध:

AVALLON PHARMACEUTICALS PTY LTD

INN (इंटरनेशनल नाम):

Esomeprazole magnesium

फार्मास्यूटिकल फॉर्म:

Tablet, enteric coated

रचना:

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

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30, 28, 10, 7

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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 esomeprazole solution administered 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

उत्पाद समीक्षा:

Visual Identification: Light brick red to brown, oval, biconvex, film-coated tablets with 'E6' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2012-02-09

सूचना पत्रक

NOUMED ESOMEPRAZOLE CMI
1
NOUMED ESOMEPRAZOLE TABLETS
_esomeprazole magnesium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
ESOMEPRAZOLE.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NOUMED
ESOMEPRAZOLE 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 NOUMED
ESOMEPRAZOLE IS
USED FOR
_REFLUX OESOPHAGITIS _
NOUMED ESOMEPRAZOLE 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.
NOUMED ESOMEPRAZOLE is
also taken to help stop reflux
oesophagitis coming back or
relapsing.
_UPPER GASTROINTESTINAL _
_SYMPTOMS ASSOCIATED WITH _
_NON-STEROIDAL ANTI-_
_INFLAMMATORY DRUGS _
_(NSAIDS) THERAPY _
NOUMED ESOMEPRAZOLE is
taken to treat the symptoms of pain
or discomfort in the stomach caused
by NSAIDs, a type of medicine for
pain or inflammation.
NOUMED ESOMEPRAZOLE 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 NOUMED
ESOMEPRAZOLE with antibiotics.
When NOUMED
ESOMEPRAZOLE and antibiotics
are taken together, they work to kill
the bacterium and let your ulcer heal.
You may need f

उत्पाद विशेषताएं

Product Information - Australia
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION - NOUMED
ESOMEPRAZOLE (ESOMEPRAZOLE (AS MAGNESIUM))
1. NAME OF THE MEDICINE
Esomeprazole magnesium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric-coated tablet of NOUMED ESOMEPRAZOLE comprises
enteric-coated pellets with esomeprazole
magnesium equivalent to esomeprazole 20 mg or 40 mg.
Excipients with known effect: sugars.
For the full list of excipients, see _SECTION 6.1 LIST OF EXCIPIENTS_.
3. PHARMACEUTICAL FORM
NOUMED ESOMEPRAZOLE esomeprazole (as magnesium) 20 mg tablets are
light brick red to brown, oval,
biconvex, enteric-coated tablets with ‘E5’ debossed on one side
and plain on other side.
NOUMED ESOMEPRAZOLE esomeprazole (as magnesium) 40 mg tablets are
light brick red to brown, oval,
biconvex, enteric-coated tablets with ‘E6’ debossed on one side
and plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NOUMED ESOMEPRAZOLE 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 ESOMEPRAZOLE
SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION.
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME AND IDIOPATHIC
HYPERSECRETION.
IN COMBINATION WITH APPROPRIATE ANTIBIOTICS FOR:
•
Healing of duodenal ulcer assoc