ESOPREZE esomeprazole 40 mg (as magnesium trihydrate) tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

esomeprazole magnesium trihydrate, Quantity: 44.5 mg (Equivalent: esomeprazole, Qty 40 mg)

제공처:

AstraZeneca Pty Ltd

약제 형태:

Tablet, enteric coated

구성:

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

관리 경로:

Oral

패키지 단위:

7 tablets, 15 tablets, 30 tablets, 100 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ESOPREZE 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 ESOPREZE 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.

제품 요약:

Visual Identification: A pink, oblong, biconvex, film-coated tablet with '40mg' on one side and 'A/EI' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2020-12-01

환자 정보 전단

ESOPREZE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING ESOPREZE?
ESOPREZE contains the active ingredient esomeprazole magnesium
trihydrate. ESOPREZE is used to treat reflux conditions and
ulcers. ESOPREZE is also taken to help stop reflux coming back or
relapsing.
For more information, see Section 1. Why am I taking ESOPREZE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ESOPREZE?
Do not take ESOPREZE if you have ever had an allergic reaction to
esomeprazole or any of the ingredients listed at the end of the
CMI. Do not use if you have allergies to any medicines containing a
proton pump inhibitor.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
ESOPREZE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ESOPREZE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE ESOPREZE?
•
Take one ESOPREZE tablet each day, unless your doctor has told you
otherwise.
•
Swallow ESOPREZE tablets whole with a glass of water. Do not crush or
chew the tablets. If the tablets are chewed or crushed
they will not work properly.
•
More instructions can be found in Section 4. How do I take ESOPREZE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ESOPREZE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are
taking ESOPREZE.
•
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking
ESOPREZE.
THINGS YOU
SHOULD NOT DO
•
Do not take it to treat any other complaints unless your doctor tells
you to.
•
Do not give this medicine to anyone else, even if their symptoms seem
similar to yours.

제품 특성 요약

ESOPREZE Product Information
Doc ID-004435580 v 2.0
1(31)
AUSTRALIAN PRODUCT INFORMATION
ESOPREZE
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
MULTIPLE UNIT PELLET SYSTEM
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in ESOPREZE is esomeprazole magnesium
trihydrate, a
substituted benzimidazole.
The ESOPREZE 20 mg and 40 mg tablets 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
ESOPREZE 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.
ESOPREZE 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ESOPREZE 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)
ESOPREZE Product Information
Doc ID-004435580 v 2.0
2(31)
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.
PATHOLO