NEXIUM TABLETS 40 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

ESOMEPRAZOLE

可用日期:

TARO INTERNATIONAL LTD, ISRAEL

ATC代码:

A02BC05

药物剂型:

TABLETS

组成:

ESOMEPRAZOLE 40 MG

给药途径:

PER OS

处方类型:

Required

厂商:

ASTRA ZENECA AB., SWEDEN

治疗组:

ESOMEPRAZOLE

治疗领域:

ESOMEPRAZOLE

疗效迹象:

Nexium tablets are indicated in adults for:Gastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (GERD)In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and:- healing of Helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.Patients requiring NSAID therapy- healing of gastric ulcers associated with NSAID therapy. - prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.Nexium 40 mg tablets are indicated in adolescents from the age of 12 years for;Gastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis

授权日期:

2021-05-31

资料单张

Page 1 of 8
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
NEXIUM
®
20 mg
NEXIUM
®
40 mg
Tablets
Tablets
Active ingredient:
Active ingredient:
Each tablet contains:
Each tablet contains:
esomeprazole 20 mg
(as magnesium trihydrate)
esomeprazole 40 mg
(as magnesium trihydrate)
Inactive ingredients and allergens: See section 2 under ‘Important
information about
some of this medicine’s ingredients’ and section 6 ‘Further
information’.
Read the entire leaflet carefully before you start using this
medicine.
This leaflet contains concise information about this medicine. If you
have any further
questions, contact your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them even if it seems to you that their illness is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
In adults, Nexium 20 mg and 40 mg are intended:
•
For treatment of heartburn, with or without inflammation of the
gullet, caused
by reflux of gastric acid. Nexium reduces the production of acid and
helps
heal the gullet by reducing pain and inflammation.
•
For treatment of ulcers in the upper part of the gut or stomach caused
by
_Helicobacter pylori_ bacteria. Nexium in combination with suitable
antibiotics
treats the infection, and leads to healing of the ulcer and prevention
of
recurrence.
•
For healing of gastric ulcer caused by use of non-steroidal
anti-inflammatory
drugs (NSAIDs), which are also used to treat arthritis (rheumatism).
•
For prevention of formation of gastric ulcers, if you might possibly
develop
them as a result of taking non-steroidal anti-inflammatory drugs
(NSAIDs),
which are also used to treat arthritis (rheumatism).
•
For prolonged treatment with Nexium tablets to prevent recurrent
bleeding of
a gastric or duodenal ulcer, after primary intravenous Nexium
treatment.
In adolescents, Nexium 20 mg is intended:
•
For treatment o

产品特点

Nexium Tablets– notification April 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the Medicinal Product
NEXIUM
®
Tablets 20 mg
NEXIUM
®
Tablets 40 mg
2.
Qualitative and Quantitative Composition
NEXIUM
®
Tablets 20 mg - Each tablet contains: 20 mg esomeprazole (as magnesium
trihydrate).
NEXIUM
®
Tablets 40 mg - Each tablet contains: 40 mg esomeprazole (as magnesium
trihydrate).
Excipients with known effect:
Nexium Tablets 20 mg: Sucrose 28 mg.
Nexium Tablets 40 mg: Sucrose 30 mg.
For a full list of excipients, see section 6.1.
3.
Pharmaceutical Form
Gastro-resistant tablet
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side
and
A
EH
on the other side.
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and
A
EI
on the other side.
2
4.
Clinical Particulars
4.1
Therapeutic indications
Nexium Tablets are indicated in adults for:
Gastroesophageal Reflux Disease (GERD)
-
treatment of erosive reflux esophagitis.
-
long-term management of patients with healed esophagitis to prevent
relapse.
-
symptomatic treatment of gastroesophageal reflux disease (GERD).
In
combination
with
an
appropriate
antibacterial
therapeutic
regimen
for
the
eradication of Helicobacter pylori and
-
healing of
Helicobacter pylori
associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with
Helicobacter pylori
associated ulcers.
Patients requiring NSAID therapy
-
healing of gastric ulcers associated with NSAID therapy.
-
prevention of gastric and duodenal ulcers associated with NSAID
therapy in
patients at risk.
Prolonged treatment after i.v. induced prevention of rebleeding of
peptic ulcers.
Nexium Tablets 40 mg are indicated in adolescents from the age of 12
years for:
Gastroesophageal Reflux Disease (GERD)
-
treatment of erosive reflux esophagitis.
Nexium Tablets 20 mg are indicated in adolescents from the age of 12
years for:
3
Gastroesophageal Reflux Disease (GERD)
-
treatment of erosive reflux esophagitis.
-
long-term management of patients with he