NEXIUM TABLETS 20 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ESOMEPRAZOLE

Inapatikana kutoka:

ASTRAZENECA (ISRAEL) LTD

ATC kanuni:

A02BC05

Dawa fomu:

TABLETS

Tungo:

ESOMEPRAZOLE 20 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

ASTRA ZENECA AB., SWEDEN

Eneo la matibabu:

ESOMEPRAZOLE

Matibabu dalili:

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 20 mg tablets are indicated in adolescents from the age of 12 years forGastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagi

Idhini ya tarehe:

2018-06-11

Taarifa za kipeperushi

Nexium Tablets-PIL-ENG-0221-final
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
COMPOSITION
COMPOSITION
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 THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others.
It may harm them even if it seems to you that their ailment is
similar.
1. WHAT IS THE 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.
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.
Healing of gastric ulcer caused by use of non-steroidal
anti-inflammatory drugs
(NSAIDs), such as preparations to treat arthritis (rheumatism).
Prevention of formation of gastric ulcers, if you might possibly
develop them as a
result of taking non-steroidal anti-inflammatory drugs (NSAIDs), such
as preparations
to treat arthritis (rheumatism).
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 of heartburn, with or without inflammation of

Tabia za bidhaa

Nexium Tablets– MAH change-Feb 2021
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 healed eso