Emanera 40 mg gastro-resistant capsules

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

MAH:

PAHANG PHARMACY SDN. BHD.

INN:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

units_in_package:

14capsule Capsules; 28capsule Capsules

manufactured_by:

KRKA, d.d., Novo mesto

PIL

EMANERA
Esomeprazole gastro-resistant capsules, hard (20 mg and 40 mg)
_ _
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What _Emanera _is used for
2.
How _Emanera_ works
3.
Before you use _Emanera_
4.
How to use _Emanera_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Emanera_
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT _EMANERA_ IS USED FOR
_Emanera_ is used to treat the following
conditions:
-
"Gastro-oesophageal reflux disease"
(GORD). This is where acid from
the stomach escapes into the gullet
(the tube which connects your throat
to
your
stomach)
causing
pain,
inflammation
and
heartburn
(acid
indigestion with a burning sensation
in the chest).
-
Ulcers in the stomach or upper part
of
the
gut
(intestine)
that
are
infected
with
bacteria
called
"_Helicobacter pylori_". If you have
this condition, your doctor may also
prescribe
antibiotics
to
treat
the
infection and allow the ulcer to heal.
-
Stomach ulcers caused by medicines
called
NSAIDs
(Non-Steroidal
Anti-Inflammatory
Drugs).
Emanera can also be used to stop
stomach ulcers from forming if you
are taking NSAIDs.
-
Prolonged
treatment
after
prevention of rebleeding of ulcers
with intravenous esomeprazole.
-
Too
much
acid
in
the
stomach
caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
HOW _EMANERA_ WORKS
_Emanera_
contains
a
medicine
called
esomeprazole. This belongs to a group
of
medicines
called
"proton
pump
inhibitors". They work by reducing the
amount
of
acid
that
your
stomach
produces.
BEFORE YOU USE _EMANERA _
-
_When you must not use it _

If you are allergic (hypersensitive)
to esomeprazol or any of the other
ingredients of _Emanera_.

If you are allergic to other proton
pump inhibitor medicines.

If
you
are
taking
atazanavir
(a
medicine used to treat HIV).
Do
not
take
_Emanera_
if
any
of
the
above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking _Emanera_.
_ _
-
_Before you start use it _

SPC

1.3.1
Esomeprazole
SPC, Labeling and Package Leaflet
MY
SmPCPIL163312_1
16.02.2021 – Updated: 16.02.2021
Page 1 of 12
EMANERA 20 MG GASTRO-RESISTANT CAPSULES, HARD
EMANERA 40 MG GASTRO-RESISTANT CAPSULES, HARD
COMPOSITION
Each gastro-resistant capsule, hard, contains 20 mg esomeprazole (as
esomeprazole magnesium
dihydrate).
Each gastro-resistant capsule, hard, contains 40 mg esomeprazole (as
esomeprazole magnesium
dihydrate).
Excipient with known effect:
20 mg gastro-resistant
capsule, hard
40 mg gastro-resistant
capsule, hard
sucrose
28.46–32.56 mg
56.93–65.11 mg
PRODUCT DESCRIPTION
20 mg: the body and the cap are slightly pink; the capsules are filled
with white to almost white
pellets. Capsule size no. 3.
40 mg: the body and the cap are off-pink; the capsules are filled with
white to almost white pellets.
Capsule size no. 1.
THERAPEUTIC INDICATIONS
Emanera capsules are indicated 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 APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS 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 CONTINUED 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 IV INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
POSOLOGY AND METHOD OF ADMINISTRATION
The capsules should be swallowed whole with some water. The capsules
should not be chewed or
crushed.
For patients who have difficulty in swallowing, the capsules can also
be opened and the pellets mixed
in half a glass of non-carbonated water. No other liquids should be
used as th