Pantium-40mg Tablets

Country: Malaysia

Language: English

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

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

JETPHARMA SDN. BHD.

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Units in package:

100Tablet Tablets

Manufactured by:

INTAS PHARM LTD

Patient Information leaflet

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PANTIUM TABLET
Pantoprazole Sodium Sesquihydrate (20 mg, 40 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Pantium Tablet is used
for
2.
How Pantium tablet works
3.
Before
you
use
Pantium
tablet
4.
How to take Pantium tablet.
5.
While you are using Pantium
tablet.
6.
Side effects
7.
Storage
and
disposal
of
Pantium tablet.
8.
Product description.
9.
Manufacturer
and
product
registration holder
10.
Date of revision
WHAT PANTIUM TABLET IS USED
FOR
Pantoprazole is indicated in the
treatment of
- Duodenal ulcer
- Gastric ulcer
-In
combination
with
two
appropriate
antibiotics
for
the
eradication
of
Helicobacter
pylori (bacteria) in people with
stomach ulcers with the objective
of
reducing
the
recurrence
of
duodenal
and
gastric
ulcers
caused by these bacteria.
- Moderate and severe cases of
inflammation of the esophagus
(reflux esophagitis).
- It is also used to treat conditions
where the stomach produces too
much
acid,
such
as
Zollinger-
Ellison syndrome.
HOW PANTIUM TABLET WORKS
Pantoprazole is a proton pump
inhibitor
(PPI)
that
suppresses
the gastric acid production. This
effect
leads
to
prevention
of
gastric acid secretion.
BEFORE YOU USE PANTIUM TABLET
Tell your doctor before taking
this medicine, if you are due to
have
a
specific
blood
test
(Chromogranin A).
-
_When you must not take it _
You
must
not
take
this
medication if you are allergic to
pantoprazole
or
to
any
other
Benzimidazole medication such
as Albendazole or Mebendazole
or to any of the ingredients listed
at the end of this leaflet.
Pantoprazole tablets must not be
used
in
combination
treatment
for eradication of Helicobacter
pylori
bacteria
in
people
with
moderate
to
severe
liver
or
kidney function disturbances.
PREGNANCY AND LACTATION
Do not take Pantium tablet if you
are
pregnant,
trying
to
get
pregnant or think you may be
pregnant.
Do not take Pantium tablet if you
are
breast-feeding.
Ask
your
doctor or pharmacist for advice
before taking any medicine.
Your doctor or pharmacist will
discuss
the
possible

Summary of Product characteristics

PANTIUM
(Pantoprazole Sodium Tablets 20mg and 40mg)
Pantoprazole is a substituted benzimidazole. It is a specific proton
pump inhibitor. It is useful for
the treatment of duodenal ulcer, gastric ulcer, and moderate to severe
reflux oesophagitis.
DOSAGE FORM
Tablet
DESCRIPTION:
PANTIUM-20
Lemon Yellow coloured, round biconvex, beveled edges enteric coated
tablets plain on both
sides.
Average Weight: 150.0 mg ± 5% (142.5 mg to 157.5 mg)
Thickness: 3.0 ± 0.2 mm (2.8 to 3.2 mm)
Diameter: 7.0 ± 0.2 mm (6.8 to 7.2 mm)
PANTIUM-40
Light brownish Yellow coloured, round biconvex, beveled edges enteric
coated tablets plain on
both sides.
Average Weight: 150.0 mg ± 5% (142.5 mg to 157.5 mg)
Thickness: 3.0 ± 0.2 mm (2.8 to 3.2 mm)
Diameter: 7.0 ± 0.2 mm (6.8 to 7.2 mm)
PHARMACODYNAMICS:
Mechanism of Action
Pantoprazole inhibits proton pump in a dose proportionate manner. It
inhibits H+ /K+- ATPase
enzyme which is responsible for acid secretion in the parietal cells
of the stomach, in the acidic
environment of the parietal cells, pantoprazole gets converted into
the active form, a cyclic
sulphenamide, which then binds to the H-/K+- ATPase, thus inhibiting
the proton pump. This
results in potent and long lasting suppression of the basal and the
stimulated gastric acid secre-
tion. Since pantoprazole acts distally to the receptor level, it can
inhibit gastric acid secretion
irrespective of the nature of the stimulus (acetylcholine, gastrin,
histamine). Pantoprazole exerts
its full therapeutic effect in a strongly acidic environment (pH<3)
remaining mostly inactive at
higher pH values. Pantoprazole has the same effect whether
administered orally or intravenously.
During treatment with antisecretory medicinal products, serum gastrin
increases in responses to
the decreased acid secretion. Also CgA increases due to decreased
gastric acidity. The increased
CgA level may interfere with investigations for neuroendocrine
tumours.
Available published evidence suggests that proton pump inhibitors
should be discontinued
between 5 day