CORPOCID 20 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Activo Health (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS OMEPRAZOLE 20,0 mg

Authorization status:

Registered

Authorization date:

2014-06-03

Patient Information leaflet

Activo Health
(Pty) Ltd
43/11.4.3/0502
Corpocid
20
mg
PATIENT INFORMATION LEAFLET
USRN
Approval: 15/04/2021
20
mg
Omeprazole Tablets
READ ALL
OF
THIS LEAFLET CAREFULLY BEFORE
YOU
START TAKING CORPOCID
20
MG TABLETS
•
Keep this leaflet. You
may
need
to
read
it
again.
•
If
you
have
further
questions, please
ask
your
doctor
or
your
pharmacist.
•
CORPOCID
20
MG
has
been prescribed
for
you
personally and you should not
share
your
medicine with other people.
It
may
harm
them, even
if
their
symptoms
are
the
same
as
yours.
SCHEDULING STATUS:
S4
PROPRIETARY NAME: (AND DOSAGE FORM)
CORPOCID
20
mg
(coated tablet)
1.
WHAT
CORPOCID
20
MG
CONTAINS
Each coated tablet contains:
Omeprazole
20
mg
The
other inactive ingredients are:
Ascorbyl pa Imitate,
black
iron oxide (E172), crospovidone (polyplasdone XL), glycerol
triacetate (triacetin), hypromellose phthalate
(HP
50 -
seppic), lactose monohydrate (lactose
80
mesh), magnesium stearate, microcrystalline cellulose, povidone
K29-32), red iron oxide
(E172), talc.
2.
WHAT CORPOCID
20
MG
IS
USED
FOR
CORPOCID
20
MG
is
a type
of
medicine called a "proton pump inhibitor".
It
reduces
the
production
of
acid in
your
stomach.
It
is
used
to
treat
the
following conditions:
•
Ulcers in
the
upper
part
of
the
intestine (duodenal ulcer).
•
Stomach ulcers (gastric ulcer).
•
Ulcers which
are
infected with bacteria called
_Heficobacter pylori. _
If
you have this
condition,
your
doctor
may
also prescribe antibiotics
to
treat
the
infection and
allow
the
ulcer
to
heal.
•
Inflammation
of
the
food pipe caused
by
a return flow
of
fluid from
the
stomach (reflux
oeso phag itis
).
•
Hormone producing tumours in
the
pancreas causing
excess
acid in the stomach
(Zollinger-Ellison syndrome).
Approved
&
Signed
PIL
-
USRN
(22/05/2020)
R
JV
RENSBURG
2021
-11%-
I
5
_4 _
1.3.2 Pg.
1
of
7
Activo Health (Pty) Ltd
43/11.4.3/0502 Corpocid 20 mg
USRN Approval: 15/04/2021
20
mg Omeprazole Tablets
•
Ulcers caused
by
medicines called
NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs).
CORPOCID
20
MG
can
also
be

Summary of Product characteristics

Activo Health
(Pty)
Ltd
43/11.4.3/0502 Corpocid
20
mg
SCHEDULING STATUS:
S4
PROPRIETARY NAME (AND DOSAGE FORM):
CORPOCID
20
mg
(coated tablet)
COMPOSITION:
Each coated tablet contains:
Omeprazole
20
mg
Excipients:
USRN Approval: 15/04/2021
20
mg
Omeprazole Tablets
Ascorbyl palmitate, black iron oxide (E172), crospovidone
(polyplasdone XL), glycerol
triacetate (triacetin), hypromellose phthalate
(HP
50
-
seppic), lactose monohydrate (lactose
80
mesh), magnesium stearate, microcrystalline cellulose, povidone
K29-32}, red iron oxide
(E172), talc.
PHARMACOLOGICAL CLASSIFICATION:
A.
11.4.3
Medicines acting
on
gastro-intestinal tract -
Other
PHARMACOLOGICAL ACTION:
_PHARMACODYNAMIC PROPERTIES: _
Omeprazole reduces gastric acid secretion.
It
is
a
specific inhibitor
of
the gastric proton
pump in the parietal cell.
It
produces reversible control
of
gastric
acid secretion with once
daily dosing.
_Site _
_and _
_mechanism _
_of _
_action: _
Omeprazole
is
a
weak
base and
is
concentrated and converted
to
the
active form in
the
acid
environment
of
the
intracellular canaliculi within
the
parietal
cell,
where
it
inhibits
the
enzyme
H+, K+-ATPase -
the
proton pump. This
effect on
the
final step
of
the gastric acid formation
process is dose-dependent and provides
for
effective inhibition
of
both basal acid secretion
and stimulated acid secretion irrespective
of
the
secretagogue.
Omeprazole
has
no
effect
on
acetylcholine, histamine
or
gastrin receptors.
_Effect _
_on _
_gastric secrehon: _
Oral dosing with omeprazole
20
mg
once daily provides inhibition
of
gastric acid secretion
with maximum effect being achieved within four
days
of
treatment. In duodenal ulcer patients,
a mean decrease
of
approximately
80
%
in twenty-four
hour
intragastric acidity is then
maintained, with
the
mean
decrease
in
peak acid output
after
pentagastrin stimulation being
about
70
%,
twenty-four
hours after dosing with omeprazole.
_PHARMACOKINETIC PROPERTIES: _
Approved
&
Signed
PI -
USRN (22/05/2020)
R
JV
RENSBURG
_D[) _
2021
-04-
15
';
1.3.1
.1
Pg.1
of8
A