CONTROLOC 20MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PANTOPRAZOLE SODIUM

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

PANTOPRAZOLE SODIUM

Unit dalam pakej:

14Tablet Tablets; 7 Tablet Tablets

Dikeluarkan oleh:

Takeda GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CONTROLOC 20MG TABLETS
_ _
Pantoprazole sodium (20mg)
__________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Controloc is used for
2.
How Controloc works
3.
Before you use Controloc
4.
How to use Controloc
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Controloc
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CONTROLOC IS USED FOR
Controloc is used in adults and
children 12 years and older:
-
Mild reflux disease
and associated
symptoms (e.g.
heartburn, acid
regurgitation, pain on
swallowing)
-
Long-term management
and prevention of relapse
reflux esophagitis
(inflammation or irritation
of esophagus caused by a
return flow of fluid from
stomach)
In adults:
-
Prevention of stomach and
intestinal ulcer induced by
Non-Steroidal Anti-
Inflammatory Drugs
(NSAIDs)
HOW CONTROLOC WORKS
Controloc belongs to a
medicine group known as
proton pump inhibitors (PPIs).
Controloc reduces the amount
of acid in your stomach.
Controloc may help your acid-
related symptoms, but you
could still have serious
stomach problems. Talk with
your doctor.
BEFORE YOU USE CONTROLOC
-
_When you must not use it _
You should not take Controloc
if you are allergic to
pantoprazole or any of the
other ingredients of this
medicine.
-
_Before you start to use it _
Before you take Controloc,
tells your doctor if you
:
•
have liver problems
•
Are pregnant or plan to
become pregnant. It is not
known if Controloc can
harm your unborn baby.
•
are breast-feeding or
planning to breast-feed.
Your doctor should
decide if you will take
Controloc or breast-feed.
You should not do both
without first talking with
your doctor.
•
Have reduced body stores
or risk factors for reduced
vitamin B12 absorption
•
Doctor will plan a few
tests if you have any
alarm symptom (e.g.
significant unintentional
weight loss, recurrent
vomiting, swallowing
difficulty, vomiting
blood, low

Ciri produk

CONTROLOC
® 20 MG
GASTRO-RESISTANT TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each
gastro-resistant
tablet
contains
22.6mg
pantoprazole
sodium
sesquihydrate
(corresponding to 20mg pantoprazole) and the following excipients:
Sodium carbonate; Mannitol; Crospovidone; povidone K90; Calcium
stearate; Hypromellose;
Povidone K25; Propylene glycol; Methacrylic
acid-ethylacrylate-copolymer (1:1); Polysorbate 80;
Sodium laurylsulphate; Triethyl citrate; colours (E 171 and E 172);
printing ink
PRODUCT DESCRIPTION
Gastro-resistant tablet.
Yellow, oval, biconvex film-coated tablet imprinted with “P20” in
brown ink on one side.
PHARMACOLOGICAL PROPERTIES
PHARMACOTHERAPEUTIC / INDICATION GROUP / ACTION MECHANISM
Selective proton pump inhibitor, substituted benzimidazole, ATC code:
A02BC02
PHARMACODYNAMIC PROPERTIES
MECHANISM OF ACTION
Pantoprazole is a substituted benzimidazole which inhibits the
secretion of hydrochloric acid in
the stomach by specific blockade of the proton pumps of the parietal
cells. Pantoprazole is
converted to its active form in the acidic environment in the parietal
cells where it inhibits the
H
+
, K
+
-ATPase enzyme, i.e. the final stage in the production of hydrochloric
acid in the stomach.
The inhibition is dose-dependent and affects both basal and stimulated
acid secretion. In most
patients, freedom from symptoms is achieved within 2 weeks. As with
other proton pump
inhibitors
and
H
2
receptor
inhibitors,
treatment
with
pantoprazole
reduces
acidity
in
the
stomach and thereby increases in gastrin in proportion to the
reduction in acidity. The increase
in gastrin is reversible. Since pantoprazole binds to the enzyme
distal to the cell receptor level, it
can
inhibit
hydrochloric
acid
secretion
independently
of
stimulation
by
other
substances
(acetylcholine, histamine, gastrin). The effect is the same whether
the products are given orally
or intravenously. The fasting gastrin values increase under
pantoprazole. On short-term use, in
most cases they do not exceed the upper limit of normal. Duri