CONTROLOC 40MG TABLET

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

PANTOPRAZOLE

Dostępny od:

Takeda Malaysia Sdn Bhd

INN (International Nazwa):

PANTOPRAZOLE

Sztuk w opakowaniu:

14Tablet Tablets; 14 Tablet Tablets; 7 Tablet Tablets

Wyprodukowano przez:

Takeda GmbH

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CONTROLOC 40MG TABLETS
_ _
Pantoprazole sodium (40mg)
__________________________________________________________________________________________
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:
-
Treatment of moderate
and severe reflux
oesophagitis
(inflammation or
irritation of esophagus
caused by a return
flow of fluid from
stomach)
In adults:
-
Treatment of gastric
and intestinal ulcers
-
Hormone producing tumors
in the pancreas causing
excess acid in the stomach
(Zollinger-Ellison
Syndrome) and other
pathological hypersecretory
conditions.
-
Eradication of H. pylori in
people with peptic ulcer in
combination with two
appropriate antibiotics
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.
-
You have moderate to
severe liver and
kidney problems
-
You have mild
gastrointestinal
complain
-
_Before you start to use it _
Before you take Controloc,
tells your doctor if you
:
•
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
•
Docto

Charakterystyka produktu

CONTROLOC
®
40 MG
GASTRO-RESISTANT TABLETS
ACTIVE INGREDIENT: PANTOPRAZOLE SODIUM SESQUIHYDRATE
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each gastro-resistant tablet contains 45.1mg pantoprazole sodium
sesquihydrate
(corresponding to 40mg pantoprazole) and the following excipients:
Sodium
carbonate;
Mannitol;
Crospovidone;
Povidone
K90;
Calcium
stearate;
Hypromellose 2910; Povisone K25; Titanium dioxide E171; Yellow ferric
oxide E172;
Propylene glycol; Triethyl citrate; Methaacrylic acid – ethyl
acrylate Copolymer (1:1);
Polysorbate 80; Sodium Laurisulfate; Printing ink.
PRODUCT DESCRIPTION
Gastro-resistant tablet.
Yellow, oval, biconvex film-coated tablet imprinted with “P40” in
brown ink on one
side.
PHARMACOLOGICAL PROPERTIES
PHARMCODYNAMICS PROPERTIES
PHARMACOTHERAPEUTIC / INDICATION GROUP / ACTION MECHANISM
Selective proton pump inhibitor, substituted benzimidazole, ATC code:
A02BC02
_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
H2 receptor inhibitors, treatment with pantoprazole reduces acidity in
the stomach
and thereby increases 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 product is given orally or intravenously.
The fasting gastrin values increase under pantoprazole. On sh