VENCID ENTERIC-COATED TABLET 40MG

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Disponibil de la:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (nume internaţional):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Unități în pachet:

2 x 7`s Tablets; 4 x 7`s Tablets

Produs de:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
___________________________________________________________________________________________________________________________
_
_ _
VENCID ENTERIC-COATED TABLET 40MG
Pantoprazole 40mg (as Pantoprazole Sodium Sesquihydrate)
WHAT IS IN THIS LEAFLET
1.
What Vencid is used for
2.
How Vencid works
3.
Before you use Vencid
4.
How to use Vencid
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Vencid
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS VENCID USED FOR
It is used for the treatment of acid-related
diseases of the stomach and intestine.

Moderate
to
severe
forms
of
gastro-
oesophageal
reflux
(oesophagus
inflammation
accompanied
by
the
regurgitating of stomach acid).
_ _

Duodenal and stomach ulcer.

An
infection
with
a
bacterium
called
_Helicobacter _
_pylori_
in
patients
with
duodenal ulcers and stomach ulcers in
combination
with
two
antibiotics
(Eradication therapy).
_ _

Zollinger-Ellison
syndrome
and
other
conditions producing too much acid in
the stomach.
_ _
_ _
HOW VENCID WORKS
Pantoprazole is a “selective proton pump
inhibitor” something
which reduces the
amount of acid produced in your stomach.
BEFORE YOU USE VENCID
_- When must not to use it _
Do not take this medicine if you are:

allergic
(hypersensitivity)
to
the
pantoprazole or any other ingredients
in this medicine.

taking atazanavir (a drug to treat HIV/
AIDS).

in
combination
treatment
with
antibiotics,
and
have
moderate
to
severe liver or kidney problems.
_- Before you start use it _
Tell your doctor or pharmacist if you
have:

mild gastrointestinal complaints.

unintentional weight loss.

repeated vomiting.

difficulty in swallowing.

vomiting blood.

anaemia.

blood in stools

severe liver problems.

are pregnant or breast-feeding.
_ _
Moreover, tell your doctor before taking
this medicine, if you are due to have a
specific blood test (Chromogranin A).
_- Taki

Caracteristicilor produsului

During treatment with antisecretory medicinal products, serum gastrin
increases in response to the
decreased acid secretion. Also, Chromogranin A (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
days and 2 weeks prior to CgA measurements. This is to allow CgA
levels that might be spuriously elevated
following PPI treatment to return to reference range.
Pantoprazole is not indicated for mild gastrointestinal complaints,
e.g, nervous stomach.
dysphagia, haematemesis, anemia or melaena) and when gastric ulcer is
suspected or present, malignancy
should be excluded, as treatment with pantoprazole may alleviate
symptoms and delay diagnosis.
Further investigation is to be considered if symptoms persist despite
adequate treatment.
In the case of combination therapy, the prescribing information for
the respective drugs must be observed.
Patient with severe hepatic impairment should be given 40mg of
pantoprazole on alternate day. In patients
with severe liver impairment, the liver enzymes should be monitored
regularly during therapy, particularly on
long-term use. Pantoprazole should be stopped if elevation of liver
enzymes occurs.
Pantoprazole, as other proton pump inhibitors, might be expected to
increase the counts of bacteria normally
present in the upper gastrointestinal tract. Treatment with
pantoprazole may lead to slightly increased risk of
gastrointestinal infections caused by bacteria (e.g. _ Salmonella,
Campylobacter_ and
)
REGULAR SURVEILLANCE: Patients on proton pump inhibitor treatment
(particularly those treated for long
term) should be kept under regular surveillance.
SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (SCLE): Proton pump inhibitors
are associated with very
infrequent
cases
of
subacute
cutaneous
lupus
erythematosus
(SCLE).
If
lesions
occur,
especially
in
sun-exposed areas of the skin, and if accompanied by arthralgia, th