Pantoprazole Sandoz Gastro-resistant Tablet 40mg

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Tersedia dari:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Internasional):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Unit dalam paket:

14 Tablets; 7tablet Tablets; 14tablet Tablets

Diproduksi oleh:

Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.

Selebaran informasi

PANTOPRAZOLE SANDOZ GASTRO-
RESISTANT TABLETS
Pantoprazole 40 mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What is Pantoprazole Sandoz used
for
2.
How Pantoprazole Sandoz works
3.
Before you use Pantoprazole
Sandoz
4.
How to use Pantoprazole Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Pantoprazole Sandoz
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS PANTOPRAZOLE
SANDOZ USED FOR
Pantoprazole is used:
In adults and adolescent 12 years of
age and above:
•
For reflux oesophagitis
(inflammation of the
oesophagus accompanied by the
regurgitating of stomach acid)
In adults:
•
In combination with appropriate
antibiotics for the eradication of
_Helicobacter pylori_
(bacteria) in
patients with
_Helicobacter _
_pylori _
associated ulcers.
•
For stomach and duodenal
ulcer.
•
Zollinger-Ellison-Syndrome and
other conditions producing too
much acid in the stomach as
long-term treatment.
HOW PANTOPRAZOLE
SANDOZ WORKS
Pantoprazole Sandoz is a selective
“proton pump inhibitor”, a medicine
which reduces the amount of acid
produced in your stomach.
BEFORE YOU USE
PANTOPRAZOLE SANDOZ
-
_When you must not use it _
Do NOT take Pantoprazole Sandoz:
•
If you are allergic
(hypersensitive) to pantoprazole
or any of the ingredients of
Pantoprazole Sandoz.
•
If you are allergic to medicines
containing other proton pump
inhibitors.
Pantoprazole Sandoz must not be
used as combination treatment for
the eradication of
_H. pylori_
if you
have moderate to severe liver or
kidney function disturbances.
-
_Before you start to use it _
Tell your doctor if you have or have
had any medical condition
especially the following:
•
If you have severe liver
problems. Doctor will check
your liver enzymes more
frequently, especially when you
are taking Pantoprazole Sandoz
as a long-term treatment. If the
liver enzyme levels increase,
then treatment should be
stopped.
•
If you need to take medicines
called NSAIDs continuou

Karakteristik produk

Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazole Sandoz Gastro-resistant Tablet 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg pantoprazole (as
pantoprazole sodium sesquihydrate).
Excipient:
Each gastro-resistant tablet contains 2 µg of the colouring agent
Ponceau 4R aluminium lake (E124) per gastro-
resistant tablet.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
A yellow, oval coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults and adolescents 12 years of age and above
•
Reflux oesophagitis
Adults
•
Eradication of _Helicobacter pylori _(_H. pylori_) in combination with
appropriate antibiotic therapy in patients with
_H. pylori _associated ulcers
•
Gastric and duodenal ulcer
•
Zollinger-Ellison-Syndrome and other pathological hypersecretory
conditions
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tablets should not be chewed or crushed, and should be swallowed whole
1 hour before a meal with some water.
Reflux esophagitis
One tablet of Pantoprazole 40 mg per day. In individual cases, the
dose may be doubled (increase to 2 tablets of
Pantoprazole 40 mg daily) especially when there has been no response
to other treatment.
Eradication of _H. pylori _in Combination with Appropriate Antibiotics
In cases of duodenal or gastric ulcer in which infection with
_Helicobacter pylori _has been confirmed, the
microorganism should be eradicated by combination treatment.
Depending upon the resistance pattern, the following combinations can
be recommended:
•
One pantoprazole 40-mg tab twice daily + amoxicillin 1000 mg twice
daily + clarithromycin 500 mg twice daily;
•
One pantoprazole 40-mg tab twice daily + metronidazole 500 mg twice
daily + clarithromycin 500 mg twice daily;
•
One pantoprazole 40-mg tab twice daily + amoxicillin 1000 mg twice
daily + metronidazole 500 mg twice daily.
Treatment of gastric and duodenal ulcer
One tablet of Pantoprazole 40 mg per day. In individual cases, the
dose may be doubled (increase to 2 tablets of
Pant