Panto-Denk 40

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pantoprazole (pantoprazole sodium sesquihydrate)

Available from:

Advance Pharma GmbH

INN (International Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dosage:

40mg

Pharmaceutical form:

tablets gastro-resistant

Prescription type:

Prescription

Patient Information leaflet

_Panto-Denk 40_
Gastro-resistant tablet – oral use
Active substance: pantoprazole
Proton pump inhibitor
PACKAGE LEAFLET:
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor or pharmacist
– This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
– If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharma-
cist.
IN THIS LEAFLET:
1. What Panto-Denk 40 is and what it is used for
2. Before you take Panto-Denk 40
3. How to take Panto-Denk 40
4. Possible side effects
5. How to store Panto-Denk 40
6. Further information
1.
WHAT PANTO-DENK 40 IS AND
WHAT IT IS USED FOR
Panto-Denk 40 is a medicine that reduces the
production of stomach acid (selective proton
pump inhibitor).
PANTO-DENK 40 IS USED
– to treat duodenal ulcers,
– to treat stomach ulcers,
– to treat moderate and severe forms of reflux
oesophagitis (inflammation of the gullet),
– for the long-term treatment of conditions asso-
ciated with excess stomach acid production
(e.g. Zollinger-Ellison syndrome),
– in combination with antibiotics in the treat-
ment of an infection caused by _Helicobacter_
_pylori._ This is a bacterial infection, which can
cause inflammation of the stomach. It can also
cause ulcers in the stomach or duodenum.
Treating _Helicobacter pylori_ infection helps to
heal these conditions and prevent them from
returning.
2.
BEFORE YOU TAKE PANTO-DENK 40
DO NOT TAKE PANTO-DENK 40
– if you are allergic (hypersensitive) to panto -
prazole, soya, peanuts or any of the other
ingredients of Panto-Denk 40,
– if you are taking medicines with the active
substance atazanavir (used to treat HIV in -
fections).
– in combined therapy of _Helicobacter pylori,_
when you suffer from moderate or severely
reduced kidney or liver functi

Summary of Product characteristics

Page: 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panto-Denk 40
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gastro-resistant tablet contains 40 mg pantoprazole (equivalent to
45.1 mg pantoprazole
sodium 1.5 H
2
O).
Excipients: 1 tablet contains 76.85 mg maltitol (see section 4.4).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablets
Yellow, oval tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Duodenal ulcer
-
Gastric ulcer
-
Moderate and severe forms of reflux oesophagitis
-
Long-term treatment of Zollinger-Ellison syndrome and other disorders
associated with
pathological hypersecretion of gastric acid
-
Eradication of
_Helicobacter pylori_
, in combination with antibiotics in patients with
duodenal ulcer or gastric ulcer
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER
_ _
Moderate and severe forms of reflux oesophagitis
The recommended dose for reflux oesophagitis is 1 Panto-Denk 40
gastro-resistant tablet dai-
ly.
In individual cases, especially in patients yet to respond to therapy
with other medicinal prod-
ucts, the dose can be doubled (i.e. 2 Panto-Denk 40 gastro-resistant
tablets daily).
ADULTS
Page: 2 of 11
Gastric and duodenal ulcers
For monotherapy with Panto-Denk 40, the following dosing guidelines
apply:
For gastroduodenal ulcers, the dose is 1 Panto-Denk 40
gastro-resistant tablet daily.
In individual cases, especially in patients yet to respond to therapy
with other medicinal prod-
ucts, the double dose can be given (an increase to 2 Panto-Denk 40
gastro-resistant tablets
daily).
Zollinger-Ellison syndrome
For the long-term therapy of Zollinger-Ellison syndrome and other
disorders associated with
pathological hypersecretion of gastric acid, the recommended starting
dose is 80 mg daily
(2 Panto-Denk 40 tablets).Thereafter, the dosage can be individually
adjusted to the extent of
gastric acid secretion. At dosages of more than 80 mg daily, the daily
dose should be