Pantoprazol Heumann 40 mg, maagsapresistente tabletten

Држава: Холандија

Језик: Холандски

Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активни састојак:

PANTOPRAZOL NATRIUM 1,5-WATER SAMENSTELLING overeenkomend met ; PANTOPRAZOL

Доступно од:

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 NÜRNBERG (DUITSLAND)

АТЦ код:

A02BC02

INN (Међународно име):

PANTOPRAZOL NATRIUM 1,5-WATER COMPOSITION corresponding to ; PANTOPRAZOL

Фармацеутски облик:

Maagsapresistente tablet

Састав:

AMMONIA (E 527) ; BRUINE INKT ; CALCIUMSTEARAAT (E 470A) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MANNITOL (D-) (E 421) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Пут администрације:

Oraal gebruik

Терапеутска област:

Pantoprazole

Резиме производа:

Hulpstoffen: AMMONIA (E 527); BRUINE INKT; CALCIUMSTEARAAT (E 470A); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MANNITOL (D-) (E 421); NATRIUMCARBONAAT 0-WATER (E 500 (I)); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Датум одобрења:

2011-01-07

Информативни летак

Pantoprazol Heumann ,40 mg, maagsapresistente tabletten –
NL/H/1846/002/DC
Page 1
NL pl
NL/p/002/12/9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANTOPRAZOL HEUMANN 40 MG, MAAGSAPRESISTENTE TABLETTEN
Pantoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [product name] is and what it is used for
2.
What you need to know before you take [product name]
3.
How to take [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product name] contains the active substance pantoprazole. [product
name] is a selective “proton
pump inhibitor”, a medicine which reduces the amount of acid
produced in your stomach. It is used
for treating acid-related diseases of the stomach and intestine.
[PRODUCT NAME] IS USED TO TREAT:
_ _
_Adults and adolescents 12 years of age and above for: _
−
Reflux oesophagitis. An inflammation of your oesophagus (the tube
which connects your
throat to your stomach) accompanied by the regurgitation of stomach
acid.
_[product name] is used to treat adults for_
:
−
An infection with a bacterium called
_Helicobacter pylori _
in patients with duodenal ulcers and
stomach ulcers in combination with two antibiotics (eradication
therapy). The aim is to get rid
of the bacteria and so reduce the likelihood of these ulcers
returning.
−
Stomach and duodenal ulcers.
−
Zollinger-Ellison-Syndrome and other conditions producing too much
acid in the stomach.
2.
WHAT YOU NEE

Карактеристике производа

Pantoprazol Heumann 40 mg, maagsapresistente tabletten –
NL/H/1846/002/DC
NL SmPC
NL/s/001/12/7
Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazol Heumann 40 mg, maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg pantoprazole (as
pantoprazole sodium sesquihydrate).
Excipients with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow coloured, oval shaped, biconvex, enteric-coated tablets,
imprinted with “40” on one side
and plain on other side.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_[product name] 40 mg gastro-resistant tablets is indicated for use in
adults and adolescents 12 years _
_of age and above for:_

Reflux oesophagitis.
_[product name] 40 mg gastro-resistant tablets is indicated in adults
for:_

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
Posology
_ _
_Adults and adolescents 12 years of age and above _
Reflux oesophagitis
One tablet of [product name] per day. In individual cases the dose may
be doubled (increase to 2
tablets [product name] daily) especially when there has been no
response to other treatment. A 4-week
period is usually required for the treatment of reflux oesophagitis.
If this is not sufficient, healing will
usually be achieved within a further 4 weeks.
_ _
_Adults _
Eradication of _H. pylori _in combination with two appropriate
antibiotics
In _H. pylori _positive patients with gastric and duodenal ulcers,
eradication of the germ by a
combination therapy should be achieved. Considerations should be given
to official local guidance
(e.g. national recommendations) regarding bacterial resistance and the
appropriate use and
prescription of an