Pantoprazol Sandoz 40 mg, maagsapresistente tabletten

Երկիր: Նիդերլանդեր

Լեզու: հոլանդերեն

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

Ակտիվ բաղադրիչ:

PANTOPRAZOL NATRIUM 1,5-WATER 45,1 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 40 mg/stuk

Հասանելի է:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC կոդը:

A02BC02

INN (Միջազգային անվանումը):

PANTOPRAZOL NATRIUM 1,5-WATER 45,1 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 40 mg/stuk

Դեղագործական ձեւ:

Maagsapresistente tablet

Կազմը:

CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Կառավարման երթուղին:

Oraal gebruik

Թերապեւտիկ տարածք:

Pantoprazole

Ապրանքի ամփոփագիր:

Hulpstoffen: CALCIUMSTEARAAT (E 470A); CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL ALUMINIUMLAK (E 104); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 400; NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PONCEAU 4R ALUMINIUMLAK (E 124); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Հաստատման ամսաթիվը:

2007-11-23

Տեղեկատվական թերթիկ

Sandoz B.V.
Page 1/8
Pantoprazol Sandoz 40 mg, maagsapresistente tabletten
RVG 33653
1313-v16
1.3.1.3 Package Leaflet
Augustus 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOL SANDOZ
® 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance
pantoprazole. Pantoprazole 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.
[Nationally completed 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.
[Nationally completed 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

Ապրանքի հատկությունները

Sandoz B.V.
Page 1/13
Pantoprazol Sandoz 40 mg, maagsapresistente
tabletten
RVG 33653
1311-V12
1.3.1.1 Summary of Product Characteristics
November 2021
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazol Sandoz 40 mg, maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium
sesquihydrate).
Excipient with known effect
Each gastro-resistant tablet contains 2 microgram of azo colouring
agent Ponceau 4R aluminium lake (E
124).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
A yellow, oval coated tablet, approx. 11.7 x 6.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for use in adults and
adolescents 12 years of age and above
for:
−
Reflux oesophagitis.
_ _
[Nationally completed name] 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 [Nationally completed name] 40 mg per day. In individual
cases the dose may be
doubled (increase to 2 tablets [Nationally completed name] 40 mg
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 _
Sandoz B.V.
Page 2/13
Pantoprazol Sandoz 40 mg, maagsapresistente
tabletten
RVG 33653
1311-V12
1.3.1.1 Summary of Product Characteristics
November 2021
_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