Pantoprazol Orion 40 mg Enterotablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

pantoprazolnatriumseskvihydrat

Tillgänglig från:

Orion Corporation

ATC-kod:

A02BC02

INN (International namn):

pantoprazole sodium sesquihydrate

Dos:

40 mg

Läkemedelsform:

Enterotablett

Sammansättning:

pantoprazolnatriumseskvihydrat 45,112 mg Aktiv substans; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 7 tabletter; Blister, 14 tabletter; Blister, 15 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Blister, 500 tabletter; Burk, 14 tabletter; Burk, 60 tabletter; Burk, 98 tabletter; Burk, 100 tabletter; Burk, 140 tabletter; Burk, 500 tabletter; Burk, 56 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-01-24

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOL ORION 40 MG GASTRO-RESISTANT TABLETS
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 Pantoprazol Orion is and what it is used for
2.
What you need to know before you take Pantoprazol Orion
3.
How to take Pantoprazol Orion
4.
Possible side effects
5.
How to store Pantoprazol Orion
6.
Contents of the pack and other information
1.
WHAT PANTOPRAZOL ORION IS AND WHAT IT IS USED FOR
Pantoprazol Orion 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.
Pantoprazol Orion 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.

_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 NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOL ORION
DO NOT TAKE PANTOPRAZOL ORION

if you are allergic to pantopr

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazol Orion 20 mg gastro-resistant tablets
Pantoprazol Orion 40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains pantoprazole sodium
sesquihydrate equivalent to 20 mg or 40 mg
pantoprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
20 mg: Light yellow, oval, biconvex tablets, 8.7 mm x 4.5 mm.
40 mg: Yellow, oval, biconvex tablets, 11.9 mm x 6.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pantoprazol Orion 20 mg is indicated in
•
_adults and adolescents 12 years of age and above for_
:

symptomatic gastro-oesophageal reflux disease

long-term management and prevention of relapse in reflux oesophagitis.
•
_adults for_

prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-
inflammatory drugs (NSAIDs) in patients at risk with a need for
continuous NSAID
treatment (see section 4.4).
Pantoprazol Orion 40 mg is indicated in
•
_adults and adolescents 12 years of age and above for_
:

reflux oesophagitis
•
_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
PANTOPRAZOL ORION 20 MG
Adults and adolescents 12 years of age and above
_Symptomatic gastro-oesophageal reflux disease_
The recommended oral dose is one 20 mg tablet per day. Symptom relief
is generally accomplished
within 2–4 weeks. If this is not sufficient, symptom relief will
normally be achieved within a further
4 weeks. When symptom relief has been achieved, reoccurring symptoms
can be controlled using an
on-demand regimen of 20 mg once daily, taking one tablet when
required. A switch to continuous
therapy may be considered in case