Jorveza
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
06-12-2022
Produktets egenskaber
(SPC)
06-12-2022
Offentlige vurderingsrapport
(PAR)
04-06-2020
Aktiv bestanddel:
Budesonide
Tilgængelig fra:
Dr. Falk Pharma GmbH
ATC-kode:
A07EA06
INN (International Name):
budesonide
Terapeutisk gruppe:
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Terapeutisk område:
Esophageal Diseases
Terapeutiske indikationer:
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Produkt oversigt:
Revision: 6
Autorisation status:
Authorised
Autorisation dato:
2018-01-08
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JORVEZA 0.5 MG ORODISPERSIBLE TABLETS
JORVEZA 1 MG ORODISPERSIBLE TABLETS
budesonide
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 Jorveza is and what it is used for
2.
What you need to know before you take Jorveza
3.
How to take Jorveza
4.
Possible side effects
5.
How to store Jorveza
6.
Contents of the pack and other information
1.
WHAT JORVEZA IS AND WHAT IT IS USED FOR
Jorveza contains the active substance budesonide, a corticosteroid
medicine that reduces inflammation.
It is used in adults (older than 18 years of age) to treat
eosinophilic oesophagitis, which is an
inflammatory condition of the gullet (food pipe) that causes problems
with swallowing food.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE JORVEZA
DO NOT TAKE JORVEZA
−
if you are allergic to budesonide or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Jorveza if you have:
−
tuberculosis
−
high blood pressure
−
diabetes, or if somebody in your family has diabetes
−
weakening of the bones (osteoporosis)
−
ulcers in the stomach or first part of the small intestine (peptic
ulcer)
−
increased pressure in your eye (which can cause glaucoma) or eye
problems such as clouding of
the lens (cataracts) or if somebody in your family has glaucoma
−
liver disease.
If you have any of the conditions mentioned above you may be at
increased risk of side effects. Your
doctor
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Jorveza 0.5 mg orodispersible tablets
Jorveza 1 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jorveza 0.5 mg orodispersible tablets
Each orodispersible tablet contains 0.5 mg of budesonide.
_ _
_Excipient with known effect _
Each 0.5 mg orodispersible tablet contains 26 mg sodium.
Jorveza 1 mg orodispersible tablets
Each orodispersible tablet contains 1 mg of budesonide.
_Excipient with known effect _
Each 1 mg orodispersible tablet contains 26 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
Jorveza 0.5 mg orodispersible tablets
White, round, biplane orodispersible tablets, with a diameter of 7.1
mm and height of 2.2 mm. They
are debossed with “0.5” on one side.
Jorveza 1 mg orodispersible tablets
White, round, biplane orodispersible tablets, with a diameter of 7.1
mm and height of 2.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jorveza is indicated for the treatment of eosinophilic esophagitis
(EoE) in adults (older than 18 years
of age).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment with this medicinal product should be initiated by a
gastroenterologist or a physician
experienced in the diagnosis and treatment of eosinophilic
esophagitis.
Posology
_Induction of remission _
The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in
the morning and one 1-mg-
tablet in the evening.
3
The usual duration of induction treatment is 6 weeks. For patients who
are not appropriately
responding during 6 weeks the treatment can be extended to up to 12
weeks.
_Maintenance of remission _
_ _
The recommended daily dose is 1 mg budesonide as one 0.5-mg-tablet in
the morning and one 0.5-mg-
tablet in the evening or 2 mg budesonide as one 1-mg-tablet in the
morning and one 1-mg-tablet in the
evening, depending on the individual clinical requirement of the
patient.
A maintenance dose of 1 mg budesonide twice daily is recommended for
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