Zurampic
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
06-07-2017
Fachinformation
(SPC)
06-07-2017
Öffentlichen Beurteilungsberichts
(PAR)
09-03-2016
Wirkstoff:
lesinurad
Verfügbar ab:
Grünenthal GmbH
ATC-Code:
M04AB05
INN (Internationale Bezeichnung):
lesinurad
Therapiegruppe:
Antigout preparations
Therapiebereich:
Hyperuricemia
Anwendungsgebiete:
Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,
Produktbesonderheiten:
Revision: 4
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2016-02-18
Gebrauchsinformation
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZURAMPIC 200 MG FILM-COATED TABLETS
lesinurad
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Zurampic is and what it is used for
2.
What you need to know before you take Zurampic
3.
How to take Zurampic
4.
Possible side effects
5.
How to store Zurampic
6.
Contents of the pack and other information
1.
WHAT ZURAMPIC IS AND WHAT IT IS USED FOR
Zurampic contains the active ingredient lesinurad and is used to treat
gout in adult patients by lowering
the levels of uric acid in the blood. Zurampic must be taken together
with allopurinol or febuxostat,
which are medicines called ‘xanthine oxidase inhibitors’ and are
also used to treat gout by lowering
the amount of uric acid in your blood.
Your doctor will prescribe Zurampic if your current medicine is not
controlling your gout. You must
use Zurampic together with either allopurinol or febuxostat.
HOW ZURAMPIC WORKS:
Gout is a type of arthritis caused by an accumulation of urate
crystals around the joints. By lowering
the amount of uric acid in the blood, Zurampic stops this accumulation
and may prevent further joint
damage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZURAMPIC
DO NOT TAKE ZURAMPIC:
-
if you are allergic to lesinurad or any of the other ingred
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zurampic 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of lesinurad.
Excipient with known effect: Each tablet contains 52.92 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, 5.7 x 12.9 mm, blue tablets.
Tablets are engraved with “LES200” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zurampic, in combination with a xanthine oxidase inhibitor, is
indicated in adults for the adjunctive
treatment of hyperuricaemia in gout patients (with or without tophi)
who have not achieved target
serum uric acid levels with an adequate dose of a xanthine oxidase
inhibitor alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Zurampic is 200 mg once daily in the morning.
This is also the maximum
dose (see section 4.4).
Zurampic tablets must be co-administered at the same time as the
morning dose of a xanthine oxidase
inhibitor, i.e. allopurinol or febuxostat. The recommended minimum
dose of allopurinol is 300 mg, or
200 mg for patients with moderate renal impairment (creatinine
clearance [CrCL] of 30-59 mL/min). If
treatment with the xanthine oxidase inhibitor is interrupted, Zurampic
dosing must also be interrupted.
Patients should be informed that failure to follow these instructions
may increase the risk of renal
events (see section 4.4).
Patients should be instructed to stay well hydrated (e.g. 2 litres of
liquid per day).
The target serum uric acid level is less than 6 mg/dL (360 µmol/L).
In patients with tophi or persistent
symptoms, the target is less than 5 mg/dL (300 µmol/L). Testing for
t
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