Febuxostat Mylan

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

febuxostat

Διαθέσιμο από:

Mylan Pharmaceuticals Limited

Φαρμακολογική κατηγορία (ATC):

M04AA03

INN (Διεθνής Όνομα):

febuxostat

Θεραπευτική ομάδα:

Antigout preparations

Θεραπευτική περιοχή:

Hyperuricemia; Arthritis, Gouty; Gout

Θεραπευτικές ενδείξεις:

Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Mylan is indicated in adults.

Περίληψη προϊόντος:

Revision: 11

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-06-15

Φύλλο οδηγιών χρήσης

64
B. PACKAGE LEAFLET
65
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEBUXOSTAT VIATRIS 80 MG FILM-COATED TABLETS
FEBUXOSTAT VIATRIS 120 MG FILM-COATED TABLETS
febuxostat
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 Febuxostat Viatris is and what it is used for
2.
What you need to know before you take Febuxostat Viatris
3.
How to take Febuxostat Viatris
4.
Possible side effects
5.
How to store Febuxostat Viatris
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT VIATRIS IS AND WHAT IT IS USED FOR
Febuxostat Viatris tablets contain the active substance febuxostat and
are used to treat gout,
which is associated with an excess of a chemical called uric acid
(urate) in the body. In some
people, the amount of uric acid builds up in the blood and may become
too high to remain
soluble. When this happens, urate crystals may form in and around the
joints and kidneys. These
crystals can cause sudden, severe pain, redness, warmth and swelling
in a joint (known as a gout
attack). Left untreated, larger deposits called tophi may form in and
around joints. These tophi
may cause joint and bone damage.
Febuxostat Viatris works by reducing uric acid levels. Keeping uric
acid levels low by taking
Febuxostat Viatris once every day stops crystals building up, and over
time it reduces
symptoms. Keeping uric acid levels sufficiently low for a long enough
period can also shrink
tophi.
Febuxostat Viatris 120 mg tablets are also used to treat and prevent
high blood levels of uric
acid that may occur whe

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat Viatris 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat.
Excipient with known effect
Each tablet contains 236.0 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
A yellow, capsule shaped, biconvex tablet approximately 16 x 7 mm,
debossed with M on one
side of the tablet and FX3 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of chronic hyperuricaemia in conditions where urate
deposition has already occurred
(including a history, or presence of, tophus and/or gouty arthritis).
Febuxostat Viatris is
indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of Febuxostat Viatris is 80 mg once daily
without regard to food. If
serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat
Viatris 120 mg once
daily may be considered.
Febuxostat Viatris works sufficiently quickly to allow retesting of
the serum uric acid after 2
weeks. The therapeutic target is to decrease and maintain serum uric
acid below 6 mg/dL
(357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
_Elderly_
No dose adjustment is required in the elderly (see section 5.2).
_Renal impairment _
The efficacy and safety have not been fully evaluated in patients with
severe renal impairment
(creatinine clearance <30 mL/min, see section 5.2).
No dose adjustment is necessary in patients with mild or moderate
renal impairment.
3
_Hepatic impairment_
The efficacy and safety of febuxostat has not been studied in patients
with severe hepatic
impairment (Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80
mg. Limited information
is available in patients with moderate hepatic impairment.
_Paediatric population_
The safety and the efficacy of febuxostat in children aged below the
age of 18 year