Febuxostat Krka

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

febuxostat

Disponibil de la:

Krka, d.d., Novo mesto

Codul ATC:

M04AA03

INN (nume internaţional):

febuxostat

Grupul Terapeutică:

Antigout preparations

Zonă Terapeutică:

Hyperuricemia; Gout

Indicații terapeutice:

Febuxostat Krka 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 Krka is indicated in adults.

Rezumat produs:

Revision: 4

Statutul autorizaţiei:

Authorised

Data de autorizare:

2019-03-28

Prospect

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEBUXOSTAT KRKA 80 MG FILM-COATED TABLETS
FEBUXOSTAT KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Febuxostat Krka
3.
How to take Febuxostat Krka
4.
Possible side effects
5.
How to store Febuxostat Krka
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT KRKA IS AND WHAT IT IS USED FOR
Febuxostat Krka 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 Krka works by reducing uric acid levels. Keeping uric acid
levels low by taking Febuxostat
Krka 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 Krka 120 mg tablets are also used to treat and prevent high
blood levels of uric acid that
may occur when you start to receive chemother

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat Krka 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg febuxostat.
Excipient(s) with known effect
-
lactose (as monohydrate): 73 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Off pink, oval, biconvex, film-coated tablets scored on one side.
Tablet dimension: approximatelly
16 mm × 8 mm. The score line is only to facilitate breaking for ease
of swallowing and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuxostat Krka 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 Krka is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of Febuxostat Krka 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 Krka
120 mg once daily may be
considered.
Febuxostat Krka 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.
_Hepatic impairment_
The efficacy and safety of febuxostat has not been studied in patients
with severe hepatic impairment
(Child Pugh Class C).
3
The recommended dose in patients with mild hepatic impairment is 80
mg. Limited information is
available in patients with moderate hepatic impairment.