Adenuric

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

febuxostat

Saatavilla:

Menarini International Operations Luxembourg S.A. (MIOL)

ATC-koodi:

M04AA03

INN (Kansainvälinen yleisnimi):

febuxostat

Terapeuttinen ryhmä:

Antigout preparations

Terapeuttinen alue:

Gout

Käyttöaiheet:

80 mg strength:Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Adenuric is indicated in adults.120 mg strength:Adenuric 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).Adenuric 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).Adenuric is indicated in adults.

Tuoteyhteenveto:

Revision: 23

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2008-04-21

Pakkausseloste

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADENURIC 80 MG FILM-COATED TABLETS
ADENURIC 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 ADENURIC is and what it is used for
2.
What you need to know before you take ADENURIC
3.
How to take ADENURIC
4.
Possible side effects
5
How to store ADENURIC
6.
Contents of the pack and other information
1.
WHAT ADENURIC IS AND WHAT IT IS USED FOR
ADENURIC 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.
_ _
ADENURIC works by reducing uric acid levels. Keeping uric acid levels
low by taking ADENURIC
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.
ADENURIC 120 mg tablets is also used to treat and prevent high blood
levels of uric acid that may
occur when you start to receive chemotherapy for blood cancers.
When chemotherapy is given, cancer cells are destroyed,

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ADENURIC 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
Each tablet contains 80 mg of febuxostat.
Excipient(s) with known effects:
Each tablet contains 76.50 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved
with “80” on one side and a score
line on the other side.
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
Treatment of chronic hyperuricaemia in conditions where urate
deposition has already occurred
(including a history, or presence of, tophus and/or gouty arthritis)._
_
ADENURIC is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of ADENURIC is 80 mg once daily without
regard to food. If serum uric
acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, ADENURIC 120 mg once
daily may be considered.
ADENURIC 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.
_Paediatric population _
Th