Feburo 120 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

febuxostathemihydrat

Tillgänglig från:

G.L. Pharma GmbH

ATC-kod:

M04AA03

INN (International namn):

febuxostathemihydrat

Dos:

120 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

mannitol Hjälpämne; natriumlaurilsulfat Hjälpämne; febuxostathemihydrat 123,42 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 14 tabletter (Al); Blister, 14 tabletter (plast/Al); Blister, 28 tabletter (Al); Blister, 28 tabletter (plast/Al); Blister, 42 tabletter (Al); Blister, 42 tabletter (plast/Al); Blister, 56 tabletter (Al); Blister, 56 tabletter (plast/Al); Blister, 84 tabletter (Al); Blister, 84 tabletter (plast/Al); Blister, 98 tabletter (Al); Blister, 98 tabletter (plast/Al); Blister, 10 tabletter (Al); Blister, 30 tabletter (Al); Blister, 10 tabletter (plast/Al); Blister, 30 tabletter (plast/Al)

Bemyndigande status:

Godkänd

Tillstånd datum:

2017-10-02

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEBURO 80 MG FILM-COATED TABLETS
FEBURO 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 Feburo is and what it is used for
2.
What you need to know before you take Feburo
3.
How to take Feburo
4.
Possible side effects
5
How to store Feburo
6.
Contents of the pack and other information
1.
WHAT FEBURO IS AND WHAT IT IS USED FOR
Feburo 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.
Feburo works by reducing uric acid levels. Keeping uric acid levels
low by taking Feburo 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.
Feburo 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, and uric acid
levels increase in the blood
acco

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Feburo 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of febuxostat.
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 of 19.0 x
7.6 mm, plain on both sides and
engraved with “F120” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Feburo 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).
Feburo 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).
Feburo is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout:_
The recommended oral dose of febuxostat 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 120 mg
once daily may be considered.
Febuxostat 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).
_Tumor Lysis Syndrome:_
The recommended oral dose of febuxostat is 120 mg once daily without
regard to
food. Febuxostat should be started two days before the beginning of
cytotoxic therapy and continued for a
minimum of 7 days; however treatment may be prolonged up to 9 days
according to chemotherapy
duration as per clinical judgment.
_Elderly people_
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 i