Febuxostat PharOS 80mg film-coated tablet

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

FEBUXOSTAT

Disponible des:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

Codi ATC:

M04AA03

Designació comuna internacional (DCI):

FEBUXOSTAT 80 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

FEBUXOSTAT 80 mg

tipo de receta:

POM

Área terapéutica:

ANTIGOUT PREPARATIONS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2017-09-19

Informació per a l'usuari

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
FEBUXOSTAT PHAROS 80 MG FILM-COATED TABLETS
FEBUXOSTAT PHAROS 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 PharOS is and what it is used for
2.
What you need to know before you take Febuxostat PharOS
3.
How to take Febuxostat PharOS
4.
Possible side effects
5.
How to store Febuxostat PharOS
6.
Contents of the pack and other information
1.
WHAT FEBUXOSTAT PHAROS IS AND WHAT IT IS USED FOR
Febuxostat PharOS 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 PharOS works by reducing uric acid levels. Keeping uric
acid levels low by taking
Febuxostat PharOS 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 PharOS 120 mg: _
Febuxostat PharOS 120 mg tablets is also used to treat and prevent
high blood levels of uric acid
that may

Fitxa tècnica

Page
1
of
18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat PharOS 80 mg film-coated tablets
Febuxostat PharOS 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Febuxostat PharOS 80 mg: Each tablet contains 80 mg of febuxostat
equivalent to 82.28 mg
febuxostat hemihydrate.
Febuxostat PharOS 120 mg: Each tablet contains 120 mg of febuxostat
equivalent to 123.42 mg
febuxostat hemihydrate.
Excipient(s) with known effect:
Febuxostat PharOS 80 mg: Each tablet contains 72.68 mg of lactose (as
monohydrate).
Febuxostat PharOS 120 mg: Each tablet contains 109.02 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Febuxostat PharOS 80 mg: Pale yellow to yellow, film-coated, capsule
shaped tablets, engraved
with “80” on one side and plain on the other, with dimensions 16.5
mm x 7.0 mm ± 5%.
Febuxostat PharOS 120 mg: Pale yellow to yellow, film-coated, capsule
shaped tablets, engraved
with “120” on one side and plain on the other, with dimensions
18.5 mm x 9.0 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuxostat PharOS 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 PharOS 120 mg: _
Febuxostat PharOS 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 PharOS is indicated in adults.
Page
2
of
18
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout:_
The recommended oral dose of Febuxostat PharOS 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 PharOS 120 mg
once daily may be considered.
Febuxostat PharOS works sufficiently quickly to allow retesting of the
serum uric acid after 2
weeks. The therapeutic t