Febuxostat Alvogen Tablet, film coated 80mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FEBUXOSTAT

Available from:

Alvogen Malta Operations (ROW) Ltd Malta Life Sciences Park, Building 1, Level 4 Sir Temi, Zammit Buildings, San Gwann, Malta

ATC code:

M04AA03

INN (International Name):

FEBUXOSTAT 80 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FEBUXOSTAT 80 mg

Prescription type:

POM

Therapeutic area:

ANTIGOUT PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2018-07-30

Patient Information leaflet

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

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat Alvogen 80 mg film-coated tablets
Febuxostat Alvogen 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Febuxostat Alvogen 80 mg film-coated tablets: Each tablet contains 80
mg of febuxostat (as
febuxostat hemihydrate)
Febuxostat Alvogen 120 mg film-coated tablets: Each tablet contains
120 mg of febuxostat (as
febuxostat hemihydrate)
Excipient(s) with known effect:
Febuxostat Alvogen 80 mg film-coated tablets: Each tablet contains
76.50 mg of lactose
as
monohydrate.
Febuxostat
Alvogen
120 mg
film-coated
tablets:
Each
tablet
contains
114.75
mg
of
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Febuxostat Alvogen 80 mg film-coated tablets: 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 Alvogen 120 mg film-coated tablets: 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 Alvogen 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 Alvogen 120 mg: _
Febuxostat Alvogen 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 Alvogen is indicated in adults.
Page 2 of 18
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout: _The recommended oral dose of Febuxostat Alvogen 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 Alvogen 120 mg
once daily may be considered.
Febuxostat Alvogen works suffic