Febuksostat Actavis Tablet, film coated 120mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FEBUXOSTAT

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

M04AA03

INN (International Name):

FEBUXOSTAT 120 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FEBUXOSTAT 120 mg

Prescription type:

POM

Therapeutic area:

ANTIGOUT PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2018-01-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Febuksostat Actavis
80 MG FILM-COATED TABLETS
Febuksostat Actavis
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Febuksostat Actavis is and what it is used for
2.
What you need to know before you take Febuksostat Actavis
3.
How to take Febuksostat Actavis
4.
Possible side effects
5.
How to store Febuksostat Actavis
6.
Contents of the pack and other information
1.
WHAT
Febuksostat Actavis i
S AND WHAT IT IS USED FOR
Febuksostat Actavis contains the active substance febuxostat and is
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.
Febuksostat Actavis works by reducing uric acid levels. Keeping uric
acid levels low by taking
Febuksostat Actavis 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.
Febuksostat Actavis 120 mg is also used to treat and prevent high
blood levels of uric acid that may
occur when you start to recei

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Febuksostat Actavis 80 mg film-coated tablets
Febuksostat Actavis 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80.00 mg febuxostat (as febuxostat
hemihydrate).
Excipient with known effect:
Each film-coated tablet contains 107.09 mg of lactose (as
monohydrate).
Each film-coated tablet contains 120.00 mg febuxostat (as febuxostat
hemihydrate).
Excipient with known effect:
Each film-coated tablet contains 160.63 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, biconvex, capsule-shaped, film-coated tablet, marked
“A275” on one side and “80” on the
other. The dimensions of the tablet are16 mm x 7 mm.
Yellow, biconvex, capsule-shaped, film-coated tablet, marked
“A265” on one side and “120” on the
other. The dimensions of the tablet are 19 mm x 8.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Febuksostat Actavis 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).
Febuksostat Actavis 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).
Febuksostat Actavis is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Gout: _
The recommended oral dose of Febuksostat Actavis is 80 mg once daily
without regard to
food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks,
Febuksostat Actavis 120 mg
once daily may be considered.
Febuksostat Actavis 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