Febulus 80 (Febuxostat 80mg Film Coated Tablets)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Febuxostat

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

Febuxostat

Unit dalam pakej:

1 X 14 Tablets; 2 X 14 Tablets

Dikeluarkan oleh:

INDOCO REMEDIES LIMITED

Risalah maklumat

FEBULUS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Febuxostat 80mg Film Coated Tablets
1
WHAT IS IN THIS LEAFLET
1.
What Febulus is used for
2.
How Febulus works
3.
Before you use Febulus
4.
How to use Febulus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Febulus
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT FEBULUS IS USED FOR
FEBULUS
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. FEBULUS
works by reducing uric acid levels.
Keeping
uric
acid
levels
low
by
taking
FEBULUS
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. FEBULUS is for adults.
HOW FEBULUS TABLETS WORKS
The active substance in FEBULUS,
febuxostat, reduces the formation of
uric acid. It works by blocking an
enzyme
called
xanthine
oxidase,
which is needed to make uric acid in
the body. By reducing the production
of uric acid, FEBULUS can reduce
levels of uric acid in the blood and
keep
them
low,
stopping
crystals
from building up. This can reduce the
symptoms of gout. Keeping uric acid
levels low for long enough can also
shrink tophi.
BEFORE YOU USE FEBULUS TABLETS
-
_When you must not use it _
_ _
Do not take FEBULUS if you are
hypersensitive to Febuxostat or any
other ingredients of this medicine.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children
under the age of 18 because the safety
and
efficacy
have
n

Ciri produk

50 mm
FEBULUS 80 (FEBUXOSTAT 80MG FILM COATED TABLETS)
1. NAME OF THE MEDICINAL PRODUCT
FEBULUS 80 (FEBUXOSTAT 80MG FILM COATED TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film Coated Tablet Contains:
Febuxostat ………..80mg
3. PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow to yellow coloured, capsule shaped biconvex, film coated
tablets, debossed with '80' on one side and breakline on
other side.
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).
FEBUXOSTAT is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of FEBUXOSTAT is 40 mg or 80 mg once daily
without regard to food. The recommended
starting dose of FEBUXOSTAT is 40 mg once daily. If serum uric acid is
> 6.0 mg/dL (357 µmol/L) after 2-4 weeks,
FEBUXOSTAT 80 mg once daily may be considered. The 80 mg tablet can be
divided into equal halves. In order to provide a
40 mg dose, the tablet should be split just before use. Prescribers
should advise patients on how to break the tablets in half and
to keep the other half for the next dose.
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 6.0 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended.
_Elderly_
No dose adjustment is required in the elderly.
_Renal _
impairment
The efficacy and safety have not been fully evaluated in patients with
severe renal impairment (creatinine clearance <30
mL/min.
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).
No dose adjustment is necessary in patients with mild hepatic
impairment. Limited information is available in patient