Feburic 80 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

febuxostat

Boleh didapati daripada:

Astellas Pharma Malaysia Sdn Bhd

INN (Nama Antarabangsa):

febuxostat

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Pantheon France

Risalah maklumat

FEBURIC
® FILM-COATED TABLETS
Febuxostat (80mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_FEBURIC_
is used for
2.
How
_FEBURIC_
works
3.
Before you use
_FEBURIC_
4.
How to use
_FEBURIC_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_FEBURIC_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1.
WHAT _FEBURIC _IS USED FOR
FEBURIC 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.
FEBURIC works by reducing uric acid
levels. Keeping uric acid levels low by
taking FEBURIC 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.
FEBURIC is for adults.
2.
HOW _FEBURIC _WORKS
The active substance in FEBURIC,
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,
FEBURIC 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.
3.
BEFORE YOU USE _FEBURIC_
-
_When you must not use it _
Do not take
FEBURIC
if you are allergic
to febuxostat or any of the 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

1
1. NAME OF THE MEDICINAL PRODUCT
Feburic ® film -coated tablets 80 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of febuxostat.
Excipient(s) with known effects:
Each tablet contains 76.50 mg of lactose (as monohydrate )
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet.
Pale yellow to yellow rectangle film -coated tablet with a break line on one side and “80”
engraved on the other side.
4. CLINICAL PARTICUL ARS
4.1 Therape utic indications
Treatment of chronic hyperuricaemia in conditions where urate deposition has already
occurred (including a history, or presence of, tophus and/or gouty arthritis).
Feburic is indicated in adults.
4.2 Posology and method of administra tion
Posology
The recommended oral dose of Feburic is 40 mg or 80 mg once daily without regard to food.
The recommended starting dose of Feburic is 40 mg once daily. If serum uric acid is
> 6.0 mg/dL (357 µmol/L) after 2 -4 weeks, Febu ric 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.
Feburic 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 (see section 4.4).
Elderly
No dose adjustment is required in the elderly (see section 5.2).
Renal impairment
The efficacy and safety have not been fully evaluat ed in patients with severe renal
impairment (creatinine clearance