Goutric 80mg Film Coated Tablets

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

Febuxostat

Pieejams no:

NOVUGEN PHARMA SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

Febuxostat

Vienības iepakojumā:

10 Tablets; 30 Tablets; 50 Tablets; 100 Tablets

Ražojis:

NOVUGEN PHARMA SDN. BHD.

Lietošanas instrukcija

_Consumer Medication Information Leaflet (RiMUP) _
GOUTRIC FILM COATED TABLETS
Febuxostat 40mg, 80mg
1
WHAT IS IN THIS LEAFLET
1.
What Goutric is used for
2.
How Goutric works
3.
Before you use Goutric
4.
How to use Goutric
5.
While you are using Goutric
6.
Side effects
7.
Storage and Disposal of Goutric
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT GOUTRIC IS USED FOR
Goutric
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.
Goutric works by reducing uric acid
levels. Keeping uric acid levels low by
taking Goutric 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.
Goutric is for adults.
HOW GOUTRIC WORKS
The
active
substance
in
Goutric,
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,
Goutric 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 GOUTRIC
−
_When you must not use it _
Do not take Goutric 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

Produkta apraksts

GOUTRIC 40MG
GOUTRIC 80MG
1.
NAME OF THE MEDICINAL PRODUCT
Goutric 40mg Film Coated Tablets
Goutric 80mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GOUTRIC 40MG FILM COATED TABLETS:
Each tablet contains 40 mg of Febuxostat. Each tablet
contains 37.500mg of lactose (as monohydrate).
GOUTRIC 80MG FILM COATED TABLETS:
Each tablet contains 80 mg of Febuxostat. Each tablet
contains 75.000mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
GOUTRIC 40MG FILM COATED TABLETS:
Pale yellow to yellow film coated, round shaped tablet
debossed with “N” on one side and ‘33’ on the other side.
GOUTRIC 80MG FILM COATED TABLETS:
Pale yellow to yellow film coated, capsule shaped
tablet debossed with “N 32” on one side and break line on the
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).
Goutric is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended oral dose of Goutric is 40 mg or 80 mg once daily
without regard to food.
The recommended starting dose of Goutric is 40 mg once daily. If serum
uric acid is > 6.0
mg/dL (357 µmol/L) after 2-4 weeks, Goutric 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.
Goutric 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