UNIQUIN (Hydroxychloroquine Sulfate 200mg Film Coated Tablet)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

HYDROXYCHLOROQUINE SULPHATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

HYDROXYCHLOROQUINE SULPHATE

Unit dalam pakej:

6 x 10 tablet Tablets

Dikeluarkan oleh:

INCEPTA PHARMACEUTICALS LTD

Risalah maklumat

UNIQUIN (HYDROXYCHLOROQUINE
Consumer Medication Information Leaflet (RiMUP)
SULPHATE 200MG FILM COATED TABLET)
(Hydroxychloroquine Sulphate 200mg)
WHAT IS IN THIS LEAFLET
1.
What Uniquin is used for
2.
How Uniquin works
3.
Before you Uniquin
4.
How to use Uniquin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Uniquin
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT UNIQUIN IS USED FOR
UNIQUIN
contains
a
medicine
called
hydroxychloroquine
sulphate.
And
is
used
for
Treatment
of
rheumatoid
arthritis
(inflammation
of
the
joint),
juvenile chronic arthritis (in children),
discoid
and
systemic
lupus
erythematosus (a disease of the skin or
the internal organs), and dermatological
conditions
caused
or
aggravated
by
sunlight (skin problem which are worsen
by sunlight).
HOW UNIQUIN WORKS
UNIQUIN
works
by
reducing
inflammation in people with autoimmune
disease (this is where the body immune
system attacks itself by mistake.
BEFORE YOU USE UNIQUIN
When you must not use it
Do not take UNIQUIN if you:

Think
you
may
be
allergic(hypersensitive) to :
- hydrochloroquine ,
- other similar medicine such as
quinolones and quinine,
- any other ingredients of UNIQUIN

have
an
eye
problem
which
affects the retina, the inside of the eye
(maculopathy) or you get a change in eye
colour or any other eye problem.
Signs of an allergic reaction including: a
rash, swallowing or breathing problems,
swellings
of
your
lips,face,throat
or
tongue.
You are pregnant, might become
pregnant or think you may be pregnant
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking UNIQUIN.
Pregnancy and lactation
Do not take UNIQUIN if :
-
You
are
pregnant,
might
become
pregnant
or
think
you
may
be
pregnant
- You are breast feeding or planning to
breast-feed.
This
is
because
small
amount may pass into mothers’ milk
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or brest-f

Ciri produk

UNIQUIN
(HYDROXYCHLOROQUINE SULFATE 200MG FILM COATED TABLET)
W =180 mm, H = 267 mm
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each tablet contains Hydroxychloroquine Sulfate BP 200 mg.
DESCRIPTION
Round shaped, light yellow colored film coated tablet having score
line
on one side and ‘INCEPTA’ debossed on other.
PHARMACODYNAMICS
MECHANISM OF ACTION
Antimalarial agents like chloroquine and hydroxychloroquine have
several
pharmacological
actions
which
may
be
involved
in
their
therapeutic effect in the treatment of rheumatic disease, but the role
of
each is not known. These include interaction with sulphydryl groups,
interference with enzyme activity (including phospholipase, NADH -
cytochrome C reductase, cholinesterase, proteases and hydrolases),
DNA
binding,
stabilisation
of
lysosomal
membranes,
inhibition
of
prostaglandin formation, inhibition of polymorph nuclear cell
chemotax-
is and phagocytosis, possible interference with interleukin 1
production
from monocytes and inhibition of neutrophil superoxide release.
PHARMACOKINETICS
Hydroxychloroquine has actions, pharmacokinetics and metabolism
similar to those of chloroquine. Following oral administration,
hydroxy-
chloroquine is rapidly and almost completely absorbed. In one study,
mean peak plasma hydroxychloroquine concentrations following a
single dose of 400mg in healthy subjects ranged from 53-208ng/ml with
a mean of 105ng/ml. The mean time to peak plasma concentration was
1.83 hours. The mean plasma elimination half-life varied, depending on
the post-administration period, as follows: 5.9 hours at Cmax-10
hours), 26.1 hours (at 10-48 hours) and 299 hours (at 48-504 hours).
The parent compound and metabolites are widely distributed in the
body and elimination is mainly via the urine, where 3% of the adminis-
tered dose was recovered over 24 hours in one study.
INDICATION
Treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid
and
systemic lupus erythematosus, and dermatological conditions caused
or aggravated by sunlight.
RECOMMENDED DOSAGE