QUINNEL 200 mg Film-Coated Tablet

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

HYDROXYCHLOROQUINE SULPHATE

Saatavilla:

IMEKS PHARMA SDN. BHD.

INN (Kansainvälinen yleisnimi):

HYDROXYCHLOROQUINE SULPHATE

Kpl paketissa:

100 Tablets

Valmistaja:

Sriprasit Pharma Co. Ltd.

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
QUINNEL 200 MG FILM-COATED TABLET
Hydroxychloroquine Sulfate (200 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
_QUINNEL_
is used for
2.
How
_QUINNEL_
works
3.
Before you use
_QUINNEL_
4.
How to use
_QUINNEL_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_QUINNEL_
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT _QUINNEL_ IS USED FOR
_QUINNEL_
is used in the treatment of:
• Rheumatoid arthritis (inflammation of the
joints characterized by stiffness, swelling and
pain) in adult and children.
• Discoid and systemic lupus erythematosus
(where the immune system attacks the body
causing tissue damage and inflammation).
•
Skin
problems
that
are
triggered
or
worsened by sunlight.
HOW _QUINNEL_ WORKS
_QUINNEL_
contains
the
active
ingredient
_hydroxychloroquine _
_sulfate._
It
works
by
reducing inflammation and thus can reduce
pain, swelling and joint stiffness.
BEFORE YOU USE _QUINNEL _
-
_When you must not use it_
Do not take
_QUINNEL_
if:
• You are allergic (hypersensitive) to:
-
_hydroxychloroquine sulfate_
or 4-amino-
quinoline
compounds
(e.g.
_chloroquine_
,
_amodiaquine_
)
or
any
of
the
other
ingredients in the formulation.
Signs of allergic reaction include: a rash,
swallowing
or
breathing
problems,
swelling of lips, face, throat or tongue.
• You 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.
_ _
_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 _
_QUINNEL. _
_ _
-
_Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before
taking
_QUINNEL_
if:
• You have liver or kidney problems.
• You have serious stomach or gut problems.
• You have heart problems.
• You have any problems with your blood.
You may have blood tests to check this.
• You have any problems with your nervous
system o

Valmisteyhteenveto

COMPOSITION
Each film-coated tablet contains Hydroxychloroquine sulfate 200 mg.
DESCRIPTION
White round biconvex film-coated tablet debossed with “H, 200” on
one side
and plain on the other.
PHARMACODYNAMICS
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
polymorphonuclear cell chemotaxis 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.
Absorption: Following oral administration, peak blood concentrations
is
achieved in approximately 4 hours. Oral absolute bioavailability is
79%.
Distribution: Hydroxychloroquine has a large volume of distribution
due to
extensive tissue accumulation (5500 L in blood, 44000 L in plasma),
and has
been shown to accumulate in blood cells, with a blood to plasma ratio
of 7.2.
Approximately 50% of hydroxychloroquine is bound to plasma proteins.
Metabolism:
Hydroxychloroquine
is
mainly
metabolized
to
N-desethyl-
hydroxychloroquine, and two other metabolites in common with
chloroquine,
desethylchloroquine and bidesethylchloroquine. It can be extrapolated
from
chloroquine, that hydroxychloroquine could be metabolized_ in vitro_
by the
same CYPs as for chloroquine, i.e. CYP2C8 and CYP3A, and to a lesser
extent by CYP2D6.
Elimination: Hydroxychloroquine presents a multi-phasic elimination
profile
with a long terminal half-life ranging from 30 to 60 days.
Approximately 20-
25% of the hydroxychloroquine dose is eliminated as unchanged drug in
t