Plaquenil

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hydroxychloroquine sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

PLAQUENIL TABLETS

_hydroxychloroquine sulfate_
CONSUMER MEDICINE INFORMATION (CMI)

PLEASE READ THIS LEAFLET BEFORE YOU START TO TAKE THIS MEDICINE.

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plaquenil Tablets. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. In deciding to give you
Plaquenil, your doctor has weighed
the risks of taking Plaquenil against
the benefits it will have for you.
KEEP THIS INFORMATION WITH THE
TABLETS. YOU MAY WISH TO READ IT
AGAIN LATER.
WHAT IS PLAQUENIL
USED FOR
Plaquenil may be used for any of the
following conditions:
_RHEUMATOID ARTHRITIS_
Rheumatoid arthritis is a form of
arthritis with inflammation of the
joints, characterised by stiffness,
swelling and pain. Plaquenil may be
used for short or long-term
rheumatoid arthritis treatment.
In treating rheumatoid arthritis,
Plaquenil may slow down the
substances which harm the joints.
_SYSTEMIC LUPUS_
_ERYTHEMATOUS (SLE)_
SLE is a disease in which a person's
normal immunity is upset. The body
produces an excess of blood proteins
called antibodies and these antibodies
may cause problems in any organ of
the body.
These antibodies may end up, for
example, in the skin causing a variety
of skin rashes or deposit in the
kidney, brain, lung and joints causing
injury.
_DISCOID LUPUS_
_ERYTHEMATOUS (DLE)_
DLE is similar to SLE except it only
affects the skin and is characterised
by a scaling, red rash.
_MALARIA (TREATMENT AND_
_CONTROL OF SYMPTOMS)_
Malaria is an infectious disease
caused by the presence of parasites in
red blood cells.
The disease is characterised by chills,
fever and sweats.
In malaria, Plaquenil destroys the
harmful parasite which causes the
illness.
Your doctor may have prescribed this
medicine for another reason. Ask
your doctor if you have any questions
about why Plaquenil has been
prescribed for you.
Plaquenil is not addictive. This
medicine is available only with a

Summary of Product characteristics

PRODUCT INFORMATION  
Sep-2013 
Plaquenil - hydroxychloroquine sulfate  

plaquenil-ccdsv7-piv5-16sep13 
1 
PRODUCT INFORMATION 
PLAQUENIL 
NAME OF MEDICINE 
AUSTRALIAN APPROVED NAME 
PLAQUENIL hydroxychloroquine sulfate 200mg  
CHEMICAL STRUCTURE

Hydroxychloroquine sulfate is designated chemically as 2 {N
(4-(7-Chloro-4-
quinolylamino)pentyl)- -N-ethylamino}ethanol sulfate, and
has the following chemical structure: 

C
18
H
26
ClN
3
O, H
2
SO
4
 Molecular Weight: 433.96 
CAS REGISTRY NUMBER 
747-36-4 (hydroxychloroquine sulphate) 
118-42-3 (hydroxychloroquine). 
DESCRIPTION 
Film coated tablets containing hydroxychloroquine sulfate 200 mg
(equivalent to 155 mg base). 
The tablets also contain the inactive
ingredients calcium hydrogen phosphate, maize starch, 
purified water, and magnesium stearate.  The film coating contains small amounts of 
hypromellose, macrogol 400, titanium dioxide, polysorbate
80, carnauba wax, black ink (Tekprint 
SB-9014SD), and purified water. 

N
Cl
.
H
N
CH
3
N
CH
3
OH
H
2
SO
4

PRODUCT INFORMATION  
Sep-2013 
Plaquenil - hydroxychloroquine sulfate  

plaquenil-ccdsv7-piv5-16sep13 
2 
PHARMACOLOGY 
PHARMACODYNAMICS 
MECHANISM OF ACTION 
Anti-malarial.  Plaquenil also
exerts a beneficial effect in mild systemic and discoid lupus 
erythematosus and rheumatoid arthritis.  The precise
mechanism of action is not known. 
MALARIA 
Like chloroquine phosphate, Plaquenil is highly active
against the erythrocytic forms of _P.vivax_ 
and _P.malariae _and most strains
of _P.falciparum_ (but not the gametocytes of _P.falciparum_). 
Plaquenil does not prevent relapses in patients with
vivax or malariae malaria because it is not 
effective
against exo-erythrocytic forms of the parasite, nor will it prevent vivax or malariae 
infection when administered as a
prophylactic.  It is highly effective