LEFLUNOMIDE AN leflunomide 100mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
leflunomide
Available from:
Southern Cross Pharma Pty Ltd
INN (International Name):
Leflunomide
Authorization status:
Registered
Patient Information leaflet
________________________________________________________________________________
C: Products/Leflunomide/CMI AN_15042014
Page
1 of 4
LEFLUNOMIDE AN TABLETS
_leflunomide_
CONSUMER MEDICINE INFORMATION
_ _
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LEFLUNOMIDE AN.
What is in this leaflet
This leaflet answers some common
questions about Leflunomide AN.
It does not contain all of the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Leflunomide AN against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
What Leflunomide AN is
used for
Leflunomide AN is a type of medicine
used to treat rheumatoid or psoriatic
arthritis. Leflunomide AN helps to
slow down the process of joint damage
and to relieve the symptoms of the
disease, such as joint tenderness and
swelling, pain and morning stiffness.
Leflunomide AN works by selectively
interfering with the ability of white
blood cells called lymphocytes to
produce the disease response that
ultimately leads to pain, inflammation
and joint damage.
Your doctor, however, may have
prescribed Leflunomide AN for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
Before you take it
_When you must not take it _
DO NOT TAKE LEFLUNOMIDE AN IF YOU:
HAVE ANY DISEASES WHICH REDUCE
YOUR BODY'S NATURAL DEFENCES
SUCH AS BACTERIAL OR VIRAL
INFECTIONS
HAVE ANY DISEASES OF THE BLOOD
HAVE ANY SERIOUS SKIN DISORDERS
HAVE LIVER DISEASE
HAVE A CONDITION CALLED
HYPOPROTEINAEMIA (WHEN YOU DO
NOT HAVE ENOUGH PROTEIN IN YOUR
BLOOD)
ARE PREGNANT OR PLAN TO BECOME
PREGNANT
ARE NOT USING RELIABLE BIRTH
CONTROL
ARE BREASTFEEDING
YOU MUST NOT BECOME PREGNANT
WHILE TAKING LEFLUNOMIDE AN AN
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Summary of Product characteristics
C:Products/Leflunomide/PI AN_10082015
Page 1 of 30
PRODUCT INFORMATION
LEFLUNOMIDE AN TABLETS
NAME OF THE MEDICINE
PROPRIETARY NAME:
Leflunomide AN 10, 20 and 100 mg tablets
NON PROPRIETARY NAME:
Leflunomide tablets
The chemical name for leflunomide is 5-methyl-
_N_
-[4-
(trifluoromethyl)phenyl]isoxazole-4-
carboxamide, an isoxazole derivative.
The chemical structure of leflunomide is:
Molecular formula: C
12
H
9
F
3
N
2
O
2
MW: 270.2
CAS number: 75706-12-6
DESCRIPTION
Leflunomide is a white to off white powder, practically insoluble in
water and freely
soluble in methanol, ethanol or acetone and sparingly soluble in
methylene chloride.
Leflunomide tablets also contain microcrystalline cellulose, lactose,
maize starch,
povidone, crospovidone, colloidal anhydrous silica and magnesium
stearate. The 10
mg and 100 mg tablets contain the proprietary ingredient Opadry II
complete film
coating system OY LS 28908 White (ARTG 12435) and 20 mg tablet
contains the
proprietary ingredient Opadry aqueous film coating OY SR 6497 Yellow
(ARTG
3965).
PHARMACOLOGY
_SITE AND MODE OF ACTION_
Leflunomide is an isoxazole immunomodulatory agent which is effective
in animal
models of arthritis and other autoimmune diseases, allergy and
transplantation. In
vivo, leflunomide is rapidly metabolised to the ring opened form,
A771726, which is
the active drug. It has immunomodulating / immunosuppressive
characteristics, acts
as an antiproliferative agent, and displays weak anti-inflammatory
properties. The
antiproliferative activity is reversed by the addition of uridine to
the cell culture,
indicating that A771726 acts at the level of the pyrimidine
biosynthesis pathway.
Binding studies using radiolabelled ligand demonstrate that the active
metabolite
binds to and inhibits the human enzyme dihydroorotate dehydrogenase
(DHODH, an
C:Products/Leflunomide/PI AN_10082015
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enzyme involved in de novo pyrimidine synthesis). Together, these data
suggest that,
in vivo, at concentrations achievable in patients receiving
Leflunomide, pyrimid
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