LEFLUNOMIDE GH leflunomide 20mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Leflunomide

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Leflunomide

Patient Information leaflet

leflunomide-gh-ccdsv18-19-cmiv7-31jul14
1
LEFLUNOMIDE GH
®
_leflunomide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Leflunomide GH.
It does not contain all 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
GH 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 GH
IS USED FOR
Leflunomide GH is a type of
medicine used to treat rheumatoid or
psoriatic arthritis. Leflunomide GH
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 GH 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 GH 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 GH 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 GH AND
FOR A CERTAIN PERIOD OF TIME AFTER
STOPPING LEFLUNOMIDE GH.
Leflunomide GH may increase the
risk of
birth defects.
WOMEN OF CHILDBEARING POTENTIAL
MUST USE RELIABLE CONTRACEPTION
WHILE

Summary of Product characteristics

PRODUCT INFORMATION
October 2015
Leflunomide GH
leflunomide-gh--ccdsv20piv2-14oct15
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PRODUCT INFORMATION
LEFLUNOMIDE GH
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Leflunomide
CHEMICAL STRUCTURE
Each tablet of Leflunomide GH contains 10 mg or 20 mg of leflunomide.
The chemical
structure of leflunomide is shown below:
Molecular Formula: C
12
H
9
F
3
N
2
O
2
Molecular Weight: 270.2
Chemical Name:
N-(4-trifluoromethylphenyl)-5-methylisoxazol-4-carboxamide),
an isoxazole derivative
CAS REGISTRY NUMBER
75706-12-6
DESCRIPTION
Each tablet contains leflunomide, lactose, maize starch, povidone,
colloidal anhydrous silica,
magnesium stearate, crospovidone, hypromellose, macrogol 8000, talc
and titanium dioxide.
The 20mg tablets also contain iron oxide yellow. Leflunomide is a
white to off white powder,
practically insoluble in water and freely soluble in ethanol or
acetone.
PRODUCT INFORMATION
October 2015
Leflunomide GH
leflunomide-gh--ccdsv20piv2-14oct15
Page 2
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM 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 metabolized to the ring opened form, A771726, which is the
active drug. It has
immunomodulating/immunosuppressive characteristics, acts as an
anti-proliferative 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 enzyme involved in de novo pyrimidine synthesis). Together,
these data suggest
that, in vivo, at concentrations achievable in patients receiving
Leflunomide GH, pyrimidine
synthesis in lymphocytes and other rapidly dividing cell populations
may be inhibited. Further,
the inhibition o