Apo-Leflunomide

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Leflunomide 10mg

Available from:

Apotex NZ Ltd

INN (International Name):

Leflunomide 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Leflunomide 10mg Excipient: Colloidal silicon dioxide Crospovidone Lactose Magnesium stearate

Units in package:

Blister pack, Alu/Alu, 30 tablets, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Formosa Laboratories Inc.

Therapeutic indications:

Apo-Leflunomide is indicated for the treatment of: · Rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. Leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · Active Psoriatic Arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu/Alu, 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-08-18

Patient Information leaflet

New Zealand Consumer Medicine Information
APO-LEFLUNOMIDE
_LEFLUNOMIDE _
10mg and 20mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Leflunomide.
This leaflet answers some common questions about Apo-Leflunomide. 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 using
Apo-Leflunomide against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-LEFLUNOMIDE IS USED FOR
The
name
of
your
medicine
is
Apo-Leflunomide
tablet.
It
contains
the
active
ingredient leflunomide.
Apo-Leflunomide is a type of medicine used to
treat:
•
rheumatoid arthritis or
•
psoriatic arthritis.
Leflunomide 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 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 may have prescribed Apo-Leflunomide for another reason.
Ask your doctor if you have any questions about why Apo-Leflunomide
has been
prescribed for you.
2
This medicine is available only with a doctor's prescription.
BEFORE YOU USE APO-LEFLUNOMIDE
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Leflunomide 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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-LEFLUNOMIDE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 26
1.
APO-LEFLUNOMIDE (10MG AND 20MG TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEFLUNOMIDE 10MG OR 20MG
Chemical Structure:
Leflunomide
or
N-(4-trifluoromethylphenyl)-5-methylisoxazol-4-carboxamide),
an
isoxazole
derivative.
Its empirical formula is C
12
H
9
F
3
N
2
O
2
The chemical structure of leflunomide is shown below:
EXCIPIENT(S) WITH KNOWN EFFECT
Apo-Leflunomide do not contain gluten.
Apo-Leflunomide contain lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
APO-LEFLUNOMIDE 10mg are white, round, biconvex tablet engraved "LE"
over "10" on one side
and "APO" on the other side.
Each tablet typically weighs 70mg.
APO-LEFLUNOMIDE 20mg are white,
arc triangular shaped biconvex tablet,
engraved "LE" over
"20" on one side and "APO" on the other side.
Each tablet typically weighs 140mg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-LEFLUNOMIDE is indicated for the treatment of:
•
Rheumatoid arthritis, to improve signs and symptoms to retard joint
destruction and to
improve functional ability and quality of life. Leflunomide may be
used in patients who
have failed to respond to other treatments or as a first line of
treatment in patients who
have a contraindication to other treatments.
•
Active Psoriatic Arthritis.
Leflunomide is not
indicated for the treatment
of
psoriasis
that is not associated with manifestations of arthritic disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
LOADING DOSE
Leflunomide therapy is started with a loading dose of 100mg once daily
for 3 days. Avoiding a loading
dose may decrease the risk
of
adverse events
if
leflunomide is
used in combination with
methotrexate.
This could be especially important
for
patients at
risk of
haematologic or
hepatic
toxicity,
such
as
those
receiving
concomitant
treatment
with
methotrexate
or
other
immunosuppressive agents or
on such similar
medications in the recent
past.
(_see