LEFLUNOMIDE SANDOZ leflunomide 100mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
leflunomide, Quantity: 100 mg
Available from:
Southern Cross Pharma Pty Ltd
INN (International Name):
Leflunomide
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; povidone; colloidal anhydrous silica; crospovidone; maize starch; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000
Administration route:
Oral
Units in package:
3 tablet
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of active rheumatoid arthritis.,Treatment of active psoriatic arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of leflunomide with other disease modifying antirheumatic drugs (DMARDs) has not been adequately studied (see Precautions).
Product summary:
Visual Identification: White, oblong biconvex tablets with a scoreline on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-04-02
Patient Information leaflet
________________________________________________________________________________
Leflunomide Sandoz
®
Page
1 of 4
LEFLUNOMIDE SANDOZ
®
_leflunomide_
CONSUMER MEDICINE INFORMATION
_ _
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LEFLUNOMIDE
SANDOZ.
What is in this leaflet
This leaflet answers some common
questions about Leflunomide Sandoz.
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 Sandoz
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
Sandoz is used for
Leflunomide Sandoz is a type of
medicine used to treat rheumatoid or
psoriatic arthritis. Leflunomide Sandoz
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 Sandoz 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 Sandoz 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 SANDOZ 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
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Summary of Product characteristics
190830-Leflunomide Sandoz-pi
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
LEFLUNOMIDE SANDOZ (LEFLUNOMIDE) TABLET
1.
NAME OF THE MEDICINE
Leflunomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg Leflunomide Sandoz tablets contains 10 mg leflunomide.
Each 20 mg Leflunomide Sandoz tablets contains 20 mg leflunomide.
Each 100 mg Leflunomide Sandoz tablets contains 100 mg leflunomide.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets, film coated - 10 mg: white, round biconvex tablets; 20 mg:
yellow, round biconvex
tablets with a scoreline on one side; 100 mg*: white, oblong biconvex
tablets with a scoreline
on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
T
_reatment of active rheumatoid arthritis_. _Treatment of active
psoriatic arthritis. _Leflunomide
is not indicated for the treatment of psoriasis that is not associated
with manifestations of
arthritic disease.
The
combined
use
of
leflunomide
with
other
disease
modifying
antirheumatic
drugs
(DMARDs) has not been adequately studied (see Section 4.4 Special
warnings and precautions
for use).
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS. _
_Loading dose._ Leflunomide therapy is started with a loading dose of
100 mg once daily for
three 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
increased risk of haematological or hepatic toxicity, e.g. those
receiving concomitant treatment
with methotrexate or other immunosuppressive agents or on such
medications in the recent
past. (See Section 4.4 Special warnings and precautions for use/
Concomitant use with
hepatotoxic and haematotoxic agents, and Hepatotoxicity.)
_Maintenance _
_dose._
The
recommended
maintenance
dose
for
rheumatoid
arthritis
is
leflunomide 20 mg once daily. Doses higher than 20 mg/day are not
recommended. If dosing
at 20 mg/day is not well tolerated, the
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