LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leflunomide, Quantity: 10 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Leflunomide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; crospovidone; magnesium stearate; lactose monohydrate; maize starch; titanium dioxide; hypromellose; macrogol 4000

Administration route:

Oral

Units in package:

30 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, round biconvex tablet; Container Type: Bottle; Container Material: HDPE; 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
®
™
1
LEFLUNOMIDE SANDOZ
_leflunomide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Leflunomide Sandoz.
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
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.
It belongs to a group of medicines
called disease-modifying
antirheumatic drugs (DMARDs).
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE
LEFLUNOMIDE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEFLUNOMIDE SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
leflunomide or teriflunomide
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING M

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