Arava

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Leflunomide 100mg

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Leflunomide 100 mg

Dosage:

100 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Leflunomide 100mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Povidone Purified talc Titanium dioxide

Units in package:

Blister pack, Al-Al, 3 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Therapeutic indications:

Arava 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. Arava 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, Al-Al - 3 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1998-05-20

Patient Information leaflet

Arava®
_1_
ARAVA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ARAVA?
Arava contains the active ingredient leflunomide. Arava is used to
treat rheumatoid or psoriatic arthritis. For more information,
see Section 1. Why am I using Arava? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARAVA?
Do not use if you have ever had an allergic reaction to leflunomide,
teriflunomide or any of the ingredients listed at the end of
the CMI. Do not use if you are pregnant or plan to become pregnant,
are not using reliable birth control, or are breastfeeding.
There are a number of other circumstances in which a person must not
use this medicine. Check if these apply to you before
taking Arava (see the full CMI for more details).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES. For more information, see Section 2.
What should I know before I use Arava? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Arava and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE ARAVA?
•
The standard dose for this medicine is 100 mg per day for the first 3
days, and after that one 10 mg or 20 mg tablet daily.
•
Swallow the tablets whole with a full glass of water, at about the
same time each day. You can take it with or without food.
More instructions can be found in Section 4. How do I use Arava? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARAVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Arava.
•
CALL YOUR DOCTOR STRAIGHT AWAY IF: you become pregnant while you are
taking this medicine; you have
an infection/notice a fever or signs of an infection; your skin
becomes itchy or yellow / the whites of
your eyes become yellow / if you start to bleed or bruise easily; you
dev

Summary of Product characteristics

arava-ccdsv21-dsv14-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
ARAVA (TABLETS)
Arava 10 mg film-coated tablet
Arava 20 mg film-coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Arava 10 mg tablet contains 10 mg of leflunomide.
Excipients of known effect: sugars as lactose.
Each Arava 20 mg tablet contains 20 mg of leflunomide.
Excipients of known effect: lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Arava 10 mg tablets, white, round, film-coated tablets embossed with
ZBN on one side.
Arava 20 mg tablets, yellow, triangular, film-coated tablets embossed
with ZBO on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arava 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. Arava 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
arava-ccdsv21-dsv14-20jun22
Page 2
•
Active Psoriatic Arthritis. Arava 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
Arava therapy is started with a loading dose of 100 mg once daily for
3 days. Avoiding a loading
dose may decrease the risk of adverse events if Arava is used in
combination with methotrexate.
This could be especially important for patients at increased risk of
haematologic or hepatic
toxicity, such as those receiving concomitant treatment with
methotrexate or other
immunosuppressive agents or on such medications in the recent past.
(See section 4.4,
“Concomitant use with hepatotoxic and haematotoxic agents” and
“hepatotoxicity” sections.)
MAINTENANCE DOSE
The recommended maintenance dose for rheumatoid arthritis is Arava 20
mg once daily. Doses
higher than 20 mg/day are not recommended. If dosing at 20 mg/day is
not well tolerated, the
dose may be