ARAVA 10MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEFLUNOMIDE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LEFLUNOMIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Opella Healthcare International SAS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ARAVA
® TABLETS
Leflunomide (10mg, 20mg)
WHAT IS IN THIS LEAFLET
1.
What Arava is used for
2.
How Arava works
3.
Before you use Arava
4.
How to use Arava
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Arava
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ARAVA IS USED FOR
Arava is used to treat adult with:
•
Active rheumatoid arthritis to
improve physical function of the body
-Arthritis symptoms include
inflammation of joints, swelling,
difficulty in moving and pain. Other
symptoms that affect the entire body
include loss of appetite, fever, loss of
energy and anaemia (lack of red blood
cells).
•
Active psoriatic arthritis
-Symptoms include patches of red,
scaly skin (skin lesions).
HOW ARAVA WORKS
Arava belongs to a group of medicines
called anti-rheumatic medicines. It
contains the active substance
leflunomide. It works by reducing pain,
inflammation, swelling and stiffness
over a period of weeks or months by
slowing down the disease and its
effects on the joints.
BEFORE YOU USE ARAVA
-
_When you must not use it _
Do not take Arava if:
•
You are allergic (hypersensitive) to
leflunomide (especially a serious skin
reaction, often accompanied by fever,
joint pain, red skin stains, or blisters
e.g. Stevens-Johnson syndrome) or to
any of the other ingredients of this
medicine (listed in Ingredients below).
•
You have any liver problems
•
You have moderate to severe kidney
problems
•
You have severely low numbers of
proteins in your blood
(hypoproteinaemia)
•
You suffer from any problem which
affects your immune system (such as
AIDS)
•
You have any problems with your
bone marrow, or if you have low
numbers of red or white cells in your
blood or a reduced number of platelets
•
You are suffering from a serious
infection
•
You are pregnant, think you may be
pregnant, or are breast-feeding.
•
You are not using reliable birth
control.
Do not use this medicine if any of the
abov

Ciri produk

ARAVA 10MG
ARAVA 20MG
NAME OF THE MEDICINAL PRODUCT
Arava 10mg film-coated tablets
Arava 20mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Arava 10mg - Each tablet contains 10mg of leflunomide.
Arava 20mg - Each tablet contains 20mg of leflunomide.
_Excipients with known effect: _
Arava 10mg - Each tablet contains 78mg of lactose monohydrate.
Arava 20mg - Each tablet contains 72mg of lactose monohydrate
PHARMACEUTICAL FORM
Film-coated tablet.
Arava 10mg - White to almost white, round film-coated tablet,
imprinted with ZBN on one side.
Arava 20mg - Yellowish to ochre and triangular film-coated tablet,
imprinted with ZBO on one side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Leflunomide is indicated for the treatment of adult patients with:
•
active rheumatoid arthritis as a "disease-modifying antirheumatic
drug" (DMARD), to improve physical function,
•
active psoriatic arthritis.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs
(e.g. methotrexate) may result in an increased
risk of serious adverse reactions; therefore, the initiation of
leflunomide treatment has to be carefully considered regarding
these benefit/risk aspects.
Moreover, switching from leflunomide to another DMARD without
following the washout procedure may also increase the
risk of serious adverse reactions even for a long time after the
switching.
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by specialists
experienced in the treatment of rheumatoid arthritis and
psoriatic arthritis.
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase
(SGPT) and a complete blood cell count, including
a differential white blood cell count and a platelet count, must be
checked simultaneously and with the same frequency:
•
before initiation of leflunomide,
•
every two weeks during the first six months of treatment, and
•
every 8 weeks thereafter.
_Posology _
•
In rheumatoid arthritis: leflunomide therapy is usually started with a
loading dose of 100 mg once d