LUNAVA leflunomide 20mg tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

leflunomide, Quantity: 20 mg

Tilgjengelig fra:

Medis Pharma Pty Ltd

INN (International Name):

Leflunomide

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: povidone; colloidal anhydrous silica; maize starch; microcrystalline cellulose; magnesium stearate; crospovidone; lactose monohydrate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000

Administreringsrute:

Oral

Enheter i pakken:

30 Tablet

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of active rheumatoid arthritis. The combined use of leflunomide with other disease modifying antirheumatic drugs (DMARDs) has not been adequately studied (see Precautions). Lunava is not indicated for the treatment of psoriatic arthritis or psoriasis (whether or not associated with manifestations of psoriatic arthritis).

Produkt oppsummering:

Visual Identification: Yellow, round biconvex tablets with a scoreline on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2011-03-25

Informasjon til brukeren

________________________________________________________________________________
Lunava CMI 270115
Page
1 of 4
LUNAVA
® TABLETS
_leflunomide_
CONSUMER MEDICINE INFORMATION
_ _
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LUNAVA.
What is in this leaflet
This leaflet answers some common
questions about Lunava.
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 Lunava 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 Lunava is used for
Lunava is a type of medicine used to
treat rheumatoid arthritis. Lunava 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.
Lunava 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 Lunava 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 LUNAVA 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 LUNAVA AND FOR A
CERTAIN PERIOD OF TIME AFTER STOPPING
LUNAVA.
Lunava may increase the risk of birth
defects.
WOMEN OF CHILDBEARI

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION - LUNAVA
®
(LEFLUNOMIDE)
TABLETS
1.
NAME OF THE MEDICINE
Leflunomide
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Lunava 10 mg, 20 mg and 100 mg tablets contain the active ingredient
leflunomide.
For the full list of excipients, see Section 6.1 List of Excipients.
Excipients with known effect: Contains sugars as lactose.
3.
PHARMACEUTICAL FORM
Lunava 10 mg tablets: white, round biconvex, film coated tablets.
Lunava 20mg tablets: yellow, round biconvex tablets with a scoreline
on one side
Lunava 100mg tablets: white, oblong biconvex tablets with a scoreline
on one side
4.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of active rheumatoid arthritis.
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).
Lunava is not indicated for the treatment of psoriatic arthritis or
psoriasis (whether or not
associated with manifestations of psoriatic arthritis).
DOSE AND METHOD OF ADMINISTRATION
RHEUMATOID 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 dose may be decreased to 10 mg daily.
Liver enzymes and haematological parameters must be monitored and dose
adjustments or
discontinuation may be ne