ATARIS 10 leflunomide 10mg tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

leflunomide, Quantity: 10 mg

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

INN (International Name):

Leflunomide

Legemiddelform:

Tablet, film coated

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

30 Tablet

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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).

Produkt oppsummering:

Visual Identification: White, round biconvex tablet; 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

ATARIS CMI V2
1
ATARIS 10 & ATARIS 20
_leflunomide _
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START ATARIS 10 OR
ATARIS 20.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ATARIS.
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 ATARIS 10
or ATARIS 20 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 ATARIS IS USED
FOR
ATARIS is a type of medicine used
to treat rheumatoid or psoriatic
arthritis. ATARIS 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.
ATARIS 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 ATARIS 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
ATARIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ATARIS IF YOU:
•
HAVE ANY DISEASES WHICH REDUCE
YOUR BODY'S NATURAL DEFENCES
SUCH AS BACTERIAL OR VIRAL
INFECTIONS
•
AN ILLNESS WHICH SEVERELY LOWERS
YOUR BODY'S RESISTANCE TO
DISEASE, SUCH AS AIDS
•
HAVE ANY DISEASES OF THE BLOOD
OR BONE MARROW, SUCH AS
ANAEMIA
•
HAVE ANY SERIOUS SKIN DISORDERS,
SUCH AS STEVENS-JOHNSON
SYNDROME, TOXIC EPIDERMAL
NECROLYSIS OR ERYTHEMA
MULTIFORME
•
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 B

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
ATARIS 10MG, 20MG FILM COATED TABLETS
_ _
1. NAME OF THE MEDICINE
Leflunomide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Leflunomide is a white to off white powder, practically insoluble in
water and freely soluble in methanol,
ethanol or acetone and sparingly soluble in methylene chloride.
ATARIS 10 mg and 20 mg tablets contain sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ATARIS 10 TABLETS:
film coated - 10 mg: white, round biconvex tablets
ATARIS 20 TABLETS:
film coated - 20 mg: yellow, round biconvex tablets with a scoreline
on one side
4. CLINICAL PARTICULARS
4.1. 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 Section 4.4 SPECIAL WARNING AND PRECAUTIONS
FOR USE).
4.2. DOSE AND METHOD OF ADMINISTRATION
RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS
Loading dose
ATARIS 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 ATARIS 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 WARNING AND PRECAUTIONS FOR
USE).
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. The recommended maintenance dose for
psoriatic arthritis is 20 mg once daily.
Liver enzymes and haematological parame