APO-LEFLUNOMIDE leflunomide 20mg tablet bottle

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

leflunomide, Quantity: 20 mg

MAH:

Arrotex Pharmaceuticals Pty Ltd

INN:

Leflunomide

pharmaceutical_form:

Tablet, film coated

composition:

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

administration_route:

Oral

units_in_package:

30 Tablet

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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).

leaflet_short:

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; Container Closure: Child resistant closure

authorization_status:

Licence status A

authorization_date:

2015-12-22

PIL

LEFLUNOMIDE APOTEX
TABLETS
_Leflunomide_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about leflunomide. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Leflunomide is used to treat
rheumatoid arthritis and psoriatic
arthritis.
It belongs to a group of medicines
called disease-modifying anti-
rheumatic drugs (DMARDs).
_HOW IT WORKS_
Leflunomide 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.
Leflunomide 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children under 18 years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE 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,
throat or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YO

SPC

1
AUSTRALIAN PRODUCT INFORMATION
LEFLUNOMIDE APOTEX (LEFLUNOMIDE) TABLET
1
NAME OF THE MEDICINE
Leflunomide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg of Leflunomide, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLETS
White, round biconvex tablet.
20 MG TABLETS
Yellow, round biconvex tablets with a scoreline on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of:
•
Active Rheumatoid Arthritis.
•
Active Psoriatic Arthritis. This medicine 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
Anti-Rheumatic Drugs
(DMARDs) has not been adequately studied (see SECTION 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
RHEUMATOID ARTHRITIS & PSORIATIC ARTHRITIS
Loading Dose
Leflunomide therapy is started with a loading dose of 100 mg (five 20
mg tablets or ten10 mg
tablets) 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, such as 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.
The recommended maintenance dose for psoriatic arthritis is 20 mg once
daily.
Liver enzymes and haematological parameters must be mon