LEFLUNOMIDE GENERICHEALTH leflunomide 20mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-09-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
leflunomide, Quantity: 20 mg
Available from:
Southern Cross Pharma Pty Ltd
INN (International Name):
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 indications:
Leflunomide generichealth is indicated for the treatment of: - Active Rheumatoid Arthritis; - Active Psoriatic Arthritis. Leflunomide generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.,The combined use of Leflunomide generichealth with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied (see Precautions).
Product summary:
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
Authorization status:
Licence status A
Authorization date:
2014-04-02
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
LEFLUNOMIDE GENERICHEALTH
(LEFLUNOMIDE) FILM-COATED TABLETS
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LEFLUNOMIDE
GENERICHEALTH.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Leflunomide generichealth.
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
Leflunomide generichealth
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 LEFLUNOMIDE
GENERICHEALTH IS USED FOR
Leflunomide generichealth is a
type of medicine used to treat
rheumatoid or psoriatic arthritis.
Leflunomide generichealth 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.
Leflunomide generichealth
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 Leflunomide
generichealth 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
LEFLUNOMIDE
GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEFLUNOMIDE
GENERICHEALTH IF YOU:
•
have any diseases which
reduce your body's natural
defences such as bacterial or
viral infections;
•
have 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
hypoproteinaem
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – LEFLUNOMIDE GENERICHEALTH
(LEFLUNOMIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Leflunomide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Leflunomide generichealth tablets contains the active ingredient
leflunomide. Each tablet contains
10 mg or 20 mg of leflunomide as the active ingredient.
List of excipients with known effects: lactose monohydrate and sugars.
_ _
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Leflunomide generichealth 10 mg: white, round biconvex film-coated
tablets.
Leflunomide generichealth 20 mg: yellow, round biconvex film-coated
tablets with a scoreline on one
side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leflunomide generichealth is indicated for the treatment of:
•
Active Rheumatoid Arthritis.
•
Active Psoriatic Arthritis. Leflunomide generichealth is not indicated
for the treatment of psoriasis
that is not associated with manifestations of arthritic disease.
The combined use of Leflunomide generichealth with other Disease
Modifying Anti-Rheumatic Drugs
(DMARDs) has not been adequately studied (see SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
4.2 DOSE AND METHOD OF ADMINISTRATION
RHEUMATOID ARTHRITIS AND PSORIATIC 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, eg.
those receiving concomitant treatment with methotrexate or other
immunosuppressive agents or on
Leflunomide generichealth PI v2.0
Page 2 of 30
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 2
Read the complete document
