ARABLOC leflunomide 20mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leflunomide, Quantity: 20 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; crospovidone; hypromellose; macrogol 8000; titanium dioxide; purified talc; iron oxide yellow

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARABLOC is indicated for the treatment of: Active rheumatoid arthritis. Active Psoriatic Arthritis. ARABLOC is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of ARABLOC with other Disease Modifying Anti-Rheumatic Drugs (DMARDS) has not been adequately studied (see PRECAUTIONS).

Product summary:

Visual Identification: YELLOWISH TO OCHRE, SPHERICAL TRIANGULAR FILM-COATED TABLETS, EMBOSSED ZBO ON ONE SIDE; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2003-02-14

Patient Information leaflet

ARABLOC
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ARABLOC?
Arabloc contains the active ingredient leflunomide. Arabloc is used to
treat rheumatoid or psoriatic arthritis. For more information,
see Section 1. Why am I using Arabloc? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARABLOC?
Do not use if you have ever had an allergic reaction to leflunomide,
teriflunomide or any of the ingredients listed at the end of the
CMI. Do not use if you are pregnant or plan to become pregnant, are
not using reliable birth control, or are breastfeeding.
There are a number of other circumstances in which a person must not
use this medicine. Check if these apply to you before taking
Arabloc (see the full CMI for more details).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES. For more information, see Section
2. What should I know before I use Arabloc? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Arabloc and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE ARABLOC?
•
The standard dose for this medicine is 100 mg per day for the first 3
days, and after that one 10 mg or 20 mg tablet daily.
•
Swallow the tablets whole with a full glass of water, at about the
same time each day. You can take it with or without food.
More instructions can be found in Section 4. How do I use Arabloc? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARABLOC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Arabloc.
•
CALL YOUR DOCTOR STRAIGHT AWAY IF: you become pregnant while you are
taking this medicine; you have
an infection/notice a fever or signs of an infection; your skin
becomes itchy or yellow / the whites of your
eyes become yellow / if you start to

Summary of Product characteristics

arabloc-ccdsv22-piv14-07jul22
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION – ARABLOC®
(LEFLUNOMIDE)
1
NAME OF THE MEDICINE
Leflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Arabloc 10 mg tablet contain 10 mg of leflunomide.
Excipients of known effect: sugars as lactose.
Each Arabloc 20 mg tablet contain 20 mg of leflunomide.
Excipients of known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Arabloc 10 mg tablets: white to almost white, round, film-coated
tablets embossed with ZBN
on one side.
Arabloc 20 mg tablets: yellowish to ochre, spherical triangular,
film-coated tablets embossed
with ZBO on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arabloc is indicated for the treatment of:
•
Active Rheumatoid Arthritis.
•
Active Psoriatic Arthritis. Arabloc is not indicated for the treatment
of psoriasis that is
not associated with manifestations of arthritic disease.
The combined use of Arabloc with other Disease Modifying
Anti-Rheumatic Drugs
(DMARDs) has not been adequately studied (see Section 4.4 Special
warnings and
precautions for use).
arabloc-ccdsv22-piv14-07jul22
Page 2 of 32
4.2
DOSE AND METHOD OF ADMINISTRATION
LOADING DOSE
Arabloc therapy is started with a loading dose of 100 mg once daily
for 3 days. Avoiding a
loading dose may decrease the risk of adverse events if Arabloc is
used in combination with
methotrexate.
This could be especially important for patients at increased risk of
haematologic 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 Section 4.4 Special warnings and precautions for use –
Hepatotoxicity.
MAINTENANCE DOSE
The recommended maintenance dose for rheumatoid arthritis is Arabloc
20 mg once daily.
Doses higher than 20 mg/day are not recommended. If dosin