Leflunomide 100 mg Film Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Leflunomide

Available from:

Morningside Healthcare Limited

ATC code:

L04AA; L04AA13

INN (International Name):

Leflunomide

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective immunosuppressants; leflunomide

Authorization status:

Not marketed

Authorization date:

2011-05-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE 100 MG FILM-COATED TABLETS
LEFLUNOMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Leflunomide Tablets are and what they are used for
2.
What you need to know before you take Leflunomide Tablets
3.
How to take Leflunomide Tablets
4.
Possible side effects
5.
How to store Leflunomide Tablets
6.
Contents of the pack and other information
1.
WHAT LEFLUNOMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Leflunomide belongs to the group of drugs known as anti-rheumatic
medicines which are used in the
treatment of adult patients with active rheumatoid arthritis or with
active psoriatic arthritis. It
contains the active substance leflunomide.
Symptoms of Rheumatoid Arthritis include inflammation of joints,
swelling, difficulty moving and
pain. Other symptoms that affect the entire body include loss of
appetite, fever, loss of energy and
anaemia (lack of red blood cells).
Symptoms of Active Psoriatic Arthritis include inflammation of joints,
swelling, difficulty moving,
pain and patches of red, scaly skin (skin lesions).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEFLUNOMIDE TABLETS
DO NOT TAKE LEFLUNOMIDE TABLETS IF YOU

are ALLERGIC to leflunomide or any of the other ingredients of this
medicine (listed in section 6),

have decreased LIVER FUNCTION,

have moderate to severe decreased KIDNEY FUNCTION,

have severely low amounts of PROTEIN IN YOUR BLOOD (hypoproteinaemia),

suffer from any problem which affects your IMMUNE SYSTEM (e.g. AIDS),

have

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2019
CRN00995M
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Leflunomide 100 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of leflunomide.
Excipients with known effect:
Each film-coated tablet contains 655.0 mg lactose (as lactose
monohydrate and anhydrous).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
White coloured, oval, biconvex film-coated tablet, plain on both
sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leflunomide is indicated for the treatment of adult patients with:
- active rheumatoid arthritis as a disease-modifying antirheumatic
drug (DMARD).
- active psoriatic arthritis.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs
(e.g. methotrexate) may result in an increased risk
of serious adverse reactions; therefore, the initiation of leflunomide
treatment has to be carefully considered regarding these
benefit/risk aspects.
Moreover, switching from leflunomide to another DMARD without
following the washout procedure (see section 4.4) may also
increase the risk of serious adverse reactions even for a long time
after the switching.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by specialists
experienced in the treatment of rheumatoid arthritis and
psoriatic arthritis.
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase
(SGPT) and a complete blood cell count, including a
differential white blood cell count and a platelet count, must be
checked simultaneously and with the same frequency:
• before initiation of leflunomide,
• every two weeks during the first six months of treatment, and
• every 8 weeks thereafter (see section 4.4).
_Posology_
Leflunomide therapy is started with a loading dose of 100 mg once
daily for 3 days.
• The recommended maintenance dose for rheumatoid arthritis is
leflunomide 10 mg to 20 mg once daily