Leflunomide 20mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Leflunomide

Boleh didapati daripada:

European Regulatory Affairs t/a Ivowen

Kod ATC:

L04AA; L04AA13

INN (Nama Antarabangsa):

Leflunomide

Dos:

20 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

Selective immunosuppressants; leflunomide

Status kebenaran:

Not marketed

Tarikh kebenaran:

2011-08-12

Risalah maklumat

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEFLUNOMIDE 10, 20MG FILM-COATED TABLET
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
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Leflunomide is and what it is used for
2.
What you need to know before you take Leflunomide
3.
How to take Leflunomide
4.
Possible side effects
5.
How to store Leflunomide
6.
Contents of the pack and other information
1.
WHAT LEFLUNOMIDE IS AND WHAT IT IS USED FOR
Leflunomide belongs to a group of medicines called anti-rheumatic
medicines. It contains
the active substance leflunomide.
Leflunomide is used to treat adult patients with active rheumatoid
arthritis or with active
psoriatic arthritis.
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
DO NOT TAKE LEFLUNOMIDE
-
if you have ever had an
ALLERGIC
reaction to leflunomide (especially a serious skin
reaction, often accompanied by fever, joint pain, red skin stains, or
blisters e.g.
Stevens-Johnson syndrome) or to any of the other ingredients of this
medicine
(listed in section 6),
-
if you have any
LIVER PROBLEMS
,
-
if you have moderate to severe
KIDNEY PROBLEMS
,
-
if you have severely

Ciri produk

Health Products Regulatory Authority
29 January 2021
CRN00C3C3
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Leflunomide 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg of leflunomide.
Excipients with known effect: each tablet contains 38.40mg of lactose
monohydrate equivalent to 36.48 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
- Leflunomide 20mg film-coated tablets are yellow, round biconvex,
with a scoreline on one side. The score-line is for the
purpose of identification only.
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_

In rheumatoid arthritis: leflunomide therapy is started with a loading
dose of 100 mg once daily for 3 days.
Omiss