Leflunomide 20mg film-coated tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Leflunomide

Доступна с:

Aspire Pharma Limited

код АТС:

L04AA; L04AA13

ИНН (Международная Имя):

Leflunomide

дозировка:

20 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

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

Терапевтические области:

Selective immunosuppressants; leflunomide

Статус Авторизация:

Not marketed

Дата Авторизация:

2011-08-12

тонкая брошюра

Package leaflet: Information for the user
LEFLUNOMIDE 10, 20MG
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 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 low

Характеристики продукта

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.
Omission of the loading dose may decrease the risk of adverse events
(see section 5.1). The recommended