Leflunomide 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Leflunomide

Available from:

Zentiva

ATC code:

L04AA13

INN (International Name):

Leflunomide

Dosage:

20mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5000283654483

Patient Information leaflet

_créé le_
_par_
_modifié le_
_par_
_Laboratoires_
_Pays_
16/04/2014
E WASCZCZYK
21/05/2014
E WASCZCZYK
SANOFI
UK
_Couleur_
_Nbre/Réf._
1
PROCESS
BLACK U
_Version N°_
3
_Type Article_
NOTICE TRIPLE
LEFLUNOMIDE
R772190
20 MG
CPRS
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini_
_caractères_
NA
NA
1-606251A
606251-1A
150 X 210 MM
9 PTS
_Numéro de Pages_
1 /
6
_Code sécurité_
R772190
COMPIÈGNE
COMPIÈGNE
PACKAGE LEAFLET:
INFORMATION FOR
THE USER
LEFLUNOMIDE WINTHROP
®
20 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 any possible side
effects not
listed in this leaflet.
See section 4.
WHAT
IS IN THIS LEAFLET:
1.
What
Leflunomide Winthrop is and what
it
is used for
2.
What
you need to know before you take Leflunomide Winthrop
3.
How to take Leflunomide Winthrop
4.
Possible side effects
5.
How to store Leflunomide Winthrop
6.
Contents of
the pack and other
information
1.
WHAT
LEFLUNOMIDE WINTHROP IS AND WHAT
IT
IS USED FOR
Leflunomide Winthrop belongs to a group of
medicines called anti-rheumatic medicines.
It
contains the
active substance leflunomide.
Leflunomide Winthrop 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).
Symp

Summary of Product characteristics

OBJECT 1
LEFLUNOMIDE 20MG TABLETS
Summary of Product Characteristics Updated 19-Feb-2015 | Zentiva
1. Name of the medicinal product
Leflunomide Winthrop 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 20 mg of leflunomide.
Excipients with known effect:
Each tablet contains 72 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellowish to ochre and triangular film-coated tablet, imprinted with
ZBO on one side.
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 usually 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 recomme