AUBAGIO 14mg Film-coated Tablets

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

Teriflunomide

Disponible desde:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

Teriflunomide

Unidades en paquete:

28tablet Tablets

Fabricado por:

SANOFI WINTHROP INDUSTRIE

Información para el usuario

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AUBAGIO 14MG FILM-COATED TABLETS
Teriflunomide 14 mg
_1 _
_ _
WHAT IS IN THIS LEAFLET
1.
What AUBAGIO is used for
2.
How AUBAGIO works
3.
Before you use AUBAGIO
4.
How to use AUBAGIO
5.
While you are using AUBAGIO
6.
Side effects
7.
Storage and Disposal of
AUBAGIO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT AUBAGIO
IS USED FOR
AUBAGIO is used for the treatment of
adult patients with relapsing remitting
multiple sclerosis (MS).
HOW AUBAGIO WORKS
AUBAGIO helps to protect against
attacks on the central nervous system
by the immune system by limiting the
increase of some white blood cells
(lymphocytes). This limits the
inflammation that leads to nerve
damage in MS.
BEFORE YOU USE AUBAGIO
_ _
_WHEN YOU MUST NOT TAKE IT _
Do not take AUBAGIO if you:

are allergic to the active substance
or any of the ingredients in this
medicine (listed in
_Product _
_Description_
)

have ever developed a severe skin
rash or skin peeling, blistering
and/or mouth sores after taking
teriflunomide or leflunomide

have severe liver problems

are
PREGNANT
, think you may be
pregnant, or are breast-feeding

suffer from a serious problem
which affects your immune system
(e.g. AIDS)

have serious problems with your
bone marrow, or if you have low
numbers of red or white cells in
your blood or a reduced number of
blood platelets

are suffering from a serious
infection

have severe kidney problems
which require dialysis

have very low levels of protein in
your blood (hypoproteinaemia)
If you are not sure, talk to your doctor
or pharmacist before taking
AUBAGIO.
_BEFORE YOU START TO TAKE IT _
Talk to your doctor or pharmacist
before taking AUBAGIO if:

you have liver problems and/or if
you drink large amounts of
alcohol. Your doctor will carry
out blood tests before and during
treatment to check how well your
liver is working. If your test
results show a problem with your
liver, your doctor may st

Ficha técnica

MY/AUB/0323/SmPC0521
AUBAGIO 14 MG FILM-COATED TABLETS
NAME OF THE MEDICINAL PRODUCT
AUBAGIO 14 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Excipient with known effect: Each tablet contains 72 mg of lactose (as
monohydrate) and 0.3 mg of sodium.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pale blue to pastel blue, pentagonal film-coated tablets with imprint
on one side (‘14’) and engraved with a
corporate logo on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
AUBAGIO is indicated for the treatment of adult patients with
relapsing remitting multiple sclerosis (MS).
(please refer to section _Pharmacodynamic properties_ for important
information on the population for which
efficacy has been established).
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in the management of multiple
sclerosis.
Posology
The recommended dose of AUBAGIO is 14 mg once daily.
Special populations
_Elderly population _
AUBAGIO should be used with caution in patients aged 65 years and over
due to insufficient data on safety
and efficacy.
_Renal impairment _
No dosage adjustment is necessary for patients with mild, moderate or
severe renal impairment not
undergoing dialysis.
Patients
with
severe
renal
impairment
undergoing
dialysis
were
not
evaluated.
Teriflunomide
is
contraindicated in this population (see section _Contraindications_).
_Hepatic impairment _
No dosage adjustment is necessary for patients with mild and moderate
hepatic impairment. Teriflunomide
is contraindicated in patients with severe hepatic impairment (see
section _Contraindications_).
_Paediatric population _
The safety and efficacy of AUBAGIO in children aged from 10 to less
than 18 years has not yet been
established. There is no relevant use of teriflunomide in children
aged from birth to less than 10 years for
the treatment of multiple sclerosis.
No data are available.
Method of administration
VV-REG-136751