Aubagio 14mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Teriflunomide

Inapatikana kutoka:

Genzyme Therapeutics Ltd

ATC kanuni:

L04AA31

INN (Jina la Kimataifa):

Teriflunomide

Kipimo:

14mg

Dawa fomu:

Tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 08020400; GTIN: 5000283656463

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT_ _
AUBAGIO 14 MG FILM-COATED TABLETS
teriflunomide
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AUBAGIO is and what it is used for
2.
What you need to know before you take AUBAGIO
3.
How to take AUBAGIO
4.
Possible side effects
5.
How to store AUBAGIO
6.
Contents of the pack and other information
1.
WHAT AUBAGIO IS AND WHAT IT IS USED FOR
WHAT AUBAGIO IS
AUBAGIO contains the active substance teriflunomide which is an
immunomodulatory agent and
adjusts the immune system to limit its attack on the nervous system.
WHAT AUBAGIO IS USED FOR
AUBAGIO is used in adults to treat relapsing remitting multiple
sclerosis (MS).
WHAT MULTIPLE SCLEROSIS IS
MS is a long-term illness that affects the central nervous system
(CNS). The CNS is made up of the
brain and spinal cord. In multiple sclerosis, inflammation destroys
the protective sheath (called
myelin) around the nerves in the CNS. This loss of myelin is called
demyelination. This stops nerves
from working properly.
People with relapsing form of multiple sclerosis will have repeated
attacks (relapses) of physical
symptoms caused by their nerves not working properly. These symptoms
vary from patient to patient
but usually involve:
•
difficulty walking
•
vision problems
•
balance problems.
Symptoms may disappear completely after the relapse is over, but over
time, some problems may
remain between relapses. This can cause physical disabilities that may
interfere with your daily
activities.
HOW AUBAGIO WORK

Tabia za bidhaa

OBJECT 1
AUBAGIO 14 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Jun-2018 | Genzyme
Therapeutics
1. Name of the medicinal product
AUBAGIO 14 mg film-coated tablets
2. 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).
For the full list of excipients, see section 6.1.
3. 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.
4. Clinical particulars
4.1 Therapeutic indications
AUBAGIO is indicated for the treatment of adult patients with
relapsing remitting multiple sclerosis
(MS).
(please refer to section 5.1 for important information on the
population for which efficacy has been
established).
4.2 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 teriflunomide 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 4.3).
_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 4.3).
_Paediatric population_
The safety and efficacy of teriflunomide 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.