Teriflunomide Mylan

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

Teriflunomide

Fáanlegur frá:

Mylan Pharmaceuticals Limited

ATC númer:

L04AA31

INN (Alþjóðlegt nafn):

teriflunomide

Meðferðarhópur:

Immunosuppressants

Lækningarsvæði:

Multiple Sclerosis, Relapsing-Remitting

Ábendingar:

Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established). 

Vörulýsing:

Revision: 1

Leyfisstaða:

Authorised

Leyfisdagur:

2022-11-09

Upplýsingar fylgiseðill

34
PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TERIFLUNOMIDE MYLAN 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 Teriflunomide Mylan is and what it is used for
2.
What you need to know before you take Teriflunomide Mylan
3.
How to take Teriflunomide Mylan
4.
Possible side effects
5.
How to store Teriflunomide Mylan
6.
Contents of the pack and other information
1.
WHAT TERIFLUNOMIDE MYLAN IS AND WHAT IT IS USED FOR
WHAT TERIFLUNOMIDE MYLAN IS
Teriflunomide Mylan contains the active substance teriflunomide which
is an immunomodulatory
agent and adjusts the immune system to limit its attack on the nervous
system.
WHAT TERIFLUNOMIDE MYLAN IS USED FOR
Teriflunomide is used in adults and in children and adolescents (10
years of age and older) 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 com

Vara einkenni

1
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Teriflunomide Mylan 14 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Excipient(s) with known effect
Each tablet contains 85.4 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 coloured, round, biconvex, film-coated
tablets debossed with ‘T’ on one side
and ‘1’ on the other side, approximately 7.6 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriflunomide Mylan is indicated for the treatment of adult patients
and paediatric patients aged
10 years and older 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
_Adults _
In adults, the recommended dose of teriflunomide is 14 mg once daily.
_Paediatric population (10 years and older) _
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body
weight:
-
Paediatric patients with body weight > 40 kg: 14 mg once daily.
-
Paediatric patients with body weight ≤ 40 kg: 7 mg once daily.
Paediatric patients who reach a stable body weight above 40 kg should
be switched to 14 mg once
daily.
Teriflunomide Mylan is only available as 14 mg film-coated tablets.
Thus, it is not possible to
administer Teriflunomide Mylan to patients that require less than a
full 14 mg dose. If an alternate
dose is required, other teriflunomide products offering such an option
should be used.
Special populations
3
_Elderly population _
Teriflunomide should be used with caution in patients aged 65 years
and over due to insufficient data
on safety and efficacy.
_Renal impairment _
No dose adjustment is