Teriflunomid beta 7 mg Filmtabletten

Country: Գերմանիա

language: գերմաներեն

source: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

MAH:

betapharm Arzneimittel GmbH (3364323)

dosage:

7 mg

pharmaceutical_form:

Filmtablette

administration_route:

zum Einnehmen

authorization_status:

zugelassen

authorization_date:

2023-07-22

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
7 MG FILM-COATED TABLETS
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IS

contains the active substance teriflunomide which is an
immunomodulatory agent
and adjusts the immune system to limit its attack on the nervous
system.
WHAT IS USED FOR
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 completely after the r

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
7 mg film-coated tablets
14 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 7 mg film-coated tablets _
Each film-coated tablet contains 7 mg of teriflunomide.
Excipient with known effect
Each tablet contains 35.25 mg of lactose (as monohydrate).
_ 14 mg film-coated tablets _
Each film-coated tablet contains 14 mg of teriflunomide.
Excipient with known effect
Each tablet contains 70.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
_ 7 mg film-coated tablets _
White, round, film-coated 6 mm tablet with imprint on one side
(‘O’)
_ 14 mg film-coated tablets _
Blue, round, film-coated 7 mm tablet with imprint on one side
(‘C14’)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
2
_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.
Special populations
_Elderly _
should be used with caution in patients aged 65 years
and over due to insufficient
data on safety and efficacy.
_ _
_Renal impairment