Teriflunomide MSN 14mg, film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

MSN Labs Europe Limited KW20A, Corradino Park, Paola PLA 3000, Malta

ATC code:

L04AA31

INN (International Name):

TERIFLUNOMIDE 14 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TERIFLUNOMIDE 14 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-01-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TERIFLUNOMIDE MSN 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 MSN is and what it is used for
2.
What you need to know before you take Teriflunomide MSN
3.
How to take Teriflunomide MSN
4.
Possible side effects
5.
How to store Teriflunomide MSN
6.
Contents of the pack and other information
1.
WHAT TERIFLUNOMIDE MSN IS AND WHAT IT IS USED FOR
WHAT TERIFLUNOMIDE MSN IS
Teriflunomide MSN 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 MSN IS USED FOR
Teriflunomide MSN 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 relapse is over, but o

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Teriflunomide MSN 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 79 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Blue colored, pentagonal shaped, biconvex, film coated tablets
(approximately 7 mm length and 7 mm
width), debossed with “14” on one side and “T” on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriflunomide MSN 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.
Teriflunomide 14 mg is not suitable for paediatric patients with a
body weight ≤40 kg; other medicinal
products are available in a lower strength (as 7 mg film-coated
tablets).
Paediatric patients who reach a stable body weight above 40 kg should
be switched to 14 mg once
daily.
Film-coated tablets can be taken with or without food.
Special populations
2
_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 necessary for patients with mild, moderate or
severe renal impairment not
undergoing dialysis.
Patient