Teriflunomide Torrent 14mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Torrent Pharma (Malta) Limited Central Business Centre, Level 2, Triq Hal Tarxien, Gudja, GDJ 1907, 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

Authorization status:

Authorised

Authorization date:

2023-12-21

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERIFLUNOMIDE TORRENT 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 Torrent is and what it is used for
2.
What you need to know before you take Teriflunomide Torrent
3.
How to take Teriflunomide Torrent
4.
Possible side effects
5.
How to store Teriflunomide Torrent
6.
Contents of the pack and other information
1.
WHAT TERIFLUNOMIDE TORRENT IS AND WHAT IT IS USED FOR
WHAT TERIFLUNOMIDE TORRENT IS
Teriflunomide
Torrent
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 TORRENT IS USED FOR
Teriflunomide Torrent 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.
Page 2 of 8
Sympto

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Teriflunomide Torrent
_ _
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 118.75 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Teriflunomide Torrent 14 mg film-coated tablets are Pale blue to
pastel blue, pentagon shaped
film-coated
tablets
debossed
with
“T14”
on
one
side
and
plain
on
other
side
having
approximately largest dimension of 7.25 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriflunomide Torrent 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 Torrent is only available as 14 mg film-coated tablets.
Thus, it is not possible to
administer Teriflunomide Torrent to paediatric patients with body
weight ≤ 40 kg that require
Page 2 of 24
less thana full 14-mg dose. If an alternate dose is required, other
teriflunomide products
offering such an option should be used.
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
_Elderly population _
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