Tergio 14 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

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:

2022-12-22

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tergio 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 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 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.
Tergio is only available as 14 mg film-coated tablets. Thus, it is not
possible to administer Tergio 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
_Elderly population _
Tergio 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, moder