Teriflunomide Clonmel 14 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Teriflunomide

Available from:

Clonmel Healthcare Ltd

ATC code:

L04AA31

INN (International Name):

Teriflunomide

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

teriflunomide

Authorization status:

Not marketed

Authorization date:

2023-07-07

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERIFLUNOMIDE CLONMEL 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 Clonmel is and what it is used for
2.
What you need to know before you take Teriflunomide Clonmel
3.
How to take Teriflunomide Clonmel
4.
Possible side effects
5.
How to store Teriflunomide Clonmel
6.
Contents of the pack and other information
1.
WHAT TERIFLUNOMIDE CLONMEL IS AND WHAT IT IS USED FOR
WHAT TERIFLUNOMIDE CLONMEL IS
Teriflunomide Clonmel contains the active substance teriflunomide
which is an immunomodulatory
medicine and adjusts the immune system to limit its attack on the
nervous system.
WHAT TERIFLUNOMIDE CLONMEL IS USED FOR
This medicine 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 (MS) 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 disappe

Summary of Product characteristics

Health Products Regulatory Authority
07 July 2023
CRN00DFYR
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teriflunomide Clonmel 14 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 14 mg of teriflunomide.
Excipients with known effect
Each tablet contains 48 mg of lactose monohydrate (corresponding to 45
mg lactose anhydrous).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Round shaped, light blue coloured, scored film-coated tablet with
diameter of approximately 7 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teriflunomide Clonmel 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.
For paediatric patients with body weight ≤ 40 kg, the scored
film-coated tablet of Teriflunomide Clonmel can be divided in two
equal doses, in order to provide a precise dose of 7 mg or to
facilitate administration.
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_
Teriflunomide Clonmel should be used with caution in patients aged 65
years and over, due to insufficient data on safet