FINGOLIMOD TEVA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

FINGOLIMOD AS HYDROCHLORIDE

Disponível em:

TEVA ISRAEL LTD

Código ATC:

L04AA27

Forma farmacêutica:

CAPSULES

Composição:

FINGOLIMOD AS HYDROCHLORIDE 0.5 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

TEVA ISRAEL LTD, ISRAEL

Área terapêutica:

FINGOLIMOD

Indicações terapêuticas:

Indicated for the treatment of patients with relapsing forms of multiple sclerosis ( MS ) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disabiliry.

Data de autorização:

2021-10-31

Folheto informativo - Bula

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Fingolimod Teva
Capsules
Composition
Each capsule contains:
Fingolimod (as HCl) 0.5 mg
For information regarding inactive ingredients and
allergens, see section 2 “Important information about
some of the ingredients of the medicine” and section
6 “Additional information”.
Read the entire leaflet carefully before using the
medicine. This leaflet contains concise information
about the medicine. If you have additional questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment
of your illness. Do not pass it on to others. It may
harm them even if it seems to you that their medical
condition is similar.
In addition to the leaflet, the Fingolimod Teva
preparation has a patient safety information card.
This card contains important safety information
that you must know before starting treatment with
Fingolimod Teva and during the treatment, and
act accordingly.
Please review the patient safety information card
and the patient leaflet before starting to use the
preparation. You should keep the card for further
review, if necessary.
Taking the first dose:
After taking the first dose of Fingolimod Teva,
observation by a healthcare professional is required
for at least 6 hours.
This recommendation also applies if you are resuming
treatment after interrupting treatment with Fingolimod
Teva.
The full instructions for taking the first dose are
detailed in section 2 “Special warnings regarding
the use of the medicine”.
1. WHAT IS THE MEDICINE INTENDED FOR?
Fingolimod Teva is intended for the treatment
of relapsing forms of multiple sclerosis (MS), to
reduce the number of relapses and to slow down
the progression of physical problems (disability)
caused by the disease.
Therapeutic group
Selective immunosuppressant
Sphingosine-1-phosphate receptor modulator
What is multiple sclerosis?
Multiple sclerosis is a chronic disease that af