Fingolimod 0.5 mg

Capsules for Oral use


Product leaflet summary

Therapeutic Indications

Fingolimod is used in adults to treat relapsing-remitting multiple sclerosis (MS), more specifically in:

Patients who have failed to respond despite treatment with an MS treatment.


Patients who have rapidly evolving severe MS.

Fingolimod does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.


Dosage and Administration

The dose is one capsule per day. Take fingolimod once a day with a glass of water. Fingolimod can be taken with or without food.

Taking fingolimod at the same time each day will help you remember when to take your medicine.

Do not exceed the recommended dose.



If you have a lowered immune response (due to an immunodeficiency syndrome, a disease or to medicines that suppress the immune system).

If you have a severe active infection or active chronic infection such as hepatitis or tuberculosis.

If you have an active cancer.

If you have severe liver problems.

If you are allergic to fingolimod or any of the other ingredients of this medicine


Pregnancy and Lactation

Before you start treatment with fingolimod your doctor may ask you to do a pregnancy test in order to ensure that you are not pregnant. You should avoid becoming pregnant while taking fingolimod or in the two months after you stop taking it because there is a risk of harm to the baby. Talk with your doctor about reliable methods of birth control that you should use during treatment and for 2 months after you stop treatment.


Pediatric Population:

Fingolimod is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.


Ability to Drive and Use Machinery

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Fingolimod is not expected to have an influence on your ability to drive and use machines.

However, at initiation of treatment you will have to stay at the doctor’s surgery or clinic for 6 hours after taking the first dose of fingolimod. Your ability to drive and use machines may be impaired during and potentially after this time period.


Package Presentation:

Fegona supplied in a pack of 28 film coated tablets.