If you have questions about how long to take Gilenya, talk to your doctor or your pharmacist.

If you take more Gilenya than you should
If you have taken too much Gilenya, call your doctor straight away.

If you forget to take Gilenya
If you forget to take a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gilenya
Do not stop taking Gilenya or change your dose without talking to your doctor first.

Gilenya will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. After stopping Gilenya you may have to wait for 6-8 weeks before starting a new MS treatment.

If you have to restart Gilenya more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur. Talk to your doctor to check if you need to take the first capsule in the doctor-s surgery or clinic.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?
Like all medicines, Gilenya can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows:

Some side effects could be or could become serious
Common:

Uncommon:

Other side effects
Very common

Common

Uncommon

Rare

If any of these affects you severely, tell your doctor

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?
Keep out of the reach and sight of children.
Do not use Gilenya after the expiry date which is stated on the carton and blister foil after “EXP”. The expiry date refers to the last day of the month.
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
Do not use any pack that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors
What is it?
Gilenya is a medicine that contains the active substance fingolimod. It is available as capsules (0.5 mg).

What is it used for?
Gilenya is used to treat adults with highly active multiple sclerosis (MS). MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells. Gilenya is used in the type of MS known as ‘relapsing-remitting’, when the patient has attacks (relapses) in between periods with decreased symptoms (remissions). It is used when the disease has failed to respond to a beta-interferon (another type of medicine used in MS), or is severe and getting worse rapidly.

The medicine can only be obtained with a prescription.

How is it used?
Treatment with Gilenya should be started and supervised by a physician experienced in MS. The recommended dose is one capsule taken once a day by mouth.

How does it work?
In MS, the body’s immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord). The active substance in Gilenya, fingolimod, reduces the ability of T cells (a