ou have any of the following medical conditions:
if you have a slow resting heart rate (less than 55 beats per minute), if you are taking medicines that slow your heart rate, if you have irregular or abnormal heartbeat or a history of sudden loss of consciousness.
if you have no history of chickenpox or have not been vaccinated against varicella zoster virus. Your doctor may decide to test your status and vaccinate you against this virus (if you do not have enough antibodies to this virus). In this case you will start Gilenya one month after the vaccination.
if you plan to get vaccinated. During and for up to 2 months after treatment with Gilenya, you should not get certain types of vaccines (live attenuated vaccines) and some others may not work well.
if you have a lowered immune response (due to a disease or medicines that suppress the immune system). You may get infections more easily or an infection you already have may get worse.
if you have or have had visual disturbances or other signs of swelling in the central vision area at the back of the eye (a condition known as macular oedema), inflammation or infection of the eye (uveitis) or if you have diabetes. Your doctor may want you to undergo an eye examination before you start Gilenya and at regular intervals after the start of Gilenya treatment.
problems with your liver. Gilenya may increase the risk of abnormal results of liver function tests.
If you are not sure whether any of the above conditions apply to you, your doctor can advise you.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
You may need to take different amounts of your medicines or to take different medicines while you are taking Gilenya. Your doctor and pharmacist have more information.
Tell your doctor if you are taking any of the following medicines:
medicines for irregular heartbeat such as quinidine, procainamide, amiodarone or sotalol. Your doctor may decide not to use Gilenya if you take these medicines due to a possible added effect on irregular heartbeat;
medicines that slow down heartbeat (called beta-blockers) such as atenolol due to a possible added effect on heartbeat on the first days you start Gilenya;
medicines that suppress or modulate the immune system including other medicines used to treat MS such as beta-interferon, glatiramer acetate, natalizumab or mitoxantrone due to a possible added effect on the immune system;
vaccines. During and for up to 2 months after treatment with Gilenya, administration of some vaccines containing live virus may result in infection that the vaccination should prevent, while others may not work well.
If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.
How to take Gilenya
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
The usual dose is one capsule per day (0.5 mg of fingolimod). Do not exceed the recommended dose.
How to take it
Swallow Gilenya capsules with a glass of water.
Gilenya can be taken with or without food.
First dose precaution
Before you take the first dose of Gilenya, your doctor may do an ECG to check your heart rate and rhythm.
You will need to stay at the doctor& |
