ell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are taking any of the following medicines:
- Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as beta interferon, glatiramer acetate, natalizumab or mitoxantrone. You must not use Gilenya together with such medicines as this could intensify the effect on the immune system (see also „Do not take Gilenya-).
- Vaccines. During and for up to 2 months after treatment with Gilenya, you should not be given certain types of vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to prevent. Other vaccines may not work as well as usual if given during this period.
- Medicines that slow the heartbeat (for example beta blockers, such as atenolol). Use of Gilenya together with such medicines could intensify the effect on heartbeat in the first days after starting Gilenya.
- Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. Your doctor may decide not to prescribe Gilenya if you are taking such a medicine because it could intensify the effect on irregular heartbeat.
- Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or telithromycin.
Pregnancy and breast-feeding
Before you start treatment with Gilenya 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 Gilenya 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.
If you do become pregnant while taking Gilenya, stop taking the medicine and tell your doctor straight away. You and your doctor will decide what is best for you and your baby.
You should not breast-feed while you are taking Gilenya. Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Gilenya 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 Gilenya. Your ability to drive and use machines may be impaired during and potentially after this time period.
How is it used?
Treatment with Gilenya will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Always take Gilenya exactly as your doctor has told you. You should check with your doctor if you are not sure.
The dose is one capsule per day. Take Gilenya once a day with a glass of water. Gilenya can be taken with or without food.
Taking Gilenya at the same time each day will help you remember when to take your medicine.
Do not exceed the recommended dose.
Your doctor may switch you directly from beta interferon to Gilenya if there are no signs of abnormalities caused by your previous treatment. Your doctor may have to do a blood test in order to exclude such abnormalities. After stopping natalizumab you may have to wait for 2-3 months before starting
