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Fingolimod Oral Capsule (FINGOLIMOD - ORAL)

For multiple sclerosis.

Brand Name(s): Gilenya

Generic Name: Fingolimod

Instructions

Keep the medicine in its original container.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Avoid prolonged or excessive sunlight exposure. Use sunscreen lotion with SPF 15 or higher.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Use effective birth control to avoid pregnancy.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 2 months after stopping to prevent pregnancy.

If you have had a heart attack or a stroke within the past 6 months, talk to your doctor before using this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • back pain
  • coughing
  • diarrhea
  • headaches
  • high blood pressure

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • loss of balance
  • chest pain
  • changes in memory, mood, or thinking
  • confusion
  • pain in the eye
  • fainting
  • fever or chills
  • swelling in the neck or throat
  • severe or persistent headache
  • fast, irregular, or slow heartbeat
  • sensitivity to light
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • seizures
  • shortness of breath
  • light colored stool
  • blurring or changes of vision
  • vision problems - blind spots or dark spots
  • vision problems - changes in seeing color
  • vomiting
  • weakness on one side of the body

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.