Gilenya 0.5 mg fingolimod Capsules × 28

What Fingolimod hcl is used for:

• • Fingolimod hcl is used to treat relapsing forms or severe rapidly progressing cases of multiple sclerosis (MS).

Do not take Fingolimod hcl:

• • If you’re allergic to the active substances or any other component of this medicine.

• • If you have had a heart attack, unstable angina, stroke or mini-stroke or certain types of heart failure in the last 6 months.

• • If have certain types of irregular or abnormal heartbeat (arrhythmia) or heart rhythm.

• • If you have a heart rhythm problem that needs treatment with certain medicines.

• • If you are at risk of having infections due to decreased immunity.

Possible side effects:

• • Stop using this product and seek immediate medical help if you develop rash; hives; itching; red, swollen, blistered, or peeling skin; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Serious side effects:

• • Slow heart rate (bradycardia)

• • Liver damage

• • Swelling of the blood vessels in your brain called PRES (Posterior Reversible Encephalopathy Syndrome) where you experience headache and confusion

• • Trouble breathing

• • A problem with your vision called macular edema

• • Types of skin cancer called basal cell carcinoma (BCC) and melanoma

• • High blood pressure

Other medicines and Fingolimod hcl:

• • Tell your doctor about all the medicines you are taking.

• • Medications that interact with Fingolimod hcl include:

• • Medicines that decrease your immunity

• • Corticosteroids

• • Medicines that affect your heartbeats or heart rhythm

• • Drugs for seizures

• • Some anti-infectives (ketoconazole, azole antifungals, clarithromycin)

• • Vaccines

How to take Fingolimod hcl :

• • This medicine is intended for adults and children 10 years of age and older.

• • Take this medicine as indicated by your doctor.

• • The usual recommended dose for adults is one 0.5 mg capsule daily.

• • For children and adolescents with body weight equal to or below 40 kg, the recommended dose is one 0.25 mg capsule per day.

• • For children and adolescents with body weight above 40 kg, the recommended dose is one 0.5 mg capsule per day.

How to store Fingolimod hcl :

• • Store at room temperature 68 to 77°F (20 to 25°C).

• • Keep this medicine out of reach of children.

• • Do not use this medicine after the expiry date stated on the package.

• The expiry date refers to the last day of that month.