Gilenya 0.5mg 28 capsule

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.

Warnings and precautions:

• Talk to your doctor about all your medical conditions before taking this medicine including:


• If you have any heart problems including irregular heartbeat or rhythm.


• If you have a history of stroke or mini-stroke.


• If you have a history of repeated fainting (syncope).


• If you have a fever or infection, or you are unable to fight infections due to a disease or medicines that lower your immune system.


• If you recently received a vaccine or are scheduled to receive a vaccine.


• If you have eye problems.


• If you have diabetes.


• If you have breathing problems, including during your sleep.


• If you have liver problems.


• If you have high blood pressure.


• If you have certain types of skin cancer called basal cell carcinoma (BCC) or melanoma.


• After the first dose of Fingolimod hcl, a transient decrease in heart rate may be observed.


• As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop.


• This medicine puts you at risk of having infections easily.

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.