ORILISSA

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Visit your care team for regular checks on your progress.
This medication may cause weak bones (osteoporosis). Only use this product for the amount of time your care team tells you to. The longer you use this product the more likely you will be at risk for weak bones. Ask your care team how you can keep strong bones.
Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, call your care team.
You may have a change in bleeding pattern or irregular periods. Many patients stop having periods while taking this medication.
Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Estrogen and/or progestin hormones may not work as well while you are taking this medication. If you are using estrogen and/or progestin hormones for contraception, a barrier contraceptive, such as a condom or diaphragm, is recommended during and for 28 days after stopping treatment. Talk to your care team about other forms of contraception.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.
It is important to get rid of the medication as soon as you no longer need it, or it is expired. You can do this in two ways:
-Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medication, follow the directions in the MedGuide.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.