Zuranolone Oral Capsule (ZURANOLONE - ORAL)

Instructions

Take with food or a milky drink that contains fat.

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.

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

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

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.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

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

Cautions

Though it helps many people, this medicine may sometimes cause addiction, especially if it is used for a long time. This risk for addiction may be higher if you have a substance use disorder - such as overuse of or addiction to drugs or alcohol. Speak with your doctor about the benefits and risks of using this medicine.

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

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

This medicine may impair your ability to stay alert or react quickly. Do not drive, operate machinery, or do anything else that requires alertness for at least 12 hours after you take this medication. After 12 hours, you may do those activities if you are alert enough to do them safely.

Family should check on the patient often. Call the doctor if patient becomes more depressed, has thoughts of suicide, or shows changes in behavior.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

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 1 week after stopping to prevent pregnancy.

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.

• diarrhea
• dizziness or drowsiness
• lack of energy and tiredness

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

• confusion
• falls
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• suicidal thoughts
• unsteadiness while walking

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.