When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to vortioxetine.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at the same time each day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take vortioxetine if you have taken a MAO inhibitor, methylene blue, or linezolid in the past 2 weeks. Do not start taking an MAO inhibitor within 21 days of stopping vortioxetine.
• Some medicines can affect how vortioxetine works. Tell your doctor if you are using the following:
  
  • Carbamazepine, fentanyl, lithium, phenytoin, quinidine, rifampin, tramadol, St John's wort
  • A diuretic (water pill), triptan medicine for migraine headaches, a tryptophan supplement, other medicine for depression (such as buspirone, bupropion, fluoxetine, paroxetine), an NSAID pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, naproxen), or a blood thinner (such as warfarin)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or glaucoma.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  
  • Serotonin syndrome (more likely when used with certain other medicines)
  • Increased risk of bleeding
  • Low sodium levels in the blood
• This medicine may make you dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Confusion, weakness, and muscle stiffness or twitching
• Feeling more excited or energetic than usual
• Thoughts of hurting yourself or others, unusual behavior
• Trouble sleeping, unusual dreams
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Dizziness
• Eye pain, vision changes, seeing halos around lights
• Nausea, vomiting, constipation
• Sexual problems

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088