Vortioxetine (vor-tye-OX-e-teen)

Treats depression.

Brand Name(s):

Trintellix

When This Medicine Should Not Be Used:

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 (including isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, tranylcypromine) in the past 14 days. 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, meperidine, methadone, phenytoin, quinidine, rifampin, St John's wort, tramadol
  • Amphetamines
  • Antiplatelet medicine (including clopidogrel)
  • Blood thinner (including heparin, warfarin)
  • Diuretic (water pill)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Other medicine to treat depression (including buspirone, bupropion, fluoxetine, paroxetine, SNRIs, SSRIs, TCAs)
  • Triptan medicine to treat migraine headaches
  • Tryptophan supplements
• 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, bleeding problems, glaucoma, or a history of seizures.
• 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 (may be life-threatening when used with certain other medicines)
  • Increased risk of bleeding problems
  • Sexual problems
• 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.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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, muscle stiffness or twitching
• Feeling more excited or energetic than usual
• Loss in sexual ability, desire, drive, or performance, delayed or inability to have an orgasm, inability to have or keep an erection
• 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

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