Vortioxetine (vor tee OX e teen) is used to treat depression.

Take this medicine by mouth with 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 this medicine unless your health care provider tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

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 pediatrician regarding the use of this medicine in children. It is not approved for use in children.

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose
• changes in vision
• elevated mood, decreased need for sleep, racing thoughts, impulsive behavior
• eye pain
• hallucinations
• low sodium levels (headache; difficulty concentrating, confusion; feeling faint or lightheaded, falls; weakness; seizures)
• serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)
• suicidal thoughts or other mood changes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance
• constipation
• dizziness
• dry mouth
• nausea

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

They need to know if you have any of these conditions:

• bipolar disorder or a family history of bipolar disorder
• bleeding disorder
• glaucoma
• liver disease
• low levels of sodium in the blood
• seizures
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• take medicines that treat or prevent blood clots
• taken an MAOI such as Marplan, Nardil, or Parnate in the last 14 days
• an unusual or allergic reaction to vortioxetine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

Do not take this medicine with any of the following medications:

• linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• methylene blue (injected into a vein)

This medicine may also interact with the following medications:

• aspirin and aspirin-like medicines
• carbamazepine
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• diuretics
• fentanyl
• furazolidone
• isoniazid
• lithium
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• phenytoin
• procarbazine
• quinidine
• rasagiline
• rifampin
• safinamide
• supplements like St. John's wort, kava kava, valerian
• tramadol
• tryptophan

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.

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse.

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, especially at the beginning of treatment or after a change in dose, call your healthcare professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.