TRINTELLIX can cause serious side effects.

1. TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children under 18.
2. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions?

• Pay close attention to any changes, especially new or sudden changes in mood, behavior, thoughts, or feelings.
  

• Call your healthcare professional or get emergency help right away if you have symptoms such as suicidal thoughts or actions, impulsivity, aggressive or violent actions, depression, anxiety or panic attacks, agitation, restlessness, anger, irritability, trouble sleeping, an increase in activity or talking, or other unusual changes in behavior or mood; especially if they are new, worse, or worry you.

• Keep all follow-up visits with your healthcare professional as scheduled. Call your healthcare professional between visits as needed, especially if you have concerns about symptoms

Call your healthcare professional or get emergency help right away if you have symptoms, especially if they are new, worse, or worry you.

1.  Attempts to commit suicide
2.  Thoughts about suicide or dying
3. Feeling agitated, restless, angry or irritable
4. Other unusual changes in behavior or mood
5.  Acting on dangerous impulses
6.  New or worse depression
7.  Trouble sleeping
8.  Acting aggressive or violent
9. New or worse anxiety or panic attacks
10. An increase in activity or talking more than what is normal for you

TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD).

Do not start or take TRINTELLIX if you:

• are allergic to vortioxetine or any of the ingredients in TRINTELLIX
• take a Monoamine Oxidase Inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue

Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX.

Before taking TRINTELLIX, tell your healthcare professional:

• about all your medical and other health conditions
• if you are pregnant or plan to become pregnant, since TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester may cause your baby to have withdrawal symptoms after birth or to be at increased risk for a serious lung problem at birth. Tell your healthcare professional right away if you become or think you are pregnant while taking TRINTELLIX.
• if you are breastfeeding or plan to breastfeed, since it is not known if TRINTELLIX passes into your breast milk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since TRINTELLIX and some medicines may cause serious side effects (or may not work as well) when taken together.

Especially tell your doctor if you take:

• Medicines for migraine headache called triptans
  
• Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclic antidepressants, lithium, or buspirone
• Opioids (such as fentanyl and tramadol)
• Over-the-counter supplements such as tryptophan or St. John's Wort
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Aspirin
• Warfarin (Coumadin, Jantoven)
• Diuretics

Ask your healthcare professional if you are not sure if you are taking any of these medicines. Before you take TRINTELLIX with any of these medicines, talk to your healthcare professional about serotonin syndrome. For more information, review the possible side effects of TRINTELLIX in the question below. Know the medicines you take. Keep a list of them to show your healthcare professional or pharmacist when you get new medicine.

• Take TRINTELLIX exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of TRINTELLIX until it is the right dose for you.
• Take TRINTELLIX 1 time each day.
• TRINTELLIX may be taken with or without food.
• If you take too much TRINTELLIX, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

TRINTELLIX may cause serious side effects, including:

• See, “What is the most important information I should know about TRINTELLIX?”
• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take TRINTELLIX with certain other medicines. See, “Who should not take TRINTELLIX?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

• Increased risk of bleeding. Taking TRINTELLIX with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take TRINTELLIX. Symptoms may include:

• Discontinuation syndrome. Suddenly stopping TRINTELLIX may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:

• Eye problems (angle-closure glaucoma). TRINTELLIX may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
• Low levels of sodium in your blood (hyponatremia). Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with TRINTELLIX. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness and unsteadiness on your feet which can lead to falls
  In more severe or more sudden cases, signs and symptoms include:
  • seeing or hearing things that are not real (hallucinations)
  • fainting
  • seizures
  • coma
  • stopping breathing (respiratory arrest)
• Sexual problems (dysfunction). 
  Taking TRINTELLIX may cause sexual problems.
  Symptoms in males may include:
  • Delayed ejaculation or inability to have an ejaculation
  • Decreased sex drive
  • Problems getting or keeping an erection
  Symptoms in females may include:
  • Decreased sex drive
  • Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX. There may be treatments your healthcare provider can suggest.

The most common side effects of TRINTELLIX include nausea, constipation, vomiting.
These are not all the possible side effects of TRINTELLIX.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store TRINTELLIX at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TRINTELLIX and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take TRINTELLIX for a condition for which it was not prescribed. Do not give TRINTELLIX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TRINTELLIX that is written for healthcare professionals.

Active ingredient: vortioxetine hydrobromide
Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating consisting of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)