MEDICATION GUIDE

BRINTELLIX [brin'-tel-ix]

(vortioxetine) Tablets

Read this Medication Guide before you start taking BRINTELLIX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about BRINTELLIX?

BRINTELLIX and other antidepressant medicines may cause serious side effects.

1.

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.

2.

Depression or other serious 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 sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

•

Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

•

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

Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• attempts to commit suicide	• trouble sleeping
• acting on dangerous impulses	• an extreme increase in activity or talking (mania)
• acting aggressive, being angry or violent	• other unusual changes in behavior or mood
• thoughts about suicide or dying	• panic attacks
• new or worse depression	• new or worse irritability
• new or worse anxiety
• feeling agitated, restless, angry or irritable

What is BRINTELLIX?

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

It is important to talk with your healthcare provider about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare provider.

•

Talk to your healthcare provider if you do not think that your condition is getting better with BRINTELLIX treatment.

Who should not take BRINTELLIX?

Do not take BRINTELLIX if you:

•

are allergic to vortioxetine, or any of the ingredients in BRINTELLIX. See the end of this Medication Guide for a complete list of ingredients in BRINTELLIX.

•

take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.

•

Do not take an MAOI within 21 days of stopping BRINTELLIX.

•

Do not start BRINTELLIX if you stopped taking an MAOI in the last 14 days.

What should I tell my healthcare provider before taking BRINTELLIX?

Tell your healthcare provider if you:

•

have liver problems

•

have or had seizures or convulsions

•

have mania or bipolar disorder (manic depression)

•

have low salt (sodium) levels in your blood

•

have or had bleeding problems

•

drink alcohol

•

have any other medical conditions

•

are pregnant or plan to become pregnant. It is not known if BRINTELLIX will harm your unborn baby.

•

are breastfeeding or plan to breastfeed. It is not known if BRINTELLIX passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take BRINTELLIX.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRINTELLIX and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

Especially tell your healthcare provider if you take:

•

medicines used to treat migraine headache (e.g. triptans)

•

medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), buspirone, or antipsychotics

•

MAOIs (including linezolid, an antibiotic)

•

Tramadol or fentanyl

•

over-the-counter supplements such as tryptophan or St. John's Wort

•

nonsteroidal anti-inflammatory drugs (NSAIDs)

•

aspirin

•

warfarin (Coumadin, Jantoven)

•

diuretics

•

rifampicin

•

carbamazepine

•

phenytoin

•

quinidine

Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Before you take BRINTELLIX with any of these medicines, talk to your healthcare provider about serotonin syndrome. See "What are the possible side effects of BRINTELLIX?"

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get new medicine.

How should I take BRINTELLIX?

•

Take BRINTELLIX exactly as your healthcare provider tells you to take it.

•

Take BRINTELLIX at about the same time each day.

•

Your healthcare provider may need to change the dose of BRINTELLIX until it is the right dose for you.

•

Do not start or stop taking BRINTELLIX without talking to your healthcare provider first. Suddenly stopping BRINTELLIX when you take higher doses may cause you to have side effects, including:

•

headache

•

stiff muscles

•

mood swings

•

sudden outburst of anger

•

dizziness or feeling lightheaded

•

runny nose

•

BRINTELLIX may be taken with or without food.

•

If you take too much BRINTELLIX, call the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking BRINTELLIX?

•

Do not drive, operate heavy machinery, or do other dangerous activities until you know how BRINTELLIX affects you.

•

Avoid drinking alcohol while taking BRINTELLIX.

What are the possible side effects of BRINTELLIX?

BRINTELLIX may cause serious side effects, including:

•

See "What is the most important information I should know about BRINTELLIX?"

•

serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as BRINTELLIX are taken with certain other medicines. Symptoms of serotonin syndrome may include:

•

agitation, hallucinations, coma or other changes in mental status

•

problems controlling your movements or muscle twitching

•

fast heartbeat

•

high or low blood pressure

•

sweating or fever

•

nausea or vomiting

•

diarrhea

•

muscle stiffness or tightness

•

abnormal bleeding or bruising. BRINTELLIX may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

•

hypomania (manic episodes). Symptoms of manic episodes include:

•

greatly increased energy

•

severe problems sleeping

•

racing thoughts

•

reckless behavior

•

unusually grand ideas

•

excessive happiness or irritability

•

talking more or faster than usual

•

visual problems

•

eye pain

•

changes in vision

•

swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

•

low levels of salt (sodium) in your blood. Symptoms of this may include: headache, difficulty concentrating, memory changes, confusion, weakness and unsteadiness on your feet. Symptoms of severe or sudden cases of low salt levels in your blood may include: hallucinations (seeing or hearing things that are not real), fainting, seizures and coma. If not treated, severe low sodium levels can cause death.

Common side effects in people who take BRINTELLIX include:

•

nausea

•

constipation

•

vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BRINTELLIX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BRINTELLIX?

Store BRINTELLIX at room temperature between 59°F to 86°F (15°C to 30°C).

Keep BRINTELLIX and all medicines out of the reach of children.

General information about the safe and effective use of BRINTELLIX.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRINTELLIX for a condition for which it was not prescribed. Do not give BRINTELLIX to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about BRINTELLIX. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about BRINTELLIX that is written for healthcare professionals.

For more information, go to www.BRINTELLIX.com or call 1-877-TAKEDA-7 (1-877-825-3327).

What are the ingredients in BRINTELLIX?

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, 15 mg, and 20 mg) and iron oxide yellow (10 mg and 15 mg)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed and Marketed by:

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

Marketed by:

Lundbeck

Deerfield, IL 60015

BRINTELLIX is a trademark of H. Lundbeck A/S registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

©2013, 2014 Takeda Pharmaceuticals America, Inc.

LUN205 R4 July 2014