Uses of Brintellix:

• It is used to treat low mood (depression).

What do I need to tell my doctor BEFORE I take Brintellix?

• If you have an allergy to vortioxetine or any other part of Brintellix (vortioxetine).
• If you are allergic to Brintellix (vortioxetine); any part of Brintellix (vortioxetine); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.

This is not a list of all drugs or health problems that interact with Brintellix (vortioxetine).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Brintellix (vortioxetine) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Brintellix?

• Tell all of your health care providers that you take Brintellix (vortioxetine). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Brintellix (vortioxetine) affects you.
• Do not stop taking Brintellix (vortioxetine) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Brintellix (vortioxetine), you will want to slowly stop it as ordered by your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• In depression, sleep and appetite may get better soon after starting Brintellix (vortioxetine). Other low mood signs may take up to 4 weeks to get better.
• This medicine may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
• Some people may have a higher chance of eye problems with Brintellix (vortioxetine). Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• Low blood sodium levels may happen with Brintellix (vortioxetine). In very bad cases, this can be deadly. Talk with the doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• Some drugs may look the same as Brintellix (vortioxetine) or may have names that sound like Brintellix (vortioxetine). Always check to make sure you have the right product. If you see any change in the way Brintellix (vortioxetine) looks like shape, color, size, or wording, check with your pharmacist.
• If you are 65 or older, use Brintellix (vortioxetine) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking Brintellix (vortioxetine) late in pregnancy may raise the chance of breathing or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Talk with the doctor.

How is this medicine (Brintellix) best taken?

Use Brintellix (vortioxetine) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take Brintellix (vortioxetine) at the same time of day.
• Keep taking Brintellix (vortioxetine) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Trouble sleeping.
• Very bad dizziness or passing out.
• Sex problems like lowered interest in sex or ejaculation problems.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.

What are some other side effects of Brintellix?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Dry mouth.
• Dizziness.
• Diarrhea or constipation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Brintellix?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Brintellix (vortioxetine) is refilled. If you have any questions about Brintellix (vortioxetine), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• Does Trintellix (vortioxetine) cause weight gain or loss?
• How long does it take for Trintellix (vortioxetine) to start working?
• Is Trintellix (vortioxetine) good for anxiety?
• Shall I take Trintellix (vortioxetine) in the night or morning?
• Can I take Cymbalta (duloxetine) and Trintellix (vortioxetine) together?
• Is Trintellix the same as Brintellix?

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