Vortioxetine

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as vortioxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, there are also risks when depression is not treated in children and teenagers. Talk to your child's doctor about these risks and whether your child should take an antidepressant. Vortioxetine has not been studied in children younger than 18 years of age.

You should know that your mental health may change in unexpected ways when you take vortioxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking vortioxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vortioxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

WHY is this medicine prescribed?

Vortioxetine is used to treat depression in adults. Vortioxetine is in a class of medications called serotonin modulators. It works mainly by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vortioxetine comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take vortioxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vortioxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may adjust your dose of vortioxetine depending on how well you respond to treatment and whether you experience side effects. Be sure to talk to your doctor about how you are feeling during your treatment with vortioxetine.

It may take 2 to 4 weeks or longer before you feel the full benefit of vortioxetine. Continue to take vortioxetine even if you feel well. Do not stop taking vortioxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking vortioxetine, you may experience withdrawal symptoms such as headache, mood changes, irritability, agitation, nausea, dizziness, burning, numbness, or tingling in the hands or feet, anxiety, confusion, sweating, shaking, frenzied or abnormally excited mood, ringing in the ears, tiredness, difficulty falling asleep or staying asleep. and seizures. Tell your doctor if you experience any of these symptoms while you are decreasing your dose of vortioxetine or soon after you stop taking vortioxetine.

What SPECIAL PRECAUTIONS should I follow?

Before taking vortioxetine,

• tell your doctor and pharmacist if you are allergic to vortioxetine, any other medications, or any of the ingredients in vortioxetine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate) or if you have stopped taking them within the past 2 weeks. Your doctor may tell you not to take vortioxetine. If you stop taking vortioxetine, you should wait at least 21 days before you start to take an MAO inhibitor.

• tell your doctor and pharmacist what other prescription and nonprescription medications, and vitamins, nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amphetamines such as amphetamine (in Adderall, in Mydayis), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants ('mood elevators') such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine; bupropion (Aplenzin, Contrave, Forfivo, Wellbutrin, Zyban); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; carbamazepine (Carbatrol, Equetro, Tegretol, others); clopidogrel (Plavix); diuretics ('water pills'); fentanyl (Actiq, Duragesic, Fentora, Subsys); heparin; lithium (Lithobid); medications for mental illness; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); phenytoin (Dilantin, Phenytek); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane); other selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Pristiq), and venlafaxine (Effexor); and tramadol (Conzip, Qdola, Ulltram, in Ultracet). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan.

• tell your doctor if you have a low level of sodium in your blood, if you drink or have ever drunk large amounts of alcohol, and if you have or have ever had seizures, glaucoma (increased pressure in the eye that may cause loss of sight), or bleeding problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking vortioxetine, call your doctor. Vortioxetine may cause problems in newborns following delivery if it is taken during the last few months of pregnancy.

• you should know that vortioxetine may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking vortioxetine.

• you should know that vortioxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Vortioxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• gas
• dry mouth
• dizziness
• unusual dreams
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• rash
• hives
• itching
• swelling of the eyes, face, lips, tongue, or throat
• hoarseness
• difficulty breathing or swallowing
• unusual bruising or bleeding
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• nosebleed
• headache
• difficulty concentrating
• memory problems
• confusion
• weakness
• unsteadiness
• hallucinations
• fainting
• seizures
• coma (loss of consciousness for a period of time)

Vortioxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• dizziness
• diarrhea
• stomach pain
• itching
• sleepiness
• flushing
• agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• seizures

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking vortioxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.