Vortioxetine

Medications such as vortioxetine may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.

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 do so.

The doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

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.

Vortioxetine comes as a tablet to take by mouth. Take with or without food once a day. Take vortioxetine at around the same time every day.

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 several 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.

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

Before taking vortioxetine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had..
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine. 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.
• some medications should not be taken with vortioxetine. Other medications may cause dosing changes or extra monitoring when taken with vortioxetine. Make sure you have discussed any medications you are currently taking or plan to take before starting vortioxetine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking vortioxetine, please get the advice of your doctor or pharmacists.
• the following nonprescription or herbal products may interact with vortioxetine: St. John's wort; tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking vortioxetine. Do not start any of these medications while taking vortioxetine without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have or have ever had seizures, 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.
• 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.
• talk to your doctor about the safe use of alcoholic beverages during your treatment with vortioxetine. Alcohol can make the side effects of vortioxetine worse.
• 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.

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

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.

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

• nausea, vomiting
• constipation
• nusual 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, itching, hives; 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
• headache; unsteadiness; problems with thinking, concentration, or memory
• chest pain, shortness of breath, dizziness, 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

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

Keep all appointments with your doctor.

Before having any laboratory test, 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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