Vortioxetine Oral tablet

Vortioxetine (vor tee OX e teen) treats depression. It increases the amount of serotonin in the brain, a substance that helps regulate mood.

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Nausea
• Vomiting

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

They need to know if you have any of these conditions:

• Bipolar disorder or a family history of bipolar disorder
• Bleeding disorder
• Glaucoma
• Liver disease
• Low levels of sodium in the blood
• Seizures
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• Take medications that treat or prevent blood clots
• Taken an MAOI such as Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to vortioxetine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• Carbamazepine
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Diuretics
• Fentanyl
• Furazolidone
• Isoniazid
• Lithium
• Medications that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Phenytoin
• Procarbazine
• Quinidine
• Rasagiline
• Rifampin
• Safinamide
• Supplements like St. John's Wort, kava kava, valerian
• Tramadol
• Tryptophan

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.