PEXEVA- paroxetine mesylate tablet, film coated 
Sebela Pharmaceuticals Inc.

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MEDICATION GUIDE

PEXEVA® (pex-EE-va)
(paroxetine mesylate)
tablets

What is the most important information I should know about PEXEVA?
PEXEVA can cause serious side effects, including:

  • Increased risk of suicidal thoughts or actions.PEXEVA and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. PEXEVA is not for use in children.
    How can I watch for or try to prevent suicidal thoughts and actions?
o Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions.
o Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.
o 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 or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
o attempts to commit suicide                                                                  o acting on dangerous impulses
o acting aggressive or violent                                                                  o thoughts about suicide or dying
o new or worse depression                                                                      o new or worse anxiety or panic attacks
o feeling agitated, restless, angry, or irritable                                           o trouble sleeping
o an increase in activity and talking more than what is normal for you        o other unusual changes in behavior or mood

What is PEXEVA?

PEXEVA is a prescription medicine used in adults to treat:

  • A certain type of depression called Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder (PD)
  • Generalized Anxiety Disorder (GAD)

Do not take PEXEVA if you:

  • take a monoamine oxidase inhibitor (MAOI)
  • have stopped taking an MAOI in the last 14 days
  • are being treated with the antibiotic linezolid or intravenous methylene blue
  • are taking thioridazine
  • are taking pimozide
  • are allergic to paroxetine or any of the ingredients in PEXEVA. See the end of this Medication Guide for a complete list of ingredients in PEXEVA.
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with PEXEVA.

Before taking PEXEVA, tell your healthcare provider about all your medical conditions, including if you:

  • have heart problems
  • have or had bleeding problems
  • have, or have a family history of bipolar disorder, mania or hypomania
  • have or had seizures or convulsions
  • have glaucoma (high pressure in the eye)
  • have low sodium levels in your blood
  • have bone problems
  • have kidney or liver problems
  • are pregnant or plan to become pregnant. PEXEVA may harm your unborn baby. 
o Taking PEXEVA during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.
o Taking PEXEVA during your third trimester of pregnancy may cause your baby to have breathing, temperature, and feeding problems, low muscle tone (floppy baby syndrome), and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take PEXEVA during pregnancy.
o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with PEXEVA.
o There is a pregnancy registry for females who are exposed to PEXEVA during pregnancy. The purpose of the registry is to collect information about the health of females exposed to PEVEXA and their baby. If you become pregnant during treatment with PEVEXA talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
  • are breastfeeding or plan to breastfeed. PEXEVA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with PEXEVA.

Tell your healthcare provider about all the medicines you take,including prescription and over-the -counter medicines, vitamins, and herbal supplements.

PEXEVA and some other medicines may affect each other causing possible side effects. PEXEVA may affect the way other medicines work and other medicines may affect the way PEXEVA works.

Especially tell your healthcare provider if you take:

  • medicines used to treat migraine headaches called triptans
  • tricyclic antidepressants
  • lithium
  • tramadol, fentanyl, meperidine, methadone, or other opioids
  • tryptophan
  • buspirone
  • amphetamines
  • St John’s Wort
  • medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or warfarin
  • diuretics
  • tamoxifen

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take PEXEVA with your other medicines.

Do not start or stop any other medicines during treatment with PEXEVA without talking to your healthcare provider first.  Stopping PEXEVA suddenly may cause you to have serious side effects. See, “What are the possible side effects of PEXEVA?”

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

How should I take PEXEVA?

  • Take PEXEVA exactly as your healthcare provider tell you to. Your healthcare provider may need to change the dose of PEXEVA until it is the right dose for you.
  • Take PEXEVA 1 time each day in the morning
  • PEXEVA may be taken with or without food.
  • If you take too much PEXEVA, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of PEXEVA?

PEXEVA can cause serious side effects, including:

• See, “What is the most important information I should know about PEXEVA?”
• Serotonin syndrome.A potentially life-threatening problem called serotonin syndrome can happen when you take PEXEVA with certain other medicines. See, “Who should not take PEXEVA?” Call your healthcare provider or go to the nearest hospital emergency room right awayif you have any of the following signs and symptoms of serotonin syndrome:
  o Agitation                                                                                o sweating
  o seeing or hearing things that are not real                                  o flushing
   (hallucinations)                                                                      o high body temperature (hyperthermia)
  o confusion                                                                               o loss of coordination
  o coma                                                                                     o shaking (tremors), stiff muscles, or muscle                                   

  o fast heart beat                                                                           twitching
  o changes in blood pressure                                                       o seizures

  o dizziness                                                                                o nausea, vomiting, diarrhea

• Medicine interactions.Taking PEXEVA with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.

• Abnormal bleeding.Taking PEXEVA with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider about any unusual bleeding or bruising.

• Manic episodes.Manic episodes may happen in people with bipolar disorder who take PEXEVA. Symptoms may include:
  o greatly increased energy                o severe problems sleeping
  o racing thoughts                             o reckless behavior
  o unusually grand ideas                    o excessive happiness or irritability
  o talking more or faster than usual

• Discontinuation syndrome.Suddenly stopping PEXEVA may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
  o nausea                                  o electric shock feeling (paresthesia)      o tiredness
  o sweating                               o tremor                                               o problems sleeping
  o changes in your mood            o anxiety                                              o hypomania
  o irritability and agitation          o confusion                                           o ringing in your ears (tinnitus)
  o dizziness                               o headache                                           o seizures

• Seizures (convulsions).

• Eye problems (angle-closure glaucoma).PEXEVA may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

• Low sodium levels in your blood (hyponatremia).Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with PEXEVA. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:
  o headache
  o difficulty concentrating
  o memory changes
  o confusion
  o weakness and unsteadiness on your feet which can lead to falls
In more severe or more sudden cases, signs and symptoms include:
  o seeing or hearing things that are not real (hallucinations)
  o fainting
  o seizures
  o coma
  o stopping breathing (respiratory arrest)

• Bone fractures.

  • Sexual Problems (Dysfunction).

Taking selective serotonin reuptake inhibitors (SSRIs), including PEXEVA, may cause sexual problems.

Symptoms in males may include:

   • Delayed ejaculation or inability to have an ejaculation

   • Decreased sex drive

   • Delayed orgasm or inability to have an orgasm

Symptoms in females may include:

   • Decreased sex drive
   • Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with PEXEVA. There may be treatments your healthcare provider can suggest.

The most common side effects of PEXEVA include:
  • weakness (asthenia)                                                                  • sweating
  • nausea                                                                                      • decreased appetite
  • dry mouth                                                                                 • constipation
  • sleepiness                                                                                 • dizziness
  • problems sleeping                                                                      • shaking (tremor)
  • nervousness                                                                              • male and female sexual function problems
  • infection


These are not all the possible side effects of PEXEVA.
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 PEXEVA?

  • Store PEXEVA at room temperature between 59°F to 86°F (15°C to 30°C).
  • Keep PEXEVA bottle closed tightly.
  • Keep PEXEVA and all medicines out of reach of children.

General information about the safe and effective use of PEXEVA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take PEXEVA for a condition for which it was not prescribed. Do not give PEXEVA to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about PEXEVA that is written for healthcare professionals.

What are the ingredients in PEXEVA?


Active ingredient:paroxetine mesylate


Inactive ingredients:dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, and iron oxide(s).


Distributed by:
Sebela Pharmaceuticals Inc., 645 Hembree Parkway, Suite I, Roswell, GA 30076


For more information about PEXEVA call (1-844-732-3521) or go to www.PEXEVA.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                                Revised 08/2023

Revised: 8/2023
Document Id: 04b2262f-adec-c53b-e063-6294a90a3610
Set id: 50fe88bd-f0dd-5fad-e054-00144ff8d46c
Version: 10
Effective Time: 20230831
Sebela Pharmaceuticals Inc.