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Paroxetine Tablets

 

MEDICATION GUIDE
Paroxetine (par·ox·e·tine) Extended-Release Tablets, USP

Read the Medication Guide that comes with Paroxetine before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about Paroxetine?

Paroxetine can cause serious side effects, including:

  • Increased risk of suicidal thoughts or actions. Antidepressant medicines may increase suicidal thoughts and actions in some children and young adults within the first few months of treatment or when the dose is changed. Paroxetine is not for use in people younger than 18 years of age.
    • How can I watch for and try to prevent suicidal thoughts and actions?
      • Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions.
      • 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.
      • 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.
      • 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:
      • attempts to commit suicide
      • acting on dangerous impulses
      • acting aggressive or violent
      • thoughts about suicide or dying
      • new or worse depression
      • new or worse anxiety or panic attacks
      • feeling agitated, restless, angry, or irritable
      • trouble sleeping
      • an increase in activity and talking more than what is normal for you
      • other unusual changes in behavior or mood

What is Paroxetine?

Paroxetine is a prescription medicine used in adults to treat:

  • A certain type of depression called Major Depressive Disorder (MDD)
  • Panic Disorder
  • Social Anxiety Disorder (SAD)
  • Premenstrual Dysphoric Disorder (PMDD)

Do not take Paroxetine 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 Paroxetine. See the end of this Medication Guide for a complete list of ingredients in Paroxetine.

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 Paroxetine.

Before taking Paroxetine, 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. Paroxetine may harm your unborn baby. Talk to your healthcare provider about the risks to your unborn baby if you take Paroxetine during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Paroxetine.
  • are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Paroxetine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Paroxetine and some other medicines may affect each other causing possible serious side effects. Paroxetine may affect the way other medicines work and other medicines may affect the way Paroxetine works.

Especially tell your healthcare provider if you take:

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

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 Paroxetine with your other medicines.

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

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 Paroxetine?

  • Take Paroxetine exactly as your healthcare provider tell you to. Your healthcare provider may need to change the dose of Paroxetine until it is the right dose for you.
  • Take Paroxetine 1 time each day in the morning.
  • Paroxetine may be taken with or without food.
  • Swallow Paroxetine tablets whole. Do not chew or crush Paroxetine tablets.
  • If you take too much Paroxetine, call your poison control center at 1-800-222-1222 or got to the nearest hospital emergency room right away.

What are possible side effects of Paroxetine?

Paroxetine can cause serious side effects, including:

  • See, “What is the most important information I should know about Paroxetine?
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Paroxetine with certain other medicines. See, “Who should not take Paroxetine?Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
    • agitation
    • sweating
    • seeing or hearing things that are not real (hallucinations)
    • flushing
    • confusion
    • high body temperature (hyperthermia)
    • coma
    • shaking (tremors), stiff muscles, or muscle twitching
    • fast heartbeat
    • loss of coordination
    • changes in blood pressure
    • seizures
    • dizziness
    • nausea, vomiting, diarrhea
  • Medicine interactions. Taking Paroxetine with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.
  • Abnormal bleeding. Taking Paroxetine 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 Paroxetine. Symptoms may include:
    • greatly increased energy
    • severe problems sleeping
    • racing thoughts
    • reckless behavior
    • unusually grand ideas
    • excessive happiness or irritability
    • talking more or faster than usual
  • Discontinuation syndrome. Suddenly stopping Paroxetine may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
    • nausea
    • electric shock feeling (paresthesia)
    • tiredness
    • sweating
    • tremor
    • problems sleeping
    • changes in your mood
    • anxiety
    • ringing in your ears (tinnitus)
    • irritability and agitation
    • confusion
    • seizures
    • dizziness
    • headache
  • Seizures (convulsions).
  • Eye problems (angle-closure glaucoma). Paroxetine may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • 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 Paroxetine. 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:
    • headache
    • confusion
    • difficulty concentrating
    • weakness and unsteadiness on your feet which can lead to falls
    • memory changes
  • In more severe or more sudden cases, signs and symptoms include:
    • seeing or hearing things that are not real (hallucinations)
    • fainting
    • seizures
    • coma
    • stopping breathing (respiratory arrest)
  • Bone fractures.

The most common side effects Paroxetine include:

  • male and female sexual function problems
  • dry mouth
  • blurred vision
  • problems sleeping
  • weakness (asthenia)
  • nausea
  • constipation
  • sleepiness
  • decreased appetite
  • sweating
  • diarrhea
  • tremor
  • dizziness

These are not all the possible side effects of Paroxetine.

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 Paroxetine?

Store Paroxetine at 20°C to 25ºC (68°F to 77°F) [see USP Controlled Room Temperature].

Keep Paroxetine and all medicines out of the reach of children.

General information about the safe and effective use of Paroxetine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take Paroxetine for a condition for which it was not prescribed. Do not give Paroxetine 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 Paroxetine that is written for healthcare professionals.

What are the ingredients in Paroxetine?

Active ingredient: paroxetine hydrochloride

Inactive ingredients in tablets: hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycols, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide, triethyl citrate. In addition, the 25 mg and 37.5 mg colorant contains FD&C Blue No. 2 aluminum lake. In addition, the 25 mg colorant also contains carmine.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

All registered trademarks in this document are the property of their respective owners.
For more information about Paroxetine call 1-844-834-0530.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

CIA76403E
Rev. 10/2019