Medication Guide

Paroxetine

(pa-ROX-a-teen)

Tablets, USP

Read the Medication Guide that comes with paroxetine tablets 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 and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Paroxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed .
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Watch for these changes and call your healthcare provider right away if you notice:

• New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

• Pay particular attention to such changes when paroxetine is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, 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 or talking more than what is normal for you
other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.

Paroxetine may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

agitation, hallucinations, coma, or other changes in mental status
coordination problems or muscle twitching (overactive reflexes)
racing heartbeat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity

3. Visual problems

eye pain
changes in vision
swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

4. Severe allergic reactions:

trouble breathing
swelling of the face, tongue, eyes, or mouth
rash, itchy welts (hives), or blisters, alone or with fever or joint pain

5. Abnormal bleeding:

Paroxetine and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®*, Jantoven®*), a non-steroidal antiinflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

6. Seizures or convulsions

7. Manic episodes:

greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

headache
weakness or feeling unsteady
confusion, problems concentrating or thinking, or memory problems

Do not stop paroxetine without first talking to your healthcare provider. Stopping paroxetine too quickly may cause serious symptoms including:

anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion

What is paroxetine ?

Paroxetine is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Paroxetine is also used to treat:

Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)

Talk to your healthcare provider if you do not think that your condition is getting better with treatment using paroxetine.

Who should not take paroxetine tablets?

Do not take paroxetine tablets if you:

are allergic to paroxetine hydrochloride or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 2 weeks of stopping paroxetine tablets unless directed to do so by your physician.
Do not start paroxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take paroxetine tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

• high fever

• uncontrolled muscle spasms

• stiff muscles

• rapid changes in heart rate or blood pressure

• confusion

• loss of consciousness (pass out)

take MELLARIL®* (thioridazine). Do not take MELLARIL®* together with paroxetine tablets because this can cause serious heart rhythm problems or sudden death.
take the antipsychotic medicine pimozide (ORAP®*) because this can cause serious heart problems.

What should I tell my healthcare provider before taking paroxetine tablets? Ask if you are not sure.

Before starting paroxetine tablets, tell your healthcare provider if you:

are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that paroxetine tablets may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby's blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used paroxetine tablets during pregnancy.
are breastfeeding. Paroxetine passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking paroxetine.
are taking certain drugs such as:

• triptans used to treat migraine headache

• other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics

• drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John's wort

• certain drugs used to treat irregular heart beats

• certain drugs used to treat schizophrenia

• certain drugs used to treat HIV infection

• certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen

• certain drugs used to treat epilepsy

• atomoxetine

• cimetidine

• fentanyl

• metoprolol

• pimozide

• procyclidine

• tamoxifen

• have liver problems

• have kidney problems

• have heart problems

• have or had seizures or convulsions

• have bipolar disorder or mania

• have low sodium levels in your blood

• have a history of a stroke

• have high blood pressure

• have or had bleeding problems

• have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Paroxetine and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take paroxetine tablets with your other medicines. Do not start or stop any medicine while taking paroxetine tablets without talking to your healthcare provider first.

If you take paroxetine tablets, you should not take any other medicines that contain paroxetine hydrochloride.

How should I take paroxetine tablets?

Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you.
Paroxetine tablets may be taken with or without food.
If you miss a dose of paroxetine tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of paroxetine tablets at the same time.
If you take too much paroxetine tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
Do not stop taking paroxetine tablets suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking paroxetine tablets, your healthcare provider can tell you how to safely stop taking it.

What should I avoid while taking paroxetine?

Paroxetine can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how paroxetine affects you. Do not drink alcohol while using paroxetine.

What are possible side effects of paroxetine?

Paroxetine may cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about paroxetine?"

Common possible side effects in people who take paroxetine include:

nausea
sleepiness
weakness
dizziness
feeling anxious or trouble sleeping
sexual problems
sweating
shaking
not feeling hungry
dry mouth
constipation
infection
yawning

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of paroxetine. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or 1-800-332-1088.

How should I store paroxetine tablets?

Store paroxetine tablets at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Keep paroxetine tablets away from light.
Keep bottle of paroxetine tablets closed tightly.

Keep paroxetine tablets and all medicines out of the reach of children.

General information about paroxetine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use paroxetine tablets for a condition for which they were not prescribed. Do not give paroxetine tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about paroxetine. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine that is written for healthcare professionals.

Address medical inquiries to, Telephone: 1-877-993-8779 or MedicalAffairs@zydususa.com.

What are the ingredients in paroxetine tablets, USP?

Active ingredient: paroxetine hydrochloride, USP

Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.

* are the registered trademarks of their respective owners.

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

This product's package insert may have been updated. For current package insert, please visit www.zydususa.com