PAROXETINE TABLETS, USP
(pa rox′ e teen hye″ droe klor′ ide)
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
What is the most important information I should know about paroxetine tablets?
Paroxetine tablets and other antidepressant medicines may cause serious side effects, including:
- Suicidal thoughts or actions:
- Paroxetine tablets 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 tablets are 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
tablets may be associated with these serious side effects:
- 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
- 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
- Abnormal bleeding: Paroxetine tablets 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 anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen) or aspirin.
- Seizures or convulsions
- 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
- Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
- Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
Do not stop paroxetine tablets without first talking to your healthcare provider.
Stopping paroxetine tablets 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 are paroxetine tablets?
Paroxetine tablets are 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 tablets are also used to treat:
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder (GAD)
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 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
- 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 breast-feeding. 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
- 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 tablets 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, including paroxetine hydrochloride
extended-release tablets and PEXEVA®* (paroxetine mesylate).
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
- If you take too much paroxetine, 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
What should I avoid while taking paroxetine tablets?
Paroxetine tablets 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 tablets affect you.
Do not drink alcohol while using paroxetine tablets.
What are possible side effects of paroxetine tablets?
Paroxetine tablets 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 tablets?”
Common possible side effects in people who take paroxetine tablets include:
- feeling anxious or trouble sleeping
- sexual problems
- not feeling hungry
- dry mouth
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 tablets. 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 it was 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 tablets. If you would like more information,
talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine tablets
that is written for healthcare professionals.
For more information about paroxetine tablets call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in paroxetine tablets?
Active ingredient: paroxetine hydrochloride
Inactive ingredients in tablets: dibasic calcium phosphate dihydrate, FD&C Blue No. 1 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide
*Brand names listed are trademarks of their respective owners and are not trademarks of Mylan Pharmaceuticals Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured in Australia by:
Alphapharm Pty Ltd
15 Garnet Street
Carole Park QLD 4300
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
UDL Laboratories, Inc.
Rockford, IL 61103