MEDICATION GUIDE
PAROXETINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
(pa rox′ e teen hye″ droe klor′ ide)
12.5 mg, 25 mg and 37.5 mg
Read the Medication Guide that comes with paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets?
Paroxetine hydrochloride extended-release tablets and other antidepressant medicines may cause serious side effects, including:
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Suicidal thoughts or actions:
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Paroxetine hydrochloride extended-release 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 hydrochloride extended-release 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 hydrochloride extended-release tablets may be associated with these serious side effects:
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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
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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
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Abnormal bleeding: Paroxetine hydrochloride extended-release 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.
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Seizures or convulsions
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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
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Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
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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 hydrochloride extended-release tablets without first talking to your healthcare provider.
Stopping paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets?
Paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets are also used to treat:
- Major Depressive Disorder (MDD)
- Panic Disorder
- Social Anxiety Disorder
- Premenstrual Dysphoric Disorder
Talk to your healthcare provider if you do not think that your condition is getting better with treatment using paroxetine hydrochloride extended-release tablets.
Who should not take paroxetine hydrochloride extended-release tablets?
Do not take paroxetine hydrochloride extended-release tablets if you:
- are allergic to paroxetine hydrochloride or any of the ingredients in paroxetine hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine hydrochloride extended-release tablets.
- take a Monoamine Oxidase Inhibitor (MAOI), such as PARNATE®* (tranylcypromine), NARDIL®* (phenelzine) or the antibiotic ZYVOX®* (linezolid). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
- Do not take an MAOI within 2 weeks of stopping paroxetine hydrochloride extended-release tablets.
- Do not start paroxetine hydrochloride extended-release tablets if you stopped taking an MAOI in the last 2 weeks.
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People who take paroxetine hydrochloride extended-release 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)
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take MELLARIL®* (thioridazine). Do not take MELLARIL®* together with paroxetine hydrochloride extended-release tablets because this can cause serious heart rhythm problems or sudden death.
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take the antipsychotic medicine pimozide (ORAP®*) because this can cause serious heart problems.
What should I tell my healthcare provider before taking paroxetine hydrochloride extended-release tablets? Ask if you are not sure.
Before starting paroxetine hydrochloride extended-release tablets, tell your healthcare provider if you:
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are pregnant, may be pregnant or plan to become pregnant. There is a possibility that paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets during pregnancy.
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are breast-feeding. Paroxetine passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking paroxetine hydrochloride extended-release tablets.
- 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 hydrochloride extended-release 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 hydrochloride extended-release tablets with your other medicines. Do not start or stop any medicine while taking paroxetine hydrochloride extended-release tablets without talking to your healthcare provider first.
If you take paroxetine hydrochloride extended-release tablets, you should not take any other medicines that contain paroxetine hydrochloride, including paroxetine tablets and PEXEVA®* (paroxetine mesylate).
How should I take paroxetine hydrochloride extended-release tablets?
- Take paroxetine hydrochloride extended-release tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine hydrochloride extended-release tablets until it is the right dose for you.
- Paroxetine hydrochloride extended-release tablets may be taken with or without food.
- Paroxetine hydrochloride extended-release tablets should not be chewed or crushed and should be swallowed whole.
- If you miss a dose of paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets at the same time.
- 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 hydrochloride extended-release tablets suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking paroxetine hydrochloride extended-release tablets, your healthcare provider can tell you how to safely stop taking it.
What should I avoid while taking paroxetine hydrochloride extended-release tablets?
Paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets affect you. Do not drink alcohol while using paroxetine hydrochloride extended-release tablets.
What are possible side effects of paroxetine hydrochloride extended-release tablets?
Paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets?”
Common possible side effects in people who take paroxetine hydrochloride extended-release tablets include:
- nausea
- sleepiness
- dizziness
- feeling anxious or trouble sleeping
- sexual problems
- sweating
- shaking
- constipation
- yawning
- blurred vision
- diarrhea
- dry mouth
- decreased appetite
- weakness
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 hydrochloride extended-release 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 hydrochloride extended-release tablets?
- Store paroxetine hydrochloride extended-release tablets at 20° to 25 °C (68° to 77°F). [See USP Controlled Room Temperature.]
- Keep paroxetine hydrochloride extended-release tablets away from light.
- Keep bottle of paroxetine hydrochloride extended-release tablets closed tightly.
Keep paroxetine hydrochloride extended-release tablets and all medicines out of the reach of children.
General information about paroxetine hydrochloride extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use paroxetine hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine hydrochloride extended-release tablets that is written for healthcare professionals.
For more information about paroxetine hydrochloride extended-release tablets call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in paroxetine hydrochloride extended-release tablets?
Active ingredient: paroxetine hydrochloride
Inactive ingredients in tablets: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate. In addition, the 25 mg product contains the following coloring agents: D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and the 37.5 mg product contains D&C Red No. 30 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lecithin and sodium alginate.
In addition, paroxetine hydrochloride extended-release tablets may also contain imprinting ink consisting of either black pigment and natural resin or black iron oxide and propylene glycol.
*Brand names listed are trademarks of their respective owners and are not trademarks of Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
REVISED MAY 2011
PRXT:R13mpbmt/MG:PRXT:R1mpb/MG:PRXT:R1mt
Additional barcode label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Physicians Total Care, Inc.