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Paroxetine controlled-release tablets

Pronunciation

Generic Name: paroxetine (par-OX-e-teen)
Brand Name: Paxil CR

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using paroxetine controlled-release tablets outweigh the risks.

Families and caregivers must closely watch patients who take paroxetine controlled-release tablets. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Paroxetine controlled-release tablets is not approved for use in children. Talk with the doctor.


Paroxetine controlled-release tablets is used for:

Treating depression, panic disorder, or social anxiety disorder. It may also be used to treat premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. It may also be used for other conditions as determined by your doctor.

Paroxetine controlled-release tablets is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Do NOT use paroxetine controlled-release tablets if:

  • you are allergic to any ingredient in paroxetine controlled-release tablets
  • you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
  • you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, fluoxetine), sibutramine, thioridazine, or tryptophan

Contact your doctor or health care provider right away if any of these apply to you.

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Before using paroxetine controlled-release tablets:

Some medical conditions may interact with paroxetine controlled-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
  • if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, narrow-angle glaucoma, diabetes, or metabolism problems
  • if you are dehydrated, have low blood sodium levels, or drink alcohol
  • if you will be having electroconvulsive therapy (ECT)
  • if you are taking a medicine that contains methylene blue

Some MEDICINES MAY INTERACT with paroxetine controlled-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anorexiants (eg, phentermine), cimetidine, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine), another SSRI (eg, fluoxetine), St. John's wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
  • Antiarrhythmics (eg, flecainide, propafenone, quinidine), astemizole, phenothiazines (eg, chlorpromazine, thioridazine), or terfenadine because severe heart problems, including irregular heartbeat, may occur
  • Cyproheptadine, HIV protease inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may decrease paroxetine controlled-release tablets's effectiveness
  • Aripiprazole, atomoxetine, clozapine, fluoxetine, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by paroxetine controlled-release tablets
  • Digoxin or tamoxifen because their effectiveness may be decreased by paroxetine controlled-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if paroxetine controlled-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use paroxetine controlled-release tablets:

Use paroxetine controlled-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Paroxetine controlled-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get paroxetine controlled-release tablets refilled.
  • Take paroxetine controlled-release tablets by mouth with or without food.
  • Swallow paroxetine controlled-release tablets whole. Do not break, crush, or chew before swallowing.
  • Taking paroxetine controlled-release tablets at the same time each day will help you remember to take it.
  • Continue to take paroxetine controlled-release tablets even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking paroxetine controlled-release tablets without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start paroxetine controlled-release tablets and whenever a change in dose is made.
  • If you miss a dose of paroxetine controlled-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use paroxetine controlled-release tablets.

Important safety information:

  • Paroxetine controlled-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use paroxetine controlled-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using paroxetine controlled-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not drink alcohol while you are taking paroxetine controlled-release tablets.
  • Several weeks may pass before your symptoms get better. Do NOT take more than the recommended dose, change your dose, or use paroxetine controlled-release tablets for longer than prescribed without checking with your doctor.
  • Children, teenagers, and young adults who take paroxetine controlled-release tablets may be at increased risk of suicidal thoughts or actions. Closely watch all patients who take paroxetine controlled-release tablets. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • If your doctor tells you to stop taking paroxetine controlled-release tablets, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking paroxetine controlled-release tablets.
  • Paroxetine controlled-release tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by paroxetine controlled-release tablets. Your risk may be greater if you take paroxetine controlled-release tablets with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by paroxetine controlled-release tablets. Your risk may be greater if paroxetine controlled-release tablets is used with certain other medicines called antipsychotics (eg, aripiprazole, risperidone). Symptoms may be similar to serotonin syndrome and may include fever, rigid muscles, blood pressure changes, and mental changes. Contact your doctor at once if you have any of these symptoms.
  • Paroxetine controlled-release tablets may affect fertility in some men. Discuss any questions or concerns with your doctor.
  • Use paroxetine controlled-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Caution is advised when using paroxetine controlled-release tablets in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
  • Paroxetine controlled-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Paroxetine controlled-release tablets may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take paroxetine controlled-release tablets.
  • PREGNANCY and BREAST-FEEDING: Paroxetine controlled-release tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking paroxetine controlled-release tablets while you are pregnant. Paroxetine controlled-release tablets is found in breast milk. If you are or will be breast-feeding while you take paroxetine controlled-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of paroxetine controlled-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; back pain; blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; gas; increased sweating; increased urination; loss of appetite; nausea; nervousness; numbness or tingling of the skin; sinus inflammation; stomach pain or upset; trouble sleeping; weakness; yawning.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory loss; new or worsening mental or mood changes (eg,agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still); persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache or dizziness; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bone pain or unexplained swelling, tenderness, or bruising; unusual bruising or bleeding; unusual weakness; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; dilated pupils; fainting; fast, slow, or irregular heartbeat; inability to urinate; seizures; severe muscle pain; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor; yellowing of the eyes or skin.

Proper storage of paroxetine controlled-release tablets:

Store paroxetine controlled-release tablets at or below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep paroxetine controlled-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about paroxetine controlled-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Paroxetine controlled-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take paroxetine controlled-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about paroxetine controlled-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to paroxetine controlled-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using paroxetine controlled-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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