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|Paroxetine Controlled-Release Tablets

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Paroxetine Controlled-Release Tablets

Generic Name: Paroxetine Controlled-Release Tablets (pa-ROX-e-teen)
Brand Name: Paxil CR

The risk of suicidal thinking and behavior was increased by antidepressants in short-term studies in children and adolescents with certain psychiatric disorders. Anyone considering the use of Paroxetine Controlled-Release Tablets or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation and communication with the prescriber. Results from several studies in children and adolescents with certain psychiatric disorders have revealed a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with antidepressants.

Paroxetine Controlled-Release Tablets is used for:

Treating social anxiety disorder (social phobia), depression, and panic disorders with or without the fear of being in open or public places. It is also used to treat premenstrual dysphoric disorder (PMDD).

Paroxetine Controlled-Release Tablets is a selective serotonin reuptake inhibitor. It is thought to work by increasing the activity of one of the brain chemicals (serotonin), which helps improve mood.

Do NOT use Paroxetine Controlled-Release Tablets if:

you are allergic to any ingredient in Paroxetine Controlled-Release Tablets
you are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
you are currently taking another paroxetine-containing product, anorexiants (eg, phentermine), astemizole, dextromethorphan, fenfluramine and its derivatives, l-tryptophan, phenothiazines (eg, thioridazine), selegiline, sibutramine, St. John"s wort, terfenadine, or tramadol

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

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 have suicidal tendencies or have attempted suicide; stomach bleeding; seizures; or mania

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:

Cyproheptadine or risperidone because the effectiveness of Paroxetine Controlled-Release Tablets may be decreased
Anorexiants (eg, phentermine), anticholinergics (eg, oxybutynin, scopolamine), atypical antipsychotics (eg, risperidone), beta-blockers (eg, metoprolol), buspirone, butyrophenones (eg, haloperidol), cimetidine, clonazepam, dextromethorphan, fenfluramine and its derivatives, H-1 antagonists (eg, diphenhydramine), l-tryptophan, linezolid, lithium, MAO inhibitors (eg, phenelzine), metoclopramide, nefazodone, selegiline, sibutramine, St. John"s wort, sumatriptan, tramadol, trazodone, zolpidem because side effects such as serotonin syndrome and central nervous system toxicity may occur
Anticoagulants (eg, warfarin), aripiprazole, astemizole, beta-blockers (eg, metoprolol), butyrophenones (eg, haloperidol), clozapine, dextromethorphan, galantamine, l-tryptophan, molindone, NSAIDs (eg, ibuprofen), norepinephrine reuptake inhibitors (eg, atomoxetine), phenothiazines (eg, thioridazine), pimozide, propafenone, risperidone, selegiline, St. John"s wort, terfenadine, tramadol, trazodone, tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of these medicines may be increased
Sumatriptan because the effectiveness of Paroxetine Controlled-Release Tablets may be decreased
Barbiturate anesthetics (eg, thiopental) for anesthesia when used with electroconvulsive therapy (ECT) because spontaneous seizures may occur

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 additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Paroxetine Controlled-Release Tablets refilled.
Paroxetine Controlled-Release Tablets may be taken with or without food.
Swallow Paroxetine Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
Symptoms usually improve within 1 to 4 weeks. Continue to take Paroxetine Controlled-Release Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Paroxetine Controlled-Release Tablets and you are taking it in the morning, take it during the afternoon if you remember. If you do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and you are taking 1 dose daily at bedtime and do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, contact your doctor or pharmacist.

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, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Paroxetine Controlled-Release Tablets. Using Paroxetine Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Do not drink alcohol while taking Paroxetine Controlled-Release Tablets.
Do not stop taking Paroxetine Controlled-Release Tablets without checking with your doctor. Stopping Paroxetine Controlled-Release Tablets suddenly may cause certain side effects, such as dizziness, nausea, sweating, agitation; abnormal skin sensations, and abnormal dreams.
Antidepressants can increase suicidal thoughts and actions in some children and teenagers, and possibly adults. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
Additional monitoring of your condition is recommended at the start of treatment with Paroxetine Controlled-Release Tablets and whenever a change in dose is made. If you experience anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, impulsive feelings, severe restlessness, or worsening of depression, contact your doctor as soon as possible. These may be signs that your condition is worsening or that your treatment with Paroxetine Controlled-Release Tablets should be evaluated. If you are a parent or caregiver of a patient that is taking Paroxetine Controlled-Release Tablets, it is important for you to watch for these symptoms. Contact your doctor as soon as possible if any of these symptoms occur.
Paroxetine Controlled-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Paroxetine Controlled-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
LAB TESTS may be performed to monitor your progress. Be sure to keep all doctor and lab appointments
Paroxetine Controlled-Release Tablets is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: Paroxetine Controlled-Release Tablets may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Paroxetine Controlled-Release Tablets during pregnancy. Paroxetine Controlled-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while you are using Paroxetine Controlled-Release Tablets, check with your doctor or pharmacist to discuss the 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:

Blurred vision; abnormal ejaculation; constipation; decreased appetite; decreased sex drive; diarrhea; dizziness; drowsiness; dry mouth; female genital disorders; fatigue; impotence; lightheadedness; loss of appetite; nausea; nervousness; sweating; tremor; trouble sleeping; vomiting; weakness; yawning.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; increased heartbeat; mental or mood changes; painful, prolonged erection; seizures; thoughts of hurting yourself; unusual bleeding or bruising; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include: confusion; dilated pupils; fast heartbeat; loss of consciousness; nausea; severe drowsiness; vomiting.

Proper storage of Paroxetine Controlled-Release Tablets:

Store Paroxetine Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep 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.

This information is a summary only. It does not contain all information about Paroxetine Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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