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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PAROXETINE CONTROLLED-RELEASE - ORAL

(pair-OX-eh-teen)

COMMON BRAND NAME(S): Paxil CR

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES: Paroxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).

SSRIs work by helping to restore the balance of certain natural substances in the brain (neurotransmitters such as serotonin). Paroxetine may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease anxiety/unreasonable fears, persistent/troubling thoughts (obsessions), and unwanted urges that keep returning (compulsions). It may decrease the number and severity of panic attacks. Paroxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using paroxetine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. This medication may make you either sleepy or wakeful. Therefore, depending on how this medication affects you, your doctor may direct you to take the entire dose once daily in either the morning or evening. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

If you are taking paroxetine for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period.

It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without first consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as mood swings, headache, tiredness, sleep changes, "shock-like" feelings) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details and report any withdrawal reactions immediately.

You should see some improvement in 1 to 2 weeks. It may take several weeks before you feel the full benefit.

Tell your doctor if your condition does not improve or if it worsens.