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IMPORTANT SAFETY INFORMATION

Depression is a serious medical condition that in some people can lead to suicidal thoughts. As with any medication, there are benefits and risks. It is important to discuss these with your doctor.

Suicidal thoughts or behaviors and antidepressant drugs

Short-term studies have shown that antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. When deciding to use PEXEVA® (paroxetine mesylate) or any other antidepressant in these patients, people must balance the risk with the potential benefit to the patient. Short-term studies did not show an increased risk of suicidality with antidepressants in adults beyond age 24; the risk decreased in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be watched closely to see if their condition worsens, it they have suicidal thoughts, or if they exhibit any unusual changes in behavior. Families and caregivers need to understand that they should watch the patient closely and tell the doctor if they have any concerns. PEXEVA® (paroxetine mesylate) is not approved for use in pediatric patients.

Who should not take PEXEVA®?

It's important for you to know that antidepressant medicines may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. Please read the accompanying Medication Guide about Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions. PEXEVA® is not approved for use in children. PEXEVA® is not recommended for use in women who are pregnant or who plan to become pregnant. These women are warned that use of paroxetine during the first 3 months of pregnancy has been shown to increase the risk of severe health problems in the unborn baby. Some of these health problems affect the baby's heart. One recent study has shown that use of several types of SSRIs, including paroxetine, during the last 3 months of pregnancy may cause dangerous lung complications in newborns. For these reasons, women who are pregnant or who plan to become pregnant should discuss other treatment choices with their doctor. Women who are breastfeeding should also talk to their doctor before taking PEXEVA®.

What side effects may occur with PEXEVA®?

With PEXEVA®, side effects are usually mild to moderate. They may become less noticeable or go away completely over time. The most common side effects that have been reported with PEXEVA® include nausea, dry mouth, constipation, decreased appetite, infection, drowsiness, tremor, sweating, muscle weakness, trouble sleeping, abnormal ejaculation, impotence and other male genital disorders, and female genital disorders.

Can I take PEXEVA® with other medicines?

PEXEVA® should not be usued with monoamine oxidase inhibitors (MAOIs), thioridazine, or pimozide. Be sure to tell your doctor if you think you are taking one of these medications. As with other antidepressants, certain medicines must be taken with caution while taking PEXEVA®. These include medications known as triptans. It's important to tell you doctor about any medicines you are taking, including over-the-counter drugs.

Can I drink alcohol while on PEXEVA®

You should avoid drinking alcohol while on PEXEVA®.

Be sure to tell your doctorhow your are feeling.

If you have any questions about PEXEVA®, call your doctor. Be sure to let your doctor know if you notice any unusual changes while taking PEXEVA®. And never stop your medicine or change your dose before speaking with your doctor.

Please see Important Safety Information, including Black Boxed WARNING.

Please see accompanying full Prescribing Information including WARNINGS-Clinical Worsening and Suicide Risk; Usage in Pregnancy: Teratogenic and Nonteratogenic Effects.