PRISTIQ EXTENDED-RELEASE- desvenlafaxine succinate tablet, extended release 
Cardinal Health

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MEDICATION GUIDE
PRISTIQ® (pris-TEEK)
(desvenlafaxine)
Extended-Release Tablets

Read this Medication Guide before you start taking PRISTIQ and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Talk to your healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

Important Information about PRISTIQ® Extended-Release Tablets

Read the patient information that comes with PRISTIQ before you take PRISTIQ and each time you refill your prescription. There may be new information. If you have questions, ask your healthcare provider. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is PRISTIQ?

Who should not take PRISTIQ?

Do not take PRISTIQ if you:

What should I tell my healthcare provider before taking PRISTIQ?

Tell your healthcare provider about all your medical conditions, including if you:

Serotonin syndrome

Rare, but potentially life-threatening conditions called serotonin syndrome can happen when medicines such as PRISTIQ are taken with certain other medicines. Serotonin syndrome can cause serious changes in how your brain, muscles, heart and blood vessels, and digestive system work. Especially tell your healthcare provider if you take the following:

Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Before you take PRISTIQ with any of these medicines, talk to your healthcare provider about serotonin syndrome. See "What are the possible side effects of PRISTIQ?"

Do not take PRISTIQ with other medicines containing venlafaxine or desvenlafaxine.

How should I take PRISTIQ?

Switching from other antidepressants

Side effects from discontinuing antidepressant medication have occurred when patients switched from other antidepressants, including venlafaxine, to PRISTIQ. Your doctor may gradually reduce the dose of your initial antidepressant medication to help to reduce these side effects.

What should I avoid while taking PRISTIQ?

What are the possible side effects of PRISTIQ?

PRISTIQ can cause serious side effects, including:

  • restlessness
  • hallucinations (seeing and hearing things that are not real)
  • loss of coordination
  • fast heart beat
  • increased body temperature
  • muscle stiffness
  • increase in blood pressure
  • diarrhea
  • coma
  • nausea
  • vomiting
  • confusion

PRISTIQ may also cause other serious side effects, including:

  • dizziness
  • nausea
  • headache
  • irritability
  • sleeping problems (insomnia)
  • anxiety
  • abnormal dreams
  • tiredness
  • sweating
  • diarrhea

Common side effects with PRISTIQ include:

  • nausea
  • dizziness
  • insomnia
  • sweating
  • constipation
  • sleepiness
  • loss of appetite
  • anxiety
  • decreased sex drive
  • delayed orgasm and ejaculation

These are not all the possible side effects of PRISTIQ. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PRISTIQ?

General Information about the safe and effective use of PRISTIQ

Medicines are sometimes used for conditions that are not mentioned in Medication Guides. Do not use PRISTIQ for a condition for which it was not prescribed. Do not give PRISTIQ to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about PRISTIQ. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PRISTIQ that is written for healthcare professionals.

For more information, go to www.pristiq.com or call 1-888-PRISTIQ (774-7847).

What are the ingredients in PRISTIQ?

Active ingredient: desvenlafaxine

Inactive ingredients: For the 50 mg tablet, hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.

For the 100 mg tablet, hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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LAB-0539-5.0

February 2013

Revised: 12/2013
 
Cardinal Health