DESVENLAFAXINE - desvenlafaxine succinate tablet, extended release
Breckenridge Pharmaceutical, Inc
Desvenlafaxine Extended-Release Tablets
(des VEN la FAX een)
What is the most important information I should know about desvenlafaxine?
Desvenlafaxine can cause serious side effects, including:
How can I watch for and try to prevent suicidal thoughts and actions?
o 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.
o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
o 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 your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
|o thoughts about suicide or dying||o trouble sleeping (insomnia)|
|o attempts to commit suicide||onew or worse irritability|
|onew or worse depression||o acting aggressive, being angry, or violent|
|o new or worse anxiety||o acting on dangerous impulses|
|o feeling very agitated or restless||o an extreme increase in activity and talking (mania)|
|o panic attacks||o other unusual changes in behavior or mood|
What is desvenlafaxine?
Do not take desvenlafaxine if you:
Do not start taking an MAOI for at least 7 days after you stop treatment with desvenlafaxine.
Before taking desvenlafaxine tell your healthcare provider about all your medical conditions, including if you:
o Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with desvenlafaxine.
o If you become pregnant during treatment with desvenlafaxine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
• are breastfeeding or plan to breastfeed. Desvenlafaxine can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with desvenlafaxine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Desvenlafaxine and other medicines may affect each other causing possible serious side effects. Desvenlafaxine may affect the way other medicines work and other medicines may affect the way desvenlafaxine works.
Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take desvenlafaxine with your other medicines.
Do not start or stop any other medicines during treatment with desvenlafaxine without talking to your healthcare provider first. Stopping desvenlafaxine suddenly may cause you to have serious side effects. See, “What are the possible side effects of desvenlafaxine?”
Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.
How should I take desvenlafaxine?
What should I avoid while taking desvenlafaxine?
What are the possible side effects of desvenlafaxine?
Desvenlafaxine can cause serious side effects, including:
|o agitation||o seeing or hearing things that are not real (hallucinations)|
|o confusion||o coma|
|o fast heart beat||o changes in blood pressure|
|o dizziness||o sweating|
|o flushing||o high body temperature (hyperthermia)|
|o tremors, stiff muscles, or muscle twitching||o loss of coordination|
|o seizures||o nausea, vomiting, diarrhea|
|o dizziness||o nausea||o headache|
|o irritability and agitation||o problems sleeping||o diarrhea|
|o anxiety||o tiredness||o abnormal dreams|
|o sweating||o confusion||o changes in your mood|
|o seizures||o electric shock sensation (paresthesia)||o hypomania|
|o ringing in your ears (tinnitus)|
In severe or more sudden cases, signs and symptoms include:
The most common side effects of desvenlafaxine include:
|• decreased appetite||•anxiety|
|• sexual function problems|
These are not all the possible side effects of desvenlafaxine.
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 desvenlafaxine?
General Information about the safe and effective use of desvenlafaxine
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine that is written for healthcare professionals.
For more information call Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or go to www.bpirx.com.
What are the ingredients in desvenlafaxine extended-release tablets?
Active ingredient: desvenlafaxine
Inactive ingredients: For the 25 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide yellow, iron oxide red, iron oxide black, polyethylene glycol, talc, and titanium dioxide.
For the 50 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.
For the 100 mg tablet, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide black, iron oxide red, polyethylene glycol, talc, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037
Alembic Pharmaceuticals Limited(Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.