Pristiq®(desvenlafaxine)

PRISTIQ can cause serious side effects, including:• Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. PRISTIQ is not for use in children.• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.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 your healthcare provider right away if you have any of the following symptoms:• thoughts about suicide or dying• attempts to commit suicide• new or worse depression or 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

PRISTIQ is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD).PRISTIQ belongs to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

• are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in PRISTIQ. See the end of this leaflet for a complete list of ingredients in PRISTIQ.• take a monoamine oxidase inhibitor (MAOI)• have stopped taking an MAOI in the last 14 days• are being treated with the antibiotic linezolid or intravenous methylene blueDo not start taking an MAOI for at least 7 days after you stop treatment with PRISTIQ.

• have high blood pressure• have heart problems• have cerebrovascular problems or had a stroke• have or had bleeding problems• have, or have a family history of, bipolar disorder, mania or hypomania• have high cholesterol or high triglycerides• have or had depression, suicidal thoughts or behavior• have kidney or liver problems• have or had seizures or convulsions• have low sodium levels in your blood• are pregnant or plan to become pregnant• are breastfeeding or plan to breastfeed. PRISTIQ can pass into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Especially tell your healthcare provider if you take:• other MAOIs• medicines to treat migraine headaches (triptans)• tricyclic antidepressants• lithium• tramadol, fentanyl, meperidine, methadone, or other opioids• tryptophan, buspirone, amphetamines• St. John's Wort• medicines that can affect blood clotting (aspirin, NSAIDs, warfarin)• other SSRIs or SNRIs

• Take PRISTIQ exactly as your healthcare provider tells you to.• Take PRISTIQ 1 time a day at about the same time each day.• PRISTIQ may be taken with or without food.• Swallow PRISTIQ tablets whole with fluid. Do not divide, crush, chew, or dissolve PRISTIQ tablets.• When you take PRISTIQ, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.• If you take too much PRISTIQ, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

• Do not drive a car or operate heavy machinery until you know how PRISTIQ affects you.• You should not drink alcohol while taking PRISTIQ.

PRISTIQ can cause serious side effects, including:• Serotonin syndrome. A potentially life-threatening problem. Call your healthcare provider or go to the nearest emergency room if you have:◦ agitation, confusion, hallucinations◦ fast heartbeat, changes in blood pressure◦ dizziness, flushing, sweating◦ tremors, stiff muscles, muscle twitching◦ high body temperature (hyperthermia)◦ nausea, vomiting, diarrhea◦ seizures, coma• New or worsened high blood pressure (hypertension). Your healthcare provider should check your blood pressure before and during treatment.• Increased chance of bleeding or bruising. Taking PRISTIQ with aspirin, NSAIDs, or blood thinners may add to this risk.• Eye problems (angle closure glaucoma). Call your healthcare provider if you have changes in your vision or eye pain.• Discontinuation syndrome. Suddenly stopping PRISTIQ may cause serious side effects including dizziness, irritability, anxiety, sweating, tremor, nausea, problems sleeping, and seizures. Your healthcare provider may want to decrease your dose slowly.• Seizures (convulsions)• Low sodium levels in your blood (hyponatremia) - can cause headache, difficulty concentrating, confusion, weakness, falls, and in severe cases, seizures and coma• Lung problems - tell your healthcare provider if you have difficulty breathing, cough, or chest discomfort• Sexual problems (dysfunction) - may include delayed ejaculation, decreased sex drive, and problems with erection or orgasmThe most common side effects of PRISTIQ include:• nausea• problems sleeping (insomnia)• constipation• decreased appetite• dizziness• sweating• feeling sleepy• anxietyThese are not all the possible side effects of PRISTIQ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store PRISTIQ at room temperature between 68°F to 77°F (20°C to 25°C).• Keep PRISTIQ and all medicines out of the reach of children.

Active ingredient: desvenlafaxineInactive ingredients:• 25 mg tablet: hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides• 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• 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