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XANAX® XR (alprazolam) extended-release tablets, CIV Information for Patients

MEDICATION GUIDE
XANAX XR (ZAN-aks XR)
(alprazolam) Tablets, C-IV
What is the most important information I should know about XANAX XR?
  • XANAX XR is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • XANAX XR can make you sleepy or dizzy, and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how XANAX XR affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX XR without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, XANAX XR may make your sleepiness or dizziness much worse.
  • Do not take more XANAX XR than prescribed.
What is XANAX XR?
  • XANAX XR is a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • XANAX XR is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep XANAX XR in a safe place to prevent misuse and abuse. Selling or giving away XANAX XR may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if XANAX XR is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking XANAX XR.
  • It is not known if XANAX XR is safe and effective in the treatment of panic disorder for use longer than 8 weeks.
Do not take XANAX XR if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in XANAX XR. See the end of this Medication Guide for a complete list of ingredients in XANAX XR.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take XANAX XR, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver or kidney problems
  • have lung disease or breathing problems
  • are pregnant or plan to become pregnant. XANAX XR may harm your unborn baby. You and your healthcare provider should decide if you should take XANAX XR while you are pregnant.
  • are breastfeeding or plan to breastfeed. XANAX XR passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take XANAX XR. You should not breastfeed while taking XANAX XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking XANAX XR with certain other medicines can cause side effects or affect how well XANAX XR or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take XANAX XR?
  • See "What is the most important information I should know about XANAX XR?"
  • Take XANAX XR exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much XANAX XR to take and when to take it.
  • If you take too much XANAX XR, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Swallow XANAX XR tablets whole. Do not crush, chew or break XANAX XR
What should I avoid while taking XANAX XR?
  • XANAX XR can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how XANAX XR affects you.
  • You should not drink alcohol while taking XANAX XR. Drinking alcohol can increase your chances of having serious side effects.
What are the possible side effects of XANAX XR?
XANAX XR may cause serious side effects, including:
  • See "What is the most important information I should know about XANAX XR?"
  • Abuse and dependence. Taking XANAX XR can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Withdrawal symptoms. You may have withdrawal symptoms if you stop taking XANAX XR suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping XANAX XR to avoid withdrawal symptoms.
  • Seizures. Stopping XANAX XR can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. XANAX XR may cause an increase in activity and talking (hypomania and mania) in people who have depression.

The most common side effects of XANAX XR include:
  • sedation
  • difficult or unclear ability to talk
  • problems with coordination
  • tiredness
  • drowsiness
  • depression
  • memory problems
These are not all the possible side effects of XANAX XR. 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 XANAX XR?
  • Store XANAX XR between 59°F to 86°F (15°C to 30°C)
  • Keep XANAX XR and all medicines out of the reach of children.
  • General information about the safe and effective use of XANAX XR.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use XANAX XR for a condition for which it was not prescribed.
  • Do not give XANAX XR 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 XANAX XR that is written for health professionals.
What are the ingredients in XANAX XR?
Active ingredient: alprazolam
Inactive ingredients: lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.
XANAX® XR is a registered trademark of Pharmacia & Upjohn Company LLC.
For more information, go to www.pfizer.com or call 1-800-438-1985.

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

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

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December 2016

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