When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tetrabenazine, or if you have liver disease, untreated depression, or suicidal thoughts or behavior.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you stop taking this medicine for more than 5 days, do not take another dose until you talk to your doctor.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine and an MAO inhibitor (MAOI) within 14 days of each other.
• Do not use this medicine if you are also using reserpine. Wait at least 20 days after stopping reserpine before starting tetrabenazine.
• Some foods and medicines can affect how tetrabenazine works. Tell your doctor if you are using any of the following:
  
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine to treat depression (including fluoxetine, paroxetine)
  • Medicine to treat an infection (including moxifloxacin)
  • Medicine to treat mental illness (including chlorpromazine, haloperidol, olanzapine, risperidone, thioridazine, ziprasidone)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart disease, heart rhythm problems (such as QT prolongation) a slow heartbeat, or had a recent heart attack.
• This medicine may cause new or worsening depression or changes in mood or behavior. Tell your doctor if you have a history of depression or suicidal thoughts.
• This medicine may cause the following problems:
  
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Changes in heart rhythm, such as QT prolongation
  • Tardive dyskinesia (a muscle disorder that could become permanent)
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, lightheadedness, or fainting
• Fever, sweating, confusion, uneven heartbeat, or muscle stiffness
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw)
• Problems with balance or walking, stiffness, shaking
• Trouble breathing, swallowing, or speaking
• Trouble sitting still, feeling restless, nervous, or irritable
• Unusual changes in mood or behavior, or thoughts of hurting yourself or others
• Worsening of depression, trouble sleeping, racing thoughts

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting
• Sleepiness, unusual drowsiness, or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088