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 dexmethylphenidate. Do not use this medicine if you have glaucoma, or if you are anxious, tense, or agitated most of the time. Do not use this medicine if you have muscle tics or a history of Tourette syndrome.

How to Use This Medicine:
Long Acting Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Extended-release capsule:
  
  • Take the capsule in the morning. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
  • Swallow the capsule whole. Do not crush, break, or chew it.
  • If you cannot swallow the capsule, carefully open it and sprinkle the beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store it. Do not crush or chew the beads.
• 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.
• 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 if you have used an MAO inhibitor (MAOI) within the past 14 days.
• Some foods and medicines can affect how dexmethylphenidate works. Tell your doctor if you are using any of the following:
  
  • a blood thinner (such as warfarin)
  • antacids or stomach acid reducers
  • blood pressure medicine
  • medicine to treat seizures (such as phenobarbital, phenytoin, primidone)
  • tricyclic antidepressants to treat depression (such as amitriptyline, clomipramine, desipramine, imipramine, nortriptyline)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eye or vision problems, heart disease, heart rhythm problems, high blood pressure, circulation problems, or a history of a heart attack or stroke. Tell your doctor if you or anyone in your family has a history of seizures, depression, bipolar disorder, suicide, mental illness, or drug or alcohol problems.
• This medicine may cause the following problems:
  
  • Sudden death in people who already have heart problems
  • Heart or blood vessel problems, including heart attack and stroke
  • Changes in behavior or unusual thoughts
  • Slow growth in children
  • Painful or prolonged erection of the penis
  • Blood circulation problem in the fingers or toes, such as Raynaud phenomenon
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy or have trouble seeing. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, or fainting
• Erection of the penis that is painful or lasts longer than 4 hours
• Extreme energy, mood or mental changes, confusion, agitation, restlessness, trouble sleeping, unusual thoughts or behavior
• Fast, slow, pounding, or uneven heartbeat
• Seeing, hearing, or feeling things that are not there
• Severe headache, trouble seeing, blurred vision
• Seizures
• Sores, coldness, numbness, or color changes on your fingers or toes
• Uncontrollable muscle movements or twitching

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

• Loss of appetite or weight loss
• Mild anxiety, restlessness, or nervousness
• Nausea, vomiting, upset stomach

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