Brand Names: Focalin, Focalin XR

Generic Name: dexmethylphenidate (Pronunciation: dex METH il FEN i date)

• What is dexmethylphenidate (Focalin XR)?
• What are the possible side effects of dexmethylphenidate (Focalin XR)?
• What is the most important information I should know about dexmethylphenidate (Focalin XR)?
• What should I discuss with my healthcare provider before taking dexmethylphenidate (Focalin XR)?
• How should I take dexmethylphenidate (Focalin XR)?
• What happens if I miss a dose (Focalin XR)?
• What happens if I overdose (Focalin XR)?
• What should I avoid while taking dexmethylphenidate (Focalin XR)?
• What other drugs will affect dexmethylphenidate (Focalin XR)?
• Where can I get more information?

What is dexmethylphenidate (Focalin XR)?

Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves).

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Dexmethylphenidate may also be used for other purposes not listed in this medication guide.

Dexmethylphenidate 10 mg-TEV

round, white, imprinted with 93, 5277

Dexmethylphenidate 2.5 mg-TEV

round, blue, imprinted with 93, 5275

Dexmethylphenidate 5 mg-TEV

round, yellow, imprinted with 93, 5276

What are the possible side effects of dexmethylphenidate (Focalin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
• fast or uneven heart rate;
• blurred vision or other visual changes;
• unusual behavior, confusion; or
• twitching or tics.

Less serious side effects may include:

• sleep problems (insomnia);
• loss of appetite;
• upset stomach;
• feeling restless, anxious, or jittery;
• dry mouth, sore throat; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dexmethylphenidate (Focalin XR)?

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have severe depression or a history of mental illness, seizures or epilepsy, high blood pressure, a history of drug or alcohol addiction, congestive heart failure, or if you have recently had a heart attack.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.