Focalin XR is a stimulant that is used to treat attention deficit hyperactivity disorder (ADHD).

Focalin XR may also be used for purposes not listed in this medication guide.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Focalin XR may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; or signs of psychosis--paranoia, aggression, new thought or behavior problems, seeing or hearing things that are not real.

Focalin XR may be habit-forming. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Focalin XR may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Focalin XR is usually taken twice per day, at least 4 hours apart.

You may take Focalin XR with or without food. Take the regular tablet twice daily, at least 4 hours apart. Take the extended-release capsule once daily in the morning.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

You should not take Focalin XR if you are allergic to Focalin XR or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use Focalin XR if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Focalin XR could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• blood circulation problems in the hands or feet; or

• alcoholism or drug addiction.

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dexmethylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 6 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Focalin XR could be fatal.

Overdose symptoms may include dry mouth, vomiting, agitation, tremor, muscle twitches, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, seizure (convulsions), or coma.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Focalin XR may cause serious side effects. Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;

• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Focalin XR can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects of Focalin XR may include:

• loss of appetite;

• nausea, stomach pain; or

• fever.

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.

Tell your doctor about all your other medicines, especially:

• an antidepressant; or

• blood pressure medication.

This list is not complete. Other drugs may affect Focalin XR, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.