Focalin XR

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

Focalin XR may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes 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 access it. Selling or giving away this medicine is against the law.

Focalin XR is usually taken twice a 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 regularly. 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.

Stimulants can lead to stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

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

Contact your doctor immediately if you experience: signs of heart problems—chest pain, feeling light-headed, or short of breath; or signs of psychosis—paranoia, aggression, new issues with thoughts or behavior, or seeing or hearing things that are not real.

Focalin XR may be habit-forming. Inform your doctor if you have a history of drug or alcohol addiction. Store the medication where others cannot access it.

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.

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 right away if you have:

• signs of heart problems--chest pain, trouble breathing, feeling faint;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new thoughts or behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or changes in skin color (pale, red, or blue appearance) in your fingers or toes; or
• painful erection of the penis that lasts 4 hours or longer.

Seek medical attention immediately 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.

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much Focalin XR could be life-threatening.

Signs of an overdose may include dry mouth, vomiting, restlessness, shaking, muscle twitches, confusion, seeing or hearing things that are not there, enlarged pupils, muscle pain or weakness, fever, sweating, headache, a strong heartbeat in your neck or ears, fast or strong heartbeats, seizures (convulsions), or coma.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

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.