Methylphenidate (By mouth)

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

Introduction

Methylphenidate (meth-il-FEN-i-date)

Treats attention deficit hyperactivity disorder (ADHD) and narcolepsy (sudden attacks of uncontrollable sleepiness). This medicine is a stimulant.

Brand Name(s)

Concerta, Methylin, Ritalin LA, Metadate CD, Ritalin, Ritalin-SR, Metadate ER

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you or your child have had an allergic reaction to methylphenidate. You should not use this medicine if you have glaucoma, or if you are anxious, tense, or agitated most of the time. You should not use this medicine if you have muscle tics or a history of Tourette's syndrome (a condition that causes you to have muscle twitches or to make sounds you are not able to control). Do not use this medicine if you have taken a medicine for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days. This medicine should not be given to a child younger than 6 years of age unless your doctor tells you otherwise.

How to Use This Medicine

Long Acting Capsule, Liquid, Tablet, Chewable Tablet, Long Acting Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• You may take this medicine with or without food.
• It is best to take the immediate-release tablet 30 to 45 minutes before meals. If you or your child have problems falling asleep, take the last dose of the day before 6 p.m.
• The extended-release form of this medicine is taken once a day, usually just before the morning meal. Swallow the capsule or tablet whole with water or other liquids. Do not break, chew, or crush it.
• If you or your child cannot swallow the extended-release capsule whole, carefully open the capsule and sprinkle the medicine on one tablespoonful of applesauce. Swallow this mixture right away and drink some water. Do not save the mixture for a later time.
• Tell your doctor if you or your child cannot swallow the extended-release tablet whole. A different form of the medicine may be needed.
• While taking the extended-release form of this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• This medicine is part of an ADHD treatment program that may also include counseling or special education. Carefully follow your doctor's instructions about all treatment measures.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

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
• Agitation, confusion, increased sweating, muscle or joint pain, or fever.
• Chest pain or shortness of breath.
• Convulsions or tremors.
• Fast, slow, pounding, or uneven heartbeat.
• Lightheadedness, dizziness, drowsiness, or fainting.
• Mood and mental changes, or unusual behavior.
• Seeing, hearing, or feeling things that are not there.
• Trouble seeing or blurred vision.
• Uncontrollable muscle movements or twitching.

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

• Dry mouth.
• Feeling anxious, irritable, restless, or nervous.
• Headache.
• Nausea, vomiting, loss of appetite, or stomach pain.
• Runny or stuffy nose, cough, or sore throat.
• Trouble sleeping.
• Weight loss.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you or your child are also using antacids, blood pressure medicine, a blood thinner (such as warfarin, Coumadin®), cold or allergy medicines, haloperidol (Haldol®), phenylbutazone, medicine for depression (such as amitriptyline, clomipramine, desipramine, imipramine, trazodone, Anafranil®, Celexa®, Effexor®, Luvox®, Norpramin®, Paxil®, Prozac®, Serzone®, Tofranil®, Vivactil®, or Zoloft®), or medicine for seizures (such as phenobarbital, phenytoin, primidone, Dilantin®, or Mysoline®).

Warnings While Using This Medicine

• Make sure your doctor knows if you or your child are pregnant, planning to become pregnant, or breastfeeding, or if you or your child have epilepsy, eye or vision problems, or a history of seizures, thyroid problems, stomach or bowel problems, heart attack, heart disease, high blood pressure, heart rhythm problems, stroke, depression or mental illness (such as bipolar disorder, mania, or psychosis), or drug or alcohol problems. Also tell your doctor if you or anyone in your family has tried to commit suicide or talked about suicide.
• This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while using this medicine.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
• Check with your doctor right away if you or your child experience blurred vision or changes in vision. This could be a sign of high blood pressure.
• This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Your doctor will need to check your or your child's blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine.