In the U.S.—

In Canada—

• Central nervous system stimulant

Methylphenidate (meth-il-FEN-i-date) belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention-deficit hyperactivity disorder (ADHD), narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep), and other conditions as determined by the doctor.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long or are easily distracted, and are impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new written prescription must be obtained from your doctor each time you or your child needs this medicine.

Methylphenidate is available in the following dosage forms:

Oral
• Tablets (U.S. and Canada)
• Extended-release tablets (U.S. and Canada)
• Extended-release capsules (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methylphenidate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to methylphenidate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether methylphenidate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with the doctor.

Children—Loss of appetite, trouble in sleeping, stomach pain, fast heartbeat, and weight loss may be especially likely to occur in children, who are usually more sensitive than adults to the effects of methylphenidate. Some children who used medicines like methylphenidate for a long time grew more slowly than expected. It is not known whether long-term use of methylphenidate causes slowed growth. The doctor should regularly measure the height and weight of children who are taking methylphenidate. Some doctors recommend stopping treatment with methylphenidate during times when the child is not under stress, such as on weekends.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of methylphenidate in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking methylphenidate, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills) or
• Bupropion (e.g., Wellbutrin, Zyban) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, hay fever or other allergies (including nose drops or sprays) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert)—Using these medicines with methylphenidate may cause severe nervousness, irritability, trouble in sleeping, or possibly irregular heartbeat or seizures

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking methylphenidate while you are taking or less than 2 weeks after taking an MAO inhibitor may cause sudden extremely high blood pressure and severe convulsions; at least 14 days should be allowed between stopping treatment with an MAO inhibitor and starting treatment with methylphenidate

• Pimozide (e.g., Orap)—Pimozide is not used to treat tics that are caused by medicines. Before tics are treated with pimozide, the doctor should find out if the tics are caused by methylphenidate

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on methylphenidate may be more likely to develop

• Epilepsy or other seizure disorders—The risk of having convulsions (seizures) may be increased

• Gilles de la Tourette's disorder (or family history of) or
• Glaucoma or
• High blood pressure or
• Psychosis or
• Severe anxiety, agitation, tension, or depression or
• Tics (other than Tourette's disorder)—Methylphenidate may make the condition worse

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Take this medicine with or after a meal or a snack.

To help prevent trouble in sleeping, take the last dose of the short-acting tablets before 6 p.m., unless otherwise directed by your doctor.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor.

If you are taking the long-acting form of this medicine:

• These tablets or capsules are to be swallowed whole. Do not break, open, crush, or chew before swallowing.
• If you are taking Concerta brand of methylphenidate extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is just the empty shell that is left after the medicine has been absorbed into your body.

Dosing—

The dose of methylphenidate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methylphenidate. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using methylphenidate.

• For attention-deficit hyperactivity disorder:
  • For short-acting oral dosage form (tablets):
    • Adults and teenagers—5 to 20 milligrams (mg) two or three times a day, taken with or after meals.
    • Children 6 years of age and older—To start, 5 mg two times a day, taken with or after breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose is reached.
    • Children up to 6 years of age—The dose must be determined by the doctor.
  • For long-acting oral dosage form (extended-release tablets):
    • Adults, teenagers, and children—The dose must be determined by the doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Adults, teenagers, and children over 6 years of age—The recommended starting dose is 20 mg a day, taken in the morning before breakfast. Your doctor may increase the dose once a week as needed up to 60 mg a day.
    • Children up to 6 years of age—The dose must be determined by the doctor.
• For narcolepsy:
  • For short-acting oral dosage form (tablets):
    • Adults and teenagers—5 to 20 mg two or three times a day, taken with or after meals.
  • For long-acting oral dosage form (extended-release tablets):
    • Adults and teenagers—The dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. Then take any remaining doses for that day at regularly spaced intervals. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits and make sure that this medicine does not cause unwanted effects, such as high blood pressure.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

If you take this medicine in large doses and/or for a long time, do not stop taking it without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before you stop completely. This is to help reduce unwanted effects.

If you think you may have become mentally or physically dependent on this medicine, check with your doctor. Some signs of dependence on methylphenidate are:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the effects of the medicine.
• Withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after the medicine is stopped.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Fast heartbeat;  increased blood pressure  
  
  

• Less common
  • Chest pain;  fever;  joint pain;  skin rash or hives;  uncontrolled movements of the body 
  
  

• Rare
  • Black, tarry stools;  blood in urine or stools;  blurred vision or other changes in vision ;  convulsions (seizures);  muscle cramps;  pinpoint red spots on skin;  uncontrolled vocal outbursts and/or tics (uncontrolled and repeated body movements);  unusual bleeding or bruising 
  
  

• With long-term use or at high doses
  • Changes in mood;  confusion;  delusions (false beliefs);  depersonalization (feeling that self or surroundings are not real);  hallucinations (seeing, hearing, or feeling things that are not there);  weight loss 
  
  

• Symptoms of overdose
  • Agitation;  confusion (severe);  convulsions (seizures);  dryness of mouth or mucous membranes;  false sense of well-being;  fast, pounding, or irregular heartbeat;  fever;  hallucinations (seeing, hearing, or feeling things that are not there);  headache (severe);  increased blood pressure;  increased sweating;  large pupils;  muscle twitching;  overactive reflexes;  trembling or shaking;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Loss of appetite;  nervousness;  trouble in sleeping 
  
  

• Less common
  • Dizziness;  drowsiness;  headache;  nausea;  stomach pain 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Mental depression (severe);  unusual behavior;  unusual tiredness or weakness  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:

• Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.