Concerta (methylphenidate) is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Concerta extended-release tablets are used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.
Concerta may also be used for purposes not listed in this medication guide.
Important information
You should not use Concerta if you have glaucoma, tics or Tourette"s syndrome, or severe anxiety, tension, or agitation.
Do not use Concerta if you have taken an MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Methylphenidate may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.
Using Concerta improperly can cause death or serious side effects on the heart.
Before taking this medicine
Do not use Concerta 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, rasagiline, selegiline, tranylcypromine, and others.
You should not use this medicine if you are allergic to methylphenidate, or if you have:
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glaucoma;
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a personal or family history of tics (muscle twitches) or Tourette"s syndrome; or
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severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).
Some stimulants have caused sudden death in certain people. Tell your doctor if you have:
To make sure Concerta is safe for you, tell your doctor if you or anyone in your family has ever had:
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depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
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motor tics (muscle twitches) or Tourette"s syndrome;
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blood circulation problems in the hands or feet;
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seizures or epilepsy;
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an abnormal brain wave test (EEG); or
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a history of drug or alcohol addiction.
It is not known whether Concerta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Concerta is not approved for use by anyone younger than 6 years old.
How should I take Concerta?
Take Concerta exactly as prescribed by your doctor. Using this medicine improperly can cause death or serious side effects on the heart.
Concerta extended-release tablets are taken once each day in the morning. Concerta is an extended-release tablet. It releases methylphenidate into your or your child"s body throughout the day.
Concerta extended-release tablets can be taken with or without food. Follow the directions on your medicine label
The extended-release tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.
Do not crush, chew, or break a Concerta extended-release tablet. Swallow the tablet whole. Breaking the tablet may cause too much of the drug to be released at one time.
While using Concerta, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.
From time to time, your doctor may stop treatment for a while to check ADHD symptoms.
If you need surgery, tell the surgeon ahead of time that you are using Concerta. You may need to stop using the medicine for a short time.
Methylphenidate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law.
Store at room temperature away from moisture and heat.
Keep track of the number of Concerta extended-release tablets used from each new bottle. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Concerta dosing information
Usual Dose for Narcolepsy and Attention Deficit Disorder:
Initial: (Methylphenidate - naive patients) 18 mg once daily in the morning before breakfast.
For patients already receiving methylphenidate:
If switching from immediate release tablets 5 mg 2 or 3 times a day: 18 mg once daily.
If switching from immediate release tablets 10 mg 2 or 3 times a day: 36 mg once daily.
If switching from immediate release tablets 15 mg 2 or 3 times a day: 54 mg once daily.
If switching from immediate release tablets 20 mg 2 or 3 times a day: 72 mg once daily.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal.
What should I avoid while taking Concerta?
Avoid drinking alcohol when taking extended-release Concerta. Alcohol may cause methylphenidate to be released into the bloodstream too fast.
Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Concerta side effects
Get emergency medical help if you have signs of an allergic reaction to Concerta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Stop taking Concerta and call your doctor at once if you have:
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chest pain, trouble breathing, feeling like you might pass out;
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hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
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a seizure (convulsions);
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numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
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muscle twitches (tics);
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changes in your vision;
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penis erection that is painful or lasts 4 hours or longer (rare); or
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unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).
Common Concerta side effects may include:
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.
See also: Side effects (in more detail)
What other drugs will affect Concerta?
Tell your doctor about all your current medicines and any you start or stop using, especially:
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an antidepressant;
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blood pressure medication;
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a blood thinner such as warfarin (Coumadin, Jantoven);
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a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine; or
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seizure medicine.
This list is not complete. Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
