Consumer Information

Concerta

Generic Name: methylphenidate (METH il FEN i date)
Brand Names: Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin LA, Ritalin-SR

What is Concerta?

Concerta is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Concerta is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). It should be used as an integral part of a treatment program that includes psychological, educational, and social measures.

Concerta may also be used for other purposes not listed here.

Important information about Concerta

Do not use Concerta if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use Concerta before the MAO inhibitor has cleared from your body. Do not use Concerta if you are allergic to methylphenidate or if you have glaucoma, overactive thyroid, severe high blood pressure, tics or Tourette's syndrome, angina, heart failure, heart rhythm disorder, recent heart attack, a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, or severe anxiety, tension, or agitation. Methylphenidate may be habit-forming and should be used only by the person it was prescribed for. Concerta should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Concerta?

Do not take Concerta if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use Concerta before the MAO inhibitor has cleared from your body.

Do not use Concerta if you are allergic to methylphenidate or if you have:

glaucoma;
overactive thyroid;
severe high blood pressure;
angina (chest pain), heart failure, heart rhythm disorder, or recent heart attack;
a personal or family history of tics (muscle twitches) or Tourette's syndrome;
severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse); or
a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have a congenital heart defect.

If you have certain other conditions, you may need a dose adjustment or special tests to safely take Concerta. Before using Concerta, tell your doctor if you are allergic to any drugs, or if you have:

a congenital heart defect;
a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;
epilepsy or other seizure disorder; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether Concerta is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Do not use Concerta without telling your doctor if you are breast-feeding a baby.

Long-term use of Concerta can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give Concerta to a child younger than 6 years old without the advice of a doctor.

How should I take Concerta?

Take Concerta exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Concerta at least 30 minutes before a meal. This medicine can be taken with or without food. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

To prevent sleep problems, take Concerta early in the day, no later than 6:00 pm.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Concerta. You may need to stop using the medicine the day of your surgery. Store Concerta at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Methylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Concerta can be fatal.

Overdose can cause vomiting, agitation, tremors, muscle twitching, seizure (convulsions), confusion, hallucinations, sweating, fast or pounding heartbeat, blurred vision, dry mouth and nose, and fainting.

What should I avoid while taking Concerta?

Concerta can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Concerta side effects

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

Stop taking Concerta and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeats;
feeling like you might pass out;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
easy bruising, purple spots on your skin; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Concerta side effects may include:

stomach pain, nausea, vomiting, loss of appetite;
vision problems, dizziness, mild headache;
sweating, mild skin rash;
numbness, tingling, or cold feeling in your hands or feet;
nervous feeling, sleep problems (insomnia); or
weight loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Concerta?

Before taking Concerta, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin);
clonidine (Catapres);
dobutamine (Dobutrex), epinephrine (EpiPen), or isoproterenol (Isuprel);
phenylbutazonie (Azolid, Butazolidin);
cold/allergy medicine that contains phenylephrine (a decongestant);
potassium citrate (Urocit-K, Twin-K), sodium acetate, sodium bicarbonate (Alka-Seltzer), citric acid and potassium citrate (Cytra-K, Poly-Citra), or sodium citrate and citric acid (Bicitra, Oracit);
medications to treat high or low blood pressure;
stimulant medications or diet pills;
seizure medicine such as phenytoin (Dilantin), phenobarbital (Luminal), primidone (Mysoline); or
an antidepressant such as amitriptyline (Elavil, Etrafon), citalopram (Celexa), doxepin (Sinequan), fluoxetine (Prozac, Sarafem), imipramine (Janimine, Tofranil), nortriptyline (Pamelor) paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with Concerta. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Concerta.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.