Concerta is a central nervous system stimulant prescription medicine. 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 hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents, and in adults up to the age of 65.

Concerta should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Is Concerta a controlled substance?

Yes, Concerta (methylphenidate) is a Schedule 2 controlled substance and therefore has a high potential for abuse. It has a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence. There may be variations in CSA schedules between individual states.

You should not use Concerta if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Call your doctor right away if you have chest pain or feel lightheaded or short of breath while taking Concerta.

Do not use Concerta if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine or have used a methylene blue injection.

Concerta may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. Call your doctor right away if you have signs of psychosis such as paranoia, aggression, new behavior problems, or seeing or hearing things that are not real.

Take Concerta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Concerta is against the law.

Take Concerta once each day in the morning. Concerta is an extended-release tablet. It releases medication into your or your child's body throughout the day.

Concerta can be taken with or without food, but take it the same way each time.

Do not chew, crush, or break the Concerta tablets. Swallow the tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow the tablet whole. A different medicine may need to be prescribed.

The Concerta 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.

Children should have their height and weight checked often while taking this medicine.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. From time to time, your doctor may stop treatment for a while to check ADHD symptoms. Your heart and blood pressure may also need to be checked often.

Store Concerta tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

You should not use Concerta if you are allergic to methylphenidate.

You should not take Concerta if you have:

• glaucoma;

• severe high blood pressure or a heart problem;

• overactive thyroid;

• a personal or family history of tics (muscle twitches) or Tourette's syndrome; or

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

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 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, 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 methylphenidate 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.

To make sure Concerta is safe for you, tell your doctor if you have:

• problems with the esophagus, stomach, or intestines; or

• seizures, epilepsy, or an abnormal brain wave test (EEG).

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 methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

Concerta is not approved for use by anyone younger than 6 years old.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how Concerta will affect you. Your reactions could be impaired.

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.

Call your doctor at once if you have:

• signs of heart problems - chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

• signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away 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.

Methylphenidate 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 Concerta side effects may include:

• sweating, increased blood pressure;

• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;

• fast heart rate, pounding heartbeats or fluttering in your chest;

• loss of appetite, weight loss;

• dry mouth, nausea, vomiting, stomach pain, indigestion; or

• headache, dizziness.

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.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven;

• blood pressure medication;

• an antidepressant;

• seizure medication; or

• cold or allergy medications that contain decongestants.

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 drug interactions are listed here.