What is Concerta?
Concerta (methylphenidate) 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 adults and children 6 years of age and older.
Concerta should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Warnings
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.
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.
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, tranylcypromine, and others.
You may not be able to use Concerta if you are allergic to methylphenidate, or if you have:
- glaucoma;
- 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.
To make sure Concerta is safe for you, tell your doctor if you or anyone in your family has ever had:
- depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
- motor tics (muscle twitches) or Tourette’s syndrome;
- blood circulation problems in the hands or feet;
- seizures or epilepsy;
- problems with the esophagus, stomach, or intestines;
- an abnormal brain wave test (EEG); or
- drug or alcohol addiction.
Tell your doctor if you are pregnant or breastfeeding.
Concerta is not approved for use by anyone younger than 6 years old.
How should I take Concerta?
Take Concerta extended-release tablets 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.
Your dose needs may change if you switch to a different brand, strength, or form of methylphenidate. Avoid medication errors by using only the medicine your doctor prescribes.
Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Never share Concerta with another person. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.
To prevent sleep problems, take this medicine in the morning.
Concerta extended-release tablets can be taken with or without food. Follow the directions on your medicine label.
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.
Tell your doctor if you have a planned surgery.
Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture and heat.
Keep track of your medicine. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Keep your medicine in a safe place where no one can access it without permission.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is later than 6:00 p.m. Do not use two doses at one time.
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.
Avoid driving or hazardous activity until you know how methylphenidate will affect you. Your reactions could be impaired.
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.
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 (rare)
Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.
Common Concerta side effects may include:
- excessive sweating;
- mood changes, feeling nervous or irritable, sleep problems (insomnia);
- fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
- loss of appetite, weight loss;
- dry mouth, nausea, stomach pain; or
- headache.
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.
What other drugs will affect Concerta?
Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
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