Treating attention deficit hyperactivity disorder (ADHD). It may also be prescribed for other conditions as determined by your doctor.
Concerta Extended-Release Tablets is a central nervous system stimulant. It works by blocking 2 chemicals in the brain. The exact way Concerta Extended-Release Tablets works is unknown.
Do NOT use Concerta Extended-Release Tablets if:
You are allergic to any ingredient in Concerta Extended-Release Tablets
You have severe anxiety, agitation, or tension
You have glaucoma
You have motor tics, Tourette syndrome, or a family history of Tourette syndrome
You are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 14 days
Before using Concerta Extended-Release Tablets:
Some medical conditions may interact with Concerta Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
If you are pregnant, plan to become pregnant, or are breast-feeding
If you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
If you have allergies to medicines, foods, or other substances
If you have a history of bizarre behavior, mood swings, fatigue, agitation, anxiety, tension, depression, psychosis, or abnormal thoughts or visions
If you have a history of seizures, convulsions, or abnormal electroencephalograms (EEGs)
If you have high blood pressure, have had a recent heart attack, or have other heart problems
If you have high thyroid hormone levels or a history of substance abuse or alcoholism
If you have an inflammation, narrowing, or blockage of the intestines; short bowel syndrome; Meckel diverticulum; or cystic fibrosis
Some MEDICINES MAY INTERACT with Concerta Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Guanethidine because the effectiveness may be decreased by Concerta Extended-Release Tablets
MAO inhibitors (eg, phenelzine) because the actions and side effects of Concerta Extended-Release Tablets may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Concerta Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Concerta Extended-Release Tablets:
Use Concerta Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Concerta Extended-Release Tablets comes with an additional patient leaflet. Read it carefully.
Concerta Extended-Release Tablets is usually taken once each day in the morning. It may be taken with or without food.
Swallow Concerta Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Concerta Extended-Release Tablets and you take one dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.
Important safety information:
Concerta Extended-Release Tablets may cause dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Concerta Extended-Release Tablets. Using Concerta Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Concerta Extended-Release Tablets should only be given to patients old enough to swallow the tablet whole.
The tablet shell does not dissolve completely after all the medicine has been released in the stomach. It is normal to sometimes notice the tablet shell in your stool.
Concerta Extended-Release Tablets should not be used to treat depression or prevent or treat normal tiredness.
Do not drink alcohol while taking Concerta Extended-Release Tablets.
There have been very rare reports of neuroleptic malignant syndrome (NMS). It is uncertain whether these cases were caused by Concerta Extended-Release Tablets alone or by some other combination factors. Notify your doctor if you experience fever, excessive sweating, shortness of breath, inability to control bladder, muscle rigidity, tremors, or unusual muscle movements.
LAB TESTS, such as complete blood cell counts and platelet counts, may be needed to monitor for side effects. Keep all doctor and laboratory appointments.
Concerta Extended-Release Tablets may reduce weight gain or growth in CHILDREN. Your health care provider will watch weight and height carefully. Your doctor may stop treatment if growing or gaining weight are not as your doctor expects. Contact your health care provider if you do not see improvement in symptoms within 1 month. Concerta Extended-Release Tablets is not recommended for use in CHILDREN younger than 6 years of age; safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Concerta Extended-Release Tablets during pregnancy. It is unknown if Concerta Extended-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while using Concerta Extended-Release Tablets, contact your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Concerta Extended-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Decreased appetite (more severe in children); diarrhea; dizziness; drowsiness; dry mouth; fever; hair loss; headache; itching; joint pain; loss of appetite; nervousness; sleeplessness; stomach upset; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bruising; changes in heart rate (fast or slow); changes in mood or personality; chest pain or pounding in the chest; confusion; convulsions or seizures; depression; involuntary muscle movements; joint pain; psychosis (abnormal thinking or hallucinations, hearing abnormal sounds); seizures; sore throat and fever; vision changes or blurred vision; weight loss; yellowing of the skin or eyes.
Last Modified 29 April 2007