Consumer Drug Information

Concerta Extended-Release Tablets

Generic Name: Methylphenidate Extended-Release Tablets (meth-il-FEN-i-date)
Brand Name: Concerta

Use Concerta Extended-Release Tablets with caution if you have a history of emotional problems, or alcohol or substance abuse. Abuse of Concerta Extended-Release Tablets may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Concerta Extended-Release Tablets. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.

Concerta Extended-Release Tablets is used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Concerta Extended-Release Tablets is a central nervous system stimulant. Exactly how it works is not known.

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 (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
you have serious heart problems (eg, heart defect, irregular heartbeat)
you are not able to swallow the tablet whole
you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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, planning 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 high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or recent heart attack, or if a family member has a history of irregular heartbeat or sudden death
if you have a history of seizures or abnormal electroencephalograms (EEGs)
if you have a history of overactive thyroid, chronic fatigue, cystic fibrosis, narrowing of the esophagus, or stomach or bowel problems (eg, blockage, inflammation, narrowing)
if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

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:

MAOIs (eg, phenelzine) because severe high blood pressure may occur
Clonidine because serious side effects may occur
Pressor agents (eg, norepinephrine) because the risk of high blood pressure may be increased
Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Concerta Extended-Release Tablets
Guanethidine or other medicines for high blood pressure because their effectiveness may be decreased by Concerta Extended-Release Tablets

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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Concerta Extended-Release Tablets refilled.
Take Concerta Extended-Release Tablets by mouth in the morning with or without food.
Swallow Concerta Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Take Concerta Extended-Release Tablets with a full glass of liquid (eg, water, milk, juice) (8 oz/240 mL).
If you miss a dose of Concerta Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Concerta Extended-Release Tablets.

Important safety information:

Concerta Extended-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Concerta Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose without checking with your doctor.
If your symptoms do not get better within 1 month or if they get worse, check with your doctor.
Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.
You may notice the tablet shell in your stool. This is normal and not a cause for concern.
Concerta Extended-Release Tablets may be visible on abdominal x-rays. If you will be having an abdominal x-ray, be sure your doctor and lab personnel know you are taking Concerta Extended-Release Tablets.
Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Concerta Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Concerta Extended-Release Tablets may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Concerta Extended-Release Tablets.
Caution is advised when using Concerta Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
Concerta Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Concerta Extended-Release Tablets while you are pregnant. It is not known if Concerta Extended-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Concerta Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Concerta Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Concerta Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Concerta Extended-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Concerta Extended-Release Tablets. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Concerta Extended-Release Tablets, your doctor will lower your dose over time.

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:

Dizziness; drowsiness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, persistent crying, unusual sadness); seizures; severe or persistent dizziness or headache; suicidal thoughts or attempts; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

Esta no es una lista completa de todos los efectos secundarios que se pueden presentar. Si tiene dudas acerca de los efectos secundarios, consulte a su profesional del cuidado de la salud. Llame a su médico para obtener asesoramiento sobre los efectos secundarios. Puede informar los efectos secundarios a la FDA al 1-800-FDA-1088. También puede informarlos al http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.

Proper storage of Concerta Extended-Release Tablets:

Store Concerta Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Concerta Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Concerta Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Concerta Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Concerta Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 3, 2008

Database Edition 08.3.1.003