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CONCERTA® - ADHD Treatment For Children

CONCERTA® Basics read more
Is CONCERTA® Right for My Child? read more
What to Expect From CONCERTA® read more
The Value of Continued ADHD Treatment read more
ADHD Resources read more
CONCERTA® Basics

The Dose Makes the Difference

Overview

  • Once-daily CONCERTA® delivers all-day ADHD symptom control
  • Covers the all-important homework hours between 4 and 6 pm
  • CONCERTA® may help your child focus at home and at school

One morning dose of CONCERTA® provides all-day ADHD symptom control. CONCERTA® is the only ADHD treatment with the unique OROS® delivery system, which slowly releases medication at an increasing rate throughout the day. One morning dose covers your child's busy day — including the all-important homework hours between the hours of 4 and 6 pm.

CONCERTA® is proven to help manage the symptoms of inattention, hyperactivity, and impulsivity. With these symptoms under control, your child can focus better and pay closer attention to the things he or she is doing throughout the day. All of this may help your child manage ADHD symptoms at school, at home, and at play.

CONCERTA® is approved for doses up to 54 mg per day in children and 72 mg per day in adolescents. Children are typically started on a daily dose of 18 mg of CONCERTA®. But, like many ADHD medications, your child's dosage may need to be adjusted to achieve better results. This approach is called titration. Your child's healthcare professional can determine which dose is right for your child.

Help your child get on the path to success in managing ADHD symptoms. If your child has been diagnosed with ADHD, ask about managing everyday challenges of ADHD with CONCERTA®.

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Is CONCERTA® Right for My Child?

Proven Effective

Overview

  • CONCERTA® delivers consistent, long-lasting ADHD symptom control
  • CONCERTA® is medication for children and adolescents with ADHD
  • Help your child manage everyday ADHD challenges with CONCERTA®

Everyday activities can be a challenge when your child has ADHD. But making the decision to treat your child's ADHD symptoms is an important first step. If your child has been diagnosed with ADHD, ask a healthcare professional how CONCERTA® can help your child manage ADHD symptoms.

Methylphenidate, the medication in CONCERTA®, is recommended among first-line therapies by the American Academy of Pediatrics as part of a total treatment program for ADHD. Part of this includes a team of people focused on helping your child like family members, caregivers, teachers, and your child's healthcare professional. This treatment approach may also include behavioral therapy.

If your child has been diagnosed with ADHD, ask his or her healthcare professional how treatment with CONCERTA® can help your child manage the everyday challenges of ADHD.

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What to Expect From CONCERTA®

Overview

  • Most children are started on a daily dose of 18 mg of CONCERTA®
  • Your child's dose may be adjusted to get the best results
  • CONCERTA® significantly improves ADHD symptoms
  • Track your child's progress and share results with your child's doctor
  • Every child is unique and will have his or her own response to ADHD

As a parent, you'll want to know what to expect from your child's treatment with CONCERTA®. Every child is unique and will have his or her own response to ADHD medication. For your child to get the most out of treatment, it's important to work closely with your child's healthcare professional. It is also important to discuss any side effects with your child’s healthcare professional.

Your child only needs to take CONCERTA® once a day, in the morning, with or without food. CONCERTA® works throughout the day to provide long-lasting ADHD symptom control.* CONCERTA® offers a unique time-released formulation (OROS® technology) that provides all-day ADHD symptom control. CONCERTA® improves focus. And can help your child control his or her hyperactive and/or impulsive behavior.

CONCERTA® should not be used in children less than 6 years old because it has not been studied in this age group. CONCERTA® may not be right for you or your child. Before starting CONCERTA®, tell your doctor or your child’s doctor about all health conditions . Your doctor or your child's doctor can discuss potential side effects. Please read the accompanying Medication Guide before speaking with your doctor or your child's doctor.

CONCERTA® comes in a range of doses so your child can get the right amount to help manage his or her symptoms. Most children are started on 18 mg of CONCERTA®. But it may be necessary to adjust this dosage to get the best treatment results. This adjustment process is called titration. CONCERTA® is approved in dosages up to 54 mg per day for children and 72 mg per day for adolescents. Children under 6 years of age should not take CONCERTA®.

A typical dose adjustment schedule may look like this:

Week 1: One 18-mg tablet once daily
Week 2: Two 18-mg tablets once daily for a total of 36 mg
Week 3: Three 18-mg tablets once daily for a total of 54 mg

During the first few weeks of treatment, it's important that you and your child's healthcare professional discuss how your child's treatment is going. This may help your child quickly get to the dose that works best. Track your child's symptoms to monitor his or her treatment progress. Only your child's healthcare professional should adjust their dose of CONCERTA®.

The most common side effect (greater than 5%) for CONCERTA® in children was abdominal pain upper.

*In Studies 1 and 2, symptoms of ADHD were evaluated by laboratory schoolteachers using the Swanson, Kotkin, Agler, M-Fynn, and Pelham (SKAMP) laboratory school rating scale. The combined results from these two studies demonstrated statistically significant improvements in attention and behavior in patients treated with CONCERTA® versus placebo that were maintained through 12 hours after dosing
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The Value of Continued ADHD Treatment

ADHD Doesn't Take a Break

Overview

  • For children with ADHD, medication may be a necessary part of their daily routine
  • Consult your child's healthcare professional before making treatment changes
  • Continued ADHD treatment is recommended as long as symptoms are present
  • CONCERTA® can help your child manage the daily challenges of ADHD

ADHD symptoms can impact your child 7 days a week, at home, school and in social settings. The symptoms of ADHD don't take a weekend or summer break. So, medication may be a necessary part of your child's everyday routine.

If you're considering a break from CONCERTA® during weekends, holidays, or summer vacation, you should first consult with your child's healthcare professional before making any decision about treatment changes.

Managing your child's ADHD symptoms can improve his or her ability to focus, even during breaks from school. Continued treatment with CONCERTA® may help your child have a better time managing his or her ADHD symptoms during weekend or summer activities like long car trips, organized sports, or summer camp.

CONCERTA® can help your child manage the daily challenges of ADHD symptoms. So, by continuing with once-daily CONCERTA® you could be providing important support to help your child maintain focus even in less-structured environments.

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ADHD Resources

More Answers and Help Are Available

The more you know about ADHD, the better you can manage your child's condition. When you understand how ADHD affects your child's life, you can start developing strategies to manage the everyday challenges of ADHD.

Here are some helpful resources you can use for education and support:

United States Department of Education

Find out about your child's rights under federal laws designed to ensure that children with disabilities, including ADHD, receive an appropriate education.
https://www.ed.gov

National Dissemination Center for Children With Disabilities (NICHCY)

NICHCY serves as a central source of information about educational rights, special education resources, individualized education programs (IEPs) and more.
http://www.nichcy.org

National Center for Learning Disabilities (NCLD)

By providing information, promoting research and advocating for educational rights, the NCLD works to help people with learning disabilities in school, work and life.
http://www.ncld.org

Attention Deficit Disorder Association (ADDA)

This international organization has been providing information, resources and networking opportunities to adults with ADHD since 1989.
http://www.add.org

American Medical Association (AMA)

This professional organization for doctors is dedicated to the art and science of medicine and promoting public health.
http://www.ama-assn.org/

CHADD.org

Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) is a national nonprofit organization that provides advocacy and support for people with ADHD.
www.chadd.org

NIMH.NIH.gov

The National Institute of Mental Health provides useful information about ADHD in children, adolescents and adults.
http://www.nimh.nih.gov

Learning Disabilities Association of America (LDA)

LDA is one of the largest nonprofit volunteer organizations advocating for individuals with learning disabilities.
http://www.ldanatl.org/

ADDitude Magazine

Stay on top of the latest information about ADHD in children, adolescents and adults.
http://www.additudemag.com

The Mayo Clinic

The Mayo Clinic is dedicated to the diagnosis and treatment of virtually every type of complex illness, including ADHD.
http://www.mayoclinic.com

IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CONCERTA®?

CONCERTA® may cause serious side effects, including:

  • Abuse, misuse, and addiction. CONCERTA® has a high chance for abuse and misuse, and may lead to substance use problems, including addiction. Misuse and abuse of CONCERTA®, other methylphenidate-containing medicines, and amphetamine-containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of CONCERTA® or when it is used in ways that are not approved, such as snorting or injection.
    • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with CONCERTA® and will monitor you or your child during treatment.
    • CONCERTA® may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
    • Do not give CONCERTA® to anyone else. See “WHAT IS CONCERTA®?” for more information.
    • Keep CONCERTA® in a safe place and properly dispose of any unused medicine.
    • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.

Your healthcare provider should check you or your child carefully for heart problems before starting treatment with CONCERTA®. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with CONCERTA®.

  • Increased blood pressure and heart rate. Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with CONCERTA®.
  • Mental (psychiatric) problems, including:
    • new or worse behavior or thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
      Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with CONCERTA®, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Do not take CONCERTA® if you or your child:

  • are allergic to methylphenidate or any of the ingredients in CONCERTA®.
  • are taking, or have stopped taking within the past 14 days, a medicine called monoamine oxidase inhibitor (MAOI)

Before taking CONCERTA®, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

  • have heart problems, heart disease, heart defects, or high blood pressure
  • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
  • have or have had seizures or have had an abnormal brain wave test (EEG)
  • have circulation problems in fingers and toes
  • have had a blockage or narrowing of the intestines
  • have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
  • have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
  • are pregnant or plan to become pregnant. It is not known if CONCERTA® will harm the unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if CONCERTA® passes into the breastmilk. Talk to your healthcare provider about the best way to feed the baby during treatment with CONCERTA®.

Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONCERTA® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with CONCERTA®. Your healthcare provider will decide whether CONCERTA® can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

  • a medicine to treat blood pressure
  • coumarin anticoagulants (a medicine that prevent blood clots, such as warfarin)
  • a medicine to treat seizures
  • a medicine to treat depression
  • risperidone

Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with CONCERTA® without first talking to your healthcare provider.

HOW SHOULD I TAKE CONCERTA®?

  • Take CONCERTA® exactly as prescribed by your or your child’s healthcare provider.
  • Your healthcare provider may change the dose or tell you to stop taking CONCERTA® if needed.
  • Take CONCERTA® 1 time each day in the morning with or without food.
  • Swallow CONCERTA® tablets whole with water or other liquids. Do not chew, crush, or divide the tablets. Tell your healthcare provider if you or your child cannot swallow CONCERTA® tablets whole. A different medicine may need to be prescribed.
  • CONCERTA® 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.
  • Your healthcare provider may do blood tests during treatment with CONCERTA® to check your or your child’s blood count.

If you or your child take too much CONCERTA®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF CONCERTA®?

CONCERTA® may cause serious side effects, including:

  • See “What is the most important information I should know about CONCERTA®?”
  • Seizures. Your healthcare provider will stop treatment with CONCERTA® if you or your child have a seizure.
  • Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

    Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with CONCERTA®.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with CONCERTA®. CONCERTA® treatment may be stopped if your child is not growing or gaining weight as expected.
  • Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with CONCERTA®.
  • Eyesight changes or blurred vision.
  • Possible blockage of the intestine. Because the CONCERTA® tablet does not change in shape in the intestines (GI tract), CONCERTA® should not be taken by people with severe intestinal problems (preexisting severe gastrointestinal narrowing).

The most common side effect of CONCERTA® in children is upper stomach-area (abdominal) pain.

The most common side effects of CONCERTA® in adults include:

  • decreased appetite
  • headache
  • dry mouth
  • nausea
  • trouble sleeping
  • anxiety
  • dizziness
  • weight loss
  • irritability
  • increased sweating

These are not all the possible side effects of CONCERTA®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736).

Please see the full Prescribing Information including Boxed WARNING and the Medication Guide for CONCERTA®.

cp-180018v3

WHAT IS CONCERTA® (methylphenidate HCl) extended-release tablets?

CONCERTA® is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in children 6 years of age and older and adults up to 65 years of age. CONCERTA® may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if CONCERTA® is safe and effective in children under 6 years of age. CONCERTA® has not been studied in adults older than 65 years of age.

CONCERTA® is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Keep CONCERTA® in a safe place to protect it from theft. Never give your CONCERTA® to anyone else because it may cause death or harm them. Selling or giving away CONCERTA® may harm others and is against the law.

IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CONCERTA®?

CONCERTA® may cause serious side effects, including:

  • Abuse, misuse, and addiction. CONCERTA® has a high chance for abuse and misuse, and may lead to substance use problems, including addiction. Misuse and abuse of CONCERTA®, other methylphenidate-containing medicines, and amphetamine-containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of CONCERTA® or when it is used in ways that are not approved, such as snorting or injection.
    • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with CONCERTA® and will monitor you or your child during treatment.
    • CONCERTA® may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
    • Do not give CONCERTA® to anyone else. See “WHAT IS CONCERTA®?” for more information.
    • Keep CONCERTA® in a safe place and properly dispose of any unused medicine.
    • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.

Your healthcare provider should check you or your child carefully for heart problems before starting treatment with CONCERTA®. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with CONCERTA®.

  • Increased blood pressure and heart rate. Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with CONCERTA®.
  • Mental (psychiatric) problems, including:
    • new or worse behavior or thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
      Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with CONCERTA®, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Do not take CONCERTA® if you or your child:

  • are allergic to methylphenidate or any of the ingredients in CONCERTA®.
  • are taking, or have stopped taking within the past 14 days, a medicine called monoamine oxidase inhibitor (MAOI)

Before taking CONCERTA®, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

  • have heart problems, heart disease, heart defects, or high blood pressure
  • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
  • have or have had seizures or have had an abnormal brain wave test (EEG)
  • have circulation problems in fingers and toes
  • have had a blockage or narrowing of the intestines
  • have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
  • have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
  • are pregnant or plan to become pregnant. It is not known if CONCERTA® will harm the unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if CONCERTA® passes into the breastmilk. Talk to your healthcare provider about the best way to feed the baby during treatment with CONCERTA®.

Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONCERTA® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with CONCERTA®. Your healthcare provider will decide whether CONCERTA® can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

  • a medicine to treat blood pressure
  • coumarin anticoagulants (a medicine that prevent blood clots, such as warfarin)
  • a medicine to treat seizures
  • a medicine to treat depression
  • risperidone

Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with CONCERTA® without first talking to your healthcare provider.

HOW SHOULD I TAKE CONCERTA®?

  • Take CONCERTA® exactly as prescribed by your or your child’s healthcare provider.
  • Your healthcare provider may change the dose or tell you to stop taking CONCERTA® if needed.
  • Take CONCERTA® 1 time each day in the morning with or without food.
  • Swallow CONCERTA® tablets whole with water or other liquids. Do not chew, crush, or divide the tablets. Tell your healthcare provider if you or your child cannot swallow CONCERTA® tablets whole. A different medicine may need to be prescribed.
  • CONCERTA® 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.
  • Your healthcare provider may do blood tests during treatment with CONCERTA® to check your or your child’s blood count.

If you or your child take too much CONCERTA®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF CONCERTA®?

CONCERTA® may cause serious side effects, including:

  • See “What is the most important information I should know about CONCERTA®?”
  • Seizures. Your healthcare provider will stop treatment with CONCERTA® if you or your child have a seizure.
  • Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

    Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with CONCERTA®.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with CONCERTA®. CONCERTA® treatment may be stopped if your child is not growing or gaining weight as expected.
  • Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with CONCERTA®.
  • Eyesight changes or blurred vision.
  • Possible blockage of the intestine. Because the CONCERTA® tablet does not change in shape in the intestines (GI tract), CONCERTA® should not be taken by people with severe intestinal problems (preexisting severe gastrointestinal narrowing).

The most common side effect of CONCERTA® in children is upper stomach-area (abdominal) pain.

The most common side effects of CONCERTA® in adults include:

  • decreased appetite
  • headache
  • dry mouth
  • nausea
  • trouble sleeping
  • anxiety
  • dizziness
  • weight loss
  • irritability
  • increased sweating

These are not all the possible side effects of CONCERTA®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736).

Please see the full Prescribing Information including Boxed WARNING and the Medication Guide for CONCERTA®.

cp-180018v3

+
WHAT IS CONCERTA® (methylphenidate HCl) extended-release tablets?

CONCERTA® is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in children 6 years of age and older and adults up to 65 years of age. CONCERTA® may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if CONCERTA® is safe and effective in children under 6 years of age. CONCERTA® has not been studied in adults older than 65 years of age.

CONCERTA® is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Keep CONCERTA® in a safe place to protect it from theft. Never give your CONCERTA® to anyone else because it may cause death or harm them. Selling or giving away CONCERTA® may harm others and is against the law.