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CONCERTA® - ADHD Treatment For Adults

CONCERTA® Basics read more
Is CONCERTA®Right for me? read more
What to Expect From CONCERTA®
read more
ADHD Resources read more
CONCERTA® Basics

The Dose Makes the Difference

Overview

If you’ve been diagnosed with ADHD, ask your healthcare professional about managing the everyday challenges of ADHD with CONCERTA®. Clinical studies showed that CONCERTA® improved overall ADHD symptoms by measuring items such as the ability to follow through on tasks, avoid careless mistakes, and pay close attention.

When properly diagnosed and treated, many adults with ADHD see improvement in their symptoms.

CONCERTA® improves the symptoms of inattention and impulsivity. With these symptoms under control, you can focus better, and pay closer attention to the things you’re doing during the day. All of this may help you better manage your ADHD symptoms at work, at home, and in your social situations.

CONCERTA® is the only ADHD treatment with the unique OROS® delivery system. One morning dose slowly releases methylphenidate at an increasing rate throughout the day.

Adults with ADHD typically start on a daily dose of 18 or 36 mg of CONCERTA®. But your dose may need to be adjusted to achieve better results. This approach is called titration. You should only take CONCERTA® as instructed by your healthcare professional.

The most common side effects (greater than 10%) for CONCERTA® in adults are dry mouth, nausea, decreased appetite, headache, and insomnia.

Is CONCERTA® Right for Me?

Effective Symptom Control

Overview

Adults with ADHD may find it difficult to manage such day-to-day responsibilities as getting organized, accomplishing tasks, and keeping appointments. ADHD symptoms affect adults at work, at home and in social situations.

CONCERTA® can significantly improve ADHD symptoms in adults, including focus, attention, organization, and the ability to control impulsive behavior.

CONCERTA® is the only ADHD treatment that combines a medication called methylphenidate, with the unique OROS® delivery system. Just one morning dose of CONCERTA® slowly releases medication at an increasing rate throughout the day.

A total approach to treating adults with ADHD includes both medication and behavioral therapy. This approach can be an effective way to manage your ADHD symptoms. If you've been diagnosed with ADHD, ask your healthcare professional about managing ADHD symptoms with CONCERTA®.

What to Expect From CONCERTA®

Overview

Adults with ADHD are typically started on a daily dose of 18 or 36 mg of CONCERTA®. But like many treatments for ADHD in adults, your dose may need to be adjusted to achieve better results. This approach is called titration.

If you don't feel your symptoms have improved enough, talk to your healthcare professional about finding the right dose for you. You should not stop taking CONCERTA® without first talking to your doctor.

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.

You only need to take CONCERTA® once a day in the morning, with or without food. CONCERTA® provides medication that's released at an increasing rate throughout the day.

CONCERTA® can help you manage the symptoms of inattention and impulsivity. With these symptoms under control, you can focus better and pay closer attention to the things you are doing during the day. Some experts agree that ADHD medication is most effective when used on an everyday basis to encourage healthy habits of planning and discipline.

The most common side effects (greater than 10%) for CONCERTA® in adults are dry mouth, nausea, decreased appetite, headache, and insomnia. Manage the everyday challenges of ADHD with CONCERTA®.

ADHD Resources

Support Is Available

The more you know about ADHD, the better you can manage it. Here are some helpful resources you can use for education and support:

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

ADD.org

The Attention Deficit Disorder Association (ADDA) is a leading ADHD organization.
http://www.add.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 adults.
http://www.nimh.nih.gov

ADDitude Magazine

Stay on top of the latest information about ADHD in adults.
http://www.additudemag.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.