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

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.