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.
o 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.
o CONCERTA may lead to physical dependence after prolonged use, even if taken as directed by your
healthcare provider.
o Do not give CONCERTA to anyone else. See “What is CONCERTA?” for more information.
o Keep CONCERTA in a safe place and properly dispose of any unused medicine. See “How should I store
CONCERTA?” for more information.
o 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:
o new or worse behavior or thought problems
o new or worse bipolar illness
o 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.
What is CONCERTA?
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.

Do not take CONCERTA if you or your child:
• are allergic to methylphenidate or any of the ingredients in CONCERTA. See the end of this Medication Guide
for a complete list of 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 CONCERTA be taken?
• 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 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:
o fingers or toes may feel numb, cool, painful
o 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 • anxiety
• headache • dizziness
• dry mouth • weight loss
• nausea • irritability
• trouble sleeping • increased sweating
These are not all the possible side effects of CONCERTA.
Call your doctor for medical advice about side effects.

How should I store CONCERTA?
• Store CONCERTA below 25°C
• Protect from moisture.
• Store CONCERTA in a safe place, like a locked cabinet.
• Dispose of remaining, unused, or expired CONCERTA by a medicine take-back program at a U.S. Drug
Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized
collector is available, mix CONCERTA with an undesirable, nontoxic substance such as dirt, cat litter, or used
coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed
plastic bag and throw away CONCERTA in the household trash. Visit www.fda.gov/drugdisposal for additional
information on disposal of unused medicines.
Keep CONCERTA and all medicines out of the reach of children.
General information about the safe and effective use of CONCERTA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use
CONCERTA for a condition for which it was not prescribed. Do not give CONCERTA to other people, even if they
have the same condition. It may harm them and it is against the law.
You can ask your healthcare provider or pharmacist for information about CONCERTA that is written for healthcare
professionals.