Learn more about Janssen’s COVID-19 response and our continued support to help patients afford and access our medicines.[x]

Privacy Policy

Supplemental Privacy Notices

Privacy Notice for California Residents
Privacy Notice for Nevada Residents

Pharmaceuticals, Inc. respects your privacy and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the website or application (hereinafter the “Service”) operated and controlled by us from which you are accessing this Privacy Policy. We encourage you to read the full Privacy Policy before using this Service or providing any personal information. By providing personal information to us or by using the Service, you acknowledge that you have read and understand this Privacy Policy.

USE BY MINORS

The Service is not directed to individuals under the age of 18, and we request that these individuals not provide personal information through the Service. If your child has submitted Personal Information and you would like to request that such Personal Information be removed, please contact us as explained below under “Contacting Us.”

INFORMATION COLLECTION

We may ask you to submit personal information in order for you to benefit from certain features (such as newsletter subscriptions, tips/pointers, or order processing) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.

We may combine the information you submit with other information we have collected from you, whether on- or offline, including, for example, your purchase history. We may also combine it with information we receive about you from other sources, such as other Johnson & Johnson Affiliates, publicly available information sources (including information from your publicly available social media profiles), and other third-party information providers.

If you submit any personal information relating to another individual to us, you represent that you have the authority to do so and to permit us to use the information in accordance with this Privacy Policy.

SENSITIVE INFORMATION

Unless we specifically request or invite it, we ask that you not send us, and you not disclose, any sensitive personal information (e.g., Social Security numbers, information related to racial or ethnic origin, political opinions, religion or philosophical beliefs, health or medical condition, sex life or sexual orientation, criminal background, or trade union membership, or biometric or genetic data) on or through the Service or otherwise directly to us.

AUTOMATIC INFORMATION COLLECTION AND USE

We and our service providers may automatically collect and use information in the following ways as you navigate around the Service:

Through your browser

Certain information is collected by most browsers, such as your Media Access Control (MAC) address, computer type (Windows or Mac), screen resolution, operating system name and version, and Internet browser type and version. We may collect similar information, such as your device type and identifier, if you access the Service through a mobile device. We use this information to ensure that the Service functions properly.

Using cookies

Cookies are pieces of information stored directly on the computer you are using. Cookies allow us to collect information such as browser type, time spent on the Service, pages visited, and language preferences. We and our service providers use the information for security purposes, to facilitate navigation, display information more effectively, and to personalize your experience while using the Service. We also use cookies to recognize your computer or device, which makes your use of the Service easier, such as to remember what is in your shopping cart. In addition, we use cookies to gather statistical information about Service usage in order to continually improve its design and functionality, understand how individuals use it, and to assist us with resolving questions regarding it. Cookies further allow us to select which of our advertisements or offers are most likely to appeal to you and display them while you are on the Service. We may also use cookies in online advertising to track consumer responses to our advertisements.

You can refuse to accept these cookies by following your browser’s instructions; however, if you do not accept them, you may experience some inconvenience in your use of the Service. You may also not receive advertising or other offers from us that are relevant to your interests and needs. To learn more about cookies, please visit https://www.allaboutcookies.org.

Using Flash cookies

Our use of Adobe Flash technology (including Flash Local Stored Objects (“Flash LSOs”)) allows us to, among other things, serve you with more tailored information, facilitate your ongoing access to and use of the Service, and collect and store information about your use of the Service. If you do not want Flash LSOs stored on your computer, you can adjust the settings of your Flash player to block Flash LSO storage using the tools contained in the Website Storage Settings Panel. You can also control Flash LSOs by going to the Global Storage Settings Panel and following the instructions. Please note that setting the Flash Player to restrict or limit acceptance of Flash LSOs may reduce or impede the functionality of some Flash applications.

Using pixel tags, web beacons, clear GIFs, or other similar technologies

These may be used in connection with some Service pages and HTML-formatted e-mail messages to, among other things, track the actions of users and e-mail recipients, measure the success of our marketing campaigns, and compile statistics about Service usage.

Interest-based advertising

We may use third-party advertising companies to serve advertisements regarding goods and services. that may be of interest to you when you access and use the Service and other online services, based on information relating to your access and use of the Service and other online services on any of your devices. To do so, these companies may place or recognize a unique cookie on your browser (including through the use of pixel tags). They may also use these technologies, along with information they collect about your online use, to recognize you across the devices you use, such as a mobile phone and a laptop.

If you would like more information about this practice, and to learn how to opt-out of it, in desktop and mobile browsers on the particular device on which you are accessing this Privacy Policy, please visit http://optout.aboutads.info/#/ and http://optout.networkadvertising.org/#/. You may download the AppChoices app at www.aboutads.info/appchoices to opt-out in mobile apps.

IP address

Your IP address is a number that is automatically assigned to your computer by your Internet Service Provider. An IP address is identified and logged automatically in our server log files whenever a user visits the Service, along with the time of the visit and the pages visited. Collecting IP addresses is standard practice and is done automatically by many online services. We use IP addresses for purposes such as calculating Service usage levels, diagnosing server problems, and administering the Service. We may also derive your approximate location from your IP address.

HOW WE USE AND DISCLOSE INFORMATION

We use and disclose information you provide to us as described to you at the point of collection. Please see the section entitled “Choices and Access” below to learn how you may opt-out of certain of our uses and disclosures.

Where required by applicable law, we will obtain your consent to our use of your personal information at the point of information collection. We may also rely on other legal bases, specifically for:

We will engage in these activities to manage our contractual relationship with you and/or to comply with a legal obligation.

We will engage in these activities to manage our contractual relationship with you, to comply with a legal obligation, and/or because we have a legitimate interest.

We will provide personalized services either with your consent or because we have a legitimate interest.

We also disclose information collected through the Service:

In addition, we may use and disclose your information as we believe to be necessary or appropriate: (a) to comply with legal process or applicable law which may include laws outside your country of residence; (b) as permitted by applicable law to respond to requests from public and government authorities, which may include authorities outside your country of residence; (c) to enforce our terms and conditions; and (d) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others. We may also use and disclose your information in other ways after obtaining your consent to do so.

We may use and disclose information we collect automatically as described above under “Automatic Information Collection and Use.”

In addition, where allowed by applicable law, we may use and disclose information that is not in personally identifiable form for any purpose. If we combine information that is not in personally identifiable form with information that is identifiable (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.

CHOICES AND ACCESS

Your choices regarding our use and disclosure of your personal information

We give you choices regarding our use and disclosure of your personal information for marketing purposes. You may opt-out from:

We will seek to comply with your request(s) as soon as reasonably practicable. Please note that if you opt-out as described above, we may not be able to directly remove your personal information from the databases of our affiliates with which we have already shared your information (i.e. as of the date that we implement your opt-out request). However, we will make reasonable efforts to inform our affiliates of your request. Please also note that if you opt-out of receiving marketing-related messages from us, we may still send you important transactional and administrative messages from which you cannot opt-out.

How you can access, change, or delete your personal information

If you would like to review, correct, update, restrict, or delete your personal information, or if you would like to request an electronic copy of your personal information for purposes of transmitting it to another company (to the extent these rights are provided to you by applicable law), please contact us via 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO BOX 200 Titusville, NJ 08560. We will respond to your request as soon as reasonably practicable and no later than one month after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response.

CROSS-BORDER TRANSFER

Your personal information may be stored and processed in any country where we have facilities or service providers, and by using our Service or by providing consent to us (where required by law), your information may be transferred to countries outside of your country of residence, including to the United States, which may provide for different data protection rules than in your country of residence. Nonetheless, appropriate contractual and other measures are in place to protect personal information when it is transferred to our affiliates or third parties in other countries.

SECURITY

We seek to use reasonable organizational, technical, and administrative measures designed to protect personal information under our control. However, no data transmission over the Internet or data storage system can be guaranteed to be 100% secure. If you have reason to believe that your interaction with us is no longer secure (for example, if you feel that the security of any account you have with us has been compromised), please immediately notify us in accordance with the “Contacting Us” section below.

RETENTION PERIOD

We will retain your personal information for as long as needed or permitted in light of the purpose(s) for which it was obtained. The criteria used to determine our retention periods include: (i) the length of time we have an ongoing relationship with you and provide the Service to you; (ii) whether there is a legal obligation to which we are subject; and (iii) whether retention is advisable in light of our legal position (such as, in regard to applicable statutes of limitations, litigation or regulatory investigations).

THIRD PARTY SITES AND SERVICES

This Service may contain links to sites of third parties. This Privacy Policy does not address, and we are not responsible for, the privacy, information, or practices of any third parties, including any third party operating any site or online service (including, without limitation, any application) that is available through this Service or to which this Service contains a link. The availability of, or inclusion of a link to, any such site or property on the Service does not imply endorsement of it by us or by our affiliates.

CONTACTING US

Janssen Pharmaceuticals, Inc., located at 1125 Trenton-Harbourton Road, Titusville, NJ 08560, is the company responsible for collection, use, and disclosure of personal information under this Privacy Policy.

If you have any questions about this Privacy Policy, please contact us via 1-800-JANSSEN (526-7736), or please write to the following address:

Janssen Medical Information
PO Box 200
Titusville, NJ 08560

UPDATES TO THIS PRIVACY POLICY

We may change this Privacy Policy. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Service. Your use of the Service following these changes means that you accept the revised Privacy Policy. We recommend that you regularly review the Privacy Policy when you visit the Service. This policy was last updated on November 2019.

PRIVACY NOTICE FOR CALIFORNIA RESIDENTS

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Effective: January 1, 2020

This Privacy Notice for California Residents supplements the information contained in the Johnson & Johnson Global Privacy Policy (above), and applies only to California residents (“You,” “your” or “consumer”).

Personal Information Collection and Purposes of Use

We collect and use information that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, to you or your devices when you visit this website, provide us your personal information, or have a contractual or business relationship with us or any of our affiliates, (“Personal Information”). Such Personal Information includes direct identifiers like a name, postal address, email address, social security number or other government identifier, and indirect identifiers that may identify, relate to, or be associated with a particular individual, such as a telephone number, device identifier, IP address and browsing history, credit card information, or inferences about consumer preferences or characteristics.

We collect this Personal Information for the following purposes:

Our Personal Information Handling Practices

In the preceding 12 months, we have collected the following categories of Personal Information from California residents who have visited this website, provided us their Personal Information, or had or have a contractual or business relationship with us or any of our affiliates:

We have collected such Personal Information from one or more of the following categories of sources:

We collected such Personal Information for the purposes noted above (see “Personal Information Collection and Purposes of Use”) and in the J&J Global Privacy Policy (see “How We Use and Disclose Information”):

We may have shared such Personal Information with the following categories of third parties:

We collected one or more of the following specific pieces of personal information:

Unless specifically stated, we do not share, disclose or sell personal information to third parties for their own use, but we do share your personal information with our affiliates and trusted partners in arrangements that may meet the broad definition of “sale” under California law. In these arrangements, use of the information we share is limited by policies, contracts, or similar restrictions.

In the preceding 12 months we may have disclosed, shared or sold, as defined by California law, one or more of the above categories of personal information.

Your Privacy Rights

You have the following rights regarding our collection and use of your personal information. To exercise those rights, you must submit a request by either calling us at 1-800-JANSSEN (526-7736) or through https://www.janssen.com/us/privacy-request/. We may ask you to provide additional information to verify your request. We may not discriminate against you if you exercise your rights as described in this notice. For example, we may not deny goods or services to you, or charge you different prices or rates, or provide a different level of quality of products or services.

Right to Information

You have the right to request the following information regarding the personal information we have collected about you:

You have the right to request the following information regarding the personal information we have sold or disclosed about you:

Right to Opt-Out of Sharing, Disclosure, or Sale of Personal Information

You have the right to direct us to not share, disclose, or sell your personal information. To exercise this right, you or your authorized representative may submit a request by clicking on the following link:

Do Not Sell My Personal Information

Right to Request Deletion

You have the right to request that we delete the personal information we have about you. However, we are not required to delete information if it is necessary to retain your information to:

Contact Us

You can contact us with questions about this Privacy Notice for California Residents or to exercise your rights as described in this Notice.

Telephone number:1-800-JANSSEN (526-7736)
Via Web:https://www.janssen.com/us/privacy-request/
Postal address:Janssen Medical Information
PO Box 200
Titusville, NJ 08560
Contact Title: Privacy Manager

PRIVACY NOTICE FOR NEVADA RESIDENTS

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Effective: October 1, 2019

This Supplemental Privacy Notice for Nevada Residents adds to the information contained in the Johnson & Johnson Global Privacy Policy (above), and applies only to Nevada residents (“You,” “your” or “consumer”).

Personal Information Collection and Purposes of Use

We collect certain personal information of Nevada consumers through our Internet websites or other online service. This information includes one or more of the following elements of personally identifiable information:

  1. A first and last name.
  2. A home or other physical address that includes the name of a street and the name of a city or town.
  3. An electronic mail address.
  4. A telephone number.
  5. A Social Security Number.
  6. An identifier that allows a specific person to be contacted either physically or online.
  7. Any other information concerning a person collected from the person through the Internet website or online service of the operator, and maintained by the operator in combination with an identifier in a form that makes the information personally identifiable.

We collect this Personal Information for the following purposes:

Your Privacy Rights

Right to access and/or correct your personal information, or opt-out of sale of personal information

If you would like to review, correct, or update your personal information, you or your authorized representative may submit your request to https//www.janssen.com/us/privacy-request/. We will respond to your verified request as soon as reasonably practicable, but no later than sixty (60) days after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response. We generally do not disclose or share personal information for profit. Under Nevada law, you have the right to direct us to not sell or license your personal information to third parties. To exercise this right, if applicable, you or your authorized representative may submit a request to https://www.janssen.com/us/privacy-request/. We will respond to your verified request as soon as reasonably practicable, but no later than sixty (60) days after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response.

Contact Us

You can contact us with questions about this Privacy Notice for Nevada Residents or to exercise your rights as described in this Notice.

Via Web: https://www.janssen.com/us/privacy-request/

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®.

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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.