INDICATION

Aptensio XR^® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.

Limitations of Use

Aptensio XR is not for use in children under 6 years of age because the safety and effectiveness have not been established.

IMPORTANT SAFETY INFORMATION

Aptensio XR 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 Aptensio XR in a safe place to protect it from theft. Never give your methylphenidate to anyone else, because it may cause death or harm to them. Selling or giving away Aptensio XR may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

Do not take Aptensio XR if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Aptensio XR, or are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Aptensio XR, as well as other stimulants, including methylphenidate-containing products and amphetamines, can cause serious side effects, including:

• Heart-related problems:
  • Sudden death, stroke, and heart attack in adults
  • Sudden death in children who have heart problems or heart defects
  • Increased blood pressure and heart rate

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Aptensio XR.

• Mental (psychiatric) problems:
  • New or worse behavior and 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

• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • Fingers or toes may feel numb, cool, or painful
  • Fingers or toes may change color from pale to blue to red

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child experience any heart-related symptoms, such as chest pain, shortness of breath or fainting, new or worsening mental symptoms or problems, especially hearing voices, seeing or believing things that are not real, new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking Aptensio XR.

Before taking Aptensio XR, tell your healthcare provider about all medical conditions, including if you or your child:

• Have heart problems, heart defects, 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 circulation problems in fingers and toes
• Are pregnant or plan to become pregnant. It is not known if Aptensio XR will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• There is a pregnancy registry for females who are exposed to Aptensio XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Aptensio XR and their babies. If you or your child become pregnant during treatment with Aptensio XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
• Are breastfeeding or plan to breastfeed. Aptensio XR passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Aptensio XR.

Possible serious side effects of Aptensio XR are heart-related problems, psychiatric disorders, circulation problems in fingers and toes, and slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Aptensio XR. Aptensio XR treatment may be stopped if a problem is found during these checkups. Painful and prolonged erections (priapism) have happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.

Common side effects include:

These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.

ADX-9-00282-1

Click here for Full Prescribing Information, including Limitations of Use and Boxed Warning.

Click here for Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Information provided is for educational use only and is intended to facilitate a discussion between you and your healthcare professional.

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