Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity
IMPORTANT SAFETY INFORMATION
Aptensio XR is a federally controlled substance (CII) because it can be abused or lead to
dependence. Keep Aptensio XR in a safe place to prevent misuse and abuse. Selling or giving
away Aptensio XR may harm others and is against the law.
Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Aptensio XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Aptensio XR, or are taking or have taken within the past
14 days an antidepressant called a monoamine oxidase inhibitor (MAOI).
Heart-related problems have been reported with methylphenidate hydrochloride and other stimulant medications:
• Sudden death in patients who have heart problems or heart defects
• Stroke and heart attack in adults
• Increased blood pressure and heart rate
Your physician should check your or your child’s blood pressure and heart rate regularly during treatment with Aptensio XR.
Psychiatric disorders have been reported with methylphenidate hydrochloride and other stimulant medications:
• New or worse behavior and thought problems
• New or worse bipolar illness
Children and Teenagers
• New psychotic symptoms, such as hearing voices, believing things that are not true, and being overly suspicious
• New manic symptoms
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon) have been reported with methylphenidate hydrochloride and other stimulant
• Fingers or toes may feel numb, cool, or painful
• Fingers or toes may change color from pale, to blue, to red
Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
Call your physician 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
(psychiatric) symptoms or new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking Aptensio XR.
Aptensio XR may not be right for you or your child. Before starting Aptensio XR tell your or your child’s physicians about all health conditions (or a family history of) including:
• Heart problems, heart defects, high blood pressure
• Mental problems, including psychosis, mania, bipolar illness, or depression
• Circulation problems in fingers and toes
• If you are pregnant or plan to become pregnant. It is not known if Aptensio XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become
• If you are breastfeeding or plan to breast-feed. Aptensio XR passes into your breast milk. You and your doctor should decide if you will take Aptensio XR or breast-feed
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 while taking Aptensio XR. Aptensio XR treatment may be stopped if a problem is
found during these checkups. Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away.
Because of the potential for lasting damage, priapism should be evaluated by a physician immediately.
Common side effects include:
• Decreased appetite
• Weight loss
• Stomach pain
• Dry mouth
• Trouble sleeping
• Mood swings
• Shaking (tremor)
• Blurred vision
• Increased blood pressure
• Fast heart beat
• Increased sweating
Talk to your physician if you or your child have side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your physician or pharmacist for more information.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch
, or call 1-800-FDA-1088.
Information provided is for educational use only and is intended to facilitate discussion between you and the healthcare
is sponsored by Rhodes Pharmaceuticals, L.P. This information is intended for use by our customers, patients and
healthcare professionals in the United States only.