IMPORTANT SAFETY INFORMATION
What is the most important information I should know about FOCALIN XR?
FOCALIN XR is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN XR
in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN XR may harm others, and is against the law.
Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take FOCALIN XR?
FOCALIN XR should not be taken if you or your child:
- are allergic to methylphenidate hydrochloride, or any of the ingredients in FOCALIN XR.
- are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:
- Heart-related problems: Sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults,
increased blood pressure and heart rate. Tell your doctor if you or your child have any heart problems, heart defects, high blood
pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting
FOCALIN XR and then check blood pressure and heart rate regularly during treatment with FOCALIN XR. Call your doctor right
away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking
- Mental (psychiatric) problems: New or worse behavior and thought problems, new or worse bipolar illness, new or worse
aggressive behavior or hostility, new psychotic symptoms (such as hearing voices, believing things that are not true, are
suspicious) or new manic symptoms. Tell your doctor about any mental problems you or your child have, or about a family history
of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental
symptoms or problems while taking FOCALIN XR, especially seeing or hearing things that are not real, believing things that
are not real, or are suspicious.
FOCALIN XR may not be right for you or your child.
Before starting FOCALIN XR, tell your or your child’s doctor about all health conditions (or family history) including:
- if you are pregnant or plan to become pregnant. It is not known if FOCALIN XR will harm your unborn baby.
- There is a pregnancy registry to collect information about the health of pregnant females exposed to FOCALIN XR and their baby.
If you or your child becomes pregnant during treatment with FOCALIN XR, talk to your healthcare provider about registering with
the National Pregnancy Registry of ADHD medications at 1-866-961-2388 or visit online at
- if you are breastfeeding or plan to breastfeed. FOCALIN XR passes into your breast milk. Talk to your healthcare provider about the
best way to feed the baby during treatment with FOCALIN XR.
Tell your doctor about all of the medicines that you or your child takes, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Do not start any new medicine while taking FOCALIN XR without talking to your doctor first.
What are the possible side effects of FOCALIN XR?
FOCALIN XR may cause serious side effects, including:
- painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek
medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
- circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon), where fingers or toes may
feel numb, cool, painful, or may change color from pale, to blue, to red. Tell your doctor if you or your child have numbness, pain, skin
color change, or sensitivity to temperature in the fingers or toes.
- Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking FOCALIN XR.
- slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking
FOCALIN XR. Treatment may be stopped if a problem is found during these check-ups.
Common side effects include:
- Children (6–17 years): Dyspepsia, decreased appetite, headache, anxiety
- Adults: Dry mouth, dyspepsia, headache, anxiety, pharyngolaryngeal pain
FOCALIN XR can be taken with or without food. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or
your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it
right away without chewing.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.