Medication Guide

Important: Methylphenidate Transdermal System is for use on the skin only.

What is the most important information I should know about methylphenidate transdermal system?

Methylphenidate transdermal may cause serious side effects including:

•

Abuse, misuse, and addiction. Methylphenidate transdermal system has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate transdermal system, 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 methylphenidate transdermal system or when it is used in ways that are not approved, such as snorting or injection.

o

Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate transdermal system and will monitor your child during treatment.

o

Methylphenidate transdermal system may lead to physical dependence after prolonged use, even if used as directed by your healthcare provider.

o

Do not give methylphenidate transdermal system to anyone else. See “What is methylphenidate transdermal system?” for more information.

o

Keep methylphenidate transdermal system in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate transdermal system?” for more information.

o

Tell your healthcare provider if your child has 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 child’s healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using methylphenidate transdermal system. Tell your child’s healthcare provider if your child has any heart problems, heart disease or heart defects.
 
Remove the methylphenidate transdermal system and call your child’s healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methylphenidate transdermal system.
 

•

Increased blood pressure and heart rate.
Your child’s healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with methylphenidate transdermal system.

•

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 manic symptoms

 

Tell your child’s healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.

 

Call your child’s healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with methylphenidate transdermal system, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.

What is methylphenidate transdermal system?

Methylphenidate transdermal system is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. Methylphenidate transdermal system may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD.

It is not known if methylphenidate transdermal system is safe and effective in children younger than 6 years.

Methylphenidate transdermal system 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 methylphenidate transdermal system in a safe place to protect it from theft. Never give your methylphenidate transdermal system to anyone else because it may cause death or harm them. Selling or giving away methylphenidate transdermal system may harm others and is against the law.

Do not use methylphenidate transdermal system if your child:

•

is allergic to methylphenidate or any of the ingredients in methylphenidate transdermal system. See the end of this Medication Guide for a complete list of ingredients in methylphenidate transdermal system.

•

is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)

Before using methylphenidate transdermal system, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:

•

has heart problems, heart disease, heart defects, or high blood pressure

•

has mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide bipolar illness, or depression

•

has seizures or have had an abnormal brain wave test (EEG)

•

has circulation problems in fingers or toes

•

has skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)

•

has a history of vitiligo or a family history of vitiligo

•

has eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)

•

has or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome

•

is pregnant or plans to become pregnant. It is not known if methylphenidate transdermal system will harm the unborn baby. Tell your child’s healthcare provider if your child becomes pregnant during treatment with methylphenidate transdermal system.

o

There is a pregnancy registry for females who are exposed to methylphenidate transdermal system during pregnancy. The purpose of the registry is to collect information about the health of women exposed to methylphenidate and their baby. If your child becomes pregnant during treatment with methylphenidate transdermal system, talk to your child’s healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.

•

is breast feeding or plan to breast feed. Methylphenidate passes into breast milk. Talk to your child’s healthcare provider about the best way to feed the baby during treatment with methylphenidate transdermal system.

•

a history of vitiligo and/or a family history of vitiligo

Tell your child’s healthcare provider about all of the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Methylphenidate transdermal system 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 methylphenidate transdermal system. Your child’s healthcare provider will decide if methylphenidate transdermal system can be used with other medicines.

Especially tell your child’s healthcare provider if your child takes:

•

blood pressure medicines (anti-hypertensive)

Know the medicines that your child takes. Keep a list of your child’s medicines with you to show your child’s healthcare provider and pharmacist when your child gets a new medicine.
Do not start any new medicine while using methylphenidate transdermal system without first talking to your child’s healthcare provider.

How should methylphenidate transdermal system be used?

•

See the detailed “Instructions for Use” at the end of this Medication Guide for information about the right way to apply, remove, and dispose of methylphenidate transdermal system.

•

Use methylphenidate transdermal system exactly as prescribed by your child’s healthcare provider.

•

Your child’s healthcare provider may change the dose if needed.

•

Apply methylphenidate transdermal system to the hip area 2 hours before an effect is needed and remove methylphenidate transdermal system within 9 hours after it is applied. Do not wear methylphenidate transdermal system longer than 9 hours a day.

•

If methylphenidate transdermal system falls off, a new patch may be applied to a different area of the same hip.

•

If you forget to apply methylphenidate transdermal system at your usual scheduled time each day, you may apply the patch later in the day. The patch should be removed at the usual time of day to lower the chance of side effects later in the day.

•

If your child has loss of appetite or trouble sleeping in the evening, ask your child’s healthcare provider if your child can take the patch off earlier in the day.

•

Contact with water while bathing, swimming, or showering can make the patch not stick well.

•

Do not use bandages, tape, or other household adhesives (glue) to hold the patch onto the skin.

If your child uses too many methylphenidate transdermal systems call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should your child avoid while using methylphenidate transdermal system?

•

After applying the methylphenidate transdermal system, avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds or other heat sources. Exposure to heat can cause too much medicine to pass into the body and cause serious side effects.

Methylphenidate transdermal system may also cause skin problems where it is applied (redness, small bumps, itching).

Your child’s doctor may do certain blood tests while your child uses methylphenidate transdermal system.

These are not all the possible side effects of methylphenidate transdermal system.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store methylphenidate transdermal system?

•

Store methylphenidate transdermal system at room temperature between 20° to 25°C (68° to 77°F).

•

Store methylphenidate transdermal system in a safe place, like a locked cabinet.

•

Do not store methylphenidate transdermal system in the refrigerator or freezer.

•

Keep methylphenidate transdermal systems in their unopened pouches until you are ready to use them.

•

Dispose of remaining, unused, or expired methylphenidate transdermal system 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, each unused patch should be removed from its individual pouch, separated from the protective liner, folded in half so that the sticky sides stick together, and flushed down the toilet. Put the pouch and liner in a container with a lid, close the container and throw away the container in the household trash. Do not flush the pouch and liner down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

 
Keep methylphenidate transdermal system and all medicines out of the reach of children.

General information about the safe and effective use of methylphenidate transdermal system.

 Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate transdermal system for a condition for which it was not prescribed. Do not give methylphenidate transdermal system to other people, even if they have the same symptoms. It may harm them and it is against the law.

 
You can ask your pharmacist or healthcare provider for information about methylphenidate transdermal system that is written for healthcare professionals.