Methylphenidate Topical: Uses, Side Effects and Dosage

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.

  • 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.
  • Methylphenidate transdermal system may lead to physical dependence after prolonged use, even if used as directed by your healthcare provider.
  • Do not give methylphenidate transdermal system to anyone else. See “What is methylphenidate transdermal system?” for more information.
  • 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.
  • 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 (patch) 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:

  • 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 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.

Methylphenidate transdermal system is not recommended for use in children under 6 years of age with ADHD. 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.

  • 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.

What are the possible side effects of methylphenidate transdermal system?

Methylphenidate transdermal system may cause serious side effects, including:

• See "What is the most important information I should know about methylphenidate transdermal system?"
• Seizures. Your child’s healthcare provider may stop treatment with methylphenidate transdermal system if your child has a seizure.
• Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If your child develops 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, or painful
  • fingers and toes may change color from pale, to blue, to red
• Tell your child’s healthcare provider if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
• Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with methylphenidate transdermal system.
• Slowing of growth (height and weight) in children. Your child should have their height and weight checked often during treatment with methylphenidate transdermal system. Your healthcare provider may stop your child’s methylphenidate transdermal system treatment if they are 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 methylphenidate transdermal system.
• Loss of skin color. Methylphenidate transdermal system may cause a persistent loss of skin-color where the patch is applied or around the patch application site. Loss of skin-color, in some cases, has been reported at locations on the skin far from any application site. The loss of skin-color may be permanent even after removing the patch or methylphenidate transdermal system is stopped. Call your healthcare provider right away if your child has changes in skin-color. Methylphenidate transdermal system treatment may be stopped if your child has changes in skin color.
• Allergic skin rash (contact sensitization). Stop using methylphenidate transdermal system and tell your child’s healthcare provider right away if your child develops swelling or blisters at or around the application site. Your child may have a skin allergy to methylphenidate transdermal system. People who have skin allergies to methylphenidate transdermal system may develop an allergy to all medicines that contain methylphenidate, even methylphenidate medicines taken by mouth.

The most common side effects of methylphenidate transdermal system in children 6 to 12 years old include:

• decreased appetite
• trouble sleeping
• nausea

• vomiting
• weight loss
• tics

• changes in mood
• trouble eating

The most common side effects of methylphenidate transdermal system in children 13 to 17 years old include:

• decreased appetite
• nausea
• trouble sleeping

• weight loss
• dizziness

• stomach pain
• trouble eating

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.

What are the ingredients in methylphenidate transdermal system?

Active ingredient: methylphenidate

Inactive ingredients: fluoropolymer-coated polyester release liner, hydrophobic colloidal silica, mineral oil, polyester/ethylene vinyl acetate laminate backing film and polyisobutylene adhesive. The white ink contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide.

Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Instructions for Use

Methylphenidate Transdermal System CII

(meth'' il fen' i date)

1. Methylphenidate Transdermal System Dosing Chart

Each carton of methylphenidate transdermal systems contains a methylphenidate transdermal system Dosing Chart to help you keep track of your methylphenidate transdermal system including:

• when you apply the transdermal system to the skin on your hip each morning
• when you remove the transdermal system
• how and where you threw the methylphenidate transdermal system away

To use the methylphenidate transdermal system Dosing Chart, follow these instructions:

• Each day, when a new methylphenidate transdermal system is applied to your hip, write down the date and time that you applied the transdermal system.
• Use the methylphenidate transdermal system schedule below so you can decide when to remove the transdermal system. For example, if the transdermal system is applied to the skin at 6:00 a.m., remove the transdermal system at 3:00 p.m. on the same day. After you remove and throw away the transdermal system, write down the time you removed the transdermal system and how and where you threw it away.

• If the transdermal system you placed on your child is missing, ask your child:

  • when the transdermal system came off
  • how the transdermal system came off
  • where the transdermal system is

Methylphenidate Transdermal System Schedule for 9 Hour Dosing

2. Where to apply methylphenidate transdermal system

• Apply the transdermal system to your hip area. Do not put the transdermal system near your waist. Clothing and movement may make your transdermal system rub off (See Figure A).
• Use your other hip when you apply a new transdermal system the next morning. Make sure there is no redness, small bumps or itching at the site where the transdermal system is going to be applied.

Figure A

3. Before you apply methylphenidate transdermal system

Make sure your skin:

• Is clean (freshly washed), dry, and cool
• Does not have any powder, oil, or lotion
• Does not have any cuts and irritation (rashes, inflammation, redness, or other skin problems).

4. How to apply methylphenidate transdermal system

• Each transdermal system is sealed in its own protective pouch.
• Carefully cut the protective pouch open with scissors, being careful not to cut the transdermal system.
• Do not use transdermal systems that have been cut or damaged in any way (See Figure B).

Figure B

• Remove the transdermal system from the protective pouch and discard additional piece of protective film above the transdermal system.
• Look at the transdermal system to make sure it is not damaged. The transdermal system should separate easily from the protective liner. Throw away the transdermal system if the protective liner is hard to remove.

The methylphenidate transdermal system has 4 layers. The 4 layers are pictured below. The pictures show both sides of the transdermal system:

Figure C Figure D

Layers:

• Protective liner: The protective liner is the layer that you remove before you put the transdermal system on (See Figure C).
• Adhesive layers with medicine: The adhesive layers with medicine consist of an adhesive reservoir layer that contains drug and an adhesive layer that sticks to your skin (See Figure C).
• Outside backing: The outside backing is the layer that you see after you put the transdermal system on your skin. The words “Methylphenidate Transdermal System” are printed on this layer (See Figure D).
• Apply the transdermal system right away after you remove the transdermal system from protective pouch.
• Hold the transdermal system with the hard protective liner facing you. The words “Methylphenidate Transdermal System” will appear backwards.
• Gently bend the transdermal system along the faint line and slowly peel one side of the liner, which covers the sticky surface of the transdermal system (See Figure E).

Figure E

• Avoid touching the sticky side of the transdermal system with your fingers.
• If you accidentally touch the sticky side of the transdermal system, apply the transdermal system, then wash your hands right away so that the medicine does not go into the skin on your hands.
• Using the other side of the protective liner as a handle, apply the sticky side of the transdermal system to the selected area of the child’s hip (See Figure F).

Figure F

• Press the sticky side of the transdermal system firmly into place and smooth it down.
• While you are still holding the sticky side down, gently fold back the other side of the transdermal system.
• Hold an edge of the remaining protective liner and slowly peel it off (See Figure G).

Figure G

• After the protective liner is removed, there should not be any adhesive (glue) sticking to the liner.

Figure H

• Press the entire transdermal system firmly into place with the palm of your hand over the transdermal system for about 30 seconds (See Figure H).
• Make sure that the transdermal system firmly sticks to your skin.
• Gently rub the edges of the transdermal system with your fingers to make sure the transdermal system sticks to your skin.
• Wash your hands after you apply your transdermal system.
• Write the time you applied your transdermal system on the dosing chart on the carton. Use the dosing schedule so you know what time you should remove your transdermal system.

5. How to remove and throw away methylphenidate transdermal system

• When you remove the transdermal system, peel it off slowly. If the transdermal system is too sticky on your skin and you need something to help you remove it:

  • Gently apply an oil-based product (petroleum jelly, olive oil, or mineral oil) to the transdermal system edges. Gently spread the oil underneath the transdermal system edges.
  • Apply an oil-based product or lotion to your skin if any adhesive (glue) remains after you remove your transdermal system. This will gently loosen and remove any adhesive that is left over.
  • If you still cannot easily remove the transdermal system, ask your doctor or pharmacist about what to do for this problem.
• Fold the used methylphenidate transdermal system in half and press it together firmly so that the sticky side sticks to itself. Flush the used transdermal system down the toilet.
• Do not flush the protective pouches or the protective liners down the toilet. These items should be thrown away in a container with a lid.
• Wash your hands after you handle the transdermal system.
• After you remove the transdermal system and throw the transdermal system away, write down the time on the dosing chart.

• Safely throw away any unused methylphenidate transdermal systems that are left over from the prescription as soon as they are no longer needed.

  To safely throw away the transdermal systems:

  • Remove the leftover transdermal systems from their protective pouches and remove the protective liners.
  • Either fold the transdermal systems in half with the sticky sides together, and flush the transdermal systems down the toilet, or
  • 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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Revised: 10/2025

MPN:R8