METHYLPHENIDATE- methylphenidate patch 
Mylan Pharmaceuticals Inc.

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Medication Guide

Methylphenidate Transdermal System     CII
(meth'' il fen' i date)

Only Use Methylphenidate Transdermal System on Your Skin

Important:

Methylphenidate transdermal system is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate transdermal system in a safe place to protect it from theft. Selling or giving away methylphenidate transdermal system may harm others and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicine or street drugs.

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

Methylphenidate transdermal system contains methylphenidate which is a central nervous system (brain) stimulant medicine. Serious side effects have been reported with methylphenidate transdermal system or other stimulant medicines, including:

1. Heart problems, including:

sudden death in people who have heart problems or heart defects
stroke and heart attack in adults
increased blood pressure and heart rate

Your doctor should check you carefully for blood pressure and heart problems before you start and while you are using methylphenidate transdermal system.

Remove the methylphenidate transdermal system and call your doctor right away if you have any signs of heart problems such as:

chest pain
shortness of breath
fainting

2. Mental (psychiatric) problems, including:

new or worse aggressive behavior, hostility, anger, or irritability
new or worse bipolar illness or mania (an extreme increase in activity or talking)
new or worse psychosis (hearing or seeing things that are not real, being suspicious or distrustful, believing things that are not true)
other unusual or extreme changes in behavior or mood

Tell your doctor right away if you have any new or worsening mental problems while using methylphenidate transdermal system.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or 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 your 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 methylphenidate transdermal system

What is methylphenidate transdermal system?

Methylphenidate transdermal system is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 to 17 years old. Methylphenidate transdermal system is a central nervous system (brain) stimulant medicine. Methylphenidate transdermal system may help you have better attention and less impulsive and hyperactive behavior. Methylphenidate transdermal system is a transdermal system that you apply to your skin on your hip. Methylphenidate transdermal system is used as part of a total treatment program for ADHD that may also include counseling or other treatments.

It is not known if methylphenidate transdermal system is safe and effective in children younger than 6 years.
Who should not use methylphenidate transdermal system?
Do not use methylphenidate transdermal system if you:

are very anxious, tense, or agitated
have glaucoma
have tics (involuntary repeated movements or sounds that cannot be controlled)
have Tourette’s Syndrome or a family history of this syndrome
are taking or have taken a monoamine oxidase inhibitor (MAOI) medicine within the past 2 weeks. Do not take a MAOI medicine for at least 2 weeks before using methylphenidate transdermal system. Ask your doctor or pharmacist if you are not sure if any of your medicines are MAOIs.
are allergic to methylphenidate or any other ingredients in methylphenidate transdermal system. See “What are the ingredients in methylphenidate transdermal system?” for a complete list of ingredients.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my doctor before using methylphenidate transdermal system?

Before you start using methylphenidate transdermal system, tell your doctor if you:

have heart problems, heart defects, high blood pressure
have mental problems including psychosis, mania, bipolar illness, or depression
have seizures or have had an abnormal brain wave test (EEG)
have circulation problems in fingers or toes
have skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)
are pregnant or plan to become pregnant. It is not known if methylphenidate transdermal system will harm your unborn baby.
o
There is a pregnancy registry for females who are exposed to ADHD medications, including methylphenidate transdermal system during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate transdermal system and their baby. If you or your child becomes pregnant during treatment with methylphenidate transdermal system, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
are breast feeding or plan to breast feed. Methylphenidate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with methylphenidate transdermal system.
a history of vitiligo and/or a family history of vitiligo

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Methylphenidate transdermal system and certain other medicines may affect each other, causing serious side effects.

Especially tell your doctor if you take:

a monoamine oxidase inhibitor (MAOI) medicine See “Who should not use methylphenidate transdermal system?”
medicines to treat depression
medicines to treat seizures
a blood pressure medicine
a blood thinner medicine
cold or allergy medicines that contain decongestants

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist. Do not start any new medicine while using methylphenidate transdermal system without talking to your doctor first.

How should I use methylphenidate transdermal system?

Read the Patient Instructions for Use at the end of this Medication Guide that comes with your methylphenidate transdermal system for information about the right way to use methylphenidate transdermal system.
Use methylphenidate transdermal system exactly as your doctor tells you to.
Your doctor may change your dose if needed.
Apply methylphenidate transdermal system to your hip 2 hours before an effect is needed.
Do not wear methylphenidate transdermal system longer than 9 hours a day.
Apply methylphenidate transdermal system to a different hip each day.
Do not cut methylphenidate transdermal systems.
Parents or caregivers should apply and remove methylphenidate transdermal system for their child if the child is not responsible enough to do so.
Your doctor may stop methylphenidate transdermal system treatment to check your ADHD symptoms.
Your doctor may do certain blood tests and check your heart and blood pressure while you use methylphenidate transdermal system.
If you forget to apply a transdermal system in the morning, you may apply the transdermal system later in the day. You should remove your transdermal system at the usual time of day to lower the chance of side effects later in the day.
If you have loss of appetite or trouble sleeping in the evening, ask your doctor if you can take the transdermal system off earlier in the day.
Contact with water while bathing, swimming, or showering can make the transdermal system not stick well or make it fall off. If your transdermal system falls off, do not touch the sticky side of the transdermal system with your fingers. You may apply a new transdermal system to a different area on the same hip. If you have to replace a transdermal system that has fallen off, the total wear time for the first and second transdermal system should not be more than a total of 9 hours in 1 day. Do not reapply the same transdermal system that fell off.
Do not wear your methylphenidate transdermal system longer than 9 hours.
If you accidentally apply or wear more than 1 transdermal system at a time, you have used too many methylphenidate transdermal systems. Remove all transdermal systems, wash the application sites right away and call your doctor.
o
Call your Poison Control Center at 1-800-222-1222 -or go to the nearest hospital emergency room right away if you have:
o
vomiting
o
agitation
o
shaking
o
confusion or mental changes
o
see things that are not there (hallucinations)
o
sweating
o
redness in your face
o
headache
o
heartbeat changes

What should I avoid while using methylphenidate transdermal system?

Do not put any medicine, cream, or lotion on your hip before you apply the methylphenidate transdermal system. Medicines, creams or lotions may affect how the transdermal system sticks to your skin and how the medicine is absorbed from the transdermal system.
Do not use bandages, tape, or other household adhesives (glue) to hold the transdermal system onto your skin.
Do not use hair dryers, heating pads, electric blankets, heated water beds or other heat sources while wearing a methylphenidate transdermal system. Too much medicine can pass into your body and cause serious side effects.
Do not drive, operate heavy machinery or do other dangerous activities until you know how methylphenidate transdermal system affects you.

What are 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. This usually happens in people with a history of seizures.
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.
Slowing of growth (weight and height). You should have your height and weight checked while using methylphenidate transdermal system.
Loss of skin color (chemical leukoderma). Methylphenidate transdermal system may cause a persistent loss of skin-color where the transdermal system is applied or around the transdermal system 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 your skin-color may be permanent even after removing the transdermal system or stopping use of methylphenidate transdermal system. Call your doctor immediately if you have changes in your skin-color.
Allergic skin rash. Stop using methylphenidate transdermal system and see your doctor right away if you have swelling or blisters at or around the application site. You 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 those methylphenidate medicines that are taken by mouth.
Eyesight changes or blurred vision

The most common side effects of methylphenidate transdermal system include:

skin problems where you apply
 
methylphenidate transdermal
 
system (redness, small
 
bumps, itching)
poor appetite
nausea
vomiting
stomach pain
weight loss
tics
trouble sleeping
mood swings
dizziness

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of methylphenidate transdermal system. For more information, ask your doctor or pharmacist.

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).
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.

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 that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about methylphenidate transdermal system. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate transdermal system that is written for health professionals.

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

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.

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 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:
o
when the transdermal system came off
o
how the transdermal system came off
o
where the transdermal system is

Methylphenidate Transdermal System Schedule for 9 Hour Dosing

If you put the transdermal system on at:

On the same day, remove the transdermal system at:

5:00 a.m.

2:00 p.m.

6:00 a.m.

3:00 p.m.

7:00 a.m.

4:00 p.m.

8:00 a.m.

5:00 p.m.

9:00 a.m.

6:00 p.m.

10:00 a.m.

7:00 p.m.

11:00 a.m.

8:00 p.m.

12:00 p.m.

9:00 p.m.

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

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

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 and Figure D

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

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

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

Figure G

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

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:
o
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.
o
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.
o
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 or put the transdermal system in a container with a lid right away.
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:
o
Remove the leftover transdermal systems from their protective pouches and remove the protective liners.
o
Either fold the transdermal systems in half with the sticky sides together, and flush the transdermal systems down the toilet, or
o
Throw the transdermal systems away in a container with a lid.


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

The brands listed are trademarks of their respective owners.

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


Revised: 7/2021
MPN:R4

Revised: 7/2021
Mylan Pharmaceuticals Inc.