DAYTRANA - methylphenidate patch 
Noven Therapeutics, LLC

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MEDICATION GUIDE
Daytrana® (day-TRON-ah)
(methylphenidate transdermal system) CII

Only Use Daytrana on Your Skin

Important:


Daytrana is a controlled substance (CII) because it can be abused or lead to dependence. Keep Daytrana in a safe place to protect it from theft. Selling or giving away Daytrana 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.

Read this Medication Guide before you start using Daytrana and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Daytrana?

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

1. Heart problems, including:

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

Remove the Daytrana patch and call your doctor right away if you have any signs of heart problems such as:

2. Mental (psychiatric) problems, including:

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

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

What Is Daytrana?

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

It is not known if Daytrana is safe and effective in children younger than 6 years.

Who should not use Daytrana?

Do not use Daytrana if you:

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

What should I tell my doctor before using Daytrana?

Before you start using Daytrana, tell your doctor if you have:

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Daytrana and certain other medicines may affect each other, causing serious side effects.

Especially tell your doctor if you take:

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 Daytrana without talking to your doctor first.

How should I use Daytrana?

What should I avoid while using Daytrana?

What are possible side effects of Daytrana?

Daytrana may cause serious side effects, including:

Stop using Daytrana 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 Daytrana. People who have skin allergies to Daytrana may develop an allergy to all medicines that contain methylphenidate, even those methylphenidate medicines that are taken by mouth.

The most common side effects of Daytrana include:

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 Daytrana. 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 Daytrana?

Keep Daytrana and all medicines out of the reach of children.

General information about Daytrana

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Daytrana for a condition for which it was not prescribed. Do not give Daytrana 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 Daytrana. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Daytrana that is written for health professionals.

For more information, go to www.daytrana.com, or call 1-877-567-7857.

What are the ingredients in Daytrana?

Active ingredient: methylphenidate

Inactive ingredients: acrylic adhesive, silicone adhesive

Instructions for Applying Daytrana

1 Daytrana Dosing Chart

Each carton of Daytrana contains a Daytrana Dosing Chart to help you keep track of your patch including:

To use the Daytrana Dosing Chart, follow these instructions:

Daytrana Schedule for 9 Hour Dosing

If you put the patch on at:On the same day, remove the patch
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 Daytrana

daytrana-ppi-fig1

Figure A

3. Before you apply Daytrana

Make sure your skin:

4. How to apply Daytrana

daytrana-ppi-fig2

Figure B

The Daytrana patch has 3 layers. The 3 layers are pictured below. The pictures show both sides of the patch:

daytrana-patch

                             Figure C                                                                  Figure D

Layers:

daytrana-ppi-fig3

Figure E

daytrana-ppi-fig4

Figure F

daytrana-ppi-fig5

Figure G

daytrana-ppi-fig6

Figure H

5. How to remove and throw away Daytrana

Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.

By: Noven Pharmaceuticals, Inc., Miami, FL 33186.
© 2009, 2013 Noven Pharmaceuticals, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 10/2013

102086-13

Revised: 12/2013
 
Noven Therapeutics, LLC