MEDICATION GUIDE

Read the Medication Guide that comes with fentanyl transdermal system before you start using it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Make sure you read and understand all the instructions for using fentanyl transdermal system. Do not use fentanyl transdermal system unless you understand everything. Talk to your healthcare provider if you have questions.

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

Fentanyl transdermal system is a skin patch that contains fentanyl.

Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems. Serious and life-threatening breathing problems can happen because of an overdose or if the dose you are using is too high for you. Call your doctor right away or get emergency medical help if you:

• have trouble breathing, or have slow or shallow breathing
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally
• have a seizure
• have hallucinations

Fentanyl transdermal system is only for adults and children over the age of two with persistent, moderate to severe chronic pain and who:

• are already using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. This is called being opioid-tolerant
• have pain that cannot be controlled with other medicines

Do not use fentanyl transdermal system:

• if you are not already using another opioid narcotic medicine and are not opioid tolerant
• if you need opioid pain medicines for only a short time
• for pain from surgery, medical or dental procedures
• if your pain can be taken care of by occasional use of other pain medicines
• in children who are less than 2 years of age
• if you have asthma symptoms or have severe asthma

A fentanyl transdermal system must be used only on the skin of the person for whom it was prescribed. If the system comes off and accidentally sticks to the skin of another person, take the system off of that person right away, wash the area with water, and get medical care for them right away.

Fentanyl transdermal system is not safe for everyone. Tell your doctor about all of your medical conditions.

Tell your doctor if you are planning to become pregnant, are pregnant, or breastfeeding. Fentanyl transdermal system may cause serious harm to a baby.

Tell your doctor about all the medicines you take. Some medicines may cause serious or life-threatening side effects when used with fentanyl transdermal system. Your doctor will tell you if it is safe to take other medicines while you are using fentanyl transdermal system.

Know the medicines you take. Keep a list of your medicines to show to your doctor and pharmacist.

How should I use fentanyl transdermal system?

Read the separate “Instructions for Applying a Fentanyl Transdermal System”.

• You must always use fentanyl transdermal systems the right way:
  • Do not use a fentanyl transdermal system if the pouch seal is broken, or the system is cut, damaged, or changed in any way.
  • Do not use heat sources such as heating pads, electric blankets, heat lamps, tanning lamps, saunas, hot tubs, or heated waterbeds while wearing a fentanyl transdermal system.
  • Do not take hot baths or sunbathe while wearing a fentanyl transdermal system.
• If you have problems with the fentanyl transdermal system not sticking:

1. Apply first aid tape only to the edges of the system.
2. If problems with the system not sticking persist, cover the system with Bioclusive™. This is a special see-through adhesive dressing.
   Never cover a fentanyl transdermal system with any other bandage or tape.

• If your fentanyl transdermal system falls off before 3 days or 72 hours, fold the sticky side together and flush down a toilet. Put a new one on at a different skin site.
• Do not change your dose unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use fentanyl transdermal system more often than prescribed. Call your doctor if your pain is not well controlled while using fentanyl transdermal system.
• Do not stop using fentanyl transdermal system suddenly. Stopping fentanyl transdermal system suddenly can make you sick with withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering). Your body can develop a physical dependence on fentanyl transdermal system. If your doctor decides you no longer need fentanyl transdermal system, ask how to slowly reduce this medicine so you don’t have withdrawal symptoms. Do not stop taking fentanyl transdermal system without talking to your doctor.
• Do not wear more than one fentanyl transdermal system at a time, unless your doctor tells you to do so.
• Call your doctor right away if
  • You get a fever higher than 102°F
  • Your body temperature increases from exercise

A fever or increase in body temperature may cause too much of the medicine in fentanyl transdermal system to pass into your body.

• If you use more fentanyl transdermal system than your doctor has prescribed, get emergency medical help right away.
• Do not drink any alcohol while using fentanyl transdermal system. Alcohol can increase your chances of having serious side effects.
• Do not drive, operate heavy machinery, or do other possibly dangerous activities until you know how fentanyl transdermal system affects you. Fentanyl transdermal system can make you sleepy. Ask your doctor to tell you when it is okay to do these activities.
• When you remove your fentanyl transdermal system, fold the sticky sides of a used fentanyl transdermal system together and flush it down the toilet. Do not put used fentanyl transdermal systems in a trash can.

What are the possible side effects of fentanyl transdermal system?

Serious side effects include:

• Life-threatening breathing problems. See “What is the most important information I should know about fentanyl transdermal system?”
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

The common side effects with fentanyl transdermal system are nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, sweating, and pain and redness where the system was applied.

Constipation is a very common side effect of all opioid medicines. Talk to your health practitioner about the use of laxatives and stool softeners to prevent or treat constipation while taking fentanyl transdermal system.

Talk to your health practitioner about any side effect that concerns you.

These are not all the possible side effects of fentanyl transdermal system. For a complete list, 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 fentanyl transdermal system?

• Store in original unopened pouch up to 25°C (77°F).
• Keep a fentanyl transdermal system in its protective pouch until you are ready to use it.
• Keep fentanyl transdermal system in a safe place out of the reach of children and pets.
• Dispose of fentanyl transdermal systems you no longer need. Open the unused packages, fold the sticky sides of the systems together, and flush them down the toilet.

General information about the safe and effective use of fentanyl transdermal system

• Do not use fentanyl transdermal system for a condition for which it was not prescribed.
• Do not give fentanyl transdermal system to other people, even if they have the same symptoms you have. Fentanyl transdermal system can harm other people and even cause death. Sharing fentanyl transdermal system is against the law.

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

For questions about fentanyl transdermal system, please call Apotex Corp. at 1-888-333-6127, 9 A.M. to 5 P.M. Eastern Time, Monday through Friday. If this is a medical emergency, please call 911.

What are the ingredients of fentanyl transdermal system?

Active Ingredient: Fentanyl

Inactive Ingredients: Polyisobutylene, Mineral Oil, Isopropyl Myristate, Polyester Films.

This Medication Guide has been approved by the United States Food and Drug Administration.

Bioclusive™ is a trademark of Ethicon, Inc.

Manufactured by:
Noven Pharmaceuticals, Inc.
Miami, FL 33186

Manufactured for:
Apotex Corp.
Weston, FL 33326

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444