FENTANYL- fentanyl patch, extended release
Bryant Ranch Prepack
FENTANYL TRANSDERMAL SYSTEM CII
• Keep fentanyl transdermal system in a safe place away from children and pets. Accidental use by a child or pet is a medical emergency and may result in death. If a child or pet accidentally uses fentanyl transdermal system, get emergency help right away.
• Make sure you read the separate “Instructions for Applying a Fentanyl Transdermal System.” Always use a fentanyl transdermal system the right way. Fentanyl transdermal system can cause serious breathing problems and death, especially if it is used the wrong way.
• Fentanyl transdermal system is a federally controlled substance (C-II) because it can be abused. Keep fentanyl transdermal system in a safe place to prevent theft. Selling or giving away fentanyl transdermal system may harm others, and is against the law.
• Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines or street drugs.
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.
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:
Fentanyl transdermal system is only for adults and children over the age of two with persistent, moderate to severe chronic pain and who:
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.
Read the separate “Instructions for Applying a Fentanyl Transdermal System”.
A fever or increase in body temperature may cause too much of the medicine in fentanyl transdermal system to pass into your body.
Serious side effects include:
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.
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.
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.
Noven Pharmaceuticals, Inc.
Miami, FL 33186
Weston, FL 33326
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