FENTANYL TRANSDERMAL SYSTEM, CII
Fentanyl transdermal system is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock
pain, in people who are already regularly using opioid pain medicine.
Important information about Fentanyl transdermal system:
- Get emergency help right away if you use too much Fentanyl transdermal system (overdose). Fentanyl transdermal system
overdose can cause life threatening breathing problems that can lead to death.
- Never give anyone else your Fentanyl transdermal system. They could die from using it. Store Fentanyl transdermal system
away from children and in a safe place to prevent stealing or abuse. Selling or giving away Fentanyl transdermal system is
against the law.
Do not use Fentanyl transdermal system if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before applying Fentanyl transdermal system, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you:
- have a fever
- are pregnant or planning to become pregnant. Fentanyl transdermal system may harm your unborn baby.
- are breastfeeding. Fentanyl transdermal system passes into breast milk and may harm your baby.
- are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
When using Fentanyl transdermal system:
- Do not change your dose. Apply Fentanyl transdermal system exactly as prescribed by your healthcare provider.
- See the detailed Instructions for Use for information about how to apply and dispose of the Fentanyl transdermal system patch.
- Do not wear more than 1 patch at the same time unless your healthcare provider tells you to.
- Call your healthcare provider if the dose you are using does not control your pain.
- Do not stop using Fentanyl transdermal system without talking to your healthcare provider.
While using Fentanyl transdermal system Do Not:
- Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps,
or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
- Drive or operate heavy machinery, until you know how Fentanyl transdermal system affects you. Fentanyl transdermal system
can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
The possible side effects of Fentanyl transdermal system are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, itching, redness, or rash where
the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness,
or you are feeling faint.
These are not all the possible side effects of Fentanyl transdermal system. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. For questions about fentanyl transdermal system, please call Upsher-Smith Laboratories, Inc. at 1-855-899-9180. If this
is a medical emergency, please call 911.
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN 55369
This Medication Guide has been approved by the U.S. FDA. Issue: July 2012
Upsher-Smith Laboratories, Inc.