The Ionsys transdermal device contains fentanyl, an opioid pain medication. An opioid is sometimes called a narcotic.

Ionsys is a patient-controlled medicine system used only in a hospital to treat acute pain after surgery.

The Ionsys transdermal device sticks to the skin of your arm or chest.

You should not use an Ionsys transdermal device if you have: a severe breathing problem, or a blockage in your stomach or intestines.

The Ionsys transdermal device is used only while you are in a hospital. You will not be allowed to use the device at home. Do not leave the hospital with this device on your skin.

Fentanyl can slow or stop your breathing. Use this device only as directed. Never allow a family member or visitor to touch or handle the Ionsys transdermal device. It should be handled only by a healthcare professional.

MISUSE OF IONSYS CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a person using the medicine without a prescription. Fentanyl may also be habit-forming. Never share an Ionsys transdermal device with another person, especially someone with a history of drug abuse or addiction.

Fentanyl may cause life-threatening withdrawal symptoms in a newborn if the mother uses Ionsys se the mediduring pregnancy.

Do not drink alcohol. Dangerous side effects or death could occur.

The Ionsys transdermal device may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the device before undergoing such a test.

Ionsys is used only while you are in a hospital. A healthcare provider will place the device on your chest or upper arm where you can reach it. A healthcare provider should also remove or replace the device when needed. Do not leave the hospital with a device on your skin.

Fentanyl can slow or stop your breathing. Use this device only as directed.

Fentanyl may be habit-forming, even at regular doses. Never share an Ionsys transdermal device with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a person using the medicine without a prescription. Selling or giving away Ionsys is against the law.

To release fentanyl from the device, press the dosing button twice. A beep will sound when the dose starts, and a green light will blink for 10 minutes while the dose is delivered. The device can only be activated once every 10 minutes. Tell your doctor if Ionsys seems to stop working as well in relieving your pain.

While you are wearing this device, only you should press the dosing button to control your pain. Do not allow others to press the dosing button for you, or you could receive a fatal overdose.

Never allow a family member or visitor to touch or handle the Ionsys transdermal device. It should be handled only by a healthcare professional. Do not remove or reposition the device yourself. The sticky side of the device contains a high concentration of fentanyl, which could cause a fatal overdose if the medicine gets on your skin. Tell your care provider if the device comes loose or falls off.

The device is worn for 24 hours or until it has delivered 80 doses of fentanyl.

The Ionsys transdermal device may burn your skin if you wear the device during an MRI (magnetic resonance imaging). Certain other medical tests can cause damage to the Ionsys transdermal device. Remove the device before undergoing an MRI, CT scan, x-ray, or similar test.

You should not use Ionsys if you are allergic to fentanyl or to Cepacol (cetylpyridinium chloride), or if you have:

• a severe breathing problem such as asthma attacks; or

• a blockage in your digestive tract (stomach or intestines).

Some medicines can cause unwanted or dangerous effects when used with Ionsys. You may not be able to use this medicine if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat hepatitis C or HIV/AIDS. Tell your doctor about all medicines you use.

Some medicines can interact with fentanyl and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Ionsys is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, mental illness, alcoholism or drug addiction;

• slow heartbeats;

• seizures or epilepsy;

• urination problems;

• liver or kidney disease; or

• problems with your gallbladder, pancreas, or thyroid.

It is not known whether Ionsys will harm an unborn baby. If you use Ionsys while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Fentanyl can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since Ionsys is applied by a healthcare professional in a hospital setting, it is not likely that you will miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

This medication is for use only on the skin. Avoid touching the gel inside a device with your fingers. Only a healthcare provider wearing gloves should handle an Ionsys transdermal device.

Do not drink alcohol. Dangerous side effects or death could occur.

This medication may impair your thinking or reactions. Do not drive or operate machinery until you know how Ionsys has affected you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction to Ionsys: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have any of these serious side effects:

• a light-headed feeling, like you might pass out;

• severe weakness,

• slow heart rate, sighing, weak or shallow breathing;

• cold, clammy skin;

• low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• symptoms of serotonin syndrome - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Breathing problems may be more likely in older adults.

Common Ionsys side effects may include:

• nausea, vomiting;

• feeling dizzy or light-headed;

• headache;

• painful or difficult urination;

• low red blood cells; or

• itching or redness where the device was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make Ionsys less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.