Fentanyl (transdermal route)

It is very important that your doctor check your or your child's progress while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may needed to check for unwanted effects.

Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking this medicine or about how it may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Fentanyl is a medicine that can harm or cause death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully dispose of any partially used units or unused medicine properly.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed while you are using this medicine.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Heat can cause the fentanyl in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water. Also, check with your doctor if you get a fever.

Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Do not touch the sticky side of the patch or the gel. Fentanyl can be quickly absorbed through the eyes and mouth and can be extremely dangerous. If you do touch the sticky side of the patch or gel, let your nurse or doctor know right away and rinse the area with large amounts of water. Do not use soaps or other cleansers.

Check with your doctor at regular times while using fentanyl. Be sure to report any side effects.

After you have been using this medicine for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of fentanyl skin patch or other opioid that you are using without first checking with your doctor.

The Ionsys® patch must be removed before a procedure called a magnetic resonance imaging (MRI) scan. It may cause skin burns if left in place during the procedure.

The Ionsys® patch may cause serious skin reactions. Call you doctor right away if you have blistering, lesions, a rash, redness, or swelling of the skin, especially at the site of application.

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Nausea or vomiting may occur, especially during the first several days of treatment. Lying down for a while may relieve these effects. However, if they are especially bothersome or if they continue for more than a few days, check with your doctor. You may be able to take another medicine to help prevent these problems.

Using opioids for a long time may cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as when you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using fentanyl.

You may bathe, shower, or swim while wearing a fentanyl skin patch. However, be careful to wash and dry the area around the patch gently. Rubbing may cause the patch to get loose or come off. If this does occur, throw away the patch and apply a new one in a different place. Make sure the area is completely dry before applying the new patch.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal symptoms.

Using too much fentanyl skin patch, or taking too much of another opioid with fentanyl skin patch, may cause an overdose. If this occurs, get emergency help right away. Your healthcare provider may prescribe naloxone to treat an overdose. Naloxone is a medicine that can temporarily reverse the effects of an overdose. If you have been prescribed naloxone, or purchased it over-the-counter, make sure your household members know how to use it in the event of an overdose. Emergency help is still needed after naloxone is used because the reversal effects are only temporary. Symptoms of an overdose include: drowsiness, extreme dizziness or weakness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, relaxed and calm, slow heartbeat or breathing, seizures, sleepiness, trouble breathing, or cold, clammy skin. Tell your doctor right away if you notice these symptoms. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.