Fentanyl

What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Iontophoretic transdermal patches—Safety and efficacy have not been established in children less than 18 years of age. This dosage form is not for use in children.

Transdermal patches—This medicine has been tested in children 2 years of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults. The child or teenager must be opioid-tolerant in order to take fentanyl. If you are unsure if your child or teenager is opioid-tolerant, talk to your doctor.

Geriatric

Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment. Your health care professional will take this into consideration when deciding on the amount of transdermal fentanyl you should receive.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of, or
• Drug dependence, especially narcotic abuse or dependence, or history of, or
• Emotional problems or
• Kidney disease or
• Liver disease or
• Mental illness (such as major depression) or
• Underactive thyroid—The chance of side effects may be increased.

• Brain tumor or
• Diarrhea caused by antibiotic treatment or poisoning or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones or
• Intestinal problems such as colitis or Crohn's disease or
• Pancreatitis, acute—Some of the side effects of fentanyl can cause serious problems in people who have these medical problems.

• Bronchial asthma, acute or severe or
• Not opioid-tolerant (if you are NOT taking a certain amount of morphine, oxycodone, hydromorphone or other opioid medicine) or
• Ongoing breathing problems—Fentanyl patches should NOT be used in these patients. It could cause very serious breathing problems.

• Paralytic ileus (intestinal blockage)—Fentanyl patches should NOT be used in patients with this condition.

• Slow or irregular heartbeat—Fentanyl can make this condition worse.