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Brand Names: Actiq

Generic Name: fentanyl citrate (oral transmucosal) (Pronunciation: FEN ta nil SIT rayt)

• What is fentanyl citrate (Actiq)?
• What are the possible side effects of fentanyl citrate (Actiq)?
• What is the most important information I should know about fentanyl citrate (Actiq)?
• What should I discuss with my health care provider before taking fentanyl citrate (Actiq)?
• How should I take fentanyl citrate (Actiq)?
• What happens if I miss a dose (Actiq)?
• What happens if I overdose (Actiq)?
• What should I avoid while taking fentanyl citrate (Actiq)?
• What other drugs will affect fentanyl citrate (Actiq)?
• Where can I get more information?

What is fentanyl citrate (Actiq)?

Fentanyl citrate is a narcotic pain medicine.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief.

Fentanyl citrate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fentanyl citrate (Actiq)?

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

Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heart rate;
• extreme sleepiness; or
• feeling light-headed, fainting.

Less serious side effects may include:

• dry mouth;
• headache, dizziness, weakness, anxiety; or
• nausea, vomiting, or constipation.

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.

What is the most important information I should know about fentanyl citrate (Actiq)?

Do not use fentanyl citrate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects could occur.

You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. An overdose of this medicine can be fatal. Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops.

Fentanyl citrate may be habit-forming and should be used only by the person it was prescribed for. Fentanyl citrate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl citrate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Do not use more than four Actiq units per day.