Actiq is an opioid pain medication, sometimes called a narcotic.

Actiq treats "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related, such as migraine headaches or pain after surgery.

Actiq may also be used for purposes not listed in this medication guide.

Actiq can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose. Never share this medicine with another person.

MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Keep this medicine out of the reach of children.

Using this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Use Actiq exactly as prescribed. Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Fentanyl can slow or stop your breathing. MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Read all patient instructions carefully before using this medicine.

The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.

Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.

Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit. Use only 1 Actiq unit at a time.

If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.

Do not stop using any other pain medicines your doctor has prescribed for you.

If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.

Pay special attention to your dental hygiene. Actiq can cause dry mouth leading to tooth decay.

Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.

Keep track of your medicine. Fentanyl citrate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep both used and unused Actiq units out of the reach of children or pets. 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 this happens.

Actiq comes with a kit and instructions for storing and disposing of the Actiq units.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, follow the instructions provided with Actiq when disposing of unused medicine.

You should not use Actiq if you are allergic to fentanyl, or if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Do not give an Actiq unit to any person who does not have a personal prescription for this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or mental illness;

• alcoholism or drug addiction;

• a seizure disorder;

• liver or kidney disease; or

• low blood pressure, heart disease, slow heartbeats.

Actiq is not approved for use by anyone younger than 16 years old.

If you use Actiq 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.

Fentanyl can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl may also cause withdrawal symptoms in a nursing infant. Do not breast-feed while using Actiq.

Since Actiq is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

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

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

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

Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak.

Remove the Actiq unit from your mouth and call your doctor at once if you have:

• slow heart rate, sighing, shallow breathing, breathing that stops during sleep;

• severe drowsiness, feeling like you might pass out;

• dizziness or an upset stomach before the medicine has completely dissolved;

• confusion, extreme fear, unusual thoughts or behavior; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Actiq side effects may include:

• dizziness, mild drowsiness, depressed mood;

• sleep problems (insomnia);

• headache, weakness, anxiety;

• nausea, vomiting, constipation; or

• mild rash.

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 Actiq 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;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;

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

• 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.