Actiq oral transmucosal

You should not use this medicine 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.

Some medicines can interact with fentanyl citrate 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 fentanyl citrate 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, or mental illness;

• a history of alcoholism or drug addiction;

• a seizure disorder;

• liver or kidney disease;

• low blood pressure, heart disease, slow heartbeats; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

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

If you use fentanyl 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 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 fentanyl citrate.

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 fentanyl citrate.

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. Fentanyl citrate can cause dry mouth leading to tooth decay.

Do not stop using fentanyl citrate 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 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 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.

After you have stopped using this medication, use wire-cutting pliers to cut the handles off any unused Actiq lozenges. Do not keep leftover lozenges. 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.

Some medicines can interact with fentanyl citrate 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 Actiq 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, or mental illness;

• a history of alcoholism or drug addiction;

• a seizure disorder;

• liver or kidney disease;

• low blood pressure, heart disease, slow heartbeats; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

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. Tell your doctor if you are pregnant or plan to become pregnant.

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.

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make fentanyl 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 citrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Common side effects of Actiq include: respiratory depression. See below for a comprehensive list of adverse effects.

Applies to fentanyl: film, lozenge/troche, spray, tablet

Other dosage forms:

• injection injectable, injection solution
• nasal spray
• transdermal patch device assisted, transdermal patch extended release

Along with its needed effects, fentanyl (the active ingredient contained in Actiq) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fentanyl:

• Black, tarry stools
• blurred vision
• chest pain
• confusion
• convulsions
• cough
• decreased urine
• difficult or labored breathing
• dizziness
• dry mouth
• fainting
• fever or chills
• increased thirst
• irregular heartbeat
• lightheadedness
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• pounding in the ears
• rapid breathing
• sneezing
• sore throat
• sunken eyes
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• wrinkled skin

• Abdominal or stomach pain
• change in walking and balance
• clumsiness or unsteadiness
• decreased awareness or responsiveness
• decreased frequency of urination
• headache
• muscle twitching or jerking
• pounding in the ears
• rhythmic movement of the muscles
• seeing, hearing, or feeling things that are not there
• seizures
• severe constipation
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• slow or fast heartbeat
• thinking abnormalities
• trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:

• Extremely shallow or slow breathing

Some side effects of fentanyl may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• discouragement
• feeling sad or empty
• irritability
• lack or loss of strength
• loss of interest or pleasure
• muscle stiffness
• pain in the joints
• sleepiness or unusual drowsiness
• tiredness
• trouble concentrating
• trouble sleeping
• weight loss

• Changes in vision
• excessive muscle tone
• feeling of constant movement of self or surroundings
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• irritation, pain, or sores at the site of application
• itching skin
• muscle tension or tightness
• rash
• sensation of spinning
• sweating

• Tooth pain
• trouble with gums
• trouble with teeth