Subsys buccal / sublingual

Do not use fentanyl unless you are already using an around-the-clock opioid medicine and are tolerant to it. You should not use fentanyl if you are allergic to it, or if you have:

• severe asthma or other breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

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

• any type of breathing problem or lung disease;

• a head injury, brain tumor, or seizures;

• low blood pressure, slow heartbeats or other heart rhythm disorder;

• drug or alcohol addiction, depression, schizophrenia, or hallucinations;

• liver or kidney disease;

• urination problems;

• problems with your thyroid, gallbladder, or pancreas; or

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

Some medicines can interact with fentanyl and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or 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.

Tell your doctor if there are children living in the home where you will store this medicine. The amount of fentanyl in this medicine can be fatal to a child.

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.

Do not breast-feed while you are using this medicine.

Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. 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.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your buccal or sublingual dose may be different.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away fentanyl is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use only 1 tablet at a time. If your pain does not go away completely, use a second tablet only if your doctor has approved it.

You must wait at least 2 hours after your last dose of Abstral before you can treat a new pain episode. You must wait at least 4 hours after your last dose of Fentora or Subsys before you can treat a new pain episode.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine. Do not treat more than 4 pain episodes per day with this medicine.

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

Never crush or break a fentanyl pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of your medicine. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each buccal or sublingual product can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Carefully follow disposal instructions when this medicine is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, throw away any unused fentanyl tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used sublingual spray units in the disposal bags provided with the medicine. Empty any unused spray units into the disposal bottle provided.

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 extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while taking fentanyl.

Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device). Subsys is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of taking this medication.

Do not use Subsys spray 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.

Subsys is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Fentanyl can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Subsys in larger amounts, or for longer than prescribed.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Before using this medicine, tell your doctor if you are taking an antibiotic or any medicines to treat high blood pressure, heart rhythm disorders, depression, or viral infections such as hepatitis, HIV or AIDS.

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

Fentanyl may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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 Subsys) 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