When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use this medicine if you had an allergic reaction to fentanyl or if you are not taking pain medicine for around-the-clock pain control.

How to Use This Medicine:
Thin Sheet, Lozenge, Spray, Tablet, Lollipop

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Use this medicine only when needed for breakthrough pain. Never use more than your doctor told you to use.
• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.
• Keep the medicine in the original blister or foil package. Open the package right before you need to use it.
• Abstral® tablets: Place the tablet under the tongue until it dissolves. Do not chew, suck, or swallow the tablet. Do not eat or drink anything until the tablet has dissolved. If your mouth is dry, use water to rinse your mouth before you place the tablet under your tongue.
• Actiq® lozenges: Place the lozenge in your mouth between the cheek and lower gum. Use the handle to move the lozenge from one side to the other every now and then. Suck the medicine for 15 minutes, and do not chew it.
• Fentora® tablets: Peel the blister back to remove the tablet. Do not push the tablet through the blister because this may damage the tablet. Place the tablet between your upper cheek and gum, above a back molar, until it dissolves. Do not chew, suck, or swallow the tablet. You may swallow the tablet with a glass of water if it does not dissolve completely after 30 minutes.
• Onsolis® film: Use your tongue to wet the side of your cheek, or rinse your mouth with water in the area where you will place the film. Do not cut or tear the film. Hold the film on a clean, dry finger with the pink side facing up. Press the film against your cheek and hold it there for 5 seconds. Leave the film in place until it dissolves, and do not touch or move the film. Do not chew or swallow the film. Place the second film on the other side of your mouth, if you must use more than one film. Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.
• Subsys® spray: Carefully spray the medicine under your tongue. Hold the medicine under your tongue for 30 to 60 seconds. Do not rinse your mouth and do not spit out any medicine.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Keep the medicine in the original blister or foil package. Do not use the medicine if the package has been damaged or opened.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
• Some foods and medicines can affect how fentanyl works. Tell your doctor if you are using St John's wort, aprepitant, cimetidine, diltiazem, modafinil, nefazodone, pioglitazone, rifabutin, rifampin, troglitazone, verapamil, a steroid medicine (such as dexamethasone, hydrocortisone, methylprednisolone, prednisone), medicine to treat an infection (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, telithromycin, troleandomycin), medicine for HIV or AIDS (such as amprenavir, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin), or a phenothiazine medicine (such as prochlorperazine, promethazine).
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, low blood pressure, lung or breathing problems (such as chronic obstructive pulmonary disease [COPD]), mucositis (sores in your mouth), seizures, or a slow heart rate. Tell your doctor if you have had a head injury or brain surgery, or if you have a history of drug addiction or alcohol abuse. Do not use this medicine for minor aches and pains, such as headaches, dental pain, or migraines, or after surgery or injuries.
• This medicine may cause the following problems:
  
  • Serious breathing problems
  • Overdose
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can cause serious harm or death to a child. Always keep this medicine out of the reach of children. Carefully and properly dispose of both used units and medicine that has not been used.
• Actiq® contains 2 grams of sugar in each unit. Schedule regular dentist visits. Be careful if you need to keep track of your sugar intake.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Ask your pharmacist about the best way to dispose of medicine you do not use.
• Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit. Empty the bottle each day.
• Subsys® spray:
  
  • Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this right after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.
  • Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin
• Chest pain or tightness
• Decrease in how much or how often you urinate
• Extreme weakness, confusion, severe drowsiness, fainting, or dizziness
• Trouble breathing or change in breathing (such as sighing, decreased urge to breathe, or uneven, fast, slow, or shallow breathing)

If you notice these less serious side effects, talk with your doctor:

• Anxiety
• Dry mouth
• Headache
• Nausea, vomiting, constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088