Fentanyl transmucosal lozenges

What is this medicine?

FENTANYL (FEN ta nil) is a pain reliever. It is used to treat breakthrough cancer pain that your long acting pain medicine does not control. Do not use this medicine for a pain that will go away in a few days like pain from surgery, doctor or dentist visits. The medicine is used only by people who have been taking an opioid or narcotic pain medicine for at least a week.

How should I use this medicine?

Follow the directions on the prescription label. Cut open the package using scissors, and remove the unit. Do not open the package until you are ready to use it. Place the unit in your mouth between your cheeks and gum and suck on it. Move the unit from one side of your mouth to the other every couple of minutes. Twirl the handle often. Do not bite or chew the unit. If you feel dizzy or sick to your stomach before you have finished the medicine, remove the unit from your mouth. Throw the handle away in a place that is out of the reach of children and pets. If medicine remains on the handle, place the handle under hot running tap water until the unit is gone. Then, throw the handle away out of the reach of children and pets. If you did not finish the entire unit and you cannot immediately get rid of the medicine, put the unit in the temporary storage bottle that you have received in the Welcome Kit. Push the unit into the opening on the top of the unit it falls completely into the bottle. NEVER leave unused or partly used units where children or pets can get to them. Empty the storage bottle, and run the handles under hot tap water to get rid of the medicine at least once a day.

The unit should be consumed over a 15 minute period. Do not use a second unit without checking with your doctor or health care professional. While your exact dose is being determined, you may need to use more than one unit to control your pain. Wait at least 30 minutes after starting a unit and 15 minutes after finishing a unit before using another.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth

• nausea, vomiting

• tiredness

What may interact with this medicine?

Do not take this medication with any of the following medicines:

• mifepristone

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• antiviral medicines for HIV or AIDS

• aprepitant

• atropine

• certain antibiotics like erythromycin and clarithromycin

• certain medicines for anxiety or sleep

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for diabetes like pioglitazone, troglitazone

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for seizures like phenobarbital, phenytoin, primidone

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• cimetidine

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• grapefruit juice

• ipratropium

• local anesthetics like lidocaine, pramoxine, tetracaine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines that relax muscles for surgery

• other narcotic medicines for pain or cough

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• rifampin

• St. John's wort

• steroid medicines like prednisone or cortisone

What if I miss a dose?

This medicine is only used when needed for pain.

Where should I keep my medicine?

Keep out of the reach of children and pets. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Protect from moisture.

You will be instructed on how to store this medicine. You should receive a Welcome Kit that includes a child-resistant lock, a portable locking pouch, and a child-resistant temporary storage bottle to help you store your medicine out of the reach of children.

This medicine may cause harm and death if it is taken by other adults, children, or pets. Return medicine that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medicine, flush it down the toilet. Do not use the medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• brain tumor

• dental disease

• diabetes mellitus

• drug abuse or addiction

• head injury

• heart disease

• if you frequently drink alcohol containing drinks

• kidney disease or problems going to the bathroom

• liver disease

• lung disease, asthma, or breathing problems

• mental problems

• skin problems

• use of a MAOI like Carbex, Eldepryl, Marplan, Nardil, and Parnate in the past 14 days

• an unusual or allergic reaction to fentanyl, other opioid analgesics, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this drug. Tolerance means that you will need a higher dose of the drug for pain relief. Tolerance is normal and is expected if you take this drug for a long time.

Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the drug. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If you have pain, you have a medical reason to take pain drug. Your health care provider will tell you how much drug to take. If your health care provider wants you to stop the drug, the dose will be slowly lowered over time to avoid any side effects.

If you take other drugs that also cause drowsiness like other narcotic pain drugs, benzodiazepines, or other drugs for sleep, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.

This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.