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Fentanyl Citrate Oral lozenge

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.

Do not take your medicine more often than directed. Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine.

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.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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

  • changes in vision

  • confusion

  • lightheadedness or fainting spells

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • problems with balance, talking, walking

  • trouble passing urine or change in the amount of urine

  • unusual bleeding or bruising

  • unusually weak or tired

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

  • constipation

  • dizziness

  • drowsiness

  • headache

  • nausea/vomiting

  • sweating

What may interact with this medicine?

  • alcohol and alcohol-containing medicines

  • antihistamines

  • anti-retroviral protease inhibitors like ritonavir

  • barbiturates like phenobarbital

  • erythromycin

  • fluconazole

  • general anesthetics

  • itraconazole

  • ketoconazole

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

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for pain

  • medicines for sleep

  • muscle relaxants

  • naltrexone

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

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. Throw away any unused medicine after the expiration date.

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.

If you are no longer using the medicine and have unused units in your home, dispose of them as soon as possible. Remove the unit from the pouch using scissors and hold the unit by the handle over the toilet. Using wire-cutting pliers, cut the medicine end off so that it falls into the toilet. Throw the handle away in a place that is out of reach of children. Flush the toilet twice after 5 units have been cut. Do not flush more than 5 units at one time. Do not flush the entire unused units, handles, or foil pouches down the toilet.

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 doctor or health care professional 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 the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time. If you need to use more than 4 units per day, call your doctor or health care professional. If you do not finish the whole unit each time you have an episode of breakthrough pain or your if pain is not relieved after finishing a whole unit, call your doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand 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 medicine. Avoid alcoholic drinks.

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

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

If you develop problems breathing or slow breathing, remove the unit from your mouth. ATTENTION CAREGIVERS: If you see the person using the unit develop breathing problems or if you have a hard time waking the person, remove the unit from their mouth, and call for emergency help.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

If you have diabetes, check your blood sugar more often. Each unit of the medicine has sugar.