Fentanyl Citrate Buccal tablet

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• breathing problems

• drug abuse or addiction

• head injury

• if you frequently drink alcohol containing drinks

• kidney disease

• liver disease

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 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

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Do not remove a tablet from the blister until you are ready to use it. Peel the blister backing away to expose the tablet. Do not push the tablet through the blister. Place the tablet in your mouth between your cheek and gum and leave in place until the tablet is dissolved. After 30 minutes if there is any tablet left, swallow it with a glass of water. Do not take your medicine more often than directed.

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain.

What may interact with this medicine?

• alcohol

• antihistamines

• barbiturates, like phenobarbital

• clarithromycin, erythromycin

• general anesthetics

• grapefruit juice

• itraconazole, ketoconazole

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for HIV

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

If you develop problems breathing or slow breathing, remove this medicine from your mouth, and call emergency for help.

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.

This 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.

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

• dry mouth

• feeling faint, lightheaded

• hallucination

• irregular heartbeat

• mouth pain, sores

• 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):

• dizzy

• headache

• loss of appetite

• nausea, vomiting

• sweating

• tingling in mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. Unintended use by a child is an emergency and can result in death. If a child accidentally uses this medicine, get emergency help right away. This drug 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 is against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Remove any unused medicine from blister packages and flush it down the toilet to reduce the chance of harm. Do not flush the blister packages or boxes. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Fentanyl Citrate Oral dissolving film

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• breathing problems

• drug abuse or addiction

• head injury

• if you frequently drink alcohol containing drinks

• kidney disease

• liver disease

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Use this medicine in the mouth. Follow the directions on the prescription label. Wet the application area with tongue or rinse mouth with water before using this medicine. Open package with dry hands just before you are ready to use it. Do not cut or tear the film. Use the tip of a dry finger to put one film in the mouth at a time with the pink side of the film facing the cheek. Hold the medicine film in place for 5 seconds. If you use more than one film for a dose, put them in different places on your cheek. Do not overlap or stack films. After you place the medicine on your cheek: (1.) leave the film in place until it dissolves away; (2.) do not move or touch the film with fingers or tongue; (3.) do not drink for 5 minutes; and (4.) do not eat until the film is gone. Do not take your medicine more often than directed.

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. This medicine is not approved for use in children.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain.

What may interact with this medicine?

• alcohol

• antihistamines

• barbiturates, like phenobarbital

• clarithromycin, erythromycin

• general anesthetics

• grapefruit juice

• itraconazole, ketoconazole

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for HIV

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

If you develop problems breathing or slow breathing, remove this medicine from your mouth, and call emergency for help.

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.

This 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.

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

• dry mouth

• feeling faint, lightheaded

• hallucination

• irregular heartbeat

• mouth pain, sores

• 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):

• dizzy

• headache

• loss of appetite

• nausea, vomiting

• sweating

• tingling in mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. Unintended use by a child is an emergency and can result in death. If a child accidentally uses this medicine, get emergency help right away. This drug 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 is against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from freezing and moisture.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm.Do not flush foil package or carton down the toilet. Throw them away in a lidded trash can. Follow the directions in the MedGuide. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain.

What may interact with this medicine?

• alcohol

• 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 sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet to reduce the chance of harm. Follow the directions in the MedGuide. Do not flush entire unused units, handles, or blister packages down the toilet. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Fentanyl Citrate Solution for injection

What is this medicine?

FENTANYL (FEN ta nil) is a pain reliever. It is used to treat pain before, during, and after surgery. This medicine is also used before, with, and in place of other medicines for sleep during a medical procedure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• breathing problems

• drug abuse or addiction

• head injury

• kidney disease

• liver disease

• 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

How should I use this medicine?

This medicine is for injection. It is given by a health-care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• alcohol

• antihistamines

• barbiturates like phenobarbital

• general anesthetics

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• narcotic medicines (opiates) for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will decide how much medicine to take.

Tell your doctor or health care professional if you continue to have pain, your pain does not go away, if it gets worse, or if you have new or different type of pain.

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

• feeling faint, lightheaded

• hallucination

• irregular heartbeat

• problems with balance, talking, walking

• trouble passing urine or change in the amount of urine

• 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

• dizzy

• headache

• loss of appetite

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Fentanyl Nasal spray, solution

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• head injury

• heart disease

• history of a drug or alcohol abuse problem

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for use in the nose. Follow the directions on the prescription label. Make sure that you are using your nasal spray correctly. Ask you doctor or health care provider if you have any questions. Do not take it more often than directed.

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. Special care may be needed.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain.

What may interact with this medicine?

• alcohol

• antihistamines

• aprepitant

• barbiturates, like phenobarbital

• certain antibiotics like clarithromycin, erythromycin, and telithromycin

• certain medicines for blood pressure like diltiazem, verapamil

• certain medicines for diabetes like pioglitazone and troglitazone

• certain medicines for fungal infections like fluconazole, ketoconazole, and itraconazole

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenytoin

• cimetidine

• general anesthetics

• grapefruit juice

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for HIV

• medicines for sleep

• muscle relaxants

• narcotic medicines (opiates) for pain

• nasal decongestants like oxymetazoline

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• supplements like St John's Wort

• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

This 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.

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

• feeling faint or lightheaded, falls

• hallucination

• irregular heartbeat

• loss of balance or coordination

• trouble passing urine or change in the amount of urine

• unusually weak or tired

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

• bleeding, congested, or runny nose

• fever

• headache

• loss of appetite

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. Unintended use by a child is an emergency and can result in death. If a child accidentally uses this medicine, get emergency help right away. This drug 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 is against the law.

Store at room temperature, up to 25 degrees C (77 degrees F). Do not freeze. Protect from light. Keep this medicine in the original container. Do not use this medicine after the expiration date.

Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages. Follow the directions in the MedGuide.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Fentanyl Sublingual tablet

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• head injury

• heart disease

• history of a drug or alcohol abuse problem

• kidney disease

• liver disease

• low blood pressure

• lung or breathing disease, like asthma

• mental illness

• seizures

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Leave the tablet in the sealed blister pack until you are ready to take it. With dry hands, open the blister and gently remove the tablet. Place the tablet under your tongue and allow it to dissolve. If more than one tablet is needed, spread them around the floor of your mouth under your tongue. Do not suck, swallow, or chew this medicine. Do not take it more often than directed.

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. Special care may be needed.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain.

What may interact with this medicine?

• alcohol

• antihistamines

• aprepitant

• barbiturates, like phenobarbital

• certain antibiotics like clarithromycin, erythromycin, and telithromycin

• certain medicines for diabetes like pioglitazone and troglitazone

• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenytoin

• cimetidine

• diltiazem

• general anesthetics

• grapefruit juice

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for HIV

• medicines for sleep

• modafinil

• muscle relaxants

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• rifabutin

• rifampin

• supplements like St John's Wort

• steroid medicines like prednisone or cortisone

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

This 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.

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

• feeling faint or lightheaded, falls

• hallucination

• irregular heartbeat

• loss of balance or coordination

• trouble passing urine or change in the amount of urine

• unusually weak or tired

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

• changes in taste

• headache

• loss of appetite

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This drug 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 is against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Remove any unused tablets from the blister card and flush them down the toilet to reduce the chance of harm. Do not flush blister cards down the toilet. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Fentanyl Sublingual/Translingual spray

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• head injury

• heart disease

• history of a drug or alcohol abuse problem

• kidney disease

• liver disease

• low blood pressure

• lung or breathing disease, like asthma

• mental illness

• mouth sores

• seizures

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the mouth. Follow the directions on the prescription label. Open package with scissors right before use. Each unit contains enough medicine for one spray. Spray the medicine into the mouth underneath the tongue. Ask you doctor or health care provider if you have any questions. Do not take your medicine more often than directed.

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. Special care may be needed.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only used when needed for pain. Do not take double or extra doses.

What may interact with this medicine?

• alcohol

• antihistamines

• aprepitant

• barbiturates, like phenobarbital

• certain antibiotics like clarithromycin, erythromycin, and telithromycin

• certain medicines for diabetes like pioglitazone and troglitazone

• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenytoin

• cimetidine

• diltiazem

• general anesthetics

• grapefruit juice

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

• medicines for depression, anxiety, or psychotic disturbances

• medicines for HIV

• medicines for sleep

• modafinil

• muscle relaxants

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• rifabutin

• rifampin

• supplements like St John's Wort

• steroid medicines like prednisone or cortisone

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

This 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.

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

• feeling faint or lightheaded, falls

• hallucination

• irregular heartbeat

• loss of balance or coordination

• trouble passing urine or change in the amount of urine

• unusually weak or tired

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

• changes in taste

• constipation

• headache

• loss of appetite

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This drug 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 is against the law.

Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages. Follow the directions in the MedGuide.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Fentanyl Transdermal patch - 72 hour

What is this medicine?

FENTANYL (FEN ta nil) is a pain reliever. It is used to treat persistent, moderate to severe chronic pain. It is used only by people who have been taking an opioid or narcotic pain medicine for more than one week.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• Crohn's disease, inflammatory bowel disease, or ulcerative colitis

• 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

• taken isocarboxazid, phenelzine, tranylcypromine, or selegiline in the past 2 weeks

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Apply the patch to your skin. Do not cut or damage the patch. A cut or damaged patch can be very dangerous because you may get too much medicine. Select a clean, dry area of skin above your waist on your front or back. The upper back is a good spot to put the patch on children or people who are confused because it will be hard for them to remove the patch. Do not apply the patch to oily, broken, burned, cut, or irritated skin. Use only water to clean the area. Do not use soap or alcohol to clean the skin because this can increase the effects of the medicine. If the area is hairy, clip the hair with scissors, but do not shave.

Take the patch out of its wrapper, and take off the protective strip over the sticky part. Do not use a patch if the packaging or backing is damaged. Do not touch the sticky part with your fingers. Press the sticky surface to the skin using the palm of your hand. Press the patch to the skin for 30 seconds. Wash your hands at once with soap and water.

Take off the old patch before putting on a new patch. Apply each new patch to a different area of skin. If a patch comes off or causes irritation, remove it and apply a new patch to different site. To get rid of used patches, fold the patch in half with the sticky sides together. Then, flush it down the toilet. Do not discard the patch in the garbage. Pets and children can be harmed if they find used or lost patches. Replace the patch every 3 days or as directed by your doctor or health care professional. Follow the directions on the prescription label. Do not take more medicine than you are told to take.

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 2 years old for selected conditions, precautions do apply.

If someone accidentally uses a fentanyl patch and is not awake and alert, immediately call 911 for help. If the person is awake and alert, call a doctor, health care professional, or the Poison Control Center.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you forget to replace your patch, take off the old patch and put on a new patch as soon as you can. Do not apply an extra patch to your skin. Do not wear more than one patch at the same time unless told to do so by your doctor or health care professional.

What may interact with this medicine?

• alcohol

• antihistamines

• clarithromycin

• diltiazem

• erythromycin

• grapefruit juice

• herbal products that contain St. John's wort

• itraconazole

• ketoconazole

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• naltrexone

• narcotic medicines (opiates) for pain

• nelfinavir

• nicardipine

• phenobarbital, phenytoin, or fosphenytoin

• rifampin

• ritonavir

• troleandomycin

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Other pain medicine may be needed the first day you use the patch because the patch can take some time to start working. 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.

Have a family member watch you for side effects during the first day you wear a patch or if your dose changes.

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. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

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.

Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help. See your dentist every 6 months.

Heat can increase the amount of medicine released from the patch. Do not get the patch hot by using heating pads, heated water beds, electric blankets, and heat lamps. You can bathe or swim while using the patch. But, do not use a sauna or hot tub. Tell you doctor or health care professional if you get a fever.

If gel leaks from the patch, wash your skin well with water only. Do not use soap or cleansers containing alcohol. Remove the patch from your skin and discard as instructed above. Medicine from a partly attached or leaking patch can transfer to a child or pet when they are being held. Exposure of children or pets to the patch can cause serious side effects and even death.

If you are going to have a magnetic resonance imaging (MRI) procedure, tell your MRI technician if you have this patch on your body. It must be removed before a MRI.

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

• feeling faint, lightheaded

• fever, flu-like symptoms

• hallucination

• high or low blood pressure

• irregular heartbeat

• 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

• dry mouth

• itching where the patch was applied

• loss of appetite

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. 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 below 77 degrees F (25 degrees C). Do not store the patches out of their wrappers.

This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medicine down the toilet as instructed above to reduce the chance of harm. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.