Buprenorphine Hydrochloride, Naloxone Hydrochloride Oral dissolving film

What is this medicine?

BUPRENORPHINE; NALOXONE (byoo pre NOR feen; nal OX one) is used to treat certain types of drug dependence.

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

• drink more than 3 alcohol-containing drinks per day

• head injury

• heart disease

• kidney disease

• liver disease

• lung or breathing disease, like asthma

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

For sublingual use (Suboxone): Drink water to moisten the mouth. Then, place the medicine under the tongue and let it dissolve. Follow the directions on the prescription label. Leave this medicine in the sealed foil pack until you are ready to use it. If your dose requires you to take more than 1 film, place the second film under the tongue on other side of the mouth. If your dose requires you to take more than 2 films, place the third film under your tongue on either side after the first 2 films have dissolved. Do not let the films touch in your mouth.After you put this medicine in your mouth, do not move it. Do not swallow, cut, or chew the film. Take your medicine at regular intervals. Do not take your medicine more often than directed.

For buccal use (Suboxone or Bunavail): Drink water to moisten the inside of the cheek. Then, place the medicine against the inside of the moistened cheek and let it dissolve. Follow the directions on the prescription label. Leave this medicine in the sealed foil pack until you are ready to use it. If your dose requires you to take more than 1 film, place the second film on the inside of the other cheek. If your dose requires you to take more than 2 films, place the third film on the inside of your right or left cheek after the first 2 films have dissolved. After you put this medicine in your mouth, do not move it. Do not swallow, cut, or chew the film. Take your medicine at regular intervals. 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.

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 miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• butorphanol

• nalbuphine

• pentazocine

This medicine may also interact with the following medications:

• alcohol

• antibiotics like erythromycin and clarithromycin

• antihistamines for allergy, cough and cold

• barbiturates like phenobarbital

• carbamazepine

• general anesthetics

• medicines for depression, anxiety, or psychotic disturbances

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

• medicines for sleep

• medicines used to treat HIV infection or AIDS like ritonavir, saquinavir, and indinavir

• muscle relaxants

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• phenytoin

• rifampin or rifampicin

• tramadol

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?

Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

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.

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

• anxiety, irritability, nervousness or restlessness

• breathing problems

• cold, clammy skin or sweating

• confusion

• diarrhea

• feeling faint or lightheaded, falls

• severe stomach pain or vomiting

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• constipation

• headache

• insomnia

• nausea

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 at room temperature between 15 and 30 degrees C (56 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 films from the foil pack and flush them down the toilet 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.

Buprenorphine Hydrochloride, Naloxone Hydrochloride Sublingual tablet

What is this medicine?

BUPRENORPHINE; NALOXONE (byoo pre NOR feen; nal OX one) is used to treat certain types of drug dependence.

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

• drink more than 3 alcohol-containing drinks per day

• head injury

• heart disease

• kidney disease

• liver disease

• lung disease such as asthma or COPD

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Place this medicine under the tongue and let it dissolve. Several minutes will be needed to let it fully dissolve. Follow the directions on the prescription label. Leave this medicine in the sealed foil pack until you are ready to use it. If your dose requires you to take more than 2 tablets at once, either place all the tablets at once under the tongue, or if you cannot fit more than 2 tablets comfortably, place 2 tablets at a time under the tongue. Either way, you should hold the tablets under the tongue until they completely dissolve. Do not swallow or chew this medicine. Take your medicine at regular intervals. 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 of age for selected conditions, precautions do apply.

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 miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• butorphanol

• nalbuphine

• pentazocine

This medicine may also interact with the following medications:

• alcohol

• antibiotics like erythromycin and clarithromycin

• antihistamines for allergy, cough and cold

• barbiturates like phenobarbital

• carbamazepine

• general anesthetics

• medicines for depression, anxiety, or psychotic disturbances

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

• medicines for sleep

• medicines used to treat HIV infection or AIDS like ritonavir, saquinavir, and indinavir

• muscle relaxants

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• phenytoin

• rifampin or rifampicin

• tramadol

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?

Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.

Wear a medical identification bracelet or chain to say that you are taking this medicine. Emergency personnel will need to know that you are taking this medicine.

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.

You will likely have your blood checked before you start taking this medicine.

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

• anxiety, irritability, nervousness or restlessness

• breathing problems

• cold, clammy skin or sweating

• confusion

• diarrhea

• fainting spells

• severe stomach pain or vomiting

• unusually weak or tired

• yellowing of the skin or the whites of the eyes

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

• constipation

• headache

• insomnia

• nausea

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 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. Flush any unused medicine down the toilet 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.