BUPRENORPHINE AND NALOXONE- buprenorphine and naloxone film, soluble 
Dr.Reddys Laboratories Inc

----------

MEDICATION GUIDE
Buprenorphine and Naloxone

(bue” pre nor’ feen) and (nal ox’ one)

Sublingual Film, CIII

for sublingual or buccal administration

IMPORTANT:
Keep buprenorphine and naloxone sublingual film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes buprenorphine and naloxone sublingual film, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children.
What is the most important information I should know about buprenorphine and naloxone sublingual film?
  • Buprenorphine and naloxone contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life‐threatening breathing problems, especially if you take or use certain other medicines or drugs.
  • Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of buprenorphine and naloxone sublingual film by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.
  • Buprenorphine and naloxone may cause serious and life‐threatening breathing problems. Get emergency help right away if you:
    • feel faint
    • feel dizzy
    • are confused
    • feel sleepy or uncoordinated
    • have blurred vision
    • have slurred speech
    • are breathing slower than normal
    • cannot think well or clearly
  • Do not take buprenorphine and naloxone with certain medicines. Taking buprenorphine and naloxone with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

  • Do not inject (“shoot‐up”) buprenorphine and naloxone. Injecting buprenorphine and naloxone may cause life‐threatening infections and other serious health problems. Injecting buprenorphine and naloxone may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

  • Do not switch from buprenorphine and naloxone sublingual film to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual film is not the same as in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine and naloxone sublingual film that may be different than other buprenorphine containing medicines you may have been taking.

  • Do not stop taking buprenorphine and naloxone suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.

  • In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone sublingual film.

  • Never give anyone else your buprenorphine and naloxone sublingual film. They could die from taking it. Selling or giving away buprenorphine and naloxone sublingual film is against the law.

  • Store buprenorphine and naloxone sublingual film securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

What is buprenorphine and naloxone sublingual film?
  • Buprenorphine and naloxone sublingual film is a prescription medicine used to treat opioid addiction in adults and is part of a complete treatment program that also includes counseling and behavioral therapy.
Who should not take buprenorphine and naloxone sublingual film?
Do not take buprenorphine and naloxone sublingual film 
if you are allergic to buprenorphine or naloxone.
Before taking buprenorphine and naloxone, tell your healthcare provider about all your medical conditions, including if you have

  • trouble breathing or lung problems

  • a curve in your spine that affects your breathing

  • Addison’s disease

  • an enlarged prostate (men)

  • problems urinating

  • liver, kidney, or gallbladder problems

  • alcoholism

  • a head injury or brain problem

  • mental health problems

  • adrenal gland or thyroid gland problems

Tell your healthcare provider if you are:
  • pregnant or plan to become pregnant. If you take buprenorphine and naloxone while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life‐threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • Breastfeeding or plan to breastfeed. Buprenorphine and naloxone can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take buprenorphine and naloxone. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with buprenorphine and naloxone.

Tell your healthcare provider about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, or herbal supplements.

How should I take buprenorphine and naloxone sublingual film?
Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to take buprenorphine and naloxone.
  • Take buprenorphine and naloxone sublingual film exactly as prescribed by your healthcare provider. Your healthcare provider may change your dose after seeing how it affects you. Do not change your dose unless your healthcare provider tells you to change it.
  • Do not take buprenorphine and naloxone sublingual film more often than prescribed by your healthcare provider.
  • Buprenorphine and naloxone is not for occasional or “as needed” use.
  • When you are beginning treatment, take buprenorphine and naloxone sublingual film only under the tongue (sublingual administration).
  • After a few days, you can choose whether you will take buprenorphine and naloxone sublingual film on the inside of your cheek (buccal administration) or under the tongue (sublingual administration).
  • Take the entire buprenorphine and naloxone sublingual film. Do not cut, tear, chew, or swallow buprenorphine and naloxone sublingual film because the medicine will not work as well.
  • If you miss a dose of buprenorphine and naloxone, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
  • Dispose of expired, unwanted, or unused buprenorphine and naloxone by removing buprenorphine and naloxone from the foil packaging, and promptly flushing down the toilet (if a drug take‐back option is not readily available).
    Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
  • If you take too much buprenorphine and naloxone or overdose, call Poison Control or get emergency medical help right away.
What should I avoid while taking buprenorphine and naloxone sublingual film?
  • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how buprenorphine and naloxone affects you. Buprenorphine can cause drowsiness and slow reaction times. Buprenorphine and naloxone can make you sleepy, dizzy, or lightheaded.
  • You should not drink alcohol or take prescription or over‐the‐counter medicines that contain alcohol while taking buprenorphine and naloxone sublingual film, because this can lead to loss of consciousness or even death.
What are the possible side effects of buprenorphine and naloxone sublingual film?

Buprenorphine and naloxone sublingual film can cause serious side effects, including:

  • Trouble breathing. Taking buprenorphine and naloxone with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death.
  • Sleepiness, dizziness, and problems with coordination.
  • Physical dependence or abuse.
  • Liver problems. Call your healthcare provider right away if you notice any of these symptoms:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • dark or “tea‐colored” urine
    • light colored stools (bowel movements)
    • loss of appetite
    • pain, aching, or tenderness on the right side of your stomach area
    • nausea
  • Your healthcare provider should do blood tests to check your liver before you start taking and while you take buprenorphine and naloxone.
  • Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.
  • Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:
    • Shaking
    • sweating more than normal
    • feeling hot or cold more than normal
    • runny nose
    • watery eyes
    • goose bumps
    • diarrhea
    • vomiting
    • muscle aches
  • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
  • The most common side effects of buprenorphine and naloxone include:
    • Headache
    • Nausea
    • Vomiting
    • constipation
    • pain
    • increased sweating
    • decrease in sleep (insomnia)
  • Buprenorphine and naloxone sublingual film may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of buprenorphine and naloxone.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‐800‐FDA‐1088.

General information about the safe and effective use of buprenorphine and naloxone sublingual film.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine and naloxone sublingual film for a condition for which it was not prescribed. Do not give buprenorphine and naloxone sublingual film to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

You can ask your doctor or pharmacist for information that is written for healthcare professionals.
For more information, call 1-888-375-3784.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

To reorder additional Medication Guides, please contact Dr. Reddy's Customer Service at 1-866-733-3952.


Rx only

Manufactured By:
Lohmann Therapy Systems, (LTS)

West Caldwell, NJ 07006

Manufactured For:
Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540, USA


Revised: 03/2021

INSTRUCTIONS FOR USE
Buprenorphine and Naloxone

(bue” pre nor’ feen) and (nal ox’ one)

Sublingual Film, CIII

for sublingual or buccal administration

This “Instructions for Use” contains information on how to correctly take buprenorphine and naloxone sublingual film.

Important Information You Need to Know Before Taking Buprenorphine and Naloxone Sublingual Film:

Preparing to take buprenorphine and naloxone sublingual film:

figure1
Figure 1


  • Before taking buprenorphine and naloxone sublingual film, drink water to moisten your mouth. This helps the film dissolve more easily.

To take buprenorphine and naloxone sublingual film under your tongue (sublingual administration):

  • Hold the film between two fingers by the outside edges.
  • Place the buprenorphine and naloxone sublingual film under your tongue, close to the base either to the left or right of the center (see Figure 3).
 
figure3
Figure 3

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Revised: 03/2021


1
Revised: 3/2021
Dr.Reddys Laboratories Inc