Medication Guide

Buprenorphine transdermal system is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not to be taken on an “as needed” basis.

Important information about buprenorphine transdermal system:

• Get emergency help or call 911 right away if you take too much buprenorphine transdermal system (overdose). When you first start taking buprenorphine transdermal system, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking buprenorphine transdermal system with other opioid medicines, benzodiazepines, and alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your buprenorphine transdermal system. They could die from taking it. Selling or giving away buprenorphine transdermal system is against the law.
• Store buprenorphine transdermal system securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not use buprenorphine transdermal system if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

Before applying buprenorphine transdermal system, tell your healthcare provider if you have a history of:

• head injury, seizures                                                       • liver, kidney, thyroid problems

• problems urinating                                                          • pancreas or gallbladder problems

• heart rhythm problems (Long QT syndrome)

• abuse of street or prescription drugs, alcohol addiction, opioid overdose or mental health problems

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take buprenorphine transdermal system, do not take more of buprenorphine transdermal system without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking buprenorphine transdermal system
• have a fever
• pregnant or planning to become pregnant. Use of buprenorphine transdermal system for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended during treatment with buprenorphine transdermal system. It may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs.
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking buprenorphine transdermal system with certain other medicines can cause serious side effects.

When using buprenorphine transdermal system:

• Do not change your dose. Apply buprenorphine transdermal system exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
• See the detailed Instructions for Use for information about how to apply the buprenorphine transdermal system patch.
• Do not apply a buprenorphine transdermal system patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
• Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
• You should wear 1 buprenorphine transdermal system patch continuously for 7 days.
• Call your healthcare provider if the dose you are using does not control your pain.
• Do not stop using buprenorphine transdermal system without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused buprenorphine transdermal systems by using the Patch-Disposal Unit. Alternatively, buprenorphine transdermal system can be disposed of by folding the patch in half and promptly flushing down the toilet, if a drug take-back option is not readily available [see Instructions for Use]. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While using buprenorphine transdermal system DO NOT:

• Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps. These can cause an overdose that can lead to death.
• Drive or operate heavy machinery, until you know how buprenorphine transdermal system affects you. Buprenorphine transdermal system can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with buprenorphine transdermal system may cause you to overdose and die.

The possible side effects of buprenorphine transdermal system are:

constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, itching, redness or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of buprenorphine transdermal system. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by:
Amneal Pharmaceuticals LLC
Piscataway, NJ 08854

Distributed by:
Amneal Pharmaceuticals LLC
Glasgow, KY 42141

Rev. 03-2024-04