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This document outlines important safety information and warnings related to the use of Suboxone film, a medication used to treat opioid use disorder. It is crucial to follow your healthcare provider's instructions and to be aware of the potential risks, precautions, and special considerations associated with its use.

• Risk of Addiction and Misuse: Suboxone contains buprenorphine, an opioid that carries a risk of misuse and dependence. Taking more than the prescribed amount increases the potential for addiction and severe side effects, including dangerously slow breathing and overdose. This risk is heightened in individuals with a history of alcohol or substance use disorder.

• Potentially Life-Threatening Respiratory Depression: Buprenorphine in Suboxone can cause dangerously slow breathing, especially when combined with other sedative medications or alcohol. Individuals over 65, those with COPD, or other conditions that affect breathing are at higher risk.

• Opioid Overdose Risk: Despite being in treatment, individuals with a history of opioid use disorder may relapse, leading to an overdose risk. Opioid overdose can occur even at prescribed doses and is particularly dangerous for children who accidentally ingest the medication.

• Cognitive Impairment and Sleepiness: Suboxone can cause significant drowsiness and impair concentration. Alcohol and other sedative medications can amplify these effects, increasing risks for individuals over 65.

• Risks to Newborns: Pregnant individuals using Suboxone risk passing opioid dependence to their unborn child, potentially leading to withdrawal symptoms after birth.

• Adrenal Insufficiency: Prolonged use of Suboxone may result in decreased adrenal hormone levels. Symptoms such as nausea, fatigue, and dizziness should be reported to a healthcare provider.

• Withdrawal Symptoms: Long-term use can lead to physical dependence, resulting in withdrawal if the medication is reduced or stopped abruptly. Symptoms include anxiety, irritability, and body aches.

• Liver Damage: Suboxone can cause liver damage, varying from mild to severe. Regular liver function tests are recommended for individuals with a history of liver issues or those using other liver-affecting medications.

• Dental Issues: Use of buprenorphine in oral film form has been linked to dental problems, including cavities and tooth loss.

• Heart Rhythm Problems: Buprenorphine may cause QT prolongation, potentially leading to serious heart rhythm disturbances. Individuals with heart conditions should exercise caution.

• Low Blood Pressure: Suboxone can lead to a significant drop in blood pressure upon standing, causing dizziness or fainting. Rise slowly from sitting or lying positions to mitigate this risk.

• Not for Pain Relief or Opioid-Naïve Individuals: Suboxone is not intended for pain management or use in individuals who have not previously taken opioids, due to the risk of fatal overdose.

• Contraindications: Do not use Suboxone if you have a severe allergy to buprenorphine or naloxone. Always consult your healthcare provider if you have concerns or experience adverse effects.

This medication can cause a range of side effects, from mild to severe. Common side effects include headache, nausea, constipation, dizziness, and drowsiness. These symptoms are often manageable and may diminish over time. To alleviate constipation, consider increasing your intake of dietary fiber, drinking plenty of water, and engaging in regular exercise. If dizziness occurs, try rising slowly from sitting or lying positions to minimize discomfort.

Some individuals might experience withdrawal symptoms, such as anxiety, goosebumps, joint pain, and a runny nose, especially when first starting the medication or if they have been using long-acting opioids like methadone. If withdrawal symptoms arise, consult your healthcare provider promptly. Other less frequent side effects include mouth numbness, burning sensations, swelling in the mouth, and general discomfort such as back pain and chills.

There are rare but serious risks associated with this medication that warrant immediate medical attention. These include severe breathing problems, especially if the medication is abused or mixed with other depressants, as well as symptoms of liver damage like persistent nausea, dark urine, and yellowing of the skin or eyes. In rare cases, serious allergic reactions may occur, presenting as a rash, swelling, or difficulty breathing. Additionally, there is a risk of heart rhythm issues, such as an irregular heartbeat or chest pain. If you notice any severe side effects, seek urgent medical care. This is not an exhaustive list, so if you experience any other unusual symptoms, contact your healthcare provider.

This medication can interact with several other products, leading to increased risk of severe side effects like slow or shallow breathing and intense drowsiness or dizziness. It is particularly important to be cautious if you are using this medication alongside mixed opioid agonist-antagonists (such as butorphanol, nalbuphine, pentazocine), naltrexone, or samidorphan. Additionally, using it with substances such as alcohol, marijuana, antihistamines (like cetirizine, diphenhydramine), sleep or anxiety medications (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other opioid pain relievers (like codeine, hydrocodone) can amplify these risks.

It's crucial to read the labels on all your medications, including allergy and cough-and-cold products, as they may contain ingredients that could contribute to drowsiness. Consult your pharmacist on how to use these products safely. There have been fatal incidents when this medication is misused by injection, especially when combined with benzodiazepines (such as diazepam) or other depressants like alcohol or additional opioids. Always inform your doctor or pharmacist about all the substances you're taking to prevent dangerous interactions.