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The following information outlines critical safety warnings associated with the use of Suboxone film (buprenorphine/naloxone). Please read carefully and consult your healthcare provider if you have any questions or concerns.

• Addiction and Misuse Risk: Suboxone is a Schedule III controlled substance due to its inclusion of buprenorphine, which poses a risk for misuse and dependence. Using more than the prescribed dosage can increase the risk of addiction and severe side effects, including dangerously slow breathing and overdose. Individuals with a history of alcohol or substance use disorder should be particularly cautious.

• Respiratory Depression: Buprenorphine in Suboxone can lead to dangerously slow breathing, which may be life-threatening, especially when combined with benzodiazepines, opioids, or alcohol. People over 65, those with chronic obstructive pulmonary disease (COPD), or other conditions that cause slow breathing should exercise caution.

• Opioid Overdose Risk: There is a risk of relapse and overdose in people treated for opioid use disorder. Overdose can occur even at recommended doses and is potentially fatal, particularly in children who accidentally ingest the medication. Those with a history of opioid use disorder or previous overdoses should be aware.

• Impaired Concentration and Sleepiness: Suboxone can cause extreme drowsiness and impair cognitive function. Concurrent use with alcohol or medications such as sedatives can exacerbate these effects. This is especially relevant for individuals over 65.

• Pregnancy Risks: Use of Suboxone during pregnancy can result in the unborn baby becoming dependent on the medication. Pregnant individuals should discuss potential risks with their healthcare provider.

• Adrenal Insufficiency: Long-term use of Suboxone can lead to low adrenal hormone levels, resulting in symptoms like nausea, tiredness, and dizziness. If you experience these symptoms, contact your healthcare provider.

• Withdrawal Symptoms: Long-term use can cause physical dependence, and sudden cessation may lead to withdrawal symptoms, such as anxiety and body aches. Gradual dose reduction is advised.

• Liver Damage: Use of buprenorphine-containing medications can lead to liver damage. Regular liver function tests are recommended, especially for those with a history of liver damage, hepatitis B or C, or injection drug use.

• Dental Health Issues: Some users have experienced dental problems, including cavities and tooth loss, due to the medication dissolving in the mouth.

• Heart Rhythm Abnormalities (QT Prolongation): Buprenorphine can cause QT prolongation, potentially leading to severe heart rhythm issues. Those with existing heart conditions should be cautious.

• Low Blood Pressure: Suboxone may cause a significant drop in blood pressure, leading to dizziness or fainting. Standing up slowly from a sitting or lying position can help minimize these effects.

• Not Suitable for Pain Management or Opioid-Naïve Individuals: Suboxone is not intended for pain relief or individuals who have never taken opioids, as fatal overdoses have occurred under these circumstances.

Contraindications: Suboxone should not be used by individuals with a severe allergy to buprenorphine or naloxone. If applicable, discuss alternatives with your healthcare provider.

When taking this medication, it's important to be aware of potential side effects. Many people may experience mild and common side effects, which generally do not cause major issues. These include headaches, which occur in about 36% of users, and symptoms of withdrawal such as anxiety and irritability, affecting 25%. Other common side effects are general pain (22%), nausea (15%), increased sweating (14%), trouble sleeping (14%), constipation (12%), and stomach pain (11%). These symptoms often resolve on their own, but if they persist or worsen, it’s advisable to consult a healthcare provider.

In addition to these common effects, there are other side effects reported by some users. These include dizziness, mouth numbness, burning sensations in the mouth or tongue, and swelling inside the mouth. You might also experience swelling in the hands or ankles, body weakness, back pain, chills, a runny nose, blurry vision, diarrhea, vomiting, a racing heart, or signs of infection. Although these effects are less common, it’s important to monitor them and seek advice if they become troublesome.

There are also serious side effects that, while rare, necessitate immediate medical attention. These include symptoms of opioid withdrawal, such as restlessness and muscle aches, as well as dangerously slow breathing marked by bluish lips or fingers. Heart rhythm problems can present as chest pain or a fluttering sensation, and serious allergic reactions may cause rash, hives, fast heartbeat, or swelling around the eyes or lips. If any of these severe symptoms occur, urgent medical care is crucial.