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This medication has potential risks that users need to be aware of to ensure safe use. Please review the following safety information carefully and consult with your healthcare provider if you have any concerns or questions.

• Risk of Abuse and Addiction: This medication can lead to dependence and misuse, increasing the risk of overdose and potentially fatal outcomes. It is crucial to follow your doctor's prescription strictly, using the smallest effective dose for the shortest duration necessary.

• Severe Breathing Problems: The medication may cause serious, life-threatening breathing difficulties, particularly when initiating treatment or if dosages are incorrect. Avoid combining this medication with alcohol or other substances that depress the central nervous system, as this can exacerbate breathing issues and lead to severe consequences.

• Interactions with Other Medications: Certain drugs can interfere with how this medication is metabolized, affecting its efficacy and safety. Avoid taking this medication with erythromycin, ketoconazole, ritonavir, or similar drugs without consulting your doctor.

• Pregnancy and Newborn Risks: This medication is not recommended during pregnancy due to the potential risk of birth defects and harm to the unborn baby, particularly if used in high doses or for extended periods near delivery. Newborns exposed to this medication may experience severe withdrawal symptoms.

• Special Populations: Older adults, individuals with pre-existing breathing problems, and those with a history of substance abuse or mental health issues should use this medication with caution. It is not recommended for children under two years of age or individuals with certain medical conditions like severe respiratory depression or those who have recently used MAO inhibitors.

• Emergency Situations: In case of overdose or if symptoms like slow or shallow breathing, unusual drowsiness, or difficulty waking occur, seek immediate medical assistance. Keep this medication secure to prevent misuse or accidental ingestion.

• Additional Side Effects: This medication may cause low blood pressure, extreme sleepiness, and difficulty concentrating. Avoid alcohol and other sedative medications when taking this drug, and be cautious when engaging in activities that require full alertness.

Consult your healthcare provider for personalized advice and to address any specific concerns related to your health condition or treatment plan.

When taking this medication, you might experience some common side effects, which are generally mild and include dizziness, drowsiness, headache, upset stomach, nausea, constipation, nervousness, or trouble sleeping. If these symptoms persist or worsen, it is advisable to speak with your healthcare provider. To minimize dizziness and lightheadedness, try to rise slowly from a sitting or lying position.

There are also some more serious side effects that require immediate medical attention. These include interrupted breathing during sleep, mental or mood changes like hallucinations, shaking, trouble urinating, weakness, and a fast or irregular heartbeat. In very rare cases, the medication can cause severe allergic reactions, characterized by a rash, itching, swelling of the face, tongue, or throat, severe dizziness, or trouble breathing. If you notice any of these symptoms, seek medical help immediately.

Additionally, this medication may cause serious mental or mood alterations and potentially life-threatening breathing problems. Some individuals might metabolize certain components like codeine into stronger opioids faster, increasing the risk of severe side effects such as slow or shallow breathing, severe drowsiness, difficulty waking up, or confusion. Immediate medical intervention is critical if such symptoms occur.

If you experience symptoms related to opioid withdrawal, such as anxiety, irritability, restlessness, or other signs like a runny nose, yawning, or sweating, consult your healthcare provider promptly. Always report any unexpected side effects to your doctor.

Some medications may interact with this drug, including Naltrexone and samidorphan. Combining this medication with MAO inhibitors can result in a serious, potentially fatal interaction. Do not use MAO inhibitors (such as isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, or Tranylcypromine) during treatment with this drug, and for two weeks before starting it. Consult your doctor about when to begin or discontinue this medication.

The likelihood of severe side effects, like difficulty breathing or extreme drowsiness, increases if this drug is used with other substances that cause drowsiness or breathing issues. Inform your healthcare provider if you are using other opioids (e.g., codeine, Hydrocodone), alcohol, marijuana, sleep aids, anxiety drugs (e.g., Alprazolam, Lorazepam, Zolpidem), muscle relaxants (e.g., Carisoprodol, Cyclobenzaprine), or antihistamines (e.g., Cetirizine, diphenhydramine).

Check all your medications, prescription or over-the-counter, for ingredients like Guaifenesin and decongestants to avoid duplication. Some allergy or cold medications may also cause drowsiness, so consult your pharmacist about their safe usage.

Other drugs can influence how this medication is metabolized in your body, affecting its efficacy. This includes azole antifungals (like Ketoconazole), bupropion, Fluoxetine, some antibiotics (like Erythromycin), paroxetine, quinidine, rifamycins (like Rifabutin, Rifampin), Ritonavir, and certain seizure medications (like Carbamazepine, Phenytoin).

Finally, this drug may interfere with certain lab tests, potentially causing inaccurate results. Ensure your medical team is aware of your use of this medication.