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Tapentadol is associated with the potential for abuse and addiction, which can result in overdose and potentially fatal outcomes. It may also lead to serious, possibly life-threatening respiratory issues. To minimize these risks, it is crucial to follow your healthcare provider's guidance by using the smallest effective dose for the shortest duration necessary.

Key Safety Information:

• Opioid Overdose Preparedness: Discuss with your healthcare professional whether you should have naloxone available to address possible opioid overdoses. Educate your family or household members on recognizing opioid overdose symptoms and administering treatment.

• Increased Risk Periods: The likelihood of severe breathing problems is heightened when initiating tapentadol treatment, after dosage increases, or if an incorrect dose or strength is taken.

• Substance Interactions: Combining this medication with alcohol or other substances that induce drowsiness or respiratory issues may result in severe side effects, including death. Ensure you understand how to properly take tapentadol and which substances to avoid.

• Emergency Response: Seek immediate medical attention if you experience symptoms such as slow or shallow breathing, extreme lightheadedness, severe drowsiness or dizziness, or difficulty waking up.

• Secure Storage: Store this medication securely to prevent theft, misuse, or abuse. In the event of accidental ingestion, seek medical help immediately.

Special Considerations:

• Pregnancy and Childbearing: Women of childbearing age should consult their healthcare provider about the risks and benefits of using tapentadol. Inform your doctor if you are pregnant or planning to become pregnant. Use during pregnancy should be limited to situations where it is clearly necessary, as it may slightly increase the risk of birth defects if taken during the first two months. Prolonged use or high doses near delivery may harm the unborn child. Infants born to mothers using this medication long-term may experience severe withdrawal symptoms. Notify a healthcare provider if your newborn exhibits symptoms such as persistent crying, slow or shallow breathing, irritability, tremors, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

You may experience nausea, vomiting, constipation, dizziness, or drowsiness when taking this medication. These are common side effects and usually not a cause for concern. However, if they persist or worsen, consult your healthcare provider. To help manage constipation, incorporate dietary fiber, stay hydrated, and engage in regular physical activity. A laxative might be necessary; consult with your pharmacist for the best option. To minimize dizziness and lightheadedness, rise slowly from sitting or lying positions.

While most users of this medication experience no severe issues, it is important to be aware of serious side effects. Contact your healthcare provider immediately if you encounter confusion, sleep apnea, stomach pain, difficulty urinating, or symptoms indicating adrenal gland issues like loss of appetite, unusual fatigue, or weight loss.

Seek urgent medical assistance if you experience slow or shallow breathing, fainting, seizures, or severe drowsiness. This medication may elevate serotonin levels, potentially leading to serotonin syndrome, a severe condition. Symptoms include a rapid heartbeat, hallucinations, loss of coordination, severe nausea, vomiting, diarrhea, muscle twitching, unexplained fever, or unusual agitation.

Allergic reactions to this medication are rare but can be serious. If you notice a rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or difficulty breathing, seek immediate medical attention. Always inform your healthcare provider of all medications you are taking to avoid interactions. If you notice any other side effects, contact your healthcare provider.

Certain medications can interact with this drug. These include some pain relievers known as mixed opioid agonist-antagonists like Butorphanol, Nalbuphine, and pentazocine, as well as Naltrexone and samidorphan. Taking this medication with MAO inhibitors can lead to a dangerous, potentially life-threatening reaction. It's important to avoid MAO inhibitors such as isocarboxazid, Linezolid, Metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, and Tranylcypromine while using this drug. Most MAO inhibitors should not be taken two weeks before starting this treatment. Consult your doctor on when to begin or stop this medication.

The chance of developing serotonin syndrome, a serious condition, increases if you are also taking drugs that boost serotonin levels. This includes certain street drugs like MDMA or "ecstasy," St. John's wort, and specific antidepressants, including SSRIs such as Fluoxetine and paroxetine, and SNRIs like Duloxetine and Venlafaxine. The risk may rise when starting or increasing doses of these medications.

Serious side effects such as slow or shallow breathing, severe drowsiness, or dizziness are more likely if this drug is combined with other substances that cause drowsiness or breathing difficulties. Inform your doctor or pharmacist if you are using other opioid pain relievers, cough suppressants (like codeine or hydrocodone), alcohol, marijuana (cannabis), sleep or anxiety medications (such as Alprazolam, Lorazepam, Zolpidem), muscle relaxants (like Carisoprodol, Cyclobenzaprine), or antihistamines (such as Cetirizine, diphenhydramine).

Check all your medications, including allergy or cough-and-cold products, since they might contain ingredients that cause drowsiness. Consult your pharmacist to ensure safe use. This drug may also affect certain lab tests, like those for amylase and lipase, leading to inaccurate results. Ensure that all lab staff and your healthcare providers are aware you are taking this medication.