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The safety information below outlines critical warnings associated with the use of Opvee (nalmefene). It is essential to understand these risks and follow the advised precautions. If you have any concerns, please consult your healthcare provider.

• Risk of Recurrent Opioid Overdose Symptoms: Even after initial successful response to Opvee (nalmefene), symptoms of an opioid overdose may resurface, particularly in cases involving multiple types of opioids, where some may have longer-lasting effects. It is crucial to seek medical assistance immediately after administering the first dose and continuously monitor the individual. If symptoms do not improve within 2 to 5 minutes, administer an additional dose using a new nasal spray in the other nostril. This is particularly important when long-acting opioids are involved.

• Need for Repeated Doses: In cases involving opioids with mixed receptor activities, such as buprenorphine, Opvee (nalmefene) may require multiple doses to effectively counteract the drug. Ensure each additional dose is delivered with a new nasal spray. This precaution is necessary for individuals taking pain medications containing buprenorphine or pentazocine.

• Opioid Withdrawal Symptoms: Administration of Opvee (nalmefene) can trigger sudden opioid withdrawal, characterized by symptoms such as pain, body aches, diarrhea, rapid heartbeat, fever, sweating, nausea, vomiting, irritability, and trembling. This risk is heightened in individuals who regularly use opioids, have recently undergone surgery, or are infants under one month old who have been exposed to opioids. Immediate notification of a healthcare provider is advised, along with close monitoring of symptoms.

Currently, there are no specified contraindications for the use of Opvee (nalmefene).

When taking this medication, some common side effects may occur, which are generally mild and manageable. You might experience nasal discomfort or a stuffy nose, headaches, nausea, dizziness, hot flushes, or vomiting. These effects are often temporary, but if they persist or worsen, consulting your healthcare provider is advisable. Additionally, some people might feel tired, experience throat irritation, or notice nose pain.

In rare cases, serious side effects can occur, necessitating prompt medical attention. Allergic reactions, although uncommon, are serious and can manifest as rash, swelling (particularly of the face, tongue, or throat), severe dizziness, or breathing difficulties. Immediate medical help is crucial if you experience these symptoms.

For those who have been using opioids regularly, this medication might trigger withdrawal symptoms. These symptoms could include anxiety, irritability, body aches, fast heartbeat, sweating, vomiting, shakiness, and increased blood pressure. Should you notice any of these severe reactions, seeking urgent medical care is imperative. Always stay vigilant and informed about how your body responds to new medications.