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Asenapine (Saphris) is associated with several important safety warnings and precautions. Please review the following information carefully and discuss any concerns with your healthcare provider.

• Increased Risk in Older Adults with Dementia: Older individuals over 65 years old with dementia who take asenapine for psychosis may face a heightened risk of death, often due to heart issues or infections. Asenapine is not approved for treating dementia-related behavior problems. Consider discussing alternative treatments with your doctor.

• Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition linked to antipsychotic drugs. Symptoms include high fever, rapid heartbeat, muscle stiffness, and confusion. Seek immediate medical attention if these symptoms occur, as a medication change might be necessary.

• Movement Disorders: Long-term use of asenapine can lead to tardive dyskinesia (TD), characterized by involuntary movements such as lip smacking or unusual blinking. This condition may be irreversible. To minimize the risk, the lowest effective dose will be prescribed, and regular assessments of your need for continued use will be conducted. Report any TD symptoms to your healthcare provider promptly.

• Metabolic Changes: Asenapine can cause high blood sugar, elevated cholesterol, and weight gain, increasing the risk of heart disease and other serious health conditions. Discuss preventive strategies with your healthcare provider.

• Allergic Reactions: Though rare, serious allergic reactions may occur. Seek medical help immediately if you experience symptoms such as rash, rapid heartbeat, swelling, or difficulty breathing.

• Blood Pressure and Heart Rate Changes: Asenapine may cause low blood pressure and changes in heart rhythm, particularly when standing up. If you have a history of heart issues or are taking medications that affect blood pressure or heart rhythm, consult your healthcare provider. Report any dizziness or abnormal heartbeats to your care team.

• Low White Blood Cell Count: This medication can reduce white blood cells, increasing infection risk. Notify your doctor if you experience fever or frequent infections. Blood tests may be required to monitor white blood cell levels.

• Seizures: Those with a history of seizures or conditions that increase seizure risk should inform their prescriber before starting asenapine.

• Elevated Prolactin Levels: Asenapine can increase prolactin levels, potentially causing menstrual changes, fertility issues, and mood or sexual problems. Discuss any concerns with your healthcare team.

• Phenylketonuria (PKU): Some asenapine formulations contain phenylalanine, which is harmful to individuals with PKU. Ensure your prescriber is aware of your condition.

• Contraindications: Asenapine should not be used by individuals with severe liver problems.

In case of an overdose, seek emergency medical attention immediately. Always adhere to your healthcare provider’s instructions and consult them before making any changes to your medication regimen.

When using this medication, some common side effects might be experienced, though they are usually mild and manageable. These include trouble sleeping, drowsiness, dizziness, constipation, vomiting, numbness or tingling in the mouth, and increased appetite, potentially leading to weight gain. It's important to rise slowly from sitting or lying positions to reduce the risk of dizziness and falls.

Other side effects that may occur include dry mouth, excessive salivation, fatigue, irritability, and stomach discomfort. While most people tolerate these effects well, consult your healthcare provider if they persist or worsen.

More serious side effects, though rare, demand immediate medical attention. These include symptoms of neuroleptic malignant syndrome, such as high fever, sweating, confusion, muscle stiffness, and changes in blood pressure. Other severe reactions can include seizures, significant mood changes or thoughts of self-harm, and changes in heartbeat.

For males, there is a rare risk of a prolonged or painful erection lasting more than four hours, which requires emergency medical help. Additionally, some individuals may experience a serious allergic reaction, characterized by rash, hives, difficulty breathing, or swelling of the face, tongue, or throat.

In rare cases, the medication can increase blood sugar levels, potentially affecting diabetes management. For women, increased prolactin levels may cause issues like unwanted breast milk or menstrual changes, while men might experience decreased sexual ability or enlarged breasts. If any of these occur, contact your healthcare provider promptly. Always keep open communication with your healthcare provider to manage any side effects effectively.

Asenapine may impact the effectiveness of other medications by slowing their elimination from the body. This is particularly relevant for medications like paroxetine. It is important to inform your healthcare provider if you are using other substances that can cause drowsiness. These include opioid painkillers or cough suppressants such as codeine and hydrocodone, alcohol, marijuana, anxiety or sleep medications like alprazolam, lorazepam, and zolpidem, muscle relaxants such as carisoprodol and cyclobenzaprine, and antihistamines like cetirizine and diphenhydramine.

Additionally, asenapine may have significant interactions with certain medications, which your doctor might need to consider before prescribing. Some medicines should not be used with asenapine, such as bepridil, bromopride, cisapride, dronedarone, mesoridazine, metoclopramide, pimozide, piperaquine, saquinavir, sparfloxacin, terfenadine, thioridazine, and ziprasidone. For other medications, including acecainide, ajmaline, alfentanil, and many others listed, concurrent use with asenapine is generally not recommended unless necessary. In such cases, your doctor may adjust the dosage or frequency of use.

Finally, while asenapine and paroxetine together may heighten the risk of side effects, this combination might be essential for your treatment plan, and your healthcare provider will manage the dosages accordingly. Always consult with your doctor or pharmacist when taking any new medication or supplement to ensure safe and effective treatment.