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The safety and warning information for Zembrace SymTouch (sumatriptan) provides essential guidance on its use, potential risks, and precautions. It is important to discuss any concerns with your healthcare provider and to understand when it might not be suitable for you:

• Heart Complications: Rarely, Zembrace SymTouch can lead to serious heart issues, including heart attacks and arrhythmias, regardless of heart disease history. Discontinue use immediately and seek medical help if you notice abnormal heartbeats or signs of a heart attack, such as chest pain spreading to the neck, shoulder, or jaw, shortness of breath, dizziness, fainting, sweating, or nausea. Avoid this medication if you have a history of heart disease or arrhythmias, and consult your healthcare provider if you have risk factors like high cholesterol, high blood pressure, diabetes, smoking, obesity, advanced age, or a family history of heart disease.

• Stroke and Cerebral Bleeding: This medication can cause strokes, which might be confused with migraine symptoms. Confirm with your healthcare provider that your headache is a migraine before using Zembrace SymTouch. Discontinue use and seek emergency care if you experience symptoms of a stroke, such as sudden weakness on one side of the body, confusion, speech difficulties, vision problems, dizziness, or difficulty walking. Avoid use if you have a history of stroke, transient ischemic attacks, hemiplegic migraine, or basilar migraine.

• Chest and Throat Discomfort: Some users may experience pain, tightness, pressure, or heaviness in the chest, throat, neck, or jaw. Although typically not linked to heart issues, inform your provider if these symptoms occur.

• Medication Overuse Headache: Using this medication alone or with other migraine treatments for 10 or more days per month can worsen headaches. Consult your provider on how to safely reduce usage if necessary.

• Serotonin Syndrome: Rarely, Zembrace SymTouch can increase serotonin levels, leading to serotonin syndrome, especially when combined with certain other medications like antidepressants, fentanyl, tramadol, buspirone, ADHD medications, or other triptans. Contact your provider immediately if you experience symptoms such as agitation, hallucinations, rapid heartbeat, excessive sweating, high fever, tremors, muscle spasms, nausea, or vomiting.

• Blood Vessel Constriction: This medication can cause blood vessels to narrow, reducing blood flow to limbs and the stomach, potentially causing pain, numbness, color changes, severe stomach pain, or bloody diarrhea. There are also reports of vision changes, including temporary or permanent blindness. If you notice these symptoms, contact your provider.

• High Blood Pressure: Rare instances of dangerously high blood pressure may occur, even in individuals without a history of it, potentially leading to life-threatening complications. Monitor your blood pressure and seek emergency help if you encounter severe symptoms like chest pain, headache, shortness of breath, vision changes, nausea, vomiting, anxiety, or seizures. Do not use if your blood pressure is uncontrolled.

• Seizures: Avoid Zembrace SymTouch if you have a history of seizures or conditions that increase seizure risk.

Contraindications: Do not use Zembrace SymTouch if you have:

• A history of heart disease or arrhythmias.
• Experienced a stroke or have hemiplegic/basilar migraines.
• Blood vessel diseases such as peripheral vascular disease or ischemic bowel disease.
• Uncontrolled high blood pressure.
• Taken other migraine medications (ergot-type or triptans) within 24 hours.
• Used MAO-A inhibitors like phenelzine or tranylcypromine in the last two weeks.
• Severe liver problems.

Consult your healthcare provider for personalized advice and to ensure Zembrace SymTouch is appropriate for you.

When taking this medication, some common side effects may occur, such as pain, redness, swelling, or bruising at the injection site. These are usually mild but should be reported to your healthcare provider if they persist or worsen. Other common sensations include tingling, dizziness, feelings of warmth or heat, burning, heaviness, pressure, and flushing. These effects are typically not serious, but consult your healthcare provider if you have any concerns.

It is important to be aware of more serious side effects that may require immediate medical attention. These include symptoms resembling a heart attack, such as chest pain spreading to the neck, shoulder, or jaw, shortness of breath, lightheadedness, sweating, and nausea. Stroke-like symptoms, such as sudden weakness on one side of the body, confusion, trouble speaking, vision changes, dizziness, and difficulty walking, should also be treated as emergencies.

In rare cases, the medication can affect blood flow, leading to pain or numbness in limbs, severe stomach pain, or bloody diarrhea. Serotonin syndrome is another serious condition, characterized by agitation, hallucinations, a racing heartbeat, heavy sweating, high fever, shakiness, muscle spasms, nausea, and vomiting. High blood pressure and abnormal heart rhythms are also potential risks.

Severe allergic reactions, although rare, can occur, presenting as a rash, difficulty breathing, or swelling of the tongue, mouth, or throat. Seizures are another possible serious side effect. If you experience any of these severe symptoms, seek urgent medical care. While this is not an exhaustive list of side effects, staying informed and communicating with your healthcare provider can help manage your health effectively.

Taking MAO inhibitors alongside this medication can lead to a severe and potentially life-threatening interaction. It is important to avoid using MAO inhibitors such as isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, and tranylcypromine while you are being treated with this drug. Additionally, most MAO inhibitors should not be used for two weeks prior to starting this medication. Consult your doctor for guidance on when to begin or discontinue this treatment.

Furthermore, the risk of developing serotonin syndrome, a serious condition, increases if you are taking other medications that elevate serotonin levels. This includes substances like MDMA ("ecstasy"), St. John's wort, and certain antidepressants, such as SSRIs (e.g., fluoxetine and paroxetine) and SNRIs (e.g., duloxetine and venlafaxine). The risk is heightened when initiating or increasing the dosage of these drugs.

If you are also using ergotamine medications (such as dihydroergotamine) or triptan drugs (like zolmitriptan and rizatriptan), it is crucial to space out the doses of sumatriptan and these medications to reduce the likelihood of serious side effects. Your doctor can provide specific guidance on how long to wait between doses of these drugs.