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This document outlines crucial safety information and warnings for individuals using the medication rufinamide (Banzel). It is important to carefully read these details and consult with your healthcare provider if you have any questions or concerns.

• Suicidal Thoughts or Behavior: Rufinamide, like other antiepileptic drugs, may increase the risk of suicidal thoughts or behaviors. Be vigilant for new or worsening signs of depression and any unusual changes in mood or behavior, especially during the initial months of treatment or following dosage adjustments. Report any concerning symptoms to your healthcare provider. Seek immediate medical assistance if you experience suicidal thoughts.

• Drowsiness and Coordination Issues: This medication may cause drowsiness, fatigue, dizziness, or coordination problems, particularly at the start of treatment or after a dosage change. Avoid activities that require full alertness, such as driving or operating heavy machinery, until you understand how the medication affects you.

• Heart Rhythm Concerns: Rufinamide can alter the heart's electrical activity, leading to QT interval shortening. This may result in dizziness, fainting, or abnormal heart rhythms. Individuals with familial short QT syndrome or those taking other medications that shorten the QT interval should exercise caution.

• Severe Allergic Reactions: Some users have experienced a serious allergic reaction known as DRESS, which involves symptoms like fever, rash, facial swelling, or swollen lymph nodes. It can also cause low blood cell counts and organ damage. Discontinue use and seek immediate medical care if you suspect a severe allergic reaction.

• Seizure Risk from Sudden Discontinuation: Do not abruptly stop taking rufinamide without consulting your healthcare provider, as this may lead to withdrawal seizures. If discontinuation is necessary, your provider will guide you on gradually reducing the dose.

• Status Epilepticus: A rare but serious condition, status epilepticus, has been observed in some patients during clinical trials. This involves prolonged seizures and is life-threatening. It is advisable to have an emergency plan in place with family and friends for managing seizures.

• Low White Blood Cell Counts: Rufinamide can reduce white blood cell counts, potentially increasing susceptibility to infections. Inform your healthcare provider if you notice an increase in infections or if they persist longer than usual.

Contraindications: Rufinamide should not be used if you have familial short QT syndrome, a genetic heart rhythm condition, as it may pose serious health risks. Always consult your healthcare provider if this condition or other concerns apply to you before starting the medication.

When taking this medication, you might experience some common side effects, which are generally mild and typically temporary. These include drowsiness, dizziness, tiredness, headache, nausea, vomiting, loss of appetite, and occasional blurred or double vision. Some might also experience bronchitis, constipation, cough, and rash. It’s important to stay vigilant and consult your healthcare provider if these symptoms persist or become bothersome.

There are also more serious side effects to be aware of, though they are rare. These include significant changes in mood or behavior, such as depression or suicidal thoughts. If you or your caregivers notice sudden alterations in your mood or thoughts, it is crucial to seek medical help immediately. Additionally, severe allergic reactions can occur, presenting as fever, swollen lymph nodes, rash, itching or swelling (particularly on the face, tongue, or throat), severe dizziness, or difficulty breathing. Immediate medical attention is required if these symptoms arise.

It's important to remember that this is not an exhaustive list of side effects. Should you notice any other unexpected reactions, reach out to your healthcare provider for guidance.

When taking this medication, be aware that it can interact with several other drugs. Notably, Orlistat and valproate are known to have interactions. Additionally, this medication may reduce the effectiveness of hormonal birth control methods such as pills, patches, or rings, which could lead to pregnancy. It's important to discuss with your doctor whether you should use alternative backup birth control methods. If you experience any unexpected spotting or breakthrough bleeding, inform your doctor, as this might indicate that your birth control is less effective.

Furthermore, this medication can interact with substances that cause drowsiness, including alcohol, marijuana, certain antihistamines (like Cetirizine and diphenhydramine), sleep or anxiety medications (such as Diazepam, Triazolam, Zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Always check the labels of any medications you are taking to ensure they do not contain drowsiness-inducing ingredients, and consult your pharmacist for safe usage.

In some cases, your doctor might prescribe this medication alongside others, such as Calcifediol or various hormonal contraceptives, despite potential interactions. Your doctor may adjust dosages to mitigate any risks. Be aware that combining this medication with others like Carbamazepine, fosphenytoin, Lamotrigine, Phenobarbital, Phenytoin, Primidone, triazolam, or Valproic Acid can increase the risk of side effects. Your doctor will consider these factors and may modify your treatment plan accordingly. Always keep your healthcare provider informed about all the medications and supplements you are taking.