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This document provides essential safety information regarding the use of this medication, highlighting potential risks, precautions, and necessary actions. Please carefully review the following points and consult with your healthcare provider if you have any questions or concerns.

• Risk of Suicidal Thoughts or Behavior: Use of antiepileptic medications like primidone (Mysoline) may increase the risk of suicidal thoughts or behaviors. Be vigilant for new or worsening depression or any unusual mood changes, particularly during the initial months of treatment or after a change in dosage. If you experience any concerning symptoms, contact your healthcare provider immediately. In the event of suicidal thoughts, seek emergency medical attention or call 911.

• Withdrawal Seizures: Do not discontinue primidone (Mysoline) without first consulting your healthcare provider. Abrupt cessation of antiepileptic medications can trigger withdrawal seizures. If discontinuation is necessary, your provider will guide you on how to gradually reduce the dosage to minimize risks.

• Low Blood Cell Counts with Long-term Use: Long-term use of primidone (Mysoline) may rarely lead to a decrease in blood cell counts. Regular blood tests may be required to monitor blood cell and electrolyte levels. Report any increased frequency of illness, unusual bruising or bleeding, or persistent feelings of weakness or breathlessness to your healthcare provider.

Contraindications: This medication should not be used under certain conditions due to potential serious health risks. Consult with your healthcare provider if you have:

• Porphyria, a disorder affecting blood cells.
• An allergy to phenobarbital.

This information is critical for ensuring safe use of the medication. Always communicate openly with your healthcare provider about any health changes or concerns while using this medication.

When taking this medication, it's common to experience mild side effects such as dizziness, drowsiness, nausea, vomiting, and a loss of appetite. These symptoms often subside as your body adjusts, but if they persist or worsen, consult a healthcare provider. Some individuals may also notice tiredness, headaches, or feelings of excitement. Feeling irritable, emotional, or experiencing mood swings can occur as well. Occasionally, users report difficulty with movement or a sensation of spinning, known as vertigo.

On the other hand, there are more serious side effects that, although rare, require prompt medical attention. These include staggering walk, clumsiness, double vision, fainting, severe tiredness or weakness, and changes in sexual function or interest. Watch for symptoms like easy bruising or bleeding, pale skin, slow heartbeat, or changes in breathing patterns. It is crucial to seek immediate medical help if you experience symptoms of depression, suicidal thoughts, or any unusual mood changes.

In very rare cases, some people might encounter a severe allergic reaction characterized by rash, itching, swelling, severe dizziness, or trouble breathing. Should any of these occur, urgent medical care is necessary. It's important to be aware that this is not an exhaustive list of side effects, and if you notice any unusual changes, consult your healthcare provider for guidance.

Primidone, also known as Mysoline, may interact with a variety of medications, potentially altering its effectiveness or increasing the risk of side effects. It's important to inform your doctor and pharmacist about all medications and supplements you are currently taking, including over-the-counter products, vitamins, and herbal supplements.

Certain drugs, such as darunavir and orlistat, may interact with primidone and affect its removal from the body, potentially altering its effectiveness. Additionally, primidone can accelerate the elimination of other medications, which may impact their efficacy. This includes medications like artemether/lumefantrine, atazanavir, cobicistat, and others.

Primidone can also decrease the effectiveness of hormonal birth control methods such as pills, patches, or rings, which could lead to unintended pregnancy. Discuss with your healthcare provider whether you should use additional contraceptive methods and report any unusual bleeding, as it might indicate reduced birth control effectiveness.

When taken with other products that induce drowsiness or respiratory issues, such as opioid pain medications, alcohol, cannabis, or certain medications for sleep or anxiety, primidone may increase the risk of severe side effects like slow or shallow breathing and profound drowsiness. It's crucial to read the labels of all your medications, as some may contain ingredients that cause drowsiness. Consult your pharmacist for guidance on safe usage.

Primidone is very similar to phenobarbital, so avoid using any medications containing phenobarbital while taking primidone to prevent adverse interactions.