Primidone Tablets

What is this medication?

PRIMIDONE (PRI mi done) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mysoline

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• Porphyria
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to primidone, phenobarbital, other barbiturates or seizure medications, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking except on the advice of your care team.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Contact your care team about the use of this medication in children. Special care may be needed. While this medication may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Voriconazole

This medication may also interact with the following:

• Cancer-treating medications
• Cyclosporine
• Disopyramide
• Doxycycline
• Estrogen or progestin hormones
• Medications for depression, anxiety or other mental health conditions
• Medications for treating HIV infection or AIDS
• Modafinil
• Prescription pain medications
• Quinidine
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be 2 to 3 weeks before you see the full effects of this medication. Do not suddenly stop taking this medication, you may increase the risk of seizures. Your care team may want to gradually reduce the dose. Wear a medical identification bracelet or chain to say you have epilepsy, and carry a card that lists all your medications.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

Birth control pills may not work properly while you are taking this medication. Talk to your care team about using an extra method of birth control.

The use of this medication may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medication. Any worsening of mood, or thoughts of suicide or dying should be reported to your care team right away.

Women who become pregnant while using this medication may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic medication use during pregnancy.

This medication may cause a decrease in vitamin D and folic acid. You should make sure that you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Loss of balance or coordination
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

This medication may cause accidental overdose and death if it is taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medication after the expiration date.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.