Primidone is the generic form of the brand-name drug Mysoline, which is used to treat and prevent seizures.
The medicine can be used alone or combined with other treatments. It’s also used to treat essential tremor and other neurological conditions.
Primidone is in a class of drugs known as anticonvulsants. It works by reducing abnormal electrical activity in the brain.
The Food and Drug Administration (FDA) first approved primidone in 1954. It’s marketed as Mysoline by Valeant Pharmaceuticals, and as generic primidone by several drug manufacturers.
Some people may have suicidal thoughts or changes in mental health while taking anticonvulsants such as primidone.
Tell your doctor right away if you experience any of the following symptoms:
- Panic attack
- Agitation or restlessness
- New or worsening irritability
- Acting on dangerous impulses
- Difficulty sleeping
- Aggressive, angry, or violent behaviors
- Abnormally excited mood
- Suicidal thoughts or actions
- Preoccupation with death
- Withdrawing from family and friends
- Other unusual changes in mood or behavior
Before taking primidone, tell your doctor if you have or have ever had:
- Porphyria (a blood disease)
- Allergies to any medications
- A history of mental health disorders or substance abuse
- Liver disease
- Lung or breathing problems
Also, be sure to tell your doctor if you’re taking sodium oxybate (Xyrem) or the recreational drug GHB before starting primidone.
Tell your doctor that you take primidone before any type of surgery, including dental procedures.
It might take several weeks before you feel the full benefits of primidone.
Don’t stop taking the medicine without first talking to your doctor. Your seizures may become worse and you may experience unpleasant withdrawal symptoms if you stop taking primidone suddenly.
Be sure to keep all appointments with your doctor and laboratory while taking this medicine.
Pregnancy and Primidone
Primidone may harm an unborn baby. Don’t take this medicine if you’re pregnant or plan to become pregnant.
You should also know that hormonal birth control pills may not work as well if you’re taking primidone. Talk to your doctor about other birth control options.
The drug is found in breast milk and may hurt a breastfeeding baby. Don’t breastfeed while taking primidone.
( My-so- lean)
Read this Medication Guide before you start taking MYSOLINE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about MYSOLINE?
Do not stop taking MYSOLINE without first talking to your healthcare provider.
Stopping MYSOLINE suddenly can cause serious problems.
MYSOLINE can cause serious side effects, including:
Like other antiepileptic drugs, MYSOLINE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop MYSOLINE without first talking to a healthcare provider.
- Stopping MYSOLINE suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What is MYSOLINE?
MYSOLINE is a prescription medicine used alone or with other medicines to treat people with:
- generalized tonic-clonic (grand mal) seizures
- complex partial (psychomotor) seizures
- partial (focal) epileptic seizures.
Who should not take MYSOLINE?
Do not take MYSOLINE if you:
- have a genetic disorder called porphyria
- are allergic to phenobarbital
What should I tell my healthcare provider before taking MYSOLINE?
Before you take MYSOLINE, tell your healthcare provider if you:
- have or have had depression, mood problems or suicidal thoughts or behavior
- have any other medical conditions
- are pregnant or planning to become pregnant. MYSOLINE may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking MYSOLINE. You and your healthcare provider will decide if you should take MYSOLINE while you are pregnant.
- If you become pregnant while taking MYSOLINE, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 . The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
- are breastfeeding or plan to breastfeed. MYSOLINE can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take MYSOLINE.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking MYSOLINE with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take MYSOLINE?
Take MYSOLINE exactly as prescribed. Your healthcare provider will tell you how much MYSOLINE to take and when to take it.
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Do not stop taking MYSOLINE without first talking to your healthcare provider. Stopping MYSOLINE suddenly can cause serious problems.
- If you take too much MYSOLINE, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking MYSOLINE?
- MYSOLINE can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking MYSOLINE without first discussing this with your healthcare provider. Taking MYSOLINE with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how MYSOLINE affects you. MYSOLINE can slow your thinking and motor skills.
What are the possible side effects of MYSOLINE?
See “What is the most important information I should know about MYSOLINE?”.
MYSOLINE may cause other serious side effects including:
- Sleepiness that can be severe, especially when you first start taking MYSOLINE.
- MYSOLINE may rarely cause blood problems. Symptoms may include:
- fever, swollen glands, or sore throat that come and go or do not go away
- Frequent infections or an infection that does not go away
- shortness of breath
- MYSOLINE may rarely cause allergic reactions. Symptoms may include:
- skin rash
- sores in your mouth
- blistering or peeling skin
The most common side effects of MYSOLINE include:
- problems with walking and moving
- feelings of dizziness, spinning, or swaying (vertigo)
These are not all the possible side effects of MYSOLINE. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 .
How should I store MYSOLINE?
Store MYSOLINE at room temperature between 68°F to 77°F (20°C to 25°C) in a tight, light-resistant container
Keep MYSOLINE and all medicines out of the reach of children.
General Information about MYSOLINE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MYSOLINE for a condition for which it was not prescribed. Do not give MYSOLINE to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about MYSOLINE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about MYSOLINE that is written for health professionals.
For more information, go to www.VALEANT.com or call 1-877-361-2719
What are the ingredients in MYSOLINE?
Active Ingredient: primidone
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, methylcellulose, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, talc, purified water and ferric oxide yellow (250 mg tablet only)
What is Primidone?
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tenofovir Alafenamide
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Dabigatran Etexilate
- Eslicarbazepine Acetate
- Ethinyl Estradiol
- Morphine Sulfate Liposome
- Sodium Oxybate
- Valproic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.