( 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
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
Call your healthcare provider between visits as needed,
especially if you are worried about symptoms.
Do not stop MYSOLINE without first talking to a
- 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
Before you take MYSOLINE, tell your healthcare provider
- 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
- 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
- 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
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
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