MYSOLINE- primidone tablet
Bausch Health US, LLC
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MYSOLINE (My-so-lean)
(primidone tablets, USP), 50 mg and 250 mg
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?
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:
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.
How can I watch for early symptoms of suicidal thoughts and actions?
What is MYSOLINE?
MYSOLINE is a prescription medicine used alone or with other medicines to treat people with:
Who should not take MYSOLINE?
Do not take MYSOLINE if you:
What should I tell my healthcare provider before taking MYSOLINE?
Before you take MYSOLINE, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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.
What should I avoid while taking MYSOLINE?
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:
The most common side effects of MYSOLINE include:
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° to 77°F (20° to 25°C) in a tight, light-resistant container.
Keep MYSOLINE and all medicines out of 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.bauschhealth.com or call 1-800-321-4576.
What are the ingredients in MYSOLINE?
Active Ingredient: primidone, USP
Inactive Ingredients: lactose monohydrate, NF; magnesium stearate, NF;
methylcellulose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl
sulfate, NF; sodium starch glycolate, NF; and talc, USP.
MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF.
Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
MYSOLINE is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2020 Bausch Health Companies Inc. or its affiliates
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 07/2020