PRIMIDONE- primidone tablet
Aphena Pharma Solutions - Tennessee, LLC
Primidone Tablets, USP, 50 mg and 250 mg
Read this Medication Guide before you start taking primidone tablets 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 primidone tablets?.
Like other antiepileptic drugs, primidone tablets 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:
Do not stop primidone tablets without first talking to a healthcare provider.
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 are primidone tablets?
Primidone tablets are a prescription medicine used alone or with other medicines to treat people with:
Who should not take primidone tablets?
Do not take primidone tablets if you:
What should I tell my healthcare provider before taking primidone tablets?
Before you take primidone tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking primidone tablets 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 primidone tablets?
Take primidone tablets exactly as prescribed. Your healthcare provider will tell you how much primidone tablets to take and when to take it.
What should I avoid while taking primidone tablets?
What are the possible side effects of primidone tablets?
See “What is the most important information I should know about primidone tablets?”.
Primidone tablets may cause other serious side effects including:
The most common side effects of primidone tablets include:
These are not all the possible side effects of primidone tablets. 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 primidone tablets?
Store primidone tablets at room temperature between 68°F to 77°F (20°C to 25°C) in a tight, light- resistant container.
Keep primidone tablets and all medicines out of the reach of children.
General Information about primidone tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use primidone tablets for a condition for which it was not prescribed. Do not give primidone tablets 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 primidone tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about primidone tablets that is written for health professionals.
For more information, call 1-844-508-1455, 8:00 AM to 4.30 PM ET, Monday – Friday.
What are the ingredients in Primidone?
Active Ingredient: primidone
Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and talc.
Primidone 250 mg tablets also contain D&C yellow #10 aluminum lake and FD&C yellow #5 aluminum lake.
Primidone Tablets 250 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
OXFORD PHARMACEUTICALS, LLC
Birmingham, AL 35211
8200023 Rev 00