RUFINAMIDE- rufinamide suspension 
Bionpharma Inc.

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Medication Guide

Rufinamide (roo fin’ a mide)

Oral Suspension

Read this Medication Guide before you start taking rufinamide oral suspension 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 rufinamide oral suspension?

Do not stop taking rufinamide oral suspension without first talking to your healthcare provider.

Stopping rufinamide oral suspension suddenly can cause serious problems.

Rufinamide oral suspension can cause serious side effects, including:

1. Like other antiepileptic drugs, rufinamide oral suspension 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:

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop rufinamide oral suspension without first talking to a healthcare provider.

2. Rufinamide oral suspension may cause you to feel sleepy, tired, weak, dizzy, or have problems with coordination and walking.

What is rufinamide oral suspension?

Rufinamide oral suspension is a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older.

It is not known if rufinamide oral suspension is safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.

Who should not take rufinamide oral suspension?

Do not take rufinamide oral suspension if you have a genetic condition called familial short QT syndrome, a problem that affects the electrical system of the heart.

What should I tell my healthcare provider before taking rufinamide oral suspension?

Before you take rufinamide oral suspension, 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 rufinamide oral suspension 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 rufinamide oral suspension?

What should I avoid while taking rufinamide oral suspension?

What are the possible side effects of rufinamide oral suspension?

See “What is the most important information I should know about rufinamide oral suspension?”

Rufinamide oral suspension may cause serious side effects including:

Call your healthcare provider right away if you have any of the following. Symptoms may include:

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of rufinamide oral suspension include:

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of rufinamide oral suspension. For more information, ask your healthcare provider or pharmacist.

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 rufinamide oral suspension?

Keep rufinamide oral suspension and all medicines out of the reach of children.

General Information about the safe and effective use of rufinamide oral suspension

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rufinamide oral suspension for a condition for which it was not prescribed. Do not give rufinamide oral suspension 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 rufinamide oral suspension. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about rufinamide oral suspension that is written for health professionals.

For more information, call 1-888-235-BION or 1-888-235-2466.

What are the ingredients in rufinamide oral suspension?

Active ingredient: rufinamide, USP

Inactive ingredients: anhydrous citric acid powder, hydrochloric acid, hydroxyethylcellulose, methylparaben, microcrystalline cellulose & carboxymethylcellulose sodium, natural and artificial orange flavor, poloxamer 188, potassium sorbate, propylene glycol, propylparaben, purified water, simethicone emulsion 30%, sodium hydroxide and sorbitol solution 70%.

Distributed by:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Revised September 2020

This Medication Guide has been approved by the U.S. Food and Drug Administration.

FDA-05

Revised: 4/2022
Bionpharma Inc.