RUFINAMIDE- rufinamide suspension
Hikma Pharmaceuticals USA Inc.
Rufinamide 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?
Do not stop taking rufinamide without first talking to your healthcare provider.
Stopping rufinamide suddenly can cause serious problems.
Rufinamide can cause serious side effects, including:
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 without first talking to a healthcare provider.
What is rufinamide?
Rufinamide 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 is safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.
Who should not take rufinamide?
Do not take rufinamide 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?
Before you take rufinamide, 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 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?
See the complete Instructions for Use below for information on how to use the dosing syringes and measure your dose of rufinamide oral suspension.
What should I avoid while taking rufinamide?
What are the possible side effects of rufinamide?
See "What is the most important information I should know about rufinamide?"
Rufinamide 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 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. 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?
Keep rufinamide and all medicines out of the reach of children.
General Information about the safe and effective use of rufinamide.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rufinamide for a condition for which it was not prescribed. Do not give rufinamide 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about rufinamide that is written for health professionals.
For more information, please call 1-800-962-8364.
What are the ingredients in rufinamide?
Active ingredient: rufinamide
Inactive ingredients: anhydrous citric acid, hydroxyethyl cellulose, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, poloxamer, potassium sorbate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbitol solution and orange flavoring.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distr. by: Hikma
Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
Revised September 2020