Important Safety Information
What is VIMPAT?
VIMPAT is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older.
- It is not known if VIMPAT injection is safe for use in children. Children age 4 years and older should only take VIMPAT by mouth. VIMPAT injection is only for use in people 17 years of age and older.
- It is not known if VIMPAT is safe and effective in children under 4 years of age.
What is the most important information I should know about VIMPAT?
Do not stop taking VIMPAT without first talking to your healthcare provider. Stopping VIMPAT suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
VIMPAT can cause serious side effects, including:
1. Like other antiepileptic drugs, VIMPAT 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
- attempt 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
2. VIMPAT may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how VIMPAT affects you.
3. VIMPAT may cause you to have an irregular heartbeat or may cause you to faint. Call your healthcare provider if you have:
- fast, slow, or pounding heartbeat
- shortness of breath
- feel lightheaded
- fainted or if you feel like you are going to faint
4. VIMPAT is a federally controlled substance (C-V) because it can be abused or lead to drug dependence. Keep your VIMPAT in a safe place, to protect it from theft. Never give your VIMPAT to anyone else, because it may harm them.
What should I tell my healthcare provider before taking VIMPAT?
Before you take VIMPAT, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had depression, mood problems or suicidal thoughts or behavior
- have heart problems
- have kidney problems
- have liver problems
- have abused prescription medicines, street drugs or alcohol in the past
- have any other medical problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
What should I avoid while taking VIMPAT?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how VIMPAT affects you. VIMPAT may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
What are the possible side effects of VIMPAT?
See "What is the most important information I should know about VIMPAT?".
VIMPAT may cause other serious side effects including:
VIMPAT may cause a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
- a skin rash, hives
- fever or swollen glands that do not go away
- shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.
The most common side effects of VIMPAT include:
- double vision
Side effects of VIMPAT in children are similar to those seen in adults.
These are not all of the possible side effects of VIMPAT. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares (1-844-599-CARE ).
Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. For more information, go to www.vimpat.com or call 1-844-599-2273.