IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SYMPAZAN?
- Do not stop taking SYMPAZAN without first talking to your healthcare provider. Stopping SYMPAZAN suddenly can cause serious side effects.
- SYMPAZAN, a benzodiazepine medicine, can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines. SYMPAZAN can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how SYMPAZAN affects you. SYMPAZAN may cause problems with your coordination, especially when walking or picking things up.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking SYMPAZAN because SYMPAZAN may make your sleepiness or dizziness much worse.
- SYMPAZAN can cause withdrawal symptoms. Do not stop taking SYMPAZAN without first talking to a healthcare provider. Stopping SYMPAZAN suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
- SYMPAZAN is a federally controlled substance (CIV) that can be abused or cause dependence. Keep SYMPAZAN in a safe place to prevent misuse and abuse by others. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
- Serious skin reactions have been seen when SYMPAZAN is taken with other medicines and may require stopping its use. Do not stop taking SYMPAZAN without first talking to your healthcare provider. Call your healthcare provider immediately if you have skin blisters, rash, sores in mouth, hives or any other allergic reaction.
- Like other antiepileptic drugs, SYMPAZAN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms: thoughts about suicide or dying; new or worse anxiety; trouble sleeping (insomnia); dangerous impulses; attempts to commit suicide; feeling agitated or restless; new or worse depression or irritability; an extreme increase in activity and talking (mania); panic attacks; acting aggressive, angry or violent, or any other unusual changes in behavior or mood. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not take SYMPAZAN if you are allergic to clobazam or any of the ingredients in SYMPAZAN.
Before you take SYMPAZAN, tell your healthcare provider about all of your medical conditions, including if you:
- have liver or kidney problems; lung problems (respiratory disease); have or have had depression, mood problems, or suicidal thoughts or behavior
- use birth control medicine. SYMPAZAN may cause your birth control medicine to be less effective.
- are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. SYMPAZAN may harm your unborn baby. If you become pregnant while taking SYMPAZAN you and your healthcare provider will decide if you should continue to take SYMPAZAN and if you will take SYMPAZAN or breast feed, you should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SYMPAZAN with certain other medicines can cause side effects or affect how well SYMPAZAN or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
The most common side effects of SYMPAZAN are: sleepiness, pain with urination, slurred speech, drooling, fever, tiredness, constipation, acting aggressive, angry, or violent, problems with breathing, cough, and difficulty sleeping. These are not all the possible side effects of SYMPAZAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide with important warning.