WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
See Medication Guide and full Prescribing Information for complete information.
ONFI is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.
- Do not take ONFI if you have a known allergy to ONFI or its ingredients.
- ONFI can make you sleepy or dizzy and 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 ONFI affects you. ONFI may cause problems with your coordination, especially when you are walking or picking things up.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking ONFI without first talking to your healthcare provider. ONFI may make your sleepiness or dizziness much worse.
- ONFI can cause withdrawal symptoms. Do not suddenly stop taking ONFI without first talking to a healthcare provider. Stopping ONFI 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.
- ONFI can be abused and cause dependence. Physical dependence is not the same as drug addiction. Talk to your healthcare provider about the differences. ONFI is a federally controlled substance (CIV) because it can be abused or lead to dependence.
- Serious skin reactions have been seen when ONFI is taken with other medicines and may require stopping its use. A serious skin reaction can happen at any time during your treatment with ONFI. Call your healthcare provider immediately if you have skin blisters, rash, sores in the mouth, hives or any other allergic reaction.
- Like other antiepileptic drugs, ONFI 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 symptoms of depression, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you.
- Tell your healthcare provider about all of your medical conditions, including liver or kidney problems, lung problems (respiratory disease), depression, mood problems, or suicidal thoughts or behavior.
- If you are pregnant or plan to become pregnant, ONFI may harm your unborn baby. You and your healthcare provider will have to decide if you should take ONFI while you are pregnant.
- ONFI can pass into breast milk. You and your healthcare provider should decide if you will take ONFI or breastfeed. 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 ONFI with certain other medicines can cause side effects or affect how well they work. ONFI may make your birth control medicine less effective. Talk to your healthcare provider about the best birth control method to use. Do not start or stop ONFI or other medicines without talking to your healthcare provider.
- ONFI oral suspension should be kept in its original bottle in an upright position and used within 90 days of first opening the bottle. After 90 days, safely throw away any unused ONFI oral suspension.
- The most common side effects of ONFI include: sleepiness; drooling; constipation; cough; pain with urination; fever; acting aggressive, being angry or violent; difficulty sleeping; slurred speech; tiredness; and problems with breathing.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.