What important information should I know about NUVIGIL?
- NUVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells, and may result in hospitalization and be life-threatening. If you develop a skin rash, hives, sores in your mouth, blisters, swelling, peeling, or yellowing of the skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop taking NUVIGIL and call your doctor right away or get emergency help.
- NUVIGIL is not approved for children for any condition. It is not known if NUVIGIL is safe or if it works in children under the age of 17.
- You should not take NUVIGIL if you have had a rash or allergic reaction to NUVIGIL or PROVIGIL® (modafinil) Tablets [C-IV], or are allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch.
What are possible side effects of NUVIGIL?
- Stop taking NUVIGIL and call your doctor or get emergency help if you get any of the following serious side effects:
- Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things that are not really there, extreme increase in activity (mania), thoughts of suicide, aggression, or other mental problems
- Symptoms of a heart problem, including: chest pain, abnormal heart beat, and trouble breathing
- Common side effects of NUVIGIL are headache, nausea, dizziness, and trouble sleeping. These are not all the side effects of NUVIGIL.
- Tell your doctor if you get any side effect that bothers you or that does not go away. Talk to your doctor for medical advice about side effects.
