PEGANONE Oral Pill By RECORDATI RARE DISEASES

Headache, nausea, vomiting, diarrhea, dizziness, drowsiness, numbness/tingling, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: loss of coordination, fainting, swollen glands (lymph nodes), butterfly-shaped rash on the nose/cheeks, vision changes (e.g., blurred vision, double vision), uncontrolled side-to-side eye movements (nystagmus). A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Severe (rarely fatal) blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with ethotoin. Discuss the risks and benefits with your doctor before starting ethotoin. Tell your doctor right away if any of these rare but very serious side effects occur: unusual bleeding/bruising, symptoms of infection (fever, chills, persistent sore throat), symptoms of anemia (tiredness, pale skin/fingernails, fast heartbeat), liver problems (e.g., severe stomach/abdominal pain, unusual weakness/tiredness, pale stools, dark urine, yellowing eyes/skin). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.