"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within "...
Peganone Consumer (continued)
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 immediately 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 immediately 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 immediately 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Peganone (ethotoin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking ethotoin, tell your doctor or pharmacist if you are allergic to it; or to other hydantoins (e.g., phenytoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, lupus, folate or vitamin B12 deficiency (megaloblastic anemia).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Older adults may be more sensitive to the side effects of this drug, especially dizziness, loss of coordination, or fainting. These side effects can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.
The use of anti-seizure drugs during pregnancy may increase the risk of bleeding in the newborn baby. Your doctor may order vitamin K injections for you/your newborn.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Peganone Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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