This medicine is an anticonvulsant used alone or with other medicines to treat certain types of seizures in certain patients. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE MAY BE TAKEN on an empty stomach or with food. Take this medicine with food if it upsets your stomach. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, or chew before swallowing. If you have difficulty swallowing this medicine whole, tell your healthcare provider. There may be another form of this medicine you can take. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, light, and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. DO NOT SUDDENLY STOP TAKING THIS MEDICINE or change your dose without first checking with your doctor. Doing so may increase the frequency of your seizures. Your dose may need to be slowly lowered to avoid this effect. IF YOU STOP TAKING THIS MEDICINE for any reason, contact your doctor right away. Do not start taking it again unless your doctor tells you to do so. Continue to take this medicine, even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
WARNING: SERIOUS AND SOMETIMES FATAL RASHES HAVE RARELY OCCURRED WITH THE USE OF THIS MEDICINE. The risk of serious rash may be greater in children younger than 16 years old than in adults. Although it has not been proven, the risk may also be greater if you start taking this medicine at a higher than recommended dose, if you take more than the recommended dose during treatment, or if you also take a medicine called valproate (eg, valproic acid, divalproex sodium). Most of the serious rashes that have occurred with the use of this medicine developed within the first 2 to 8 weeks of treatment. However, serious rashes have also occurred in patients who have used this medicine for a longer period of time. Contact your doctor at once if you develop rash symptoms, including red, swollen, blistered, or peeling skin. Treatment with this medicine should be stopped if rash occurs, unless it is clearly determined that the medicine did not cause the rash. Even if this medicine is stopped, a rash caused by this medicine may still become life-threatening or cause other serious side effects (eg, permanent scarring). SOME MEDICINES MAY INTERACT with this medicine. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: carbamazepine, valproate (eg, valproic acid, divalproex sodium), estrogens, phenobarbital, phenytoin, primidone, rifampin, succinimides (eg, methsuximide), or hormonal contraceptives (eg, birth control pills). This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver, kidney, or heart problems; certain blood problems (eg, thalassemia); a skin rash; allergies, especially to other anti-seizure medicines; pregnancy; or breast-feeding. Tell your doctor if you have a history of developing a skin rash from taking this medicine or any other medicines to treat seizures; mental or mood problems (eg, depression); or suicidal thoughts or attempts. Tell your doctor if you receive dialysis treatments. This medicine should not be used in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include: blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss. If they continue or are bothersome, check with your doctor. INCREASED SENSITIVITY TO THE SUN has been reported in some CHILDREN taking this medicine. Use a sunscreen or protective clothing if your child will be exposed to the sun. Discuss any questions or concerns with your child's doctor. ASEPTIC MENINGITIS IS A SERIOUS CONDITION THAT MAY RARELY OCCUR WITH THE USE OF THIS MEDICINE. Symptoms may include headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion. Contact your doctor right away if you experience any of these effects. Discuss any questions or concerns with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected contact your local poison control center or emergency room immediately. Symptoms of overdose may include involuntary eye movements, loss of consciousness or coordination, new or worsening seizures, or coma.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. DIFFERENT MEDICINES MAY LOOK LIKE OR HAVE NAMES SIMILAR TO THIS MEDICINE. Always check your medicine to make sure it is correct. If you notice any change in the appearance of your medicine (eg, shape, color, size, wording), check with your pharmacist. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.