Carbamazepine Tablets

GENERIC NAME: CARBAMAZEPINE (kar-ba-MAZ-e-peen)

COMMON USES: This medicine is an anticonvulsant used to treat seizures. It is also used to treat severe pain of the jaw or cheek caused by a facial nerve problem (trigeminal neuralgia). It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: 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. CHEW THOROUGHLY before swallowing. TAKE THIS MEDICINE with food or milk. Eating grapefruit or drinking grapefruit juice while you are taking this medicine may increase the amount of this medicine in your blood, which may increase your risk for serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet. DO NOT SWITCH from the tablets form of this medicine to the suspension form without checking with your doctor. The same dose may not have the same effects. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. DO NOT SUDDENDLY STOP TAKING THIS MEDICINE. You may have an increased risk of seizures. If you need to stop this medicine or add a new medicine, your doctor will gradually lower your dose. 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.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to any ingredient in this product, or to any tricyclic medicines (eg, amitriptyline). DO NOT EXCEED THE RECOMMENDED DOSE without checking with your doctor. Lab and/or medical tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. This medicine may interfere with certain lab tests. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS OR SURGERY, tell your doctor or dentist that you are taking this medicine. THIS MEDICINE MAY CAUSE drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Check with your doctor before you drink alcohol or use medicines that may cause drowsiness while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. PATIENTS WHO TAKE THIS MEDICINE MAY BE AT INCREASED RISK FOR SUICIDAL THOUGHTS OR ACTIONS. Watch patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS THAT ARE NEEDED FOR CLOTTING. To prevent bleeding, avoid situations where bruising or injury may occur. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Prevent infection by avoiding contact with people with colds or other infections. PATIENTS WHO HAVE a certain gene type called HLA-B*1502 may have an increased risk for serious skin reactions from this medicine. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY; they may be more sensitive to the effects of the medicine. FOR WOMEN: THIS MEDICINE MAY DECREASE THE EFFECTIVENESS of hormonal birth control (eg, birth control pills). To prevent pregnancy, use an additional form of birth control (eg, condoms) while taking this medicine. THIS MEDICINE MAY INTERFERE WITH SOME PREGNANCY TEST RESULTS. Check with your doctor if you have questions or concerns about your results. THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM to the human fetus. IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include drowsiness, dizziness, dry mouth, unsteadiness, nausea, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry, or bloody stools; calf pain, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; joint pain; lightheadedness; loss of appetite; new or worsening mental or mood changes (eg, aggression, agitation, anger, anxiety, depression, irritability, restlessness); menstrual changes; pain, tenderness, or unusual swelling in the neck, groin, or under the arms; red, swollen, blistered, or peeling skin; red or purple spots on your body; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; speech problems; stomach pain; sudden unusual weight gain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; swollen lymph nodes; trouble sleeping; ulcers or sores in the mouth; uncontrolled muscle movements; unusual bleeding or bruising (eg, bleeding gums, nose bleeds); unusual tiredness or weakness; vision (eg, blurred vision) or eye problems; or yellowing of the skin or eyes. 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; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: This medicine may rarely cause severe blood problems (eg, aplastic anemia, agranulocytosis). Contact your doctor right away if you develop fever, chills, or sore throat; rash; ulcers or sores in the mouth; unusual bruising or bleeding; unusual tiredness; or swollen lymph nodes. Lab tests, including complete blood cell counts, will be performed before and during treatment with this medicine. These tests will be used to check for side effects. THIS MEDICINE MAY RARELY CAUSE SERIOUS AND SOMETIMES FATAL SKIN REACTIONS. Contact your doctor at once if you develop red, swollen, blistered, or peeling skin, with or without fever. The risk of this reaction may be greater in Asian patients. Asian patients may need to have a blood test before they start this medicine to determine whether they have a greater risk of developing a severe skin reaction. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking nefazodone, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for allergies, asthma, blood thinning, cancer, diabetes, infections, inflammation, aches and pains, heartburn or reflux disease, high blood pressure, heart problems, high cholesterol, birth control, hormone replacement, immune system suppression, mental or mood problems, sleep, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort). Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of heart problems (eg, heart block, heart failure, irregular heartbeat); abnormal electrocardiogram (ECG); high blood pressure; high blood cholesterol; glaucoma or increased pressure in the eye; liver or kidney problems; mood or mental problems (eg, depression); suicidal thoughts or actions; multiple sclerosis; other types of seizures (eg, absence or atonic); blood problems, including blood problems caused by other medicine; allergies; pregnancy; or breast-feeding. Tell your doctor if you have taken this medicine before, or if you have been tested and know whether or not you have a gene type called HLA-B*1502. Tell your doctor if you are allergic to other seizure medicines (eg, phenytoin, phenobarbital). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of bone marrow problems, the blood disorder porphyria, or other severe blood disorders. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include decreased urination; fainting; fast or irregular heartbeat; loss of consciousness; muscle twitching or tremor; seizures; severe dizziness, headache, or drowsiness; severe nausea or vomiting; slow, shallow, or irregular breathing.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. THIS MEDICINE MAY CAUSE YOU TO BECOME SUNBURNED MORE EASILY. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. 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.