CARBAMAZEPINE EXTENDED RELEASE TABLETS-ORAL, Tegretol XR

WARNING: This drug rarely causes severe decrease in bone marrow function (aplastic anemia, agranulocytosis). Your doctor will monitor your blood counts to minimize this side effect. Keep all medical and laboratory appointments. Tell your doctor immediately if any of these rare but serious side effects occur: signs of infection (fever, sore throat), unusual weakness or fatigue, easy bleeding/bruising.

USES: Carbamazepine is used to prevent and control seizures and relieve one type of nerve pain (trigeminal neuralgia). It reduces excessive nerve signals in the brain.

OTHER USES: This drug may also treat certain mental/mood conditions (bipolar disorder, schizophrenia) and other types of nerve pain.

HOW TO USE: Take this medication by mouth, usually two times a day with meals, or as directed by your doctor. Swallow the tablets whole. Do not crush, chew, or break them. Inspect the tablets for chips and cracks. Do not take any damaged tablets. Dosage is based on your medical condition. Follow these directions carefully. For treatment of trigeminal nerve pain, do not take more than 1,200 milligrams per day. Avoid eating grapefruit or drinking grapefruit juice. Take this medication regularly at evenly spaced intervals to get the most benefit from it. Do not take more or stop taking it without consulting your doctor. Some conditions (seizures) may worsen if the drug is suddenly stopped. Your dose may need to be gradually decreased. Inform your doctor if your condition does not improve or worsens.

SIDE EFFECTS: Nausea, vomiting, dizziness, drowsiness, unsteadiness may occur as your body adjusts. An empty tablet shell may appear in your stool. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Tell your doctor immediately if any of these serious side effects occur: chest pain, swelling of the ankles/feet, trouble breathing, fatigue, fast/slow/irregular heartbeat, severe headache, fainting, trouble urinating, change in urine amount, decreased sexual ability, unusual eye movements, vision changes, hearing problems, mental/mood changes, pain/swelling of the arms or legs, numbness/tingling of the hands/feet, sun sensitivity, joint pain, hair loss. Tell your doctor immediately if any of these serious side effects occur: persistent nausea or vomiting, severe stomach/abdominal pain, yellowing eyes and skin, dark urine, swollen glands, persistent mouth sores. Seek immediate medical attention if you have a serious allergic reaction. Symptoms may include: rash, itching, swelling, severe dizziness, trouble breathing. Contact your doctor if you notice other effects not listed above.

PRECAUTIONS: Before taking carbamazepine, tell your doctor if you are allergic to it or other anti-seizure medications or tricyclic antidepressants. This medication should not be used if you have certain medical conditions. Before using this medication, tell your doctor your medical history. This drug may make you dizzy or drowsy; use caution when engaging in activities requiring alertness. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. This medication is not recommended during pregnancy or while breastfeeding. Consult your doctor before breastfeeding.

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DRUG INTERACTIONS: Your healthcare professionals may already be aware of any possible drug interactions. Do not start, stop or change the dosage of any medicine without checking with them first. Avoid taking MAO inhibitors within 2 weeks before or after treatment with this medication. Serious interactions may occur with delavirdine, nefazodone, telithromycin, voriconazole. Before using this medication, tell your doctor of all prescription and nonprescription/herbal products you may use, especially other anti-seizure medications, lithium, SSRI antidepressants, tramadol, drugs affecting liver enzymes, calcium channel blockers. Carbamazepine can affect the removal of other drugs from your body. This medication may decrease the effectiveness of birth control products. Use additional form of birth control while using this medication. Tell your doctor or pharmacist if you also take drugs that cause drowsiness. Check the labels on all your medicines because they may contain ingredients that cause drowsiness. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you are using this drug.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slowed breathing, loss of consciousness, muscle twitching, uncontrolled movements, very fast heartbeat.

NOTES: Do not share this medication with others. Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Keep all laboratory and medical appointments. Wear or carry identification indicating you are using this drug.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Call your doctor if you miss more than one dose a day.

STORAGE: Store the US product at room temperature below 86 degrees F away from light and moisture. Do not store in the bathroom. Store the Canadian product at room temperature below 77 degrees F away from light and moisture. Keep all medicines away from children and pets.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects to the FDA. Visit the FDA MedWatch website or call the FDA.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.