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Tegretol XR sustained-release tablets

Pronunciation

Generic Name: carbamazepine (KAR-ba-MAZ-e-peen)
Brand Name: Tegretol XR

Tegretol XR sustained-release tablets may rarely cause certain severe blood problems. Contact your doctor right away if you develop fever, chills, or sore throat; shortness of breath; 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 Tegretol XR sustained-release tablets. These tests will be used to check for side effects.

Tegretol XR sustained-release tablets 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; rash; or ulcers or sores in the mouth. The risk of this reaction may be greater in Asian patients. Asian patients may need to have a blood test before they start Tegretol XR sustained-release tablets to determine whether they have a greater risk of developing a severe skin reaction.


Tegretol XR sustained-release tablets is used for:

Treating certain types of 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 for other conditions as determined by your doctor.

Tegretol XR sustained-release tablets is an anticonvulsant. It works to control seizures by blocking certain nerve impulses in the brain. It works to treat trigeminal neuralgia by altering nerve impulses in certain facial nerves, which relieves pain.

Do NOT use Tegretol XR sustained-release tablets if:

  • you are allergic to any ingredient in Tegretol XR sustained-release tablets
  • you are allergic to tricyclic antidepressants (eg, amitriptyline), cyclobenzaprine, or similar medicines
  • you have a history of bone marrow depression or a liver problem called porphyria
  • you are taking delavirdine, another medicine similar to delavirdine, or nefazodone
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Tegretol XR sustained-release tablets:

Some medical conditions may interact with Tegretol XR sustained-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to other seizure medicines (eg, phenytoin, phenobarbital, primidone, oxcarbazepine)
  • if you have a history of other types of seizures (eg, absence, atonic), increased pressure in the eye (eg, glaucoma), liver or kidney problems, mood or mental problems, suicidal thoughts or actions, or multiple sclerosis
  • if you have a history of heart problems (eg, heart failure, heart block, irregular heartbeat), an abnormal electrocardiogram (ECG), high blood pressure, or high blood cholesterol
  • if you have a history of blood problems, including blood problems caused by other medicines
  • if you have been tested and know whether or not you have a gene type called HLA-B*1502
  • if you have previously taken carbamazepine

Some MEDICINES MAY INTERACT with Tegretol XR sustained-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many other prescription and nonprescription medicines (eg, used for allergies, asthma, blood thinning, cancer, diabetes, endometriosis, glaucoma, HIV, 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, thyroid problems), multivitamin products, or herbal or dietary supplements because they may interact with Tegretol XR sustained-release tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Tegretol XR sustained-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tegretol XR sustained-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tegretol XR sustained-release tablets:

Use Tegretol XR sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Tegretol XR sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tegretol XR sustained-release tablets refilled.
  • Take Tegretol XR sustained-release tablets by mouth with food.
  • Do not use a tablet if it is chipped, cracked, or damaged in any way.
  • Swallow Tegretol XR sustained-release tablets whole. Do not break, crush, or chew before swallowing.
  • Eating grapefruit or drinking grapefruit juice may increase the risk of Tegretol XR sustained-release tablets's side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • Do not suddenly stop taking Tegretol XR sustained-release tablets. You may have an increased risk of seizures. If you need to stop Tegretol XR sustained-release tablets, your doctor will gradually lower your dose.
  • Take Tegretol XR sustained-release tablets on a regular schedule to get the most benefit from it.
  • Taking Tegretol XR sustained-release tablets at the same time each day will help you remember to take it.
  • Continue to take Tegretol XR sustained-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of Tegretol XR sustained-release tablets, 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.

Ask your health care provider any questions you may have about how to use Tegretol XR sustained-release tablets.

Important safety information:

  • Tegretol XR sustained-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tegretol XR sustained-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Tegretol XR sustained-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Patients who take Tegretol XR sustained-release tablets may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Tegretol XR sustained-release tablets 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.
  • Tegretol XR sustained-release tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tegretol XR sustained-release tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tegretol XR sustained-release tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tegretol XR sustained-release tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tell your doctor or dentist that you take Tegretol XR sustained-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Patients who have a certain gene type called HLA-B*1502 may have an increased risk of serious skin reactions from Tegretol XR sustained-release tablets. This gene type is found most commonly in Asian patients. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. Discuss any questions or concerns with your doctor.
  • Do not switch from the tablet form of Tegretol XR sustained-release tablets to the suspension form without checking with your doctor. The same dose may not have the same effects.
  • You may notice the tablet shell in your stool with some brands of Tegretol XR sustained-release tablets. This is normal and not a cause for concern.
  • Tegretol XR sustained-release tablets may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Tegretol XR sustained-release tablets.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are taking Tegretol XR sustained-release tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Tegretol XR sustained-release tablets may interfere with some pregnancy test results. Check with your doctor if you have questions or concerns about your pregnancy test results.
  • Lab tests, including complete blood cell counts, liver and kidney function, eye exams, and carbamazepine blood levels, may be performed while you take Tegretol XR sustained-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Tegretol XR sustained-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • PREGNANCY and BREAST-FEEDING: Tegretol XR sustained-release tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Tegretol XR sustained-release tablets while you are pregnant. Tegretol XR sustained-release tablets is found in breast milk. Do not breast-feed while taking Tegretol XR sustained-release tablets.

Possible side effects of Tegretol XR sustained-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; nausea; unsteadiness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; burning, numbness, or tingling; calf pain, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; joint pain; light-headedness; menstrual changes; new or worsening mental or mood changes (eg, depression, abnormal thoughts, memory problems); new or worsening seizures; pain, tenderness, or unusual swelling in the neck, groin, or under the arms; red or purple spots on your body; red, swollen, blistered, or peeling skin; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or loss of appetite; 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; tremor; trouble concentrating; trouble sleeping; ulcers or sores in the mouth; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; vision or eye problems (eg, blurred vision); yellowing of the skin or eyes.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms 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.

Proper storage of Tegretol XR sustained-release tablets:

Store Tegretol XR sustained-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tegretol XR sustained-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Tegretol XR sustained-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Tegretol XR sustained-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Tegretol XR sustained-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tegretol XR sustained-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tegretol XR sustained-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Tegretol XR sustained-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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