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CARBAMAZEPINE ER- carbamazepine tablet, extended release


  1. Patient Information
  2. Carbamazepine Extended-release Tablets Can Cause Serious Side Effects, Including:
  3. Carbamazepine Extended-release Tablets Are A Prescription Medicine Used To Treat:
  4. Who Should Not Take Carbamazepine Extended-release Tablets?do Not Take Carbamazepine Extended-release Tablets If You:
  5. Carbamazepine Extended-release Tablets:
  6. What Should I Avoid While Taking Carbamazepine Extended-release Tablets?
  7. Carbamazepine Extended-release Tablets May Cause Other Serious Side Effects. These Include:
  8. The Most Common Side Effects Of Carbamazepine Extended-release Tablets Include:
  9. How Should I Store Carbamazepine Extended-release Tablets?
  10. Active Ingredient: Carbamazepineinactive Ingredients:

Patient Information 

8256121/1118F
Carbamazepine Extended-Release Tablets, USP

(kar-bah-MAZ-eh-peen)

Read this Medication Guide before you start taking carbamazepine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about carbamazepine extended-release tablets?
Do not stop taking carbamazepine extended-release tablets without first talking to your healthcare provider.

Stopping carbamazepine extended-release tablets suddenly can cause serious problems.

Carbamazepine Extended-release Tablets Can Cause Serious Side Effects, Including: 

1. Carbamazepine extended-release tablets may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine extended-release tablets within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine extended-release tablets to

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop carbamazepine extended-release tablets without first talking to a healthcare provider.
Stopping carbamazepine extended-release tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Carbamazepine Extended-release Tablets Are A Prescription Medicine Used To Treat: 

  • certain types of seizures (partial, tonic-clonic, mixed)
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)

Carbamazepine extended-release tablets are not a regular pain medicine and should not be used for aches or pains.

Who Should Not Take Carbamazepine Extended-release Tablets?do Not Take Carbamazepine Extended-release Tablets If You: 

  • have a history of bone marrow depression.
  • are allergic to carbamazepine extended-release tablets or any of the ingredients in carbamazepine extended-release tablets.

    • Do not stop taking carbamazepine extended-release tablets without first talking to your healthcare provider. Stopping carbamazepine extended-release tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
    • Take carbamazepine extended-release tablets exactly as prescribed. Your healthcare provider will tell you how many carbamazepine extended-release tablets to take.
    • Your healthcare provider may change your dose. Do not change your dose of carbamazepine extended-release tablets without talking to your healthcare provider.
    • Take carbamazepine extended-release tablets with food.

Carbamazepine Extended-release Tablets: 

  • Do not crush, chew, or break carbamazepine extended-release tablets.
  • Tell your healthcare provider if you can not swallow carbamazepine extended-release tablets whole.
  • If you take too many carbamazepine extended-release tablets, call your healthcare provider or local Poison Control Center right away.
  • What Should I Avoid While Taking Carbamazepine Extended-release Tablets? 

    • Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine extended-release tablets until you talk to your healthcare provider. Carbamazepine extended-release tablets taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how carbamazepine extended-release tablets affects you. Carbamazepine extended-release tablets may slow your thinking and motor skills.

    Carbamazepine Extended-release Tablets May Cause Other Serious Side Effects. These Include: 

    • Irregular heartbeat symptoms include:
      • Fast, slow, or pounding heartbeat
      • Shortness of breath
      • Feeling lightheaded
      • Fainting
    • Liver problems symptoms include:
      • yellowing of your skin or the whites of your eyes
      • dark urine
      • pain on the right side of your stomach area (abdominal pain)
      • easy bruising
      • loss of appetite
      • nausea or vomiting

    The Most Common Side Effects Of Carbamazepine Extended-release Tablets Include: 

    • dizziness
    • drowsiness
    • problems with walking and coordination (unsteadiness)
    • nausea
    • vomiting

    These are not all the possible side effects of carbamazepine extended-release tablets. For more information, ask your healthcare provider or pharmacist.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How Should I Store Carbamazepine Extended-release Tablets? 

    • Storecarbamazepine extended-release tabletsat 77 F (25 C); excursions permitted to 59 F to 86 F (15 C to 30 C).
      • Keep carbamazepine extended-release tablets dry.

    Keep carbamazepine extended-release tablets and all medicines out of the reach of children.

    General Information about carbamazepine extended-release tablets
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use carbamazepine extended-release tablets for a condition for which it was not prescribed. Do not give carbamazepine extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about carbamazepine extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about carbamazepine extended-release tablets that is written for health professionals.

    For more information about carbamazepine extended-release tablets call 1-800-525-8747.

    Active Ingredient: Carbamazepineinactive Ingredients: 

    • cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only).

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8256121/1118F



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