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CARBAMAZEPINE suspension


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Carbamazepine?
  3. Carbamazepine Can Cause Serious Side Effects, Including:
  4. Carbamazepine Is A Prescription Medicine Used To Treat:
  5. Do Not Take Carbamazepine If You:
  6. Before You Take Carbamazepine, Tell Your Healthcare Provider If You:
  7. How Should I Take Carbamazepine?
  8. What Should I Avoid While Taking Carbamazepine?
  9. What Are The Possible Side Effects Of Carbamazepine?
  10. What Are The Ingredients In Carbamazepine?
  11. Carbamazepine Oral Suspension:

Patient Information 

Carbamazepine Oral Suspension,
USP
100 mg/5 mL
(Carbamazepine)

Read this Medication Guide before you start taking Carbamazepine 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? 

Do not stop taking Carbamazepine without first talking to your healthcare provider.

Stopping Carbamazepine suddenly can cause serious problems.

Carbamazepine Can Cause Serious Side Effects, Including: 

1.
Carbamazepine 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 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 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 without first talking to a healthcare provider.

Stopping Carbamazepine 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 Is A Prescription Medicine Used To Treat: 

  • certain types of seizures (partial, tonic-clonic, mixed)
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)
    Carbamazepine is not a regular pain medicine and should not be used for aches or pains.

Do Not Take Carbamazepine If You: 

  • have a history of bone marrow depression.
  • are allergic to Carbamazepine or any of the ingredients in Carbamazepine.

Before You Take Carbamazepine, Tell Your Healthcare Provider If You: 

  • have or have had suicidal thoughts or actions, depression or mood problems
  • have or ever had heart problems
  • have or ever had blood problems
  • have or ever had liver problems
  • have or ever had kidney problems
  • have or ever had allergic reactions to medicines
  • have or ever had increased pressure in your eye
  • have any other medical conditions
  • drink grapefruit juice or eat grapefruit
  • use birth control. Carbamazepine may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and Carbamazepine.
  • are pregnant or plan to become pregnant. Carbamazepine may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Carbamazepine. You and your healthcare provider should decide if you should take Carbamazepine while you are pregnant.
  • If you become pregnant while taking Carbamazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take Carbamazepine or breastfeed; you should not do both.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking Carbamazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Carbamazepine? 

  • Do not stop taking Carbamazepine without first talking to your healthcare provider. Stopping Carbamazepine 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 exactly as prescribed. Your healthcare provider will tell you how much Carbamazepine to take.
  • Your healthcare provider may change your dose. Do not change your dose of Carbamazepine without talking to your healthcare provider.
  • Take Carbamazepine with food.

What Should I Avoid While Taking Carbamazepine? 

  • Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Carbamazepine until you talk to your healthcare provider.
    Carbamazepine 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 affects you. Carbamazepine may slow your thinking and motor skills.

What Are The Possible Side Effects Of Carbamazepine? 

  • Store Carbamazepine Oral Suspension at 20 - 25 C (68 -77 F)
  • Shake well before using.
  • Keep Carbamazepine Oral Suspension in a tight, light-resistant container.

Keep Carbamazepine and all medicines out of the reach of children.

General Information about Carbamazepine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Carbamazepine for a condition for which it was not prescribed. Do not give Carbamazepine 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. 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 that is written for health professionals.

For more information, go to www.wockhardtusa.com or call 1-800-346-6845.

What Are The Ingredients In Carbamazepine? 

Active ingredient: carbamazepine

Carbamazepine Oral Suspension: 

alcohol free lemon lime flavor, citric acid anhydrous, FD&C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0.

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

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080

LI1068 Rev. 07/16



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