CARBATROL- carbamazepine capsule, extended release 
Takeda Pharmaceuticals America, Inc.

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Medication Guide
CARBATROL® (CAR-BA-TROL)
(carbamazepine)
Extended-Release Capsules

Read this Medication Guide before you start taking CARBATROL 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 CARBATROL?

Do not stop taking CARBATROL without first talking to your healthcare provider.
Stopping CARBATROL suddenly can cause serious problems.

CARBATROL can cause serious side effects, including:

1. CARBATROL may cause rare but serious rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of CARBATROL 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 CARBATROL to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

2. CARBATROL can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body such as your liver or blood cells. You may or may not have a rash when you get these types of reactions. Call your healthcare provider right away if you have any of these symptoms:

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking CARBATROL.

3. Like other antiepileptic drugs, CARBATROL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Do not stop CARBATROL without first talking to a healthcare provider.

Stopping CARBATROL suddenly can cause serious problems.

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.

What is CARBATROL?

CARBATROL is a medicine used to treat:

CARBATROL is not a regular pain medicine and should not be used for aches or pains.

Who should not take CARBATROL?

Do not take CARBATROL if you:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

What should I tell my healthcare provider before taking CARBATROL?

Before you take CARBATROL, tell your healthcare provider if you:

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

Taking CARBATROL with certain other medicines can 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 CARBATROL?

What should I avoid while taking CARBATROL?

What are the possible side effects of CARBATROL?
See "What is the most important information I should know about CARBATROL?"

CARBATROL may cause other serious side effects including:

Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about CARBATROL".

The most common side effects of CARBATROL include:

These are not all the side effects of CARBATROL. 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 CARBATROL?

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

General information about CARBATROL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CARBATROL for a condition for which it was not prescribed. Do not give CARBATROL 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 CARBATROL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CARBATROL that is written for health professionals.

For more information go to www.carbatrol.com or call 1-800-828-2088.

What are the ingredients in CARBATROL?

Active ingredient: carbamazepine

Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and Eudragit.

In addition:

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

Distributed by:
Takeda Pharmaceuticals America, Inc.

Lexington, MA 02421

Issued [08/2020]

Revised: 11/2020
Takeda Pharmaceuticals America, Inc.