CARBAMAZEPINE- carbamazepine capsule, extended release 
Apotex Corp.

----------

Medication Guide
Carbamazepine Extended-Release Capsules

Read this Medication Guide before you start taking carbamazepine extended-release capsules 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 capsules?

Do not stop taking carbamazepine extended-release capsules without first talking to your healthcare provider. Stopping carbamazepine extended-release capsules suddenly can cause serious problems.

Carbamazepine extended-release capsules can cause serious side effects, including:

1. Carbamazepine extended-release capsules 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 carbamazepine extended-release capsules 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 capsules to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

2. Carbamazepine extended-release capsules 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:

3. Like other antiepileptic drugs, carbamazepine extended-release capsules 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 carbamazepine extended-release capsules without first talking to a healthcare provider.

Stopping carbamazepine extended-release capsules 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 carbamazepine extended-release capsule?

Carbamazepine extended-release capsule is a medicine used to treat:

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

Who should not take carbamazepine extended-release capsules?

Do not take carbamazepine extended-release capsules 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 carbamazepine extended-release capsules?

Before you take carbamazepine extended-release capsules, 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 carbamazepine extended-release capsules 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 carbamazepine extended-release capsules?

What should I avoid while taking carbamazepine extended-release capsules?

What are the possible side effects of carbamazepine extended-release capsules?

See "What is the most important information I should know about carbamazepine extended-release capsules?"

Carbamazepine extended-release capsules 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 carbamazepine extended-release capsules".

The most common side effects of carbamazepine extended-release capsules include:

These are not all the side effects of carbamazepine extended-release capsules. 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 capsules?

Store at 20˚ to 25°C (68˚ to 77°F); excursions permitted to 15˚ to 30°C (59˚ to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. 

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

General information about carbamazepine extended-release capsules

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

For more information call 1-800-667-4708.

What are the ingredients in carbamazepine extended-release capsules?

Active ingredient: carbamazepine

Inactive ingredients: ethylcellulose, colloidal silicon dioxide, and stearic acid.

In addition:

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

APOTEX INC.
CARBAMAZEPINE EXTENDED-RELEASE CAPSULES
100 mg, 200 mg and 300 mg

Manufactured by:
Apotex Inc.
Toronto, Ontario
Canada M9L 1T9
Manufactured for:
Apotex Corp.
Weston, Florida
USA 33326

Revised: June 2013

Rev. 6

Revised: 07/2013
 
Apotex Corp.