EQUETRO- carbamazepine capsule, extended release 
Validus Pharmaceuticals LLC

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Medication Guide

EQUETRO (ē-kwĕ-trō)

(carbamazepine)

Extended-Release Capsules

Read this Medication Guide before you start taking EQUETRO 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 EQUETRO?

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

Stopping EQUETRO suddenly can cause serious problems.

If you have any of the problems listed below call your healthcare provider right away. 

EQUETRO can cause serious side effects, including:

1.   EQUETRO 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 after you start taking EQUETRO, but may occur at later times. These reactions can happen to 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 EQUETRO to see if you are at higher risk for serious skin reactions with this medicine. Symptoms may include:

2.   EQUETRO may cause rare but serious blood problems. Symptoms may include:

3.   EQUETRO may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash with these types of reactions. Call a healthcare provider right away if you have any of the following 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 EQUETRO.

4.   EQUETRO 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?

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

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

Stopping EQUETRO 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.

What is EQUETRO?

EQUETRO is a prescription medicine used to treat people with:

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

EQUETRO should not be used to treat people with absence seizures (petit mal).

It is not known if EQUETRO is safe and effective in children and adolescents for the treatment of Bipolar I Disorder and nerve pain.

Who should not take EQUETRO?

Do not take EQUETRO if you:

What should I tell my healthcare provider before taking EQUETRO?

Before you take EQUETRO, 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 EQUETRO with certain other medicines may cause side effects or affect how well they work. Do not stop or start 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 EQUETRO?

What should I avoid while taking EQUETRO?

What are the possible side effects of EQUETRO?

See “What is the most important information I should know about EQUETRO?”

EQUETRO 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 EQUETRO?”

The most common side effects of EQUETRO include:

These are not all the possible side effects of EQUETRO. 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.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at

1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store EQUETRO?

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

General Information about the safe and effective use of EQUETRO.

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

For more information, go to www.EQUETRO.com or call 1-866-982-5438.

What are the ingredients in EQUETRO?

Active ingredient: carbamazepine

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

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

Manufactured for and Distributed by:
Validus Pharmaceuticals LLC
Parsippany, NJ 07054
info@validuspharma.com
http://www.equetro.com   
1-866-982-5438

Product of India

© 2021 Validus Pharmaceuticals LLC

60080-03                         June 2021

Revised: 6/2021
Validus Pharmaceuticals LLC