CLOPIDOGREL- clopidogrel tablet, film coated 
Zydus Pharmaceuticals (USA) Inc.

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Medication Guide

Clopidogrel Tablets, USP

 

Read this Medication Guide before you start taking clopidogrel and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

 

What is the most important information I should know about clopidogrel?

1. Clopidogrel may not work as well in people who:

2. Clopidogrel can cause bleeding which can be serious and can sometimes lead to death. Clopidogrel is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopidogrel:

Call your doctor right away if you have any of these signs or symptoms of bleeding:

Do not stop taking clopidogrel without talking to the doctor who prescribes it for you. People who stop taking clopidogrel too soon have a higher risk of having a heart attack or dying. If you must stop clopidogrel because of bleeding, your risk of a heart attack may be higher.

What is clopidogrel?

Clopidogrel is a prescription medicine used to treat people who have any of the following:

Clopidogrel is used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.

Platelets are blood cells that help your blood clot normally. Clopidogrel helps to prevent platelets from sticking together and forming a clot that can block an artery.

It is not known if clopidogrel is safe and effective in children.

Who should not take clopidogrel?

Do not take clopidogrel if you:

What should I tell my doctor before taking clopidogrel?

Before you take clopidogrel, tell your doctor if you:

Tell all of your doctors and your dentist that you are taking clopidogrel. They should talk to the doctor who prescribed clopidogrel for you before you have any surgery or invasive procedure.

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

Clopidogrel may affect the way other medicines work, and other medicines may affect how clopidogrel works. See "What is the most important information I should know about clopidogrel?"

Clopidogrel may increase blood levels of other medicines such as repaglinide (Prandin

®).

 

Taking clopidogrel with certain other medicines may increase your risk of bleeding. Especially tell your doctor if you take:

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take clopidogrel?

What are the possible side effects of clopidogrel?

Clopidogrel can cause serious side effects including:

•     See "What is the most important information I should know about clopidogrel?"

•    A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with clopidogrel, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels; and can happen anywhere in the body. TTP needs to be treated in a hospital right away, because it may cause death. Get medical help right away if you have any of these symptoms and they can not be explained by another medical condition:

•    purplish spots (called purpura) on the skin or in the mouth (mucous   

      membranes) due to bleeding under the skin

•     your skin or the whites of your eyes are yellow (jaundice)

•     you feel tired or weak

•     your skin looks very pale

•     fever

•     fast heart rate or feeling short of breath

•     headache

•     speech changes

•     confusion

•     coma

•     stroke

•     seizure

•     low amount of urine, or urine that is pink or has blood in it

•     stomach area (abdominal) pain

•     nausea, vomiting, or diarrhea

•     vision changes

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

Tell your doctor if you develop an allergic reaction including skin reactions while taking

clopidogrel tablets.

These are not all the possible side effects of clopidogrel. For more information, ask your doctor or pharmacist.

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 clopidogrel?

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

General information about clopidogrel

Medicines are sometimes used for purposes other than those listed in a Medication Guide. Do not take clopidogrel for a condition for which it was not prescribed. Do not give clopidogrel 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 clopidogrel. If you would like more information, talk to your doctor. Ask your doctor or pharmacist for information about clopidogrel that was written for healthcare professionals. Address medical inquiries to, Telephone: 1-877-993-8779 or MedicalAffair@zydususa.com.

What are the ingredients in clopidogrel tablets?

Active ingredient: clopidogrel bisulfate, USP

Inactive ingredients:

citric acid, colloidal silicon dioxide, corn starch, crospovidone, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol and titanium dioxide.

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

All other trademarks are property of their respective owners.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 10/18

Revised: 11/2019
Zydus Pharmaceuticals (USA) Inc.