Medication Guide

Clopidogrel Bisulfate (kloe pid' oh grel bye sul' fate) 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:

• have certain genetic factors that affect how the body breaks down clopidogrel. Your doctor may do genetic tests to make sure clopidogrel is right for you.
• take certain medicines, especially omeprazole (Prilosec®) or esomeprazole (Nexium®). Your doctor may change the medicine you take for stomach acid problems while you take clopidogrel.

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:

• you may bruise and bleed more easily
• you are more likely to have nose bleeds
• it will take longer for any bleeding to stop

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

• unexpected bleeding or bleeding that lasts a long time
• blood in your urine (pink, red or brown urine)
• red or black stools (looks like tar)
• bruises that happen without a known cause or get larger
• cough up blood or blood clots
• vomit blood or your vomit looks like coffee grounds

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:

• chest pain due to heart problems
• poor circulation in their legs (peripheral arterial disease)
• a heart attack
• a stroke

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:

• currently have a condition that causes bleeding, such as a stomach ulcer
• are allergic to clopidogrel or other ingredients in clopidogrel. See the end of this leaflet for a complete list of ingredients in clopidogrel.

What should I tell my doctor before taking clopidogrel?

Before you take clopidogrel, tell your doctor if you:

• have a history of bowel (gastrointestinal) or stomach ulcers
• have a history of bleeding problems
• plan to have surgery or a dental procedure. See "How should I take clopidogrel?"
• are pregnant or plan to become pregnant. It is not known if clopidogrel will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if clopidogrel passes into your breast milk. A decision should be made with your healthcare provider to avoid or discontinue breastfeeding when continuing clopidogrel is needed.
• have had an allergy or reaction to any medicine used to treat your disease.

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:

• aspirin, especially if you have had a stroke. Always talk to your doctor about whether you should take aspirin along with clopidogrel to treat your condition.
• Non-steroidal anti-inflammatory drugs (NSAIDs). Ask your doctor or pharmacist for a list of NSAID medicines if you are not sure.
• warfarin (Coumadin®, Jantoven®)
• selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Ask your doctor or pharmacist for a list of SSRI or SNRI medicines if you are not sure.

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?

• Take clopidogrel exactly as your doctor tells you.
• Do not change your dose or stop taking clopidogrel without talking to your doctor first. Stopping clopidogrel may increase your risk of heart attack or stroke.
• Take clopidogrel with aspirin as instructed by your doctor.
• If you miss a dose, take clopidogrel as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses of clopidogrel at the same time unless your doctor tells you to.
• If you take too much clopidogrel, call your doctor or go to the nearest emergency room right away.
• Talk with your doctor about stopping your clopidogrel before you have surgery. Your doctor may tell you to stop taking clopidogrel at least 5 days before you have surgery to avoid excessive bleeding during surgery.

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 cannot 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
• Persistent low blood sugar symptoms

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?

• Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

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