17.6 Medication Guide

Read this Medication Guide before you start taking clopidogrel tablets 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.         Clopidogrel tablets are a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopidogrel tablets:   Call your doctor right away if you have any of these signs or symptoms of bleeding:   Do not stop taking clopidogrel tablets without talking to the doctor who prescribes them for you. People who are treated with a stent, and stop taking clopidogrel tablets too soon, have a higher risk of getting a blood clot on the stent, having a heart attack, or dying. If you must stop clopidogrel tablets because of bleeding, your risk of a heart attack may be higher.   Clopidogrel tablets are a prescription medicine used to treat people who have any of the following:   Clopidogrel tablets are 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 tablets help to prevent platelets from sticking together and forming a clot that can block an artery.   It is not known if clopidogrel tablets are safe and effective in children.   Do not take clopidogrel tablets if you:     Before you take clopidogrel tablets, tell your doctor if you:   Tell all of your doctors and your dentist that you are taking clopidogrel tablets. They should talk to the doctor who prescribed clopidogrel tablets for you before you have any surgery or invasive procedure. including prescription, non-prescription medicines, vitamins and herbal supplements. Clopidogrel tablets may affect the way other medicines work, and other medicines may affect how clopidogrel tablets work. See Taking clopidogrel tablets with certain other medicines may increase your risk of bleeding.   Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.           Tell your doctor if you have any side effect that bothers you or that does not go away.   These are not all the possible side effects of clopidogrel tablets. 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.         Medicines are sometimes used for purposes other than those listed in a Medication Guide. Do not take clopidogrel tablets for a condition for which it was not prescribed. Do not give clopidogrel tablets to other people, even if they have the same symptoms that you have. They may harm them.   This Medication Guide summarizes the most important information about clopidogrel tablets. If you would like more information, talk to your doctor. Ask your doctor or pharmacist for information about clopidogrel tablets that was written for healthcare professionals. For more information, call 1-866-850-2876.      clopidogrel bisulfate crospovidone, hydrogenated castor oil, hydroxypropyl cellulose low substituted, hypromellose 15cP, iron oxide red, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol 6000, titanium dioxide, and triacetin     Coumadin  is a registered trademark of Bristol-Myers Squibb Pharma Company.  Prilosec  and Nexium are registered trademarks of AstraZeneca. Jantoven  is a registered trademark of USL Pharma.   Manufactured for: 2400 Route 130  North Dayton, NJ 08810   Manufactured by: Hyderabad-500  072, India Issued: March 2012
Medication Guide
Clopidogrel Tablets, USP  

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



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

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

2. Clopidogrel tabletscan cause bleeding which can be serious and can sometimes lead to death.

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

• 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

What are clopidogrel tablets?

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

Who should not take clopidogrel tablets?

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

What should I tell my doctor before taking clopidogrel tablets?

• 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 tablets?
• are pregnant or plan to become pregnant. It is not known if clopidogrel tablets will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if clopidogrel bisulfate passes into your breast milk. You and your doctor should decide if you will take clopidogrel tablets or breastfeed. You should not do both without talking to your doctor.

Tell your doctor about all the medicines you take,



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

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 tablets 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 ) ®®

How should I take clopidogrel tablets?

• Take clopidogrel tablets exactly as your doctor tells you.
• Do not change your dose or stop taking clopidogrel tablets without talking to your doctor first. Stopping clopidogrel tablets may increase your risk of heart attack or stroke.
• Take clopidogrel tablets with aspirin as instructed by your doctor.
• You can take clopidogrel tablets with or without food.
• If you miss a dose, take clopidogrel tablets 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 tablets at the same time unless your doctor tells you to.
• If you take too much clopidogrel bisulfate, call your doctor or go to the nearest emergency room right away.
• Talk with your doctor about stopping your clopidogrel tablets before you have surgery. Your doctor may tell you to stop taking clopidogrel tablets at least 5 days before you have surgery to avoid excessive bleeding during surgery.

What are the possible side effects of clopidogrel tablets?


Clopidogrel tabletscan cause serious side effects including:

• See  “What is the most important information I should know about clopidogrel tablets?”
• TTP can happen with clopidogrel tablets, 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: A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP).
  • 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

How should I store clopidogrel tablets?

• Store clopidogrel tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

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

General information about clopidogrel tablets







What are the ingredients in clopidogrel tablets?

Active ingredient:Inactive ingredients:



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

®
®®
®


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited