February 9, 2010
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Plavix

(clopidogrel)

DIN (Drug Identification Number)

02238682 PLAVIX 75MG TABLET

What side effects are possible with Plavix?

Many medications can cause side-effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • heartburn

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • bleeding in eye
  • bleeding in stomach or bowels
  • bruising
  • diarrhea
  • headache, dizziness, or tingling sensation
  • indigestion
  • joint or muscle pain
  • nausea or vomiting
  • nosebleeds
  • skin rash or itching
  • symptoms of liver problems (i.e., yellowing of the skin or eyes, dark urine, light coloured stools, vomiting, nausea, abdominal pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (i.e., swelling of face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Plavix?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

August 20, 2009

Health Canada has issued new restrictions concerning the use of Plavix® (clopidogrel). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Bleeding problems: Clopidogrel increases the risk of bleeding. Using other medications (e.g., warfarin, NSAIDs) may further increase the risk of bleeding. If you experience signs of serious or excessive bleeding (e.g., bleeding from rectum, easy bruising, bloody urine, dark stools, persistent abdominal pain and vomiting), contact your doctor immediately.

People with a history of bleeding disorders should be monitored by their doctor while taking this medication.

Thrombotic thrombocytopenic purpura is a rare condition that may occur while taking clopidogrel and that requires immediate medical attention. Signs include decreased number of blood cells, reduced kidney function, and fever. Seek immediate medical attention if you experience any of these symptoms while taking this medication.

Kidney or liver problems: People with decreased kidney or liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function should not take clopidogrel.

Surgery: Your doctor may want to stop clopidogrel for a few days prior to any planned surgery to prevent any unnecessary bleeding, so it is important to tell any doctors that you are taking clopidogrel.

Stomach problems: Since clopidogrel can increase the risk of bleeding, it is important to remind your doctor if you have had stomach ulcers, and have the doctor review your medications if they may cause stomach ulcers (e.g., NSAIDS such as ibuprofen, naproxen, and others).

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if clopidogrel passes into human breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Plavix?

There may be an interaction between clopidogrel and any of the following:

  • acetylsalicylic acid (ASA)
  • antacids
  • digoxin
  • heparin
  • NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen, diclofenac, and naproxen)
  • theophylline
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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