What is it?

Clopidogrel HCS is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).

Clopidogrel HCS is a ?generic medicine?. This means that Clopidogrel HCS is similar to a ?reference medicine? already authorised in the European Union (EU) called Plavix. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Clopidogrel HCS is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel HCS can be given to the following groups of patients:

  • patients who have recently had a myocardial infarction (heart attack). Clopidogrel HCS can be started between a few days and 35 days after the attack;
  • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel HCS can be started between seven days and six months after the stroke;
  • patients with peripheral arterial disease (problems with blood flow in the arteries);
  • patients who have a condition known as ?acute coronary syndrome?, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent

inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel HCS can be used in patients who are having a heart attack with ?ST segment elevation? (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ?non-Q-wave? myocardial infarction.

The medicine can only be obtained with a prescription.

How is it used?

The standard dose of Clopidogrel HCS is one 75-mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel HCS is used together with aspirin and treatment generally starts with a loading dose of four tablets. This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).

Clopidogrel HCS is converted into its active form in the body. For genetic reasons, some patients may not be able to convert Clopidogrel HCS as effectively as others, which could reduce their response to the medicine. The best dose to use in these patients has not yet been determined.

How does it work?

The active substance in Clopidogrel HCS, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming ?sticky?, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

How has it been studied?

Because Clopidogrel HCS is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Clopidogrel HCS is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Clopidogrel HCS is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The CHMP concluded that, in accordance with EU requirements, Clopidogrel HCS has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP?s view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Clopidogrel HCS be given marketing authorisation.

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