Clopidogrel HCS

What is Clopidogrel HCS?

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

Clopidogrel HCS is a "generic medicine", which means that Clopidogrel HCS is similar to a "reference medicine" already authorized in the European Union (EU) called Plavix. For more information on generic medicines, see the questions and answers by clicking here.

What is Clopidogrel HCS used for?

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

  1. patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel HCS can start in the period between a few days and 35 days after the infarction;
  2. patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of ​​the brain). Treatment with Clopidogrel HCS may start between seven days and six months after the stroke;
  3. patients with peripheral arterial disease (problems with blood circulation in the arteries).
  4. patients suffering from a disorder known as "acute coronary syndrome", which should be administered with aspirin (another medicine to prevent the formation of clots), including patients who have been implanted with a stent (a small tube inserted into an artery to prevent it obturation). Clopidogrel HCS can be used in patients who suffer a heart attack with "ST-segment elevation" (an abnormal reading on the electrocardiogram or ECG) when the doctor believes the treatment can be beneficial; it can also be used in patients who do not have this abnormal ECG reading, when suffering from unstable angina (a severe form of chest pain) or myocardial infarction "without Q waves".

The medicine can only be obtained with a prescription.

How is Clopidogrel HCS used?

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

In the body, Clopidogrel HCS is converted to the active form. For genetic reasons, some individuals may not be able to convert Clopidogrel HCS as effectively as other patients, which may lower the degree of response to the medicine. The most suitable dose for this type of patient has not yet been identified.

How does Clopidogrel HCS work?

The active substance in Clopidogrel HCS, clopidogrel, is an inhibitor of platelet aggregation, which means it helps prevent blood clots. Blood coagulation occurs following the action of special blood cells, the platelets, which aggregate (stick together). Clopidogrel blocks platelet aggregation by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents the platelets from becoming "sticky", reducing the risk of blood clots forming and helping to prevent a recurrence of heart attacks or strokes.

How has Clopidogrel HCS been studied?

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

What are the benefits and risks of Clopidogrel HCS?

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

Why has Clopidogrel HCS been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel HCS has been shown to have comparable quality and to be bioequivalent to Plavix. It is the opinion of the CHMP that, as in the case of Plavix, the benefits outweigh the risks identified. The committee recommended the granting of a marketing authorization for Clopidogrel HCS.

More information on Clopidogrel HCS:

On 28 October 2010, the European Commission granted Clopidogrel HCS a marketing authorization for Clopidogrel HCS, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed. For more information about treatment with Clopidogrel HCS, read the package leaflet (also part of the EPAR), or contact your doctor or pharmacist.

The full EPAR of the reference medicine is also found on the Agency's website.

Last update of this summary: 08-2010.