Clopidogrel Teva

What is Clopidogrel Teva?

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

Clopidogrel Teva is a "generic medicine" which means that Clopidogrel Teva 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 Teva used for?

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

patients who have recently had a myocardial infarction (heart attack); Clopidogrel Teva treatment can start in the period between a few days and 35 days after the infarction;
patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain); treatment with Clopidogrel Teva may start between seven days and six months after the stroke;
patients with peripheral arterial disease (blood circulation problem in the arteries);
patients suffering from a disorder known as "acute coronary syndrome", to which the medicine is administered with aspirin (another medicine to prevent the formation of clots), including patients who have been implanted with a stent (a small tube inserted in an artery to prevent clogging). Clopidogrel Teva can be used in patients who have a myocardial attack with "ST-segment elevation" (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks the treatment may 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 Teva used?

The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, with or without food. In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally begins with a loading dose of four 75 mg 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 elevation of the ST tract) and up to 12 months (in the presence of a syndrome without elevation of the ST tract).

How does Clopidogrel Teva work?

The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation: this means that it helps prevent blood clots. Blood coagulation occurs through 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. In this way, it prevents the platelets from becoming "sticky", reducing the risk of blood clots forming and helping to prevent another heart attack or stroke.

How has Clopidogrel Teva been studied?

Because Clopidogrel Teva 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 Teva?

Because Clopidogrel Teva 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 Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix. It is therefore 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 Teva.