Clopidogrel Krka

Product Overview

About Clopidogrel Krka

Clopidogrel Krka is a generic medicine similar to a reference medicine already authorised in the European Union (EU) called Plavix.

What it is used for

Clopidogrel Krka is used to prevent problems caused by blood clots in adults who have:

• recently had a myocardial infarction (heart attack). Clopidogrel Krka can be started between a few days and 35 days after the attack;
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel Krka can be started between seven days and six months after the stroke;
• peripheral arterial disease (problems with blood flow in the arteries);
• a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots). Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain). Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.

How it is used

Clopidogrel Krka is available as tablets containing 75 mg clopidogrel. The standard dose is one 75-mg tablet once a day. In acute coronary syndrome, 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 unstable angina or ‘non-Q-wave’ myocardial infarction). In acute coronary syndrome and atrial fibrillation, Clopidogrel Krka is used together with aspirin, the dose of which should not be higher than 100 mg. Clopidogrel Krka can only be obtained with a prescription.

How it works

The active substance in Clopidogrel Krka, 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.

Active substance: clopidogrel

Source: EMA EPAR