What is Zyllt?
Zyllt is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Zyllt is a "generic medicine". This means that it 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 Zyllt used for?
Zyllt is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Zyllt can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Zyllt can be started in the period between a few days and 35 days after the heart attack;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Zyllt can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood circulation 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 blood clots), including patients who have been implanted with a stent (a tube inserted into a artery to prevent clogging). Zyllt can be used in patients who undergo a myocardial 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 reading in the ECG, 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 Zyllt used?
The standard dose of Zyllt is one 75 mg tablet once a day, with or without food. In acute coronary syndrome, Zyllt 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 segment) or up to 12 months (in the presence of a syndrome without elevation of the ST segment).
How does Zyllt work?
The active substance in Zyllt, 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 another heart attack or stroke.
What studies have been carried out on Zyllt?
Because Zyllt 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 risks and benefits associated with Zyllt?
Because Zyllt is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Zyllt been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements in the EU, Zyllt has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, it is the CHMP's view that, as in the case of Plavix, the benefits outweigh the identified risks. The Committee recommended that Zyllt be given marketing authorization.
More information on Zyllt:
On 28 September 2009, the European Commission issued a marketing authorization for Zyllt, valid throughout the European Union, to Krka, dd, Novo mesto.
The full EPAR for Zyllt can be found here.
Last update of this summary: 07-2009.
