PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Clopidogrel ratiopharm - Clopidogrel and what is it used for?
Clopidogrel ratiopharm is an anticoagulant medicine indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel ratiopharm can be given to the following categories of patients:
- patients recently suffering from myocardial infarction (cardiac arrest). Treatment with Clopidogrel ratiopharm can be started between a few days and 35 days after the event;
- patients who have had an ischemic stroke (stroke caused by insufficient blood supply to an area of the brain). Clopidogrel ratiopharm treatment can be started between seven days and six months after the ischemic event;
- patients with peripheral arterial disease (blood circulation problem in the arteries);
- patients with acute coronary syndrome (a condition characterized by a reduced flow of blood to the heart), including patients subjected to stent placement (a short tube inserted into an artery to prevent obstruction); the medicine should be given in combination with aspirin (another medicine that prevents the formation of clots). Clopidogrel ratiopharm can be used in patients with myocardial infarction with "ST-segment elevation" (an abnormal ECG reading or electrocardiogram) when the doctor thinks they could benefit from the therapy. It can also be used in patients who do not show this abnormal ECG reading if they are suffering from unstable angina (a severe form of chest pain) or have had a myocardial infarction "without Q waves"
Clopidogrel ratiopharm can also be used to prevent problems caused by blood clots in adults with atrial fibrillation (rapid and irregular contractions of the upper cavities of the heart), in which it should be given in combination with aspirin. It is indicated in patients who present at least one risk factor for vascular events including myocardial infarction or stroke, which are not suitable for treatment with vitamin K antagonists (other medicines used to prevent clot formation) and which present a low risk of bleeding. Clopidogrel ratiopharm is a "generic" medicine. This means that Clopidogrel ratiopharm 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. Clopidogrel ratiopharm contains the active substance clopidogrel.
How is Clopidogrel ratiopharm - Clopidogrel used?
Clopidogrel ratiopharm is available as tablets containing 75 mg of clopidogrel. The standard dose is one 75 mg tablet once a day. In acute coronary syndrome 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 unstable angina or myocardial infarction without Q waves). In acute coronary syndrome and atrial fibrillation Clopidogrel ratiopharm is used in combination with aspirin, the dose of which should not exceed 100 mg. Clopidogrel ratiopharm can only be obtained with a prescription.
How does Clopidogrel ratiopharm - Clopidogrel work?
The active substance in Clopidogrel ratiopharm, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps prevent blood clots from forming. The blood coagulates when some specific blood cells, the platelets, 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 viscous, reducing the risk of blood clots forming and helping to prevent a recurrent myocardial infarction or stroke.
How has Clopidogrel ratiopharm - Clopidogrel been studied?
Because Clopidogrel ratiopharm is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence 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 ratiopharm - Clopidogrel?
Because Clopidogrel ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine's.
Why has Clopidogrel ratiopharm - Clopidogrel been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel ratiopharm has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP considered that, as in the case of Plavix, the benefits outweigh the identified risks and recommended to approve the use of Clopidogrel ratiopharm in the EU.
What measures are being taken to ensure the safe and effective use of Clopidogrel ratiopharm - Clopidogrel?
A risk management plan has been developed to ensure that Clopidogrel ratiopharm is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Clopidogrel ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Clopidogrel ratiopharm - Clopidogrel
The European Commission granted a marketing authorization valid throughout the European Union for Clopidogrel ratiopharm on 19 February 2015. For the full version of EPAR and the summary of the risk management plan for Clopidogrel ratiopharm, see the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Clopidogrel ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 02-2015.
