What is Clopidogrel / Acetylsalicylic acid Teva used for and what is it used for?
Clopidogrel / Acetylsalicylic acid Teva is an anticoagulant medicine, used to thin the blood, containing two active substances: clopidogrel and acetylsalicylic acid . It is used to prevent problems caused by blood clots, such as myocardial infarction, in adult patients who are already taking both clopidogrel and acetylsalicylic acid (more commonly known as aspirin) in separate tablets. It can be used in the following groups of patients with a condition known as "acute coronary syndrome":
- patients with unstable angina (a severe type of chest pain) or who have had a myocardial infarction without "elevation of the ST segment" (an ECG trace, or electrocardiogram, abnormal), including patients undergoing stent placement (small tube) in an artery in order to prevent shrinkage;
- patients being treated for myocardial infarction with ST segment elevation, when the doctor believes they could benefit from anticoagulant therapy.
How is Clopidogrel / Acetylsalicylic acid Teva used?
Clopidogrel / Acetylsalicylic acid Teva is available as tablets containing 75 mg of clopidogrel and 75 mg or 100 mg of acetylsalicylic acid. The medicine is taken in a single tablet instead of the single clopidogrel a tablets of acetylsalicylic acid that patients already take separately. Clopidogrel / Acetylsalicylic acid Teva can only be obtained with a prescription.
How does Clopidogrel / Acetylsalicylic acid Teva work?
Both active substances in Clopidogrel / Acetylsalicylic acid Teva, clopidogrel and acetylsalicylic acid, are antiplatelet drugs. This means that they help prevent the aggregation of blood cells called "platelets" and the formation of clots, thus helping to prevent a new myocardial infarction. Clopidogrel hinders platelet aggregation by preventing a substance called ADP from binding to a particular receptor on their surface. In this way the platelets are less "sticky", which reduces the risk of clot formation. Acetylsalicylic acid prevents platelets from aggregating by blocking an enzyme called prostaglandin cyclooxygenase. In this way the production of a substance called thromboxane is reduced, which normally favors the aggregation of platelets in clots. The combination of the two active ingredients has the effect of reducing the risk of clot formation to a greater extent than the two medicines taken separately. Both active substances have been available in the European Union (EU) for several years. Clopidogrel has been authorized since 1998 for the reduction of platelet aggregation and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.
What benefit has Clopidogrel / Acetylsalicylic acid Teva shown during the studies?
Since the two active ingredients have been used in therapeutic combination for some years, the studies presented by the company show that the active ingredients of Clopidogrel / Acetylsalicylic acid Teva taken in a single tablet are absorbed by the body in the same way as the two medicines administered separately. The company also presented the results of 3 previous studies conducted on a total of over 61, 000 patients with unstable angina or who had a myocardial infarction, from whom it was found that the combination of clopidogrel and acetylsalicylic acid taken as distinct tablets resulted more effective ne
What is the risk associated with Clopidogrel / Acetylsalicylic acid Teva?
The most common side effects with Clopidogrel / Acetylsalicylic acid Teva (which may affect more than 1 in 10 people) are hematoma (an accumulation of blood under the skin), epistaxis (bleeding from the nose), gastrointestinal bleeding (bleeding in the stomach or in the intestine), diarrhea, abdominal pain (stomach ache), dyspepsia (heartburn), ecchymosis and bleeding at the site of inoculation. For the full list of all side effects reported with Clopidogrel / Acetylsalicylic acid Teva, see the package leaflet. Clopidogrel / Acetylsalicylic acid Teva should not be used in people who are hypersensitive (allergic) to clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve pain and inflammation) such as acetylsalicylic acid or any of the others. ingredients of Clopidogrel / Acetylsalicylic acid Teva. It must also not be used in patients suffering from a disease that causes bleeding such as gastric ulcer or cerebral hemorrhage or in patients with mastocytosis (high blood levels of some white blood cells called mast cells). It is contraindicated in patients with severe hepatic or renal insufficiency or who are suffering from a medical condition characterized by a combination of asthma, rhinitis (congestion and nasal drip) and nasal polyps (nodules that develop on the lining of the nasal cavity). Clopidogrel / Acetylsalicylic acid Teva should not be used in the third trimester of pregnancy.
Why has Clopidogrel / Acetylsalicylic acid Teva been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel / Acetylsalicylic acid Teva's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that both active substances in Clopidogrel / Acetylsalicylic acid Teva have been used for some years to reduce the risk of myocardial infarction and that, taken together, they can reduce the risk more effectively than using them alone. The committee also took into account the fact that the combination of the two active ingredients in a single tablet simplifies therapy for patients, who will be able to take a reduced number of tablets.
What measures are being taken to ensure the safe and effective use of Clopidogrel / Acetylsalicylic acid Teva?
A risk management plan has been developed to ensure that Clopidogrel / Acetylsalicylic acid Teva 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 / Acetylsalicylic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Clopidogrel / Acetylsalicylic acid Teva
On 1 September 2014, the European Commission issued a marketing authorization for Clopidogrel / Acetylsalicylic acid Teva, valid throughout the European Union. For more information about treatment with Clopidogrel / Acetylsalicylic acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 9-2014.
