What is Clopidogrel / Acetylsalicylic acid Teva 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) as separate tablets. It can be used in the following patient groups. from 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 "ST segment elevation" (an abnormal "ECG, or electrocardiogram, trace"), including patients undergoing stent placement (small tube) into an artery in order to prevent narrowing;
- patients being treated for ST-segment elevation myocardial infarction, when the doctor believes they could benefit from anticoagulation 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 as a single tablet instead of the single clopidogrel and acetylsalicylic acid tablets that patients are already taking separately. Clopidogrel / Acetylsalicylic acid Teva can only be obtained with a prescription.
How does Clopidogrel / Acetylsalicylic acid Teva work?
Both of the active substances in Clopidogrel / Acetylsalicylic acid Teva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help prevent blood cells called 'platelets' from clumping together and clots from forming, thereby helping to prevent a new myocardial infarction. Clopidogrel hinders the clumping of platelets by preventing a substance called ADP from binding to a particular receptor present on their surface. This way the platelets are less 'sticky', which reduces the risk of blood clots forming. Acetylsalicylic acid prevents platelets from clumping together by blocking an enzyme called prostaglandin cyclooxygenase. This reduces the production of a substance called thromboxane, which normally promotes the aggregation of platelets into clots. The combination of the two active substances 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 licensed for the reduction of platelet aggregation since 1998 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 substances have been used in therapeutic combinations for some years, the studies presented by the company show that the active substances of Clopidogrel / Acetylsalicylic acid Teva taken in a single tablet are absorbed by the body in the same way as the two medicines given separately. The company also presented the results of 3 previous studies involving a total of over 61,000 patients with unstable angina or who had myocardial infarction, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was found to be 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 (a localized buildup of blood under the skin), epistaxis (nosebleed), gastrointestinal bleeding (bleeding in the stomach or bowel), diarrhea, abdominal pain (stomach pain), dyspepsia (heartburn), bruising and bleeding at the injection site. For a complete list of all side effects reported with Clopidogrel / Acetylsalicylic acid Teva , see 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 other ingredients. of Clopidogrel / Acetylsalicylic acid Teva. It must also not be used in patients with a disease that causes bleeding such as stomach ulcer or brain haemorrhage or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells). It is contraindicated in patients with severe liver or kidney failure or who have a medical condition characterized by a combination of asthma, rhinitis (nasal congestion and runny nose) 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 The active ingredients of Clopidogrel / Acetylsalicylic acid Teva have been used for some years to reduce the risk of myocardial infarction and which, when taken together, can reduce the risk more effectively than using them alone. The committee also took into account that the combination of the two active ingredients in a single tablet simplifies therapy for patients, who will be able to take fewer 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 added to the summary of product characteristics and package leaflet for Clopidogrel / Acetylsalicylic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
More information about Clopidogrel / Acetylsalicylic acid Teva
The European Commission granted a "Marketing Authorization" for Clopidogrel / Acetylsalicylic Acid Teva valid throughout the European Union on 1 September 2014. For more information on Clopidogrel / Acetylsalicylic Acid Teva therapy, read the package leaflet (enclosed all "EPAR) or consult your doctor or pharmacist. Last update of this summary: 9-2014.
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