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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/156994/2016

EMEA/H/C/001144

EPAR summary for the public

Clopidogrel/Acetylsalicylic acid Zentiva¹

clopidogrel / acetylsalicylic acid

This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel/Acetylsalicylic acid Zentiva.

What is Clopidogrel/Acetylsalicylic acid Zentiva?

Clopidogrel/Acetylsalicylic acid Zentiva is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin). It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.

What is Clopidogrel/Acetylsalicylic acid Zentiva used for?

Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets. It can be used in the following groups of patients who have a condition known as 'acute coronary syndrome':

•    patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no 'ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;

•    patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from treatment to dissolve blood clots.

The medicine can only be obtained with a prescription.

¹ Previously known as DuoCover.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How is Clopidogrel/Acetylsalicylic acid Zentiva used?

Clopidogrel/Acetylsalicylic acid Zentiva is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.

How does Clopidogrel/Acetylsalicylic acid Zentiva work?

Both active substances in Clopidogrel/Acetylsalicylic acid Zentiva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.

Clopidogrel stops the platelets sticking together 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. Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together. The combination of the two active substances has an additive effect, reducing the risk of blood clots forming more than either medicine alone.

Both active substances have been available in the European Union (EU) for a number of years. Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.

How has Clopidogrel/Acetylsalicylic acid Zentiva been studied?

Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in Clopidogrel/Acetylsalicylic acid Zentiva are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately. It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.

What benefit has Clopidogrel/Acetylsalicylic acid Zentiva shown during the studies?

Clopidogrel/Acetylsalicylic acid Zentiva was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.

Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.

What is the risk associated with Clopidogrel/Acetylsalicylic acid Zentiva?

The most common side effects with Clopidogrel/Acetylsalicylic acid Zentiva (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured. For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Zentiva, see the package leaflet.

Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other

Clopidogrel/Acetylsalicylic acid ZentivaOF EMA/156994/2016

ingredients in Clopidogrel/Acetylsalicylic acid Zentiva. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain, or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells). It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose). Clopidogrel/Acetylsalicylic acid Zentiva must not be used during the last three months of pregnancy.

Why has Clopidogrel/Acetylsalicylic acid Zentiva been approved?

The CHMP noted that Clopidogrel/Acetylsalicylic acid Zentiva is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single Clopidogrel/Acetylsalicylic acid Zentiva tablet simplifies treatment for patients as they will need to take fewer tablets. The Committee therefore decided that Clopidogrel/Acetylsalicylic acid Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Clopidogrel/Acetylsalicylic acid Zentiva:

The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010. The name of the medicine was changed to Clopidogrel/Acetylsalicylic acid Zentiva on 15 January 2016.

The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Clopidogrel/Acetylsalicylic acid Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2016.

Clopidogrel/Acetylsalicylic acid Zentiva0F EMA/156994/2016

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