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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/619580/2012

EMEA/H/C/002568

EPAR summary for the public

Capecitabine Medac

capecitabine

This is a summary of the European public assessment report (EPAR) for Capecitabine Medac. 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 Capecitabine Medac.

What is Capecitabine Medac?

Capecitabine Medac is a medicine that contains the active substance capecitabine. It is available as tablets (150, 300 and 500 mg).

Capecitabine Medac is a 'generic' and a 'hybrid' medicine. This means that it is similar to a 'reference medicine', but it contains capecitabine at a new strength in addition to existing strengths. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets. For more information on generic and hybrid medicines, see the question-and-answer document here.

What is Capecitabine Medac used for?

Capecitabine Medac is an anticancer medicine. It is used to treat:

•    colon (large bowel) cancer. Capecitabine Medac is used with or without other anticancer medicines in patients who have had surgery for 'stage III' or 'Dukes' stage C' colon cancer;

•    metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Capecitabine Medac is used with or without other anticancer medicines;

•    advanced gastric (stomach) cancer. Capecitabine Medac is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;

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• locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Capecitabine Medac is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed. It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.

The medicine can only be obtained with a prescription.

How is Capecitabine Medac used?

Capecitabine Medac should only be prescribed by a doctor who is qualified in the use of anticancer medicines.

Capecitabine Medac is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight). The dose depends on the type of cancer being treated. The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take. Capecitabine Medac tablets should be swallowed with water within 30 minutes after a meal.

Treatment is continued for six months after colon surgery. For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment. Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.

Full details are available in the summary of product characteristics (also part of the EPAR).

How does Capecitabine Medac work?

The active substance in Capecitabine Medac, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group 'anti-metabolites'. Capecitabine is a 'prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues. It is taken as tablets, while 5-FU normally needs to be injected.

5-FU is an analogue of pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it stops the growth of tumour cells and eventually kills them.

How has Capecitabine Medac been studied?

The company provided data from the published literature on capecitabine.

The company carried out a 'bioequivalence' study to show that 500 mg Capecitabine Medac produces the same levels of capecitabine in the blood as 500 mg Xeloda.

What are the benefits and risks of Capecitabine Medac?

Because Capecitabine Medac contains the same active substance as its reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Capecitabine Medac been approved?

The CHMP concluded that, in accordance with EU requirements, Capecitabine Medac has been shown to have comparable quality and to be bioequivalent to Xeloda. Therefore, the CHMP's view was that, as

for Xeloda, the benefit outweighs the identified risk. The Committee recommended that Capecitabine Medac be given marketing authorisation.

Other information about Capecitabine Medac

The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Medac on 19 November 2012.

The full EPAR for Capecitabine Medac 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 Capecitabine Medac, 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.

This summary was last updated in 06-2012.

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Capecitabine Medac

EMA/619580/2012