European Medicines Agency
EMEA/H/C/154
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) XENICAL EPAR summary for the public
This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
What is Xenical? Xenical is a medicine containing the active substance orlistat. It is available as turquoise capsules (120 mg). What is Xenical used for? Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/m2) who are at risk of illness because of their weight. The medicine can only be obtained with a prescription. How is Xenical used? Xenical is given as one capsule taken with water just before, during, or up to one hour after each main meal. If a meal is missed or contains no fat, Xenical should not be taken. The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables. The food in the diet should be spread over three main meals. Treatment with Xenical should be stopped after 12 weeks if patients have been unable to lose at least 5% of their body weight since the start of treatment. How does Xenical work? The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite. Orlistat blocks gastrointestinal lipases (enzymes that digest fat). When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested. The body cannot use this dietary fat for energy or convert it into fat tissue. This helps weight reduction. How has Xenical been studied? The effects of Xenical were first tested in experimental models before being studied in humans. Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients. The studies lasted from one to two years and compared three different doses of Xenical with placebo (a dummy treatment), in combination with dieting. Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study. An additional longer study in over 3,000 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.