Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
orlistat
GlaxoSmithKline (Ireland) Limited
A08AB01
orlistat
Antiobesity preparations, excl. diet products
Obesity
Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
Revision: 19
Authorised
2007-07-22
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER ALLI 60 MG HARD CAPSULES orlistat READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your doctor or pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to your doctor or pharmacist if you do not lose weight after taking alli for 12 weeks. You may need to stop taking alli. WHAT IS IN THIS LEAFLET 1. What alli is and what it is used for - Risk of being overweight - How alli works 2. What you need to know before you take alli - Do not take alli - Warnings and precautions - Other medicines and alli - alli with food and drink - Pregnancy and breast-feeding - Driving and using machines 3. How to take alli - Preparing to lose weight - Choose your start date - Decide on your weight loss goal - Set your calorie and fat targets - Taking alli - Adults 18 and over - How long should I take alli for? - If you take more alli than you should - If you forget to take alli 4. Possible side effects - Serious side effects - Very common side effects - Common side effects - Effects seen in blood tests - Learn to deal with diet-related treatment effects 5. How to store alli 6. Contents of the pack and other information - What alli contains - What alli looks like and contents of the pack - Marketing authorisation holder and manufacturer - Further helpful information 28 1. WHAT ALLI IS AND WHAT IT IS USED FOR alli 60 mg hard capsules (orlistat) is a peripherally acting antiobesity product which is used for weight loss in adults aged 18 and over who are overweight, and have a body mass index (BMI) of 28 or above. alli should be used along with a reduced calorie, lower-fat diet. Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT alli 60 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 60 mg orlistat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. The capsule has a dark blue centre band, and a turquoise cap and body bearing the imprint of “alli”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m 2 ) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ The recommended treatment dose is one 60 mg capsule to be taken three times daily. No more than three 60 mg capsules should be taken in 24 hours. Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with alli. While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to <67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over three main meals. The diet and exercise programme should continue to be followed when treatment with alli is stopped. Treatment should not exceed 6 months. If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment. _Special populations _ _Elderly (>65 years old) _ There are limited data on the use of orlistat in the elderly. However, as orlistat is minimally absorbed, no dose adjustment is necessary in the elderly. 3 _Hepatic and renal impairment _ The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied (see section 4.4). However, as orlistat is minimally absorbed, no dose adjustment is necessar Đọc toàn bộ tài liệu