Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Orlistat
GlaxoSmithKline Consumer Healthcare
A08AB01
Orlistat
60mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5000347034152 5000347033490 5000347040306
information for the user 60 mg hard capsules orlistat 31041819 visit alli and SHUTTLE are registered trade marks of the GSK group of companies. The SHUTTLE carry case is a trade mark of the GSK group of companies. www.alli.co.uk www.alli.ie 2 3 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 4 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 5 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 8 1 8 WHAT ALLI IS AND WHAT IT IS USED FOR THIS CHAPTER CONTAINS: ■ Risk of being overweight ■ How alli works 9 1 9 WHAT ALLI IS AND Les hele dokumentet
OBJECT 1 ALLI 60 MG HARD CAPSULES Summary of Product Characteristics Updated 26-Jul-2017 | GlaxoSmithKline Consumer Healthcare 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, lowerfat 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. _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 Les hele dokumentet