Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Orlistat 120mg; ;
Pharmaco (NZ) Ltd
Orlistat 120 mg
120 mg
Capsule
Active: Orlistat 120mg Excipient: Gelatin Indigo carmine Microcrystalline cellulose Povidone Purified talc Sodium laurilsulfate Sodium starch glycolate TekPrint black SW-9008 Titanium dioxide
Blister pack, PVC/PVDC, 84 capsules
Restricted
Restricted
Roche Ireland Ltd
Xenical is for weight control, including weight loss, weight maintenance and prevention of weight regain in adults with an initial body mass index (BMI) of 30 or more. Xenical should be used in conjunction with a low fat, calorie controlled diet.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 84 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
1997-02-04
Xenical CMI 220817 1 of 7 CONSUMER MEDICINE INFORMATION XENICAL ® ORLISTAT 120 MG CAPSULES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about XENICAL capsules. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor will consider the risks of your taking XENICAL capsules against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT XENICAL IS USED FOR XENICAL contains the active ingredient orlistat. XENICAL is used to assist with losing weight, maintaining a certain weight and preventing weight regain. XENICAL is used to treat adults with an initial Body Mass Index (BMI) which measures 30 or more. One way to measure if you are overweight, and how overweight you are, is to calculate your Body Mass Index (BMI). You can calculate your BMI by multiplying your height in metres by itself (squaring your height in metres), and then dividing your weight in kilograms by your squared height. weight (kg) weight (kg) BMI = ------------------------------- = -------------------- height (m) x height (m) [height (m)] 2 If your BMI is 25 or more you may be overweight, and if your BMI is 30 or more you may be very overweight. BMI may vary across different populations due, in part, to different body proportions. Talk to your pharmacist or doctor if you have any questions about your BMI. XENICAL should be taken in conjunction with a low-fat, well-balanced, calorie-controlled diet and other appropriate measures such as exercise. XENICAL belongs to a group of medicines called lipase inhibitors. These medicines work by preventing the absorption of dietary fat in your body rather than by suppressing your appetite. Xenical CMI 220817 2 of 7 Dietary fats are large molecules that need to be broken down before they can be absorbed into the body. They Lire le document complet
NEW ZEALAND DATA SHEET Xenical 003 May 2023 1 XENICAL® (120 MG CAPSULES) Orlistat 1 PRODUCT NAME Xenical® 120 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg Orlistat For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule. Xenical 120 mg hard capsules have a turquoise cap and turquoise body bearing the imprint of “XENICAL 120”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xenical is for weight control, including weight loss, weight maintenance and prevention of weight regain in adults with an initial body mass index (BMI) of 30 or more. Xenical should be used in conjunction with a low fat, calorie-controlled diet. 4.2 DOSE AND METHOD OF ADMINISTRATION _ADULTS _ The recommended dose of Xenical is one 120 mg capsule orally three times a day with each main meal (during or up to one hour after the meal). If a meal is missed, the dose of Xenical may be omitted. The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals. Doses above 120 mg three times daily have not been shown to provide additional benefit. The World Health Organisation (WHO) calculates Body Mass Index (BMI) using the following equation: BMI = weight (kg) [height (m)] 2 The WHO BMI classification for overweight adults is BMI ≥ 25, and for obese adults BMI ≥ 30. NEW ZEALAND DATA SHEET Xenical 003 May 2023 2 Note, that these BMI values are age-independent and the same for both sexes. However, BMI may not correspond to the same degree of fatness across different populations due, in part, to different body proportions. _RENAL IMPAIRMENT _ Clinical investigations in patients with renal impairment have not been undertaken. _HEPATIC IMPAIRMENT _ Clinical investigations in patients with hepatic impairment have not been undertaken. _ELDERLY Lire le document complet