Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Orlistat
Alissa Healthcare Research Limited
A08AB; A08AB01
Orlistat
120 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Peripherally acting antiobesity products; orlistat
Not marketed
2016-01-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ORLISTAT 120 MG CAPSULES, HARD ORLISTAT WHAT IS IN THIS LEAFLET 1. What Orlistat is and what it is used for 2. What you need to know before you take Orlistat 3. How to take Orlistat 4. Possible side effects 5. How to store Orlistat 6. Contents of the pack and other information 1. WHAT ORLISTAT IS AND WHAT IT IS USED FOR Orlistat is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested. Orlistat attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body. Orlistat is indicated in the treatment of obesity in conjunction with a low calorie intake diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORLISTAT DO NOT TAKE ORLISTAT: • if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Orlistat, • if you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract) • if you have cholestasis (liver disorder) • if you are breast-feeding WARNINGS AND PRECAUTIONS Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other medicines you may be taking with your doctor. Losing weight may mean you need adjustments to the dose of these medicines. To gain the maximum benefit from Orlistat you should follow the nutrition program recommended to you by your doctor. As with any weight-control program, over- consumption of fat and calories may reduce any weight loss effect. This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces. The possibility of this happening may increase if Orlistat is taken with a diet high in fat. In addition your daily intake of fat should be distributed evenly over three main meals Lue koko asiakirja
Health Products Regulatory Authority 18 September 2020 CRN009N4M Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Orlistat 120mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg orlistat. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard Capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should 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 of orlistat above 120 mg three times daily have not been shown to provide additional benefit. The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours. Special populations The effect of orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied. There is no relevant indication for use of Orlistat in children. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Chronic malabsorption syndrome. - Chole Lue koko asiakirja