Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ORLISTAT
ROCHE (MALAYSIA) SDN. BHD.
ORLISTAT
21Capsule Capsules; 42Capsule Capsules; 84Capsule Capsules
F.HOFFMANN-LA ROCHE LTD
XENICAL ® Orlistat (120 mg capsules) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Xenical is used for 2. How Xenical works 3. Before you use Xenical 4. How to use Xenical 5. While you are using it 6. Side effects 7. Storage and disposal of Xenical 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT XENICAL IS USED FOR Xenical contains the active ingredient orlistat. Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet. Xenical is effective in weight loss, weight maintenance and prevention of weight regains. Ask your doctor if you have any questions about why Xenical has been prescribed for you. HOW XENICAL WORKS XENICAL belongs to a group of medicines called lipase inhibitors. Xenical 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. Xenical 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. BEFORE YOU USE XENICAL - _When you must not use it_ Do not take or receive XENICAL if: you have had an allergic reaction to Xenical (orlistat) or any ingredients listed at the end of this leaflet you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract) you have cholestasis (liver disorder) you are breast-feeding the package is torn or shows signs of tampering the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If you are not sure you should be taking Xenical, talk to your doctor. - _Before you start to use it _ Tell your doctor if: you are pregnant or plan to become pregnant. Xenical is not recommended for use during pregnancy. you are breast feeding or intend to breas Baca dokumen lengkap
PACK INSERT FOR MALAYSIA Xenical PPPPPPP®PPPPPPP Orlistat 1. DESCRIPTION 1.1 Therapeutic/Pharmacological Class of Drug Peripherally acting anti -obesity agent 1.2 Type of Dosage Form Capsule, hard 1.3 Qualitative and Quantitative Composition Active ingredient: orlistat Capsules 120 mg. Excipients : Capsule filling: microcrystalline cellulose, sodium starch glycollate, povidone, sodium lauryl sulphate and talc. Capsule shell: gelatine, indigo carmine (E132) and titanium dioxide (E171) It is presented as turquoise cap and turquoise body bearing the imprint of “ XENICAL 120”. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indications Xenical is indicated, in conjunction with a mildly hypocaloric diet for the treatment of obese (BMI 30kg/m PPPPPPP2PPPPPPP) and overweight (BMI 28kg/m PPPPPPP2PPPPPPP) patients, including patients with risk factors associated with obesity. Xen- ical is effective in weight loss, weight maintenance and prevention of weight regains. Treatment with Xenical results in an improvement of risk factors and comorbidities associated with obesity, including hypercholesterolemia, noninsulin dependent diabetes mellitus (NIDDM), impaired glucose tolerance, hyperinsulinemia, hypertension and in a reduction of visceral fat. In type 2 diabetic patients who are overweight (BMI 28kg/m PPPPPPP2PPPPPPP) or obese (BMI 30kg/m PPPPPPP2PPPPPPP) Xen- ical, in conjunction with a mildly hypocaloric diet, provides additional glycemic control when used in combination with antidiabetic agents such as metformin, sulfonylurea and/or insulin. Treatment with Xenical should only be started if diet alone has previously produced a weight loss of at least 2.5kg over a period of 4 consecutive weeks. 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 drug therapy. 2.2 Dosage and Administration Standard Dosage The recommended dose of Xenical is one 120 mg capsule with each main meal (during Baca dokumen lengkap