Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Orlistat
Teva UK Ltd
A08AB01
Orlistat
120mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04050100; GTIN: 5017007014089
pharmacode pharmacode pharmacode pharmacode pharmacode pharmacode pharmacode pharmacode ORLISTAT 120 MG CAPSULES, HARD READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or your pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. What Orlistat 120 mg Capsules are and what they are used for 2. What you need to know before you take Orlistat 120 mg Capsules 3. How to take Orlistat 120 mg Capsules 4. Possible side effects 5. How to store Orlistat 120 mg Capsules 6. Contents of the pack and other information WHAT ORLISTAT 120 MG CAPSULES ARE AND WHAT THEY ARE USED FOR Orlistat Capsules 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 Capsules is indicated in the treatment of obesity in conjunction with a low calorie intake diet. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORLISTAT 120 MG CAPSULES DO NOT TAKE ORLISTAT CAPSULES • if you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6) • if you have chronic malabsorption syndrome (insufficient absorption of nutrients across the gastrointestinal (GI) tract) • if you have cholestasis (liver disorder) • if you are breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Orlistat Capsules. Weight loss may also affect the dos Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Orlistat 120 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 120 mg orlistat. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. The capsule has a blue cap and blue body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Orlistat 120 mg capsules 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 _Paediatric population _ The effect of orlistat in children has not been studied. There is no relevant indication for use of Orlistat in children. _Elderly (>65 years old) _ _ _ The effect of orlistat in elderly patients has not been studied. _ _ _ _ _Hepatic and renal impairment_ The effect of orlistat in patients with hepatic and/or renal impairment has no Perskaitykite visą dokumentą