Obelit Capsules (Generic Orlistat Capsules)

1. Obelit Capsules (Generic Orlistat Capsules) © The Swiss Pharmacy

2. Obelit Capsules (Generic Orlistat Capsules) Obelit Capsules (Generic Orlistat Capsules) are used for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. This medication is also used to reduce the risk for weight regain after prior weight loss. This medicine decreases the amount of fat that is absorbed from your diet. © The Swiss Pharmacy

3. Obelit Capsules (Generic Orlistat Capsules) Obelit Capsules are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 60 mg and 120 mg. © The Swiss Pharmacy

4. Obelit Capsules (Generic Orlistat Capsules) Chemical Structure © The Swiss Pharmacy

5. Obelit Capsules (Generic Orlistat Capsules) The active ingredient contained in Obelit capsules is Orlistat. Each capsule of Obelit contains 60 mg or 120 mg of Orlistat. © The Swiss Pharmacy

6. Obelit Capsules (Generic Orlistat Capsules) Uses of Obelit 60 mg and 120 mg Capsules: Orlistat is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning by decreasing the amount of fat that your body absorbs from the food you eat. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease. A healthcare provider will recommend a reduced-calorie diet when taking this medication. Orlistat works by keeping your intestines from absorbing some of the fats from the food that you eat. The undigested fat goes out of your body in your bowel movements. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

7. Obelit Capsules (Generic Orlistat Capsules) Uses of Obelit 60 mg and 120 mg Capsules: This medicine is used 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 or more) with associated risk factors. Treatment with Orlistat capsules (Obelit capsules) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

8. Obelit Capsules (Generic Orlistat Capsules) Recommended Adult Dosage For overweight adult (18 years and older) patients, the starting dose of Obelit Capsules Obelit Capsules (Generic Orlistat Capsules) is 1 capsule of 60 mg taken with each meal containing fat. Do not take more than 3 capsules daily URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

9. Obelit Capsules (Generic Orlistat Capsules) Recommended Adult Dosage For obese adult (18 years and older) patients, with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI 28 kg/m2 or more) with associated risk factors the dosage is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal). Advise patients to take a nutritionally balanced, reduced- calorie diet that contains approximately 30% of calories from fat. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

10. Obelit Capsules (Generic Orlistat Capsules) Recommended Adult Dosage Patients must distribute the daily intake of fat, carbohydrate, and protein over three main meals. Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. Take the vitamin supplement at least 2 hours before or after the administration of Obelit capsules, such as at bedtime. For patients receiving both Obelit and Cyclosporine therapy, administer Cyclosporine 3 hours after Obelit. For patients receiving both Obelit and Levothyroxine therapy, administer Levothyroxine and Obelit at least 4 hours apart. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

11. Obelit Capsules (Generic Orlistat Capsules) Missed Dose Instructions If you miss a dose of Obelit capsules, take it within 1 hour following the meal that contains fat. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you occasionally miss a meal or have a meal without fat, you can skip that dose of this medicine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

12. Obelit Capsules (Generic Orlistat Capsules) Contraindications ➔Obelit capsules are contraindicated in patients with a known hypersensitivity to Orlistat or any component of the tablet. ➔Obelit (Generic Orlistat Capsules) is also contraindicated in patients with chronic malabsorption syndrome, cholestasis and in patients who are pregnant. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

13. Obelit Capsules (Generic Orlistat Capsules) Storage Instructions Obelit Capsules (Generic Orlistat Capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

14. Obelit Capsules (Generic Orlistat Capsules) Warnings Obelit (Generic Orlistat Capsules) can decrease cyclosporine exposure. Take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition. Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported. Patients may develop increased levels of urinary oxalate following treatment with Obelit. Monitor renal function in patients at risk for renal insufficiency. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

15. Obelit Capsules (Generic Orlistat Capsules) Warnings Substantial weight loss can increase the risk of cholelithiasis. Exclude organic causes of obesity (eg, hypothyroidism) before prescribing Obelit (Generic Orlistat Capsules). Gastrointestinal events may increase when Obelit is taken with a diet high in fat (more than 30% total daily calories from fat). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

16. Obelit Capsules (Generic Orlistat Capsules) Possible Side Effects Most common Orlistat (Obelit Capsules) side effects with an incidence rate of greater than or equal to 5% and at least twice that of placebo include oily spotting, flatus with discharge, fecal urgency fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

17. Obelit Capsules (Generic Orlistat Capsules) Possible Side Effects The following side effects have been identified during postapproval use of Orlistat (Obelit Capsules) Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of Orlistat Capsules in postmarketing surveillance, with some of these cases resulting in liver transplant or death Cases of reduced concentrations of cyclosporine have been reported when cyclosporine was co-administered with Orlistat Capsules. Rare cases of hypersensitivity have been reported with the use of Orlistat Capsules. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with Orlistat Capsules and anticoagulants. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

18. Obelit Capsules (Generic Orlistat Capsules) Possible Side Effects The following side effects have been identified during postapproval use of Orlistat (Obelit Capsules): Hypothyroidism has been reported in patients treated concomitantly with Orlistat Capsules and levothyroxine. Acute oxalate nephropathy after treatment with Orlistat Capsules has been reported in patients with or at risk for renal disease. Pancreatitis has been reported with the use of Orlistat Capsules in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established. Lower gastrointestinal bleeding has been reported in patients treated with Orlistat Capsules. Most reports are nonserious; severe or persistent cases should be investigated further. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

19. Obelit Capsules (Generic Orlistat Capsules) Overdosage Single doses of 800 mg Orlistat (Obelit Capsules) and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings. Should a significant overdose of Orlistat (Obelit Capsules) occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, systemic effects attributable to the lipase-inhibiting properties of Orlistat should be rapidly reversible. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

20. Obelit Capsules (Generic Orlistat Capsules) Obelit Capsules During Pregnancy Orlistat (Obelit Capsules) has been classified by the US FDA as Pregnancy Category X. Orlistat (Obelit Capsules) is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. In animal reproductive studies, no embryotoxic or teratogenic effects were observed with orlistat. In absence of a teratogenic effect in animals, no malformative effect is expected in human beings. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy

21. Obelit Capsules (Generic Orlistat Capsules) Obelit Capsules Obelit Capsules (Generic Orlistat Capsules) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9534_Orlistat-Capsules.html © The Swiss Pharmacy