Oli One Tablet 120 mg (Orlistat)

Adult dose

○ Adults The recommended dose of this medicine is 120 mg of orlistat orally 3 times daily, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue a nutritionally balanced, mildly hypocaloric diet in which approximately 30 % of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among three meals. This medicine may be omitted if a meal is skipped or if the meal contains no fat. Because this medicine may reduce the absorption of some fat-soluble vitamins and beta-carotene, patients are advised to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before this medicine or at least 2 hours after it, such as at bedtime. Taking more than 120 mg of this medicine 3 times daily does not increase its efficacy. Based on measurements of fecal fat, the effect of this medicine appears approximately 24 ∼ 48 hours after taking it. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this medicine have not been evaluated for periods exceeding 4 years. ○ Studies have not been conducted in patients with hepatic and/or renal impairment or in elderly patients.

Child dose

Children under 12 years of age: Studies have not been conducted.

This medication should not be used in patients with chronic malabsorption syndrome or cholestasis. Additionally, it should not be taken by individuals allergic to this drug or its ingredients. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication. Because this drug contains lactose, it is not suitable for patients with lactose intolerance or certain genetic metabolic disorders. Caution should be exercised in patients with liver damage or impaired liver function after consulting a physician. Those with hyperoxaluria or kidney stones should also take care. During treatment, gastrointestinal side effects may frequently occur, but they are usually transient and mild. However, if symptoms are severe or persist, a doctor should be notified. This medication may interfere with the absorption of fat-soluble vitamins; therefore, it is recommended to take vitamin supplements. Specifically, a multivitamin containing vitamins A, D, E, K, and beta-carotene should be taken at least 2 hours before or after taking this medication. This medication may intensify gastrointestinal side effects when taken with high-fat meals; thus, it is important to appropriately regulate fat intake. If symptoms of liver dysfunction (e.g., loss of appetite, jaundice, urine discoloration) occur, a doctor should be notified immediately, and medication should be discontinued. This medication can interact with other drugs; therefore, consultation with a physician is necessary, especially if taking cyclosporine, anticoagulants, anticonvulsants, or antiretrovirals. It is not used during pregnancy or breastfeeding, and safety and efficacy have not been confirmed for children under 12 years of age. No severe side effects have been reported in case of overdose; however, 24-hour observation is necessary. For storage, keep it out of reach of children and avoid exposure to light and moisture.

• Fatty stools
• abdominal distension and flatulence
• increased frequency of stool
• steatorrhea
• fecal incontinence
• increased bowel movements
• abdominal pain/discomfort
• nausea
• infectious diarrhea
• rectal pain/discomfort

This medicine is sensitive to air, light, and moisture, so it should be stored in a tightly closed container. Additionally, it should be kept in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

Bluish-green, rectangular film-coated tablet

Package unit

90 tablets/box [(10 tablets/PTP×9)], 90 tablets/box [(10 tablets/PTP (Alu-Alu)×9)]