Zero One Tablet 60 mg (Orlistat)

Adult dose

○ Adults The recommended dose of this medicine is 120mg of orlistat per dose, taken orally 3 times daily 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 missed 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 nutritional intake. 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 120mg per dose 3 times daily does not increase the effectiveness of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 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

Studies have not been conducted in children under 12 years of age.

This drug should not be used in patients with chronic malabsorption syndrome or cholestasis. Individuals allergic to this drug or any of its components should not take it. Women who are pregnant or may become pregnant, as well as those who are nursing, should not use this medication. Additionally, patients with lactose intolerance or specific genetic metabolic disorders should not take this drug. If there are symptoms of liver damage or abnormal liver function, the use of this drug should be discontinued and a physician consulted. Patients with hyperoxaluria or calcium oxalate kidney stones should also use this drug with caution. This medication contains Tartrazine (Yellow No. 4) dye, which should be cautiously considered by individuals with a history of allergy to this component. Gastrointestinal symptoms, such as oily stools, abdominal distension, flatulence, constipation, and fecal incontinence, may occur. These symptoms typically appear within 3 months of starting treatment and are usually mild and transient. Discontinuation of the drug may occur due to adverse reactions, primarily gastrointestinal symptoms. Although liver function abnormalities may occur rarely, symptoms such as loss of appetite, jaundice, urine color changes, and abdominal pain should be reported to a physician immediately. The absorption of fat-soluble vitamins (vitamin A, D, E, K) and beta-carotene may be reduced while taking this drug, so it is advisable to take a multivitamin supplement. Vitamin supplements should be taken at least 2 hours before or after taking this drug. This medication may cause more frequent gastrointestinal adverse reactions when taken with a high-fat meal, so controlling fat intake and distributing it evenly in meals is important. If liver function abnormality symptoms appear, use should be stopped immediately and a physician consulted. Certain medications may interact with this drug, so it is essential to consult with a physician or pharmacist if taking other medications, especially when using cyclosporine, anticoagulants, anticonvulsants, antidepressants, antipsychotics, and antiretrovirals. Pregnant or nursing women should not take this drug, and its safety and efficacy have not been confirmed in children under 12 years of age. No severe side effects have been reported from an overdose, but observation for 24 hours is necessary if an overdose occurs. This medication should be kept out of reach of children and stored away from light and moisture.

• Fatty stools
• abdominal bloating and flatulence
• increased frequency of stools
• fat/fatty stool
• fatty bowel movements
• increased bowel movements
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea

This medication should be stored in a tightly closed container to protect it from air, light, and moisture. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow rectangular film-coated tablet

Package unit

90 tablets/box [(10 tablets/PTPX9)], 90 tablets/box [(10 tablets/PTP(Alu-Alu)x9)]