Zerobi Tablets 60 mg (Orlistat)

Adult dose

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, carbohydrate, and protein should be distributed evenly across three meals. This medicine may be omitted if a meal is skipped or 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 24 ∼ 48 hours after taking the medication. 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 older adults.

Child dose

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

This medicine should not be used in patients with chronic malabsorption syndrome or cholestasis. It should also not be administered in cases of allergy to this medicine or any of its components. Pregnant women, women who may become pregnant, and nursing mothers should not take this medicine. Since this medicine contains lactose, patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should refrain from use due to genetic issues. Patients with liver damage should use this medicine cautiously, and should immediately inform their doctor if any symptoms of liver dysfunction appear. Patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis should also use it with caution. This medicine contains Tartrazine (Yellow No. 5), and care should be taken if there is an allergy to this component. Gastrointestinal adverse reactions can often occur during use, mainly due to the action of inhibiting fat absorption. Symptoms include oily spot stools, abdominal distension, flatulence, constipation, and fatty stools, which are mostly mild and temporary. Adverse reactions typically appear within three months of starting treatment and tend to decrease over time. Some patients may experience adverse reactions persisting for more than six months. This medicine can occasionally cause serious liver damage or hypersensitivity reactions, with symptoms such as itching, rash, urticaria, angioedema, and anaphylaxis. Additionally, taking this medicine with anticoagulants can affect blood coagulation function, so regular blood tests are required. Weight loss may improve blood glucose control in diabetic patients; hence, adjustments to oral hypoglycemic agents or insulin doses may be necessary. Additionally, excessive weight loss may increase the risk of cholelithiasis, thus caution is advised. This medicine can reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, therefore taking vitamin supplements alongside is recommended. Vitamin supplements should be taken at least two hours before or two hours after this medicine. The safety and effectiveness of this medicine have not been established in children under 12 years old, and sufficient clinical data is lacking for the elderly. In case of overdose, special toxic symptoms are rarely seen, but it is necessary to observe the patient's condition for 24 hours. During storage, keep out of reach of children and store in the original packaging away from light and moisture.

• Chylous diarrhea
• abdominal bloating and flatulence
• increased frequency of stools
• fatty stools
• chylous excretion
• increased bowel movements
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea

This medicine should be protected from air, light, and moisture and should be stored in a tightly sealed container. To maintain the effectiveness of the medicine, it is important to store it in a cool place, specifically at a temperature below 25 degrees Celsius.

Appearance

Yellow oblong film-coated tablet

Package unit

90 tablets/box [10 tablets/PTP×9], 90 tablets/box [10 tablets/PTP (Alu-Alu)×9], 84 tablets/box [(7 tablets/PTP×12)], 84 tablets/box [(7 tablets/PTP(Alu-Alu)×12)]