Orlistat Capsule 120 mg

Adult dose

○ Adults The recommended dose of this drug 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 fat accounts for approximately 30 % of calories. Daily intake of fat, carbohydrates, and protein should be distributed evenly across the three meals. This drug may be omitted if a meal is missed or contains no fat. As absorption of some fat-soluble vitamins and beta-carotene may be reduced by this drug, 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 drug or at least 2 hours after it, such as at bedtime. Taking more than 120 mg per dose 3 times daily does not increase the efficacy of this drug. Measurements of fecal fat indicate that the effect of this drug becomes apparent 24 ∼ 48 hours after administration. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this drug 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 medicine should not be used in patients with chronic malabsorption syndrome or biliary obstruction. It should also not be used by individuals allergic to this medicine or its ingredients, pregnant or potentially pregnant women, and nursing women. Caution is needed for patients with liver damage, as impaired liver function may occur while taking this medicine, and liver function tests should be conducted frequently. Caution should be exercised in patients with hyperoxaluria or calcium oxalate kidney stones as the risk of kidney stones may increase with this medication. Various symptoms may primarily occur in the gastrointestinal system, such as oily stools, abdominal bloating, constipation, and increased flatulence, which are commonly reported. These symptoms typically appear within three months of starting the medication and are generally mild, with a gradual decrease over time. However, in some patients, gastrointestinal adverse reactions may persist for more than six months, so if symptoms are severe or persist, consultation with a physician is advised. Discontinuation of treatment due to adverse reactions may occur, especially gastrointestinal symptoms are the main reason for discontinuation during treatment. This medicine may cause gastrointestinal adverse reactions more frequently when taken with high-fat meals, so dietary guidelines must be strictly followed. Additionally, this medicine may interfere with the absorption of fat-soluble vitamins (Vitamins A, D, E, K) and beta-carotene, so taking vitamin supplements separately is advisable. Vitamin supplements should be taken at least 2 hours before or 2 hours after taking this medicine for effectiveness. Liver dysfunction symptoms include loss of appetite, itching, jaundice of the skin or eyes, dark urine, pale stools, and right upper abdominal pain, and if these symptoms appear, a physician should be informed immediately. Weight loss may occur with this medication, and for diabetic patients, dose adjustment of blood glucose control medications may be necessary. Excessive weight loss may increase the risk of gallstones, so care should be taken regarding the rate of weight loss. This medicine may interact with other medications, so patients taking ciclosporin, anticoagulants, antiepileptics, antiretrovirals, etc., should consult with their physician. It is safer not to use this medicine during pregnancy or breastfeeding, and women of childbearing potential should always consult a physician before taking it. The safety and efficacy of this medicine in children under 12 years old have not been confirmed, so it should not be used. There have not been sufficient clinical trials for the elderly, so caution is needed when they take it. No serious adverse effects have been reported in cases of overdose, but patients must be monitored for 24 hours after overdose.

• Fatty stools
• abdominal bloating and flatulence
• frequent bowel movements
• fatty/fatty stools
• increased bowel movements
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea
• rectal pain/discomfort

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

Appearance

A hard capsule with greenish-blue upper and lower parts containing white or off-white powder or granules

Package unit

300 capsules/bottle, 30 capsules/bottle