Midadown Capsule 60mg (Orlistat)

Adult dose

The recommended dose of this medicine is 120mg of orlistat orally 3 times daily, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue to follow 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 among three meals. This medicine may be omitted if a meal is skipped or contains no fat. As 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 or at least 2 hours after this medicine, such as at bedtime. Taking more than 120mg 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 administration. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this medicine for periods exceeding 4 years have not been evaluated. ○ No studies have been conducted in patients with hepatic and/or renal impairment or in elderly patients.

Child dose

No studies have been conducted in children under 12 years of age.

This medication should not be administered to patients with chronic malabsorption syndrome or biliary obstruction. Individuals allergic to this drug or its components should also avoid it. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Since liver damage may occur, if any symptoms of liver dysfunction appear, the patient should inform their doctor immediately and stop taking the medication. It is important to check liver enzyme levels through liver function tests. Patients with hyperoxaluria or calcium oxalate kidney stones should be cautious, as the use of this medication may increase urinary oxalate excretion. This drug primarily causes gastrointestinal adverse reactions, such as abdominal distension, flatulence, constipation, fatty stools, increased bowel movements, and fecal incontinence. These symptoms are mostly mild and temporary and usually occur within three months of starting treatment. However, in some patients, gastrointestinal adverse reactions may persist for over six months. If any signs of liver dysfunction appear while taking this medication, the patient should consult a doctor immediately, as serious liver damage such as hepatitis or liver failure has been reported rarely. Additionally, this medication may reduce the absorption of fat-soluble vitamins (vitamins A, D, E, K) and beta-carotene; thus, it is recommended to take vitamin supplements. The vitamin supplements should be taken at least 2 hours before or 2 hours after taking this medication. Taking this medication together with a high-fat meal may increase gastrointestinal adverse reactions; therefore, dietary control is necessary to evenly distribute fat intake throughout three meals a day. This medication may alter blood coagulation indicators when taken with oral anticoagulants; thus, patients on anticoagulants should regularly check their blood coagulation status under medical supervision. Concurrent use of this medication and cyclosporine may decrease the blood concentration of cyclosporine, so caution is advised not to take both medications simultaneously, with a recommended interval of at least 3 hours. This medication can be used in adolescents aged 12 and older, but safety and efficacy have not been established in children under 12. Pregnant or nursing women should avoid taking this medication, and it is also not recommended for women planning to become pregnant. No particularly severe adverse reactions have been reported in cases of overdose, but monitoring for 24 hours is required in such cases. This medication should be stored out of reach of children and protected from light and moisture by storing it in a well-sealed container.

• Fatty stools
• abdominal bloating and flatulence
• increased frequency of bowel movements
• fatty/greasy stools
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea
• rectal pain/discomfort
• dental abnormalities

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

Appearance

Domestic: Hard capsules with yellow upper and lower parts containing white or off-white powder or granules Export: Hard capsules with green upper and blue lower parts containing white or off-white powder

Package unit

Domestic: 90 capsules (10 capsules/PTPX9), 30 capsules/bottle, 300 capsules/bottle Export: 21 capsules/PTP packaging