Zerofat Tablets 120 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, carbohydrates, and protein should be distributed evenly among three meals. This medicine may be omitted if a meal is missed 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 effectiveness. 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. Studies have not been conducted in patients with hepatic and/or renal impairment or in older adults.

Child dose

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

This medication should not be used in patients with chronic malabsorption syndrome or biliary obstruction. Moreover, it should not be taken by individuals allergic to this medication or its ingredients, pregnant women or those who may become pregnant, and nursing mothers. Since this medication contains lactose, it should not be administered to patients with lactose intolerance or certain genetic metabolic disorders. Patients with liver function issues may experience liver damage while taking this medication, so they should notify their doctor immediately if symptoms of liver dysfunction occur. Patients with hyperoxaluria or calcium oxalate kidney stones should use this medication with caution. This medication primarily has gastrointestinal side effects, which may include fatty stools, abdominal bloating, flatulence, and constipation. These side effects are generally mild and temporary, and often manifest within three months after starting treatment. Interruption of treatment due to side effects of this medication may occur; therefore, patients should consult their doctor if symptoms are severe. This medication may interfere with the absorption of fat-soluble vitamins, so it is recommended to take a multivitamin containing vitamins A, D, E, K, and beta-carotene. Patients with obesity may have lower levels of vitamin D and beta-carotene, so they should carefully manage their nutritional status. Symptoms of liver dysfunction, such as loss of appetite, itching, jaundice, dark urine, pale stools, or upper abdominal pain, should be reported to a doctor immediately, and this medication should be discontinued. This medication induces weight loss, which may affect blood sugar regulation in diabetic patients, so adjustments to diabetes medications may be necessary. Excessive weight loss may increase the risk of gallstones, so caution is required. This medication has minimal interaction when taken with alcohol; however, it can interact with certain medications, such as cyclosporine, and should not be taken simultaneously. When taken with oral anticoagulants, frequent monitoring of blood coagulation status is required. Pregnant or nursing women should avoid taking this medication, and its safety has not been established for children under 12 years old, hence it is not used in this population. This medication should be stored out of reach of children, and it is important to keep it protected from light and moisture. In case of overdose, 24-hour monitoring is required, and most side effects resolve quickly.

• Fatty stools
• abdominal bloating and flatulence
• frequency of bowel movements
• steatorrhea
• passage of oily stools
• increased bowel movements
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea

This medication is sensitive to air, light, and moisture; therefore, it should be stored in a tightly sealed container. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain efficacy.

Appearance

Bluish-green, oblong, film-coated tablet

Package unit

84 tablets/box [7 tablets/PTPX12], 84 tablets/box [7 tablets/PTP (Alu-Alu)X12]