Orlistat 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

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

This medication should not be used in patients with chronic malabsorption syndrome or with obstructed bile secretion. Furthermore, individuals allergic to this medication or its components should not take it. Women who are pregnant or may become pregnant, as well as nursing mothers, should also avoid using this medication. It contains lactose, so those with lactose intolerance or specific genetic issues should refrain from taking it. Patients with liver function issues should be cautious while taking this medication as it may cause liver damage, and should inform a doctor immediately if symptoms of liver dysfunction occur. Additionally, patients with hyperoxaluria or calcium oxalate kidney stones should use this medication cautiously as it may increase the risk of kidney stones. This medication primarily causes gastrointestinal side effects, notably oily stools, abdominal distension, flatulence, and constipation. These symptoms are generally mild and temporary, usually occurring within 3 months of treatment and diminishing over time. However, in some patients, symptoms may persist for more than 6 months. It is important to consult a doctor if symptoms become severe or lead to treatment discontinuation due to adverse reactions. This medication may reduce the absorption of fat-soluble vitamins and beta-carotene, so it is recommended to take a multivitamin supplement containing vitamins A, D, E, K, and beta-carotene. The vitamin supplements should be taken at least 2 hours before or after taking this medication. Serious liver damage, including liver dysfunction, hepatitis, and liver failure, has occasionally been reported during treatment with this medication, so if liver dysfunction symptoms (fatigue, jaundice, changes in urine color, etc.) occur, a doctor should be notified immediately. Also, this medication can affect blood coagulation, so patients taking anticoagulants should regularly check their coagulation status. Taking this medication with a high-fat meal may increase gastrointestinal side effects, so it is advisable to spread daily fat intake evenly across three meals. Moreover, excessive weight loss can increase the risk of gallstones, requiring caution. This medication may decrease cyclosporine blood concentration when used together, so it is advisable not to take them concurrently. There may also be interactions with other medications, so it is important to consult a physician or pharmacist if other medications are being used. For children, this medication is recommended only for obese adolescents aged 12 to 16. The safety and efficacy in children under 12 have not been established. Pregnant and nursing women should not take this medication, and there is insufficient clinical data for elderly patients, so caution is needed. No severe side effects have been reported in cases of overdose, but monitoring is necessary for at least 24 hours after overdosing. This medication must be stored out of reach of children and protected from light and moisture.

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

This medication should be stored in a sealed container to protect it from air, light, and moisture. It is also important to store it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

Greenish-blue rectangular film-coated tablet

Package unit

PTP - 90 tablets/box[(10 tablets/PTP X 9)], PTP - 90 tablets/box[(10 tablets/PTP(Alu-Alu) X 9)]