I. Precautions for Use
- Do not use if you have any of the following conditions:
- Those who are sensitive to the excipients or any of the ingredients.
- Those who are taking Cyclosporin after organ transplantation, or those with severe rheumatoid arthritis or certain severe skin symptoms.
- Patients diagnosed by a physician with problems with food absorption (chronic malabsorption syndrome).
- Those with cholestasis of liver disease.
- Pregnant and breastfeeding women.
- Those taking Warfarin or other anticoagulants.
- Please consult a physician before use if you have any of the following conditions:
- Adolescents and children under the age of 18.
- Patients with high blood pressure and high cholesterol.
If you have ever had any of the following symptoms: Gallbladder problems Kidney stones Pancreatitis Consult your doctor, pharmacist, or chemist before use if you have any of the following conditions: If you are currently taking the following medications: medications for diabetes, medications for hyperthyroidism or hypothyroidism, medications for arrhythmia (Amiodarone), or oral contraceptives. Other precautions: Taking Orlistat with meals or in a diet high in fat may increase gastrointestinal discomfort. When taking Orlistat, adhere to a low-calorie, low-fat diet. Taking Orlistat may reduce the absorption of certain fat-soluble vitamins in the body. Therefore, it is recommended that you take a multivitamin containing vitamins A, D, E, and K before bed each day. A very small number of cases of hepatitis have been reported since Orlistat 60mg capsules were marketed. The link between Orlistat use and hepatitis has not been established. If you experience weakness, fatigue, fever, yellowing of the eyes or skin (jaundice), or brown urine while taking Orlistat, discontinue use immediately and consult a doctor. Rectal bleeding has occurred during Orlistat treatment. If this occurs, consult a doctor. Additional contraception is recommended to avoid severe diarrhea that could reduce the effectiveness of oral contraceptives. Diet and exercise are important parts of a weight management plan. It is recommended that you assess and understand your diet and exercise regimen before starting weight management with Orlistat 60mg capsules. When starting Orlistat 60mg capsules, please combine them with a nutritionally balanced, slightly reduced-calorie diet, ensuring that fat accounts for no more than 30% of total calories (e.g., 2000 calories per day is equivalent to less than 67 grams of fat). Divide your daily intake of fat, carbohydrates, and protein evenly across three meals. After discontinuing Orlistat 60mg capsules, continue to control your diet and maintain regular exercise. Do not take this capsule if you have not eaten a meal or your diet does not contain fat. Do not exceed six months for this weight management program. Do not take more than three Orlistat 60mg capsules within 24 hours.
- If any of the following side effects occur after taking this medication, please discontinue use immediately and consult a doctor, pharmacist, or pharmacist with this instruction manual:
- Nervous system: Anxiety.
- Digestive system: Abdominal pain, fecal incontinence, liquid stools, increased bowel movements.
- If any of the following symptoms occur after taking this medication, please discontinue use immediately and seek medical attention:
- Severe allergic reactions include: severe difficulty breathing, sweating, rash, itching, facial swelling, rapid heartbeat, and shock. Please consult your doctor immediately for medical assistance.
- Other serious side effects:
- Rectal bleeding.
Diverticulitis (colitis). Symptoms may include lower abdominal pain, especially on the left side, which may be accompanied by fever and constipation. Skin blisters. Gallstones. Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, stomach pain, and tenderness of the liver. A very small number of cases of elevated transaminase, elevated alkaline phosphatase, and severe hepatitis have been reported since this product was marketed. If you experience any of these symptoms, please inform your doctor.
- Cyclosporin: There have been cases where Cyclosporin blood concentrations decreased due to Orlistat use, thus affecting the efficacy of Cyclosporin. Therefore, do not take Cyclosporin and Orlistat concurrently.
- Anticoagulants: The International Normalized Ratio (INR) may be affected in patients treated with Orlistat and Warfarin or other anticoagulants concurrently. Do not take Orlistat and Warfarin or other anticoagulants concurrently.
- Hormonal preparations: Taking Orlistat may indirectly lower the blood concentration of oral contraceptives, thus increasing the risk of pregnancy. When severe diarrhea occurs during Orlistat treatment, alternative contraceptive methods are necessary.
Fat-soluble vitamins: Taking Orlistat may affect the absorption of fat-soluble vitamins A, D, E, and K. A 4-year follow-up study showed that most patients maintained normal levels of A, D, E, K, and beta-carotene. However, to ensure adequate vitamin intake, it is recommended to take a multivitamin before bedtime. Acarbose: Due to a lack of pharmacokinetic evidence, Orlistat is not recommended for patients taking Acarbose. Amiodarone: According to pharmacokinetic data from a normal study, Orlistat reduces amiodarone blood concentrations. The clinical effects on patients taking amiodarone are unknown. Patients taking amiodarone should consult their doctor before starting Orlistat treatment, as the dosage of amiodarone may need to be adjusted.
- Bloating, flatulence with oily stains (may stain clothing).
- Urgent bowel movements.
- Oily stools.
- Soft stools.
II. Warnings
III. Interactions
IV. Pregnancy and Lactation
According to animal reproductive studies, no fetal toxicity or teratogenic effects have been found. However, due to a lack of clinical data, pregnant women are prohibited from using Orlistat on their own. There are no studies on whether Orlistat is excreted into human breast milk; Orlistat capsules should not be taken while breastfeeding.
V. Adverse Reactions
Most of Orlistat’s side effects are gastrointestinal problems, which are related to its pharmacological effect of inhibiting fat absorption. In a trial where Orlistat 60mg was used for 18 to 24 months, gastrointestinal discomfort was found to be mostly temporary and mild, occurring in the early stages of treatment (generally within the first three months), and most patients experienced only one instance. Adhering to a low-fat diet can reduce the likelihood of gastrointestinal discomfort.
VI. Very Common Side Effects
More than one in ten people using Orlistat capsules may experience disruptions to their daily lives:
VII. Overdose
In the event of an overdose, professional medical advice should be sought.
No significant adverse reactions were observed in normal-weight subjects during a 15-day trial, whether a single dose of 800mg Orlistat or a dose of 400mg Orlistat three times a day.
In a six-month trial on obese subjects, no significant increase in adverse reactions was observed with Orlistat 240mg three times a day. If the dose is significantly exceeded, observation for 24 hours is recommended. Based on human and animal studies, any systemic reactions caused by Orlistat should recover within the shortest possible time. VIII. Medication Education Umesu Fat-Cutting Capsules are effective, specific, reversible, and long-acting gastrointestinal lipase inhibitors. According to clinical studies, using Umesu Fat-Cutting Capsules three times a day inhibits the absorption of 25% of dietary fat, with most weight loss results visible within the first six months.