Xenical contains the active ingredient orlistat, a gastrointestinal lipase inhibitor used to prevent the absorption of dietary fats. It is provided as a turquoise, hard-gelatin capsule for oral administration, with each capsule containing 120 mg of orlistat. Key inactive ingredients include microcrystalline cellulose, sodium starch glycolate, and povidone.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription or product label. Take this medication with each main meal that contains about 30 percent of the calories from fat or within 1 hour after each meal. Do not take your medication more often than directed. If you occasionally miss a meal or have a meal without fat, you can skip that dose of this medication. Talk to your care team about the use of this medication in children. Special care may be needed. While this medication may be prescribed for children as young as 12 years for selected conditions, precautions do apply. Use of this medication without a prescription is not approved in children less than 18 years.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it within 1 hour following the meal that contains fat. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you occasionally miss a meal or have a meal without fat, you can skip that dose of this medication.

Where should I keep my medication?

Keep out of the reach of children and pets. Storage at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Gas -Oily rectal discharge or stool

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -An eating disorder, such as anorexia or bulimia -Diabetes -Gallbladder disease -History of irregular heart beat -HIV or AIDS -Kidney stones -Liver disease -Organ transplant -Pancreatic disease -Problems absorbing food -Seizures -Stomach or intestine problems -Take medications that treat or prevent blood clots -Thyroid disease -An unusual or allergic reaction to orlistat, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Amiodarone -Certain antivirals for HIV or hepatitis -Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, edoxaban, and rivaroxaban -Cyclosporine -Medications for diabetes -Medications for seizures -Other medications or herbal and dietary supplements for weight loss -Supplements like vitamins A, beta-carotene, D, E and K -Thyroid hormones -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. This medication can cause decreased absorption of some vitamins. You should take a daily multivitamin that contains normal amounts of vitamins D, E, K and beta-carotene or vitamin A. Take the multivitamin once per day at bedtime unless otherwise directed by your care team. Discuss the foods you eat and the vitamins you take with your care team. You should use this medication with a reduced-calorie diet that contains no more than about 30 percent of the calories from fat. Divide your daily intake of fat, carbohydrates, and protein evenly over your 3 main meals. Follow a well-balanced, reduced-calorie, low fat diet. Try starting this diet before taking this medication. Following a low fat diet can help reduce the possible side effects from this medication. Tell your care team if you wish to become pregnant or think you might be pregnant. Losing weight while pregnant is not advised and may cause harm to the unborn child. Talk to your care team for more information. Do not use this medication if you have had an organ transplant. This medication interferes with some medications used to prevent transplant rejection.