XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity. XENICAL may help obese people lose weight and keep the weight off.

XENICAL is intended for patients with a BMI of greater than or equal to 30 kg/m2 or a BMI of greater than or equal to 27 kg/m2 in the presence of other risk factors such as hypertension, diabetes, or high cholesterol.

It is not known if XENICAL is safe and effective in children under 12 years old.

XENICAL should not be used by patients who are pregnant, patients who have food absorption problems, patients who have gallbladder problems, patients who are allergic to orlistat or any of the ingredients in XENICAL

• have liver problems
• have kidney problems
• have problems with their thyroid
• have eating problems such as anorexia or bulimia
• have diabetes
• have a seizure disorder
• have an abnormal heart rhythm (arrhythmia)
• have the human immunodeficiency virus (HIV)
• are breastfeeding or plan to breastfeed. It is not known if XENICAL passes into breast milk. Patients must talk to their doctor before they breastfeed
  and take XENICAL.
• are pregnant or plan to become pregnant. Do not take XENICAL if you are pregnant or plan to become pregnant.
  Patients must tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

XENICAL and other medicines may affect each other causing side effects. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works.

• cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
• beta-carotene or vitamin E supplements
• levothyroxine (Levo-T, Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl, Novothyrox, Synthroid, Tirosint, Unithroid)
• warfarin (Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)
• amiodarone (Cordarone, Pacerone)
• medicines used to treat seizures. They may not work as well while you take XENICAL. Talk to your doctor right away if your seizures happen more often
  or get worse while you take XENICAL.
• antiretroviral medicines used to treat HIV. They may not work as well while you take XENICAL.

• Lowered absorption of certain vitamins in the body. Patients should take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time
  each day. Patients should take a multivitamin at least 2 hours before or after they take XENICAL, such as at bedtime
• Severe liver problems. Patients must stop taking XENICAL and call their doctor right away if they have the following symptoms of liver problems:
  • loss of appetite
  • itchy skin
  • yellowing of the skin or the white part of the eyes
  • amber-colored urine
  • light-colored bowel movements (stools)
  • pain in the upper right portion of the stomach
• Kidney problems. A patient’s doctor may do certain tests to check the patient’s kidney function during treatment with XENICAL. Patients must call
  their doctor right away if they have the following symptoms of kidney problems:
  • swelling, especially of the legs and feet
  • little or no urine output
  • frequent or painful urination
  • blood in the urine
  • loss of appetite, nausea and vomiting
  • severe pain in the back, belly or groin
• Gallbladder problems (gallstones). Patients must call their doctor right away if they have the following symptoms of gallstones:
  • pain in the upper right portion of the stomach
  • nausea
  • vomiting

• oily* rectal discharge
• passing gas with oily discharge*
• urgent need to have a bowel movement
• oily* or fatty stools
• increased number of bowel movements
• being unable to control bowel movements

*Oily discharge may be clear or have an orange or brown color.

These are not all the possible side effects of XENICAL. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Patients and caregivers may also report side effects to the Safety Call Center at 1-888-236-5445.