Xenical blocks some of the fat that you eat, keeping it from being absorbed by your body.

Xenical is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. This medicine must be used together with a reduced-calorie diet and is to used only by adults.

Xenical is the prescription-strength form of orlistat. The alli brand of orlistat is available without a prescription.

Do not take Xenical if you are pregnant. Weight loss is not recommended during pregnancy.

You should not use this medicine if you have a digestive disorder (problems absorbing food). You should not use Xenical if you have gallbladder problems, or if you are pregnant. Do not use alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight.

Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Avoid a diet that is high in fat. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.

Before taking this medicine

You should not use Xenical if you are allergic to orlistat, or if you have malabsorption syndrome (an inability to absorb food and nutrients properly).

You also should not use this medicine if you have:

• gallbladder problems; or

• if you are pregnant.

Do not use alli if:

• you are not overweight;

• you have had an organ transplant; or

• you use cyclosporine (to prevent organ transplant rejection).

To make sure Xenical is safe for you, tell your doctor if you have ever had:

• kidney stones;

• gallbladder disease;

• pancreatitis;

• underactive thyroid;

• liver disease;

• kidney disease; or

• an eating disorder (anorexia or bulimia).

Do not use Xenical if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking orlistat and tell your doctor right away if you become pregnant.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Xenical is not approved for use by anyone younger than 12 years old. Do not give alli to anyone under 18 years old.

Use Xenical exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never share this medicine with another person, especially someone with a history of eating disorders.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Xenical is usually taken 3 times per day with each main meal that contains some fat (no more than 30% of the calories for that meal). You may take the medicine either with your meal or up to 1 hour after eating.

If you skip a meal or you eat a meal that does not contain any fat, skip your dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Orlistat can make it harder for your body to absorb certain vitamins, and you may need to take a vitamin and mineral supplement while you are taking Xenical. Follow your doctor's instructions about the type of supplement to use. Take the supplement at bedtime, or at least 2 hours before or after you take orlistat.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed. Throw away any unused Xenical after the expiration date on the medicine label has passed.

Keep track of your medicine. Orlistat is a medicine that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

Usual Adult Dose for Obesity:

120 mg orally three times a day with each main meal containing fat. The dose may be taken during the meal or within 1 hour of completing the meal.

Usual Pediatric Dose for Obesity:

12 years or older:
120 mg orally three times a day with each main meal containing fat. The dose may be taken during the meal or within 1 hour of completing the meal.

You should not use Xenical if you are allergic to orlistat, or if you have malabsorption syndrome (an inability to absorb food and nutrients properly).

You also should not use this medicine if you have:

• gallbladder problems; or

• if you are pregnant.

Do not use alli if:

• you are not overweight;

• you have had an organ transplant; or

• you use cyclosporine (to prevent organ transplant rejection).

To make sure Xenical is safe for you, tell your doctor if you have ever had:

• kidney stones;

• gallbladder disease;

• pancreatitis;

• underactive thyroid;

• liver disease;

• kidney disease; or

• an eating disorder (anorexia or bulimia).

Do not use Xenical if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking orlistat and tell your doctor right away if you become pregnant.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Xenical is not approved for use by anyone younger than 12 years old. Do not give alli to anyone under 18 years old.

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid eating high-fat meals or you could have unpleasant side effects on your stomach or intestines.

If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take Xenical.

If you also take levothyroxine (such as Synthroid), do not take it within 4 hours before or 4 hours after you take Xenical.

Get emergency medical help if you have signs of an allergic reaction to Xenical: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Xenical and call your doctor at once if you have:

• severe stomach pain;

• severe pain in your lower back;

• blood in your urine, painful or difficult urination;

• kidney problems - little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Xenical side effects are caused by orlistat's fat-blocking action. These are signs that the medicine is working properly. These side effects are usually temporary and may lessen as you continue using Xenical:

• oily or fatty stools;

• oily spotting in your undergarments;

• orange or brown colored oil in your stool;

• gas and oily discharge;

• loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;

• an increased number of bowel movements; or

• stomach pain, nausea, rectal pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask a doctor or pharmacist if it is safe for you to use Xenical if you are also using any of the following drugs:

• amiodarone;

• insulin or oral diabetes medicine;

• HIV or AIDS medications;

• seizure medicine (especially if your seizures get worse while taking orlistat);

• a vitamin or mineral supplement that contains beta-carotene or vitamin E; or

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with orlistat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.