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

Orlistat 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 increased physical activity. Orlistat is for use only in adults that are overweight or obese.

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

Do not take orlistat if you are pregnant.

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.

Orlistat 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 orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Before taking this medicine

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

You also should not use Xenical 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 are taking cyclosporine

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

• kidney stones;

• gallbladder disease;

• pancreatitis;

• thyroid disease;

• liver disease;

• kidney disease; or

• organ transplant; or

• an eating disorder (anorexia or bulimia).

Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking this medicine 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 orlistat 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 orlistat 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.

Orlistat 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.

Orlistat is only part of a complete program of treatment that also includes diet and exercise. 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 this medicine. 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 orlistat after the expiration date on the medicine label has passed.

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 orlistat if you are allergic to it, if you have malabsorption syndrome (an inability to absorb food and nutrients properly), or if you are pregnant.

You also should not use Xenical 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 are taking cyclosporine

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

• kidney stones;

• gallbladder disease;

• pancreatitis;

• thyroid disease;

• liver disease;

• kidney disease; or

• organ transplant; or

• an eating disorder (anorexia or bulimia).

Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop taking this medicine 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, moisture (not in the bathroom), and light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Follow the diet program your doctor has given you. You should evenly divide the amount of daily fat, carbohydrates, and protein you eat over three main meals. If you take orlistat with a diet high in fat (a diet with more than 30% of the total daily calories from fat), or with one meal very high in fat, you are more likely to experience side effects from the medication.

While you are taking orlistat, you should avoid foods that have more than 30% fat. Read the labels on all the foods you buy. When eating meat, poultry (chicken) or fish, eat only 2 or 3 ounces (55 or 85 grams) (about the size of a deck of cards) for a serving. Choose lean cuts of meat and remove the skin from poultry. Fill up your meal plate with more grains, fruits, and vegetables. Replace whole-milk products with nonfat or 1% milk and reduced- or low-fat dairy items. Cook with less fat. Use vegetable oil spray when cooking. Salad dressings; many baked items; and prepackaged, processed, and fast foods are usually high in fat. Use the low- or nonfat versions of these foods and/or cut back on serving sizes. When dining out, ask how foods are prepared and request that they be prepared with little or no added fat.

Orlistat blocks your body's absorption of some fat-soluble vitamins and beta carotene. Therefore, when you use orlistat you should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. Read the label to find a multivitamin product that contains these vitamins. Take the multivitamin once a day, 2 hours before or 2 hours after taking orlistat, or take the multivitamin at bedtime. Ask your doctor or pharmacist any questions you might have about taking a multivitamin while you are taking orlistat.

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 orlistat.

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

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

Stop using orlistat 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;

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

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

Common orlistat side effects are caused by its 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 this medicine:

• 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 orlistat if you are also using any of the following drugs:

• amiodarone;

• cyclosporine;

• insulin or oral diabetes medicine;

• HIV or AIDS medications;

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

• 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.

Keep all appointments with your doctor.

You should also follow a program of regular physical activity or exercise while you are taking orlistat. However, before you start any new activity or exercise program, talk with your doctor or health care professional.

Do not let anyone else take your prescription medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.