Xenical (Orlistat) 30 capsules per package

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. Orlistat is for use only in adults.

It is dangerous to purchase orlistat on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of “alli” purchased on the Internet have been found to contain sibutramine (Meridia), a prescription weight loss medication that can have dangerous side effects in certain people. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

Important information

Do not take orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese.

You should not take orlistat if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).

Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).

Do not give the over-the-counter brand (alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. This medication should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.

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 take orlistat if you are allergic to it, or if you have:

• gallbladder problems;
• chronic malabsorption syndrome (an inability to absorb food and nutrients properly);
• if you are pregnant.

Ask a doctor or pharmacist if it is safe for you to use orlistat if you have other medical conditions, especially:

• liver disease;
• kidney disease;
• a history of gallstones or kidney stones;
• underactive thyroid;
• a history of pancreatitis;
• type 1 or type 2 diabetes;
• an eating disorder (anorexia or bulimia);
• if you take any other weight-loss medications (prescription or over-the-counter).

Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese. 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.

Prescription orlistat (Xenical) should not be given to a child younger than 12 years old. The over-the-counter brand (alli) is not approved for use by anyone younger than 18 years old.

How should I take orlistat?

Take 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 who has a history of eating disorder. Keep the medication in a place where others cannot get to it.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. 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 orlistat 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, 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 fat-soluble vitamins, such as vitamins A, D, E, and K. Your doctor may recommend that you take vitamin and mineral supplements while you are taking this medicine. Follow your doctor’s instructions about the type of multi-vitamin or mineral supplement to use.

Take your vitamin or supplement at bedtime, or at least 2 hours before or after you take orlistat.

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

Keep track of the amount of medicine used from each new bottle. Orlistat is a drug 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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking orlistat?

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.

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.