What is XENICAL?

XENICAL is an oral prescription weight loss medication used to help obese people lose weight and keep this weight off. XENICAL works in your intestines, where it blocks some of the fat you eat from being absorbed. This undigested fat is then eliminated in your bowel movements. XENICAL should be used together with a reduced-calorie diet that your doctor will recommend. XENICAL® can also help to improve risk factors, such as high blood pressure, high cholesterol and high blood sugar which, if not treated, could lead to other diseases such as hypertension and diabetes. Each XENICAL® capsule contains 120 mg of the active substance orlistat, which acts as a lipase inhibitor.

Excess weight has been proven to contribute to an increased risk of developing many medical problems, including high blood pressure, high cholesterol, heart disease, and diabetes. The consumption of excess fatty food and calories plays a significant role in the development of excess weight. While fat is an important component of a balanced diet, the consumption of excess fat contributes to excess body weight, since fat provides twice the number of calories per gram of weight as carbohydrates and protein. Reduction of dietary fat intake is one potential way of losing weight.

How does XENICAL work?

If you eat an excess amount of fat or calories, the excess is stored as fat by the body resulting in weight gain. When you eat fat, your body breaks it down into its simplest components so that it can be absorbed. Enzymes in your intestinal tract, called lipases, help digest (or breakdown) fat. When you take XENICAL with meals, XENICAL attaches to the lipases and blocks them from breaking down some of the fat you have eaten. The undigested fat cannot be absorbed and is eliminated in your bowel movements. By working this way, XENICAL helps block about 30% of the fat eaten in food from being absorbed by your body.

Following one year of treatment, XENICAL in combination with diet was shown to be more effective in reducing weight than diet alone. In most cases, weight loss was gradual. Patients treated with XENICAL and a reduced-calorie diet for one year lost an average of 13.4 pounds while those on a reduced-calorie diet alone lost 5.8 pounds.

Who should use XENICAL?

A weight loss program that includes a reduced-calorie diet and appropriate physical activity may be adequate in some patients. You should discuss with your doctor or other health care provider whether XENICAL should be added to such a program.

XENICAL may be right for you if you are considerably overweight (at least 30% above ideal weight or a body mass index of 30 or greater). XENICAL may also be right for you if you are overweight (at least 20% above ideal weight or a body mass index of 27 or greater) and also have other risk factors such as high blood pressure, high cholesterol, heart disease, or diabetes.

How to determine your body mass index (BMI):

The chart below illustrates BMI according to a variety of weights and heights. The BMI is calculated by dividing your weight in kilograms by your height in meters squared. To use this chart:

Find the height closest to your height in the left-hand column.

Then move across the top row to find the weight closest to your weight.

The number where these two meet is your BMI. (For example, a person who weighs 180 lbs and is 5'5" would have a BMI of 30.)

Who should not use XENICAL?

Those who:

consistently have problems absorbing food (chronic malabsorption); or

have gallbladder problems; or

are pregnant or are breastfeeding a child; or

have ever had an allergic reaction to orlistat or any of the inactive ingredients in XENICAL.

What should I tell my doctor before taking XENICAL?

Before beginning treatment with XENICAL, make sure your doctor knows if you are:

allergic to any medicines, foods, or dyes;

taking any other weight-loss medication;

taking cyclosporine;

taking any other medicines (including those not prescribed by your doctor);

taking any dietary supplements, including herbal products;

planning to become pregnant; or

anorexic or bulimic.

This information will help you and your physician decide if the expected advantages of XENICAL are greater than any possible disadvantages.

How should I take XENICAL?

The recommended dose is one 120 mg capsule by mouth with liquid at each main meal that contains fat. You can take XENICAL in conjunction with a mildly reduced-calorie diet up to 3 times a day. Each time you take XENICAL, your meal should contain no more than about 30% of calories from fat. Take XENICAL during meals or up to one hour after a meal. If you occasionally miss a meal or have a meal without fat, you can omit your dose of XENICAL. Doses greater than 120 mg three times a day have not been shown to provide an additional weight loss benefit.

You should use XENICAL together with a nutritionally balanced, mildly reduced-calorie diet that contains no more than about 30% of calories from fat. You should evenly divide your daily intake of fat, carbohydrates, and protein over 3 main meals.

You should try to follow a healthy eating plan such as the one developed by the American Heart Association. Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking XENICAL.

Can I take XENICAL while taking other medications?

Be sure to discuss with your doctor all medications (including herbal products) you are currently taking, including medicines you can get without a prescription (over-the-counter), to determine if XENICAL can be taken in addition to these medications. If you are taking cyclosporine, XENICAL and cyclosporine should be taken at least 2 hours apart. If your cyclosporine levels are being measured, more frequent monitoring may be necessary.

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