HOW SUPPLIED
XENICAL is a dark-blue, hard-gelatin capsule containing pellets of powder.
XENICAL 120 mg Capsules: Dark-blue, two-piece, No. 1 opaque hard-gelatin capsule imprinted with Roche and XENICAL 120 in light-blue ink — bottle of 90 (NDC 0004-0256-52).
Storage Conditions
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.
XENICAL should not be used after the given expiration date.
27899513
PI Revised: July 2008
Important Patient Information
Patient Information about XENICAL® (orlistat) Capsules
XENICAL (zen' i-cal)
Generic Name: orlistat
Please read this information before you start taking XENICAL and each time you renew your prescription. This important information may help you successfully lose weight and maintain your weight loss while taking XENICAL. This patient information is a summary and is not intended to take the place of discussions with your doctor. It does not list all benefits and risks of XENICAL. The medication described here can only be prescribed and dispensed by a licensed health care professional, who has information about your medical condition and more information about the drug, including how to take it, what to expect, and potential side effects. If you have any questions about XENICAL, talk with your doctor.
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.
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 break down) 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.
Information for adult obese patients
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.
Information for adolescent obese patients
Following one year of treatment, XENICAL in combination with diet was shown to be more effective in reducing Body Mass Index (BMI) than diet alone. A reduction in Body Mass Index is a better indicator of weight loss in children because it takes into account changes in weight related to growing children.
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:
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Find the height closest to your height in the left-hand column.
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Then move across the top row to find the weight closest to your weight.
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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:
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consistently have problems absorbing food (chronic malabsorption); or
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have gallbladder problems; or
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are pregnant or are breastfeeding a child; or
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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:
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allergic to any medicines, foods, or dyes;
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taking any other weight-loss medication;
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taking cyclosporine;
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taking any other medicines (including those not prescribed by your doctor);
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taking any dietary supplements, including herbal products;
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planning to become pregnant; or
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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.
| IF YOUR DAILY CALORIE LEVEL IS: | THE RECOMMENDED DAILY GRAMS OF FAT (in a 30% fat diet) ARE: |
| 1500 | 50 |
| 1600 | 53 |
| 1800 | 60 |
| 2000 | 67 |
Should I take a multivitamin with XENICAL?
XENICAL interferes with your body’s absorption of some fat-soluble vitamins. Therefore, when you use XENICAL, it is highly recommended that you take a daily multivitamin supplement containing vitamins D, E, K, and beta-carotene. Take your multivitamin once a day at least 2 hours before or after taking XENICAL, such as at bedtime.
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.
How long should I use XENICAL?
The use of XENICAL for more than 4 years has not been studied. You and your doctor should discuss how long you should use XENICAL.
What are the most common side effects of XENICAL?
Because XENICAL works by blocking the absorption of dietary fat, it is likely that you will experience some changes in bowel habits. These generally occur during the first weeks of treatment; however, they may continue throughout your use of XENICAL. These changes may include oily spotting, gas with discharge, urgent need to go to the bathroom, oily or fatty stools, an oily discharge, increased number of bowel movements, and inability to control bowel movements. Due to the presence of undigested fat, the oil seen in a bowel movement may be clear or have a coloration such as orange or brown.
These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that XENICAL is working. They generally occur early in treatment, particularly after meals containing higher amounts of fat than are recommended. These symptoms are often temporary and may lessen or disappear as you continue treatment and keep to your recommended diet of meals containing no more than about 30% fat. However, these side effects may occur in some individuals over a period of 6 months or longer.
In obese adolescent patients treated with XENICAL, the side effects reported were similar to those observed in adults.
If you are concerned about these or any other side effects you experience while taking XENICAL, talk to your doctor or pharmacist.
What lifestyle changes should I consider when taking XENICAL?
You must use XENICAL with a recommended mildly reduced-calorie diet. You should also follow a program of regular physical activity, such as walking. However, before you undertake any activity or exercise program, be sure to speak with your doctor or health care professional.
How can I reduce dietary fat?
To help you get started on reducing the fat in your diet to around 30%, read the labels on all the foods you buy. You should avoid foods that contain more than 30% fat while you are taking XENICAL.
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When eating meat, poultry or fish, limit your portion to 2 or 3 ounces (roughly the size of a deck of cards). Choose lean cuts of meat and remove the skin from poultry. Fill up your meal plate by including more grains, fruits, and vegetables.
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Replace whole-milk products with nonfat or 1% milk and nonfat, reduced-fat, or low-fat dairy items.
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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 non-fat versions and/or cut back on serving sizes.
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When dining out, ask how foods are prepared and request that they be prepared with little or no added fat.
Please visit www.xenical.com to help you succeed with your weight loss goals.
27898655A
PPI Revised: October 2004
Distributed by:
Roche Pharmaceuticals
Roche Laboratories, Inc.
340 Kingsland Street
Nutley, NJ 07110–1199
Copyright© 1999-2008 by Roche Laboratories Inc. All rights reserved.
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