 Important 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 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.
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.
IF YOUR DAILY
CALORIE LEVEL IS: |
THE RECOMMENDED DAILY GRAMS OF FAT
(in a 30% fat diet) ARE: |
1500
1600
1800
2000 |
50
53
60
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, you should take a daily multivitamin
supplement that contains 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 2 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.
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.
- 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.
- Replace whole-milk products with nonfat or 1% milk and nonfat, reduced-fat,
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 non-fat versions 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.
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