Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For orlistat, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to orlistat. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Orlistat has not been studied in pregnant women. However, orlistat may decrease the amount of certain vitamins that your body can absorb from the food you eat. Make sure you have discussed with your doctor the use of this medication during pregnancy.

Breast-feeding—It is not known whether orlistat passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children— Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of orlistat in children with use in other age groups.

Older adults—There is no specific information comparing use of orlistat in the elderly with use in younger adults. However, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking orlistat, it is especially important that your health care professional know if you are taking the following:

• Warfarin—Orlistat may decrease the absorption of vitamin K and may change your bleeding time

Other medical problems—The presence of other medical problems may affect the use of orlistat. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney stones or

• Gallbladder problems—Orlistat may make the condition worse

Proper Use of This Medicine

Orlistat prevents the absorption of some of the fat you eat. Therefore, you should take it during the meal or within 1 hour of eating. If you occasionally miss a meal or eat a meal that contains no fat, you should skip the dose of orlistat.

Because orlistat may decrease the amount of some vitamins that your body can absorb from food, you will need to take a multivitamin supplement once a day. Take the vitamin supplement at least 2 hours before or after taking orlistat.

When using orlistat, your diet should contain no more than 30% of calories as fat. More fat in your diet will increase the side effects of this medicine. Your diet should be nutritionally balanced, and your daily intake of fat, carbohydrates, and protein should be distributed over three main meals.

Dosing—The dose of orlistat will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of orlistat. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (capsules):
  • For treatment of obesity:
    • Adults—120 milligrams (mg) three times a day with meals containing fat.
    • Children—Use and dose must be determined by your doctor.

Missed dose— If you miss a dose of orlistat after a fat-containing meal, skip that dose. Wait until your next meal, and take the medicine on your regular schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Why should Xenical not be prescribed?

Do not take Xenical if you suffer from "chronic malabsorption syndrome"--a condition that prevents nutrients from passing from your stomach into your bloodstream--or from cholestasis, a blockage in the supply of bile needed for digestion. You'll also need to avoid Xenical if it gives you an allergic reaction.

Special warnings about Xenical

Weight loss begins within 2 weeks and continues for 6 to 12 months. The effect of using Xenical for more than 2 years is still unknown.

Side effects such as diarrhea and abdominal pain may be worse if you continue eating a high fat diet or even take a high-fat meal. Limit your fat intake.

Your doctor will test your thyroid function before starting you on Xenical to make sure that your weight problem is not due to an underactive thyroid gland (hypothyroidism). Xenical is not an appropriate remedy for this problem.

Xenical increases the likelihood of kidney stones. Use it with caution if you have a history of this problem.

If you have diabetes, weight-loss is likely to reduce your blood sugar levels. If you're taking an oral diabetes medication or insulin, your dose may have to be reduced.

Note that the safety and efficacy of Xenical in children younger than 12 years old have not been established.