Roche Pharmaceuticals
About Xenical

You have been prescribed Xenical by your doctor. Reading this information can help you learn about Xenical (orlistat) and how to make this medicine work best for you. If you have any questions after reading this information, speak with your doctor or pharmacist.

What is Xenical?

  • Xenical is a prescription medicine which, when combined with a mildly reduced calorie diet, can help you lose weight and keep it off. Weight loss occurs because Xenical blocks the absorption of some of the fat you eat.
  • Xenical taken in combination with diabetes medications such as insulin, metformin and/or a sulfonylurea (like glyburide) may help you manage your type 2 diabetes by lowering your blood sugar.

Each capsule contains 120 mg of the active ingredient orlistat. The capsules also contain nonmedicinal or inactive ingredients.

What is Xenical used for?

Xenical is used along with a mildly reduced calorie diet to assist in weight loss and to maintain the weight loss in obese patients and overweight patients who have health risk factors such as type 2 diabetes, high blood pressure, and blood lipid problems. The weight loss will contribute to lowering the blood pressure and cholesterol and blood sugar levels.

Even a modest weight loss of 5 to 10% can lower your risk of developing health problems.

Weight Management:

  • Xenical is a fat blocker. Fats from foods need to be broken down before they can be absorbed into the body. To break down fat, your body uses enzymes, called lipases. Xenical, when taken with meals, prevents these enzymes from working. This blocks the absorption of about one third (30%) of the fat in food. The fat that is not absorbed passes out of the body in bowel movements, called stools. When you absorb less fat, you take in fewer calories, which leads to weight loss.
  • Taking Xenical can help you reach a healthier weight. This medicine works best when you take it as directed (see “How Should Xenical be Taken?” below), eat less fat and become more physically active.
  • Xenical does not suppress or change your appetite. It does not affect the brain like other medicines used for weight loss. Less than 1% of Xenical is absorbed and the rest leaves the body in the stool.

Xenical is recommended for:

  • adults with a Body Mass Index (BMI*) greater than or equal to 30, or
  • adults with a BMI* of 27 to 29 who have health problems, such as type 2 diabetes, high blood pressure, high cholesterol or a large waist measurement.

Diabetes Management:

Xenical is generally prescribed for adults with type 2 diabetes who are overweight (BMI* of 27 or greater).

*BMI is a simple measurement to estimate how overweight a person is. See your doctor to have your BMI measured.

Children under 17 years of age should not take Xenical. This medicine has not been studied in this age group.What should you tell your doctor before you start taking Xenical? Before beginning treatment with Xenical, make sure your doctor knows if:

  • you have ever had a bad reaction to orlistat (Xenical) or any of the inactive ingredients
  • you are allergic to other medicines, foods and dyes
  • you are taking cyclosporine
  • you are taking diabetes medicines such as insulin, metformin and/or a sulfonylurea
  • you are taking any other medicines, including those not prescribed by your doctor
  • you always have problems absorbing your food (chronic malabsorption syndrome)
  • you have bowel or rectal problems
  • you have gallbladder problems
  • you are pregnant, plan on becoming pregnant, or are breast-feeding.

This information will help your doctor and you decide whether you should use Xenical, and what extra care may need to be taken while you are on the medicine.

How should Xenical be taken?

Your doctor has prescribed Xenical after carefully studying your case. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours. Do not give your Xenical to anyone else.

Weight Management:

  • Take 1 capsule (120 mg) during or just following each main meal (breakfast, lunch and dinner). Swallow the capsule whole along with some water. Take the capsule no later than 1 hour after the meal is eaten.
  • For example, if you just finished eating lunch at 12:30 p.m., you should take your lunchtime dose before 1:30 p.m.
  • ‘Xenical' should be taken with a mildly reduced calorie diet that contains no more than 30% of calories from fat as recommended by your doctor, dietitian or other healthcare professional.
  • ‘Xenical' can reduce the absorption of fat-soluble vitamins and beta-carotene. In clinical studies, most people's vitamin and beta-carotene levels were within the normal range. However, your doctor may tell you to take a daily multivitamin supplement while taking Xenical. If he or she does, you should take your multivitamin 2 hours before or after your Xenical capsule, or at bedtime.
  • If you occasionally miss a main meal or if your meal contains no fat, do not take your Xenical capsule.
  • Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
  • You will not lose more weight or lose it more quickly if you take more Xenical capsules than your doctor has instructed.

If you have Type 2 Diabetes:

  • The same dosage recommendations apply as for weight management.
  • Your reduced calorie diet should be consistent with the dietary recommendations of the Canadian Diabetes Association Guidelines for the Nutritional Management of Diabetes Mellitus in the New Millennium.
  • You should talk with your doctor about diabetes medications you may be taking, as this dosage might need to be lowered.

What should you do if you forget a dose of Xenical?

If you forget to take a dose, it can be taken up to 1 hour after a meal and still be effective. Do not take double the amount if you miss one dose. Xenical cannot work properly if many doses are missed.

What else should you remember while you are taking Xenical?

  • As Xenical works by partially blocking dietary fat absorption, the expected weight loss will not occur if you replace the fat calories with carbohydrates or protein.
  • Eat foods from all food groups (for example, see “Canada's Food Guide to Healthy Eating”).
  • Divide your day's calories and fat over 3 meals.
  • Choose foods that have a lower fat content.
  • Add less fat (butter, margarine or oils) to the foods you prepare.
  • Develop healthy eating habits, such as eating more fruits and vegetables.
  • Gradually increase your physical activity as recommended by your doctor.
  • If you have to go to the hospital or if you are given a new prescription medicine, you should tell the doctor(s) that you are taking Xenical.
  • Losing weight can affect the dose of other medicines you need, such as those for diabetes, high blood pressure or high cholesterol. Your doctor may need to adjust the doses of your other medicines. He or she may ask you to have regular blood tests to check your blood sugar and/or cholesterol level.
  • If you have type 2 diabetes, you should follow the dietary recommendations of the Canadian Diabetes Association and test blood sugar and HbA1 c levels regularly.

Side Effects

The most common possible side effects from Xenical are directly related to the way Xenical works. By blocking the absorption of some dietary fat, it is likely that you will experience some change in bowel habits. These effects are generally mild and transient (occur for a short period of time). They can increase if you eat high fat foods. In clinical studies, only 3% of people experienced one of these effects more than twice:

  • oily spotting
  • gas with discharge
  • urgent need to have a bowel movement
  • fatty/oily stools
  • oily discharge
  • increased number of bowel movements
  • inability to control bowel movements.

Due to the presence of undigested fat, the oil in your bowel movement may be clear, orange or brown in color. These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that Xenical is working.

If You Have Type 2 Diabetes: Experience shows that changes in bowel habits in patients with type 2 diabetes occurred less frequently than in patients taking Xenical for weight management.

Symptoms of hypoglycemia (low blood sugar) may occur, such as:

  • sweating
  • dizziness
  • shakiness
  • hunger
  • confusion

Talk to your doctor for advice about how you can help avoid these symptoms and whether the dosage of the diabetes medications you may be taking might need to be lowered or discontinued.

How can you deal with these unwanted effects?

  • Unwanted side effects are more likely to occur if you eat meals that contain large amounts of fat. Sticking to a diet that contains no more than 30% of calories from fat in each meal will reduce side effects.
  • Try to avoid eating fatty foods.

Some unwanted side effects may go away during treatment as your body adjusts to the medicine.

If you are concerned about these or any other unexpected effects while on Xenical, talk with your doctor or pharmacist.

How should this product be stored?

  • Keep out of the reach of children.
  • Store Xenical in its original labeled container at room temperature (between 15 and 25°C) and protect it from moisture.
  • Store away from heat.
  • Do not use this medicine after the expiry date on the package.