Xenical (Orlistat)

(or' li stat)

Orlistat (prescription and nonprescription) is used with an individualized low-calorie, low-fat diet and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease. Orlistat is also used after weight-loss to help people keep from gaining back that weight. Orlistat is in a class of medications called lipase inhibitors. It works by preventing some of the fat in foods eaten from being absorbed in the intestines. This unabsorbed fat is then removed from the body in the stool.

Orlistat comes as a capsule and a nonprescription capsule to take by mouth. It is usually taken three times a day with each main meal that contains fat. Take orlistat during a meal or up to 1 hour after a meal. If a meal is missed or does not have fat, you may skip your dose. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take orlistat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or stated on the package. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient if orlistat is prescribed for you. For additional information about the nonprescription product, visit http://www.MyAlli.com.

Before taking orlistat,
• tell your doctor and pharmacist if you are allergic to orlistat or any other medications.
• talk to your doctor if you are taking medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune). If you are taking cyclosporine (Neoral, Sandimmune), take it 2 hours before or 2 hours after orlistat.
• tell your doctor and pharmacist what prescription and nonprescription, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin); medications for diabetes, such as glipizide (Glucotrol), glyburide (DiaBeta, Dynase, Micronase), metformin (Glucophage), and insulin; medications to control blood pressure; medications for thyroid disease; and any other medications for weight loss.
• tell your doctor if you have if you have had an organ transplant or if you have cholestasis (condition in which the flow of bile from the liver is blocked) or malabsorption syndrome (problems absorbing food). Your doctor will probably tell you not to take orlistat.
• tell your doctor if you have or have ever had an eating disorder such as anorexia nervosa or bulimia, diabetes, kidney stones, pancreatitis (inflammation or swelling of the pancreas), or gallbladder or thyroid disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Do not take orlistat if you are pregnant or breast-feeding.

Follow the diet program your doctor has given you. You should evenly divide the amount of daily fat, carbohydrates, and protein you eat over three main meals. If you take orlistat with a diet high in fat (a diet with more than 30% of the total daily calories from fat), or with one meal very high in fat, you are more likely to experience side effects from the medication. While you are taking orlistat, you should avoid foods that have more than 30% fat. Read the labels on all the foods you buy. When eating meat, poultry (chicken) or fish, eat only 2 or 3 ounces (55 or 85 grams) (about the size of a deck of cards) for a serving. Choose lean cuts of meat and remove the skin from poultry. Fill up your meal plate with more grains, fruits, and vegetables. Replace whole-milk products with nonfat or 1% milk and reduced- 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 nonfat versions of these foods 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. Orlistat blocks your body's absorption of some fat-soluble vitamins and beta carotene. Therefore, when you use orlistat you should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. Read the label to find a multivitamin product that contains these vitamins. Take the multivitamin once a day, 2 hours before or 2 hours after taking orlistat, or take the multivitamin at bedtime. Ask your doctor or pharmacist any questions you might have about taking a multivitamin while you are taking orlistat.

Take the missed dose as soon as you remember it unless it is more than 1 hour since you ate a main meal. If it is longer than 1 hour since you ate a main meal, skip the missed dose and continue on your regular dosing schedule. Do not take a double dose to make up for a missed one.

Orlistat may cause side effects. The most common side effect of orlistat is changes in bowel movement (BM) habits. This generally occurs during the first weeks of treatment; however, it may continue throughout your use of orlistat. Tell your doctor if any of these symptoms are severe or do not go away:

• oily spotting on underwear or on clothing
• gas with oily spotting
• urgent need to have a bowel movement
• loose stools
• oily or fatty stools
• increased number of bowel movements
• difficulty controlling bowel movements
• pain or discomfort in the rectum (bottom)
• stomach pain
• irregular menstrual periods
• headache
• anxiety

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• severe or continuous stomach pain
• excessive tiredness or weakness
• nausea
• vomiting
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• dark-colored urine
• light-colored stools

Orlistat may cause other side effects. Call your doctor if you have any unusual problems during your treatment with orlistat. Some people who took orlistat developed severe liver damage. There is not enough information to tell whether the liver damage was caused by orlistat. Talk to your doctor about the risks of taking orlistat.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, moisture (not in the bathroom), and light. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. You should also follow a program of regular physical activity or exercise while you are taking orlistat. However, before you start any new activity or exercise program, talk with your doctor or health care professional. Do not let anyone else take your prescription medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.