Orlistat, Oral

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KEY POINTS

• This medicine is taken by mouth to treat obesity. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: lipase inhibitor; obesity treatment

Generic and brand names: orlistat, oral; alli; Xenical

What is this medicine used for?

This medicine is taken by mouth to treat obesity. It helps you lose weight and not gain it back. It works in the stomach and small intestine by blocking the absorption of fat from your food. You must follow a reduced-calorie diet for this medicine to be effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An eating disorder such as anorexia or bulimia
• Diabetes
• Gallbladder problems or gallstones
• HIV/AIDS
• Kidney disease or kidney stones
• Malabsorption syndrome (unable to absorb or digest nutrients properly)
• Pancreatitis
• Seizures
• Thyroid problems

Females of childbearing age: Do not take this medicine if you are pregnant. If you are pregnant, tell your healthcare provider. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under age 18.

Take this medicine up to 1 hour after each main meal that contain fat. Your healthcare provider will recommend a reduced-calorie diet in which about 30% of calories come from fat. The diet will evenly divide the amount of daily fat, carbohydrates, and protein you eat over 3 main meals. If you eat a meal that is high in fat, your risk of side effects will increase.

What if I miss a dose?

If you miss a meal or if the meal contains no fat, you may skip the dose of medicine for that meal. If you miss taking this medicine with a meal that contains fat, you can take it up to 1 hour after your meal. But if it is more than 1 hour after your meal, wait until it's time for your next meal to take the medicine. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Follow the diet and exercise program your healthcare provider recommends.

Because this medicine makes certain vitamins and beta-carotene from food less easily absorbed by your body, you should take a multivitamin to be sure that you are getting proper nutrition. Ask your healthcare provider or pharmacist which multivitamin you should take. Take it once a day at least 2 hours before or after you take this medicine.

This medicine may increase your risk for kidney stones or gallstones. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Back, joint, or muscle pain; trouble urinating; painful urination; blood in the urine; upper right belly pain with nausea and vomiting; loss of appetite; yellowing of your skin or eyes; dark urine; light-colored bowel movements; seizures.

Other: Gas, frequent urge to move your bowels, fatty or oily bowel movements, diarrhea, stomach pain, nausea, headache, stuffy nose, tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amiodarone (Cordarone, Pacerone)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid)
• Paricalcitol (Zemplar)
• Propafenone (Rythmol)
• Retinoid medicines such as isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane) and tretinoin (Atralin, Renova, Retin-A)
• Vitamins A, D, E, and K
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.