Do NOT use Orlistat if:

• you are allergic to any ingredient in Orlistat
• you are not overweight
• you have gallbladder problems, bile flow problems (eg, cholestasis), or problems absorbing food (malabsorption).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Orlistat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an eating disorder (eg, anorexia, bulimia)
• if you have a history of gallbladder, liver, pancreas, or thyroid problems; diabetes; or kidney stones
• if you take medicine for diabetes or thyroid problems, or if you take any other medicines for weight loss
• if you have received an organ transplant or if you take cyclosporine.

Some medicines may interact with Orlistat. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Orlistat
• Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Orlistat.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Orlistat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may not help you lose more weight. It may increase your risk of side effects.
• Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
• Orlistat may cause changes in your bowel or stool (eg, gas with oily spotting, loose stools, more frequent stools). Eating a low-fat diet may help lessen these side effects.
• Tell your doctor or dentist that you take Orlistat before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - Orlistat may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Rarely, some patients taking Orlistat have developed severe liver problems. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, loss of appetite, or severe or persistent nausea.
• Orlistat should not be used in children younger 18 years; safety and effectiveness in these children have not been confirmed.
• Pregnancy and breast-feeding: Do not take Orlistat if you are pregnant. If you become pregnant, contact your doctor. It is not known if Orlistat is found in breast milk. Do not breastfeed while taking Orlistat.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; frequent or loose stools; gas with discharge; oily spotting; trouble controlling bowel movements.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody urine; new or unusual back pain; severe or persistent stomach pain (with or without nausea and vomiting); symptoms of liver damage (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.