How to Use

Take one capsule (120 mg) three times a day with each main meal - up to two hours after eating. It is also recommended that patients take an extra fat-soluble vitamin supplement, such as Vitamin D, Vitamin E, Vitamin K or beta carotene once a day, at least 2 hours before or after taking Xenical^®, for instance at bedtime.

Overdose

If you suspect an overdose of Xenical^®, seek immediate medical attention or contact your local poison center immediately. Symptoms of an overdose have not yet been fully established but in cases where patients exceeded the recommended dose of Xenical (Orlistat) for experimental purposes, no ill effects were suffered. If you do take far more than the recommended dose, the usual intestinal-related side effects can be expected, although they may be more severe - particularly in conjunction with a high-fat meal. It is probably a good idea to avoid eating fat for a few days, as this can help decrease the side effects.

Missed Dose

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not double up your dosage.

If you miss a meal, or if you have a meal without fat, you can skip your dose of Xenical^® for that meal also.

Notes

Xenical^® is indicated for individuals who are obese (BMI over 30) or who are overweight (BMI between 25 and 30) and have or are at risk for any of the medical conditions which are related to their weight or body fat, such as diabetes, high cholesterol, or hypertension.

It is recommended that this medication is used in conjunction with a diet that is moderately lower in calories and fat. Please consult your physician or dietitian for further advice.

Don't share this medication with others as they may have a condition that is not adequately treated with Xenical^®.

Storage

Store Xenical^® at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

Important Note

The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed that the taking of this medication is safe, appropriate or effective for you.

Precautions

Do not take Xenical^® if you are allergic to orlistat, or if you have:

• Chronic malabsorption syndrome (an inability to absorb food and nutrients properly)
• Gallbladder problems

If you have any of these other conditions, you may need adjust your dose of Xenical^® or have special tests:

• An underactive thyroid
• A history of gallstones
• A history of pancreatitis
• Liver disease
• Type 1 or type 2 diabetes
• An eating disorder (Anorexia or Bulimia)
• If you take any other weight loss medication (prescription or over-the-counter)

This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Xenical^® can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medication without telling your doctor if you are breast feeding a baby.

Drug Interactions

Before taking Xenical^®, tell your doctor if you are using any of the following drugs:

• Insulin or diabetes medication taken by mouth
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Digoxin (digitalis, Lanoxin, Lanoxicaps)
• Levothyroxine (Synthroid, Levoxyl, Levothroid)
• A blood thinner such as warfarin (Coumadin)

If you are using any of these drugs, you may not be able to use this medication, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Xenical^®. Tell your doctor about all the prescription and over-the-counter medication you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction:

• Hives
• Difficulty breathing
• Swelling of the face, lips, tongue or throat

Stop taking Xenical^® and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

The following side effects occur commonly with the use of this medication. They are the natural effects of Orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with Xenical^®:

• Oily spotting in your underwear
• Oily or fatty stools
• Orange or brown coloured oil in your stool
• Gas with discharge or oily discharge
• Loose stools, or an urgent need to go to the bathroom, inability to control bowel movements
• An increased number of bowel movements
• Stomach pain, nausea, vomiting, diarrhea, rectal pain
• Weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes)

Other side effects that may occur while taking Xenical^® include:

• Problems with your teeth or gums
• Cold symptoms such as stuffy nose, sneezing, cough
• Fever, chills, sore throat, flu symptoms
• Headache, back pain
• Mild skin rash

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.