XENICAL is available as a dark-blue, hard-gelatin capsule, with light-blue imprinting. Each capsule contains 120 mg of the active ingredient orlistat.

HOW DOES XENICAL WORK?

XENICAL does not act centrally on the brain to reduce appetite. Its action takes place in the lumen of the stomach and absorption of the drug into the blood is minimal. In contradistinction, most other weight loss medicines act on specific areas of the brain to reduce appetite. You eat less, you lose weight - but at a price. In order to get to the brain, these drugs must enter the blood stream. Therefore, these drugs may have systemic side effects (central nervous system and cardiovascular), ranging from minor to severe and are indicated only for short-term use. But, most important, these drugs do little if anything to help people change their eating habits or lifestyles. Therefore, when they stop taking the drugs, the weight is quickly regained.

XENICAL, on the other hand, is a reversible inhibitor of lipases made in the stomach and pancreas. Lipases are enzymes that break down fat. After we eat a fatty meal (such as meat) fats reach the stomach in a form called triglycerides. Triglycerides cannot be absorbed into the blood unless lipases break them down into compounds called fatty acids. XENICAL prevents this breakdown and the undigested triglycerides are excreted into the stool. The resulting decrease in caloric intake can have a positive effect on weight control.

HOW MUCH WEIGHT CAN I LOSE WITH XENICAL?

There is no clear-cut amount of weight that can be lost when taking XENICAL. Remember, in order for XENICAL to work optimally you must restrict your fat intake and increase exercise. If you are committed to your weight loss program there is essentially no limit as to how much weight you can loose. Nonetheless, weight loss should be gradual and always be done safely. While it is important that you decrease you fat intake it is equally as important that you eat healthy and insure you obtain all essential nutrients each and every day. Keep in mind that even a small amount of weight loss can reward you with a big gain in your health. A loss of 5 to 10% of your current weight can result in a significant reduction of risk for disease.

CLINICAL EFFICACY STUDIES:

Pooled data from multiple trials indicated that weight loss averaged 12.4 lbs. to 13.4 lbs. in patients taking XENICAL. Overall 57% of treated patients lost over 5% of their base-line body weight. Those on XENICAL showed a decrease in total blood cholesterol and LDL cholesterol (low density cholesterol). This form of cholesterol acts to promote the deposition of fatty plaques along the walls of arteries. There was a concomitant increase in HDL cholesterol (high density cholesterol). This form of cholesterol acts to inhibit the deposition of fatty plaques along the walls of arteries. In international clinical studies with thousands of patients, most individuals using XENICAL lost, on average, 10% of their initial body weight over a 6-8 month period.

ARE THERE OTHER BENEFITS TO TAKING XENICAL?

In addition to reducing weight, XENICAL reduces:

- high blood pressure.

- the amount of anti-diabetic medication required (if already diabetic).

- triglycerides.

- body fat.

- the chance of developing type II diabetes.

WHO SHOULD TAKE XENICAL?

XENICAL is a serious weight loss medication, indicated only for those who are truly obese (obesity is defined as having an initial body mass index greater than or equal to 30 kg/m2 or 27 kg/m2 in the presence of other risk factors such as hypertension, diabetes or increased serum cholesterol). The initial body mass index is calculated utilizing the patient’s height and weight. Therefore it in not generally recommended that it be used as a “summer” medication for transient weight loss. It is most commonly recommended that it be prescribed for those who are willing to make serious permanent changes in their eating and exercise habits

WHEN SHOULD I START TAKING XENICAL?

When you are ready to control your diet so that no more than one third of calories come from fat and you are willing to commit yourself to beginning and continuing with a graded exercise program you are then ready to start taking XENICAL.

HOW DO I START TAKING XENICAL?

Questions that should be answered before I begin this medicine include:

- Am I overweight?

- Am I at risk for diseases associated with being overweight?

- How much weight can I realistically lose?

- Can I achieve this goal with diet and exercise alone?

- Am I committed to managing my weight?

- What kinds of support will I require to help me manage my weight (such as nutritionist, dietician, physical therapist, or psychologist)?

- Are these resources available to me?

WHAT IS THE CORRECT DOSAGE OF XENICAL?

One capsule (120milligrams) is taken three times daily with each main meal - up two hours after eating. Taking a capsule with each meal is convenient and easy to remember.

HOW QUICKLY DOES XENICAL WORK?

In one clinical study, weight loss attributed to XENICAL was seen as early as 2 weeks after starting this medicine. In patients who participate in a graded exercise program that slowly increases the amount of physical activity performed each week, weight loss my be seen ever faster.

HOW LONG CAN I CONTINUE TAKING XENICAL?

One of the benefits of XENICAL is that while you lose weight, you are changing your eating habits and lifestyle. By the time you have reached your goal, you may be able to maintain your weight through diet and exercise alone. If, however, you start to regain weight, you can safely resume taking XENICAL. XENICAL has been shown to be safe for up to two years of continuous use. XENICAL can become part of your long-term weight maintenance program.

DO I HAVE TO TAKE VITAMIN SUPPLEMENTS?

Yes, it is worthwhile to take a vitamin supplement that contains fat-soluble vitamins such as vitamin A and D. XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene. The supplement should be taken once a day at least 2 hours before or 2 hours after a dose of XENICAL. Bedtime is a very convenient time to take your vitamin.

IF I TAKE MORE THAN ONE CAPSULE AT A TIME, WILL IT BLOCK MORE FAT?

No. There is absolutely no benefit to taking more than the recommended dose.

DO I HAVE TO TAKE A CAPSULE WITH EVERY MEAL?

If you skip a meal or your meal contains little fat (note: be careful of the hidden fats in many foods), there is no reason to take XENICAL, although there is no harm in taking the capsule. Taking a capsule with each meal will help you to remember and avoid missing dosages.

WHAT IF I EAT MORE THAN THREE MEALS A DAY?

It is strongly recommended that you eat several meals throughout the day. But, you should not take more than 3 XENICAL capsules per day.

WHAT IF I MISS TAKING A CAPSULE WITH A MEAL?

Nothing. You simply miss the benefit of the medication.

DOES XENICAL INTERACT WITH OTHER MEDICATIONS?

Clinical studies have shown that XENICAL does not interact with commonly used medications. However, before starting XENICAL it is essential that you tell us on your medical history/personal profile of any and all medications (prescription and non-prescription) that you are currently taking.

DOES XENICAL HAVE ANY SIDE EFFECTS?

XENICAL has none of the side effects normally associated with diet medications that act on the brain. XENICAL’s side effects are strictly gastrointestinal in nature and related to its action of blocking the digestion of ingested fat. The fat that is not absorbed into the bloodstream remains in the intestine and becomes mixed with the stool. The increased fat in the stool can cause any of the following:

- gas (flatulence) - sometimes with oily spotting

- increased frequency of bowel movements

- fatty/ oily stool

How often or how quickly these effects occur will vary from person to person and will depend on how much extra fat was consumed. They can occur within hours after eating a meal or up to a day or two later. These side effects usually occur early in treatment, last for only a short period, and disappear over time. Importantly, you can control the effects if you control your fat intake. Remember: it's not the XENICAL, it's the fat you eat that causes the events.

COULD I BECOME ADDICTED TO XENICAL?

Physiological dependence does not occur because XENICAL is not absorbed into the blood. Nonetheless, psychological dependence can rarely become a problem. Thus, the notion that this medicine is totally non-addictive is false.

CAN I OVERDOSE ON XENICAL?

XENICAL is very safe. There have been no cases of overdosing. In experiments, patients who took dosages of XENICAL many times over the recommended dose experienced no ill effects. Remember, taking more XENICAL gives no extra benefit.