XENICAL is a weight control medication for the management of significant obesity. XENICAL targets the absorption of fat in your body rather than suppressing your appetite. Dietary fats are large molecules which need to be broken down by enzymes called lipase's before they can be absorbed into the body. When taken with a meal, XENICAL interferes with the activity of these enzymes. This allows about 30% of the fat eaten in the meal to pass through the gut undigested. Your body therefore cannot convert these excess calories to fatty tissue or use them as a source of energy. This will therefore help you to reduce your weight, maintain your lower weight and minimize any weight regain.

XENICAL is a prescription weight-control medication useful for the long-term treatment of significant obesity. XENICAL can also help to improve risk factors, such as high blood pressure, high cholesterol and high blood sugar which, if not treated, could lead to other diseases such as hypertension and diabetes.

When should XENICAL not be used?
You should not take XENICAL if you are allergic to orlistat or to any of the other substances the capsule contains. Also, you should not use XENICAL if your doctor has diagnosed that your uptake of essential nutrients is lower than it should be (called chronic malabsorption syndrome) such as with tropical sprue and idiopathic steatorrhea.

Use in children?
XENICAL is not intended to be used in children.

When should I be especially careful while taking XENICAL?
Inform your doctor before starting treatment with XENICAL if you:

• Suffer from chronic malabsorption syndrome;
• Are allergic to other medicines, foods or dyes;
• Are taking other medicines, including those you have obtained without a prescription.

Because weight loss has many beneficial effects, it may also affect the dose of medication taken for conditions such as high cholesterol or diabetes. Be sure to discuss these and other medicines you may be taking with your doctor. Losing weight may mean you need adjustments to these medications. As with any weight-control program, over-consumption of fat and calories may reduce the effect of any weight loss effect.

This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces. The possibility of this happening may increase if XENICAL is taken with a diet high in fat. In addition, your daily intake of fat should be distributed evenly over three main meals because, if XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase.

XENICAL has no known effect on your ability to drive a car or operate machinery.

Which substances may interact with XENICAL?
Before starting treatment, make sure your doctor knows if you are taking other medicines (including those not prescribed by your doctor). This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines. XENICAL does not affect most commonly prescribed medicines. However, it increases the effect of some lipid lowering medicines therefore your doctor may change the doses of this medicine XENICAL reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor's advice in taking a well balanced diet rich in fruit and vegetables.

May XENICAL be taken during pregnancy or while breast-feeding?
The safety of XENICAL has not been established in pregnant women therefore XENICAL should not be used during pregnancy unless the potential benefit outweighs the potential risk. Discuss this with your doctor. You should not breast-feed your infant during treatment with XENICAL as it is not known whether XENICAL is secreted in human milk.

How should XENICAL be taken?
The recommended dose of XENICAL is one 120 mg capsule taken with each of the three main meals per day. It can be taken during the meal or up to one hour after the meal is consumed. XENICAL should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30% of the calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three meals. This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time. To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savory snacks.

XENICAL only works in the presence of dietary fat. If you miss a main meal or if you have a meal containing no fat, you do not need to take that particular dose of XENICAL. Tell your doctor if you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.

Method and route of administration

• Your medicine should be swallowed with water.

When and how does treatment with XENICAL end?
XENICAL is suitable for long-term treatment or as instructed by your doctor.

Weight loss normally starts within 2 weeks and continues for 6 to 12 months on XENICAL treatment. XENICAL will then help you to maintain this new lower weight and also help prevent weight being put on again. Losing even small amounts of weight and keeping it off produces additional health benefits for you especially when you are at risk from other diseases such as cardiovascular disease and diabetes. The improvement in risk factors (such as reduction in high blood pressure, normalizing blood sugar levels and lowering cholesterol levels) is usually noticed within one month of starting therapy and should be maintained during the course of XENICAL treatment.

Actions to be taken in case of overdose

• If you take more capsules than you have been told to take, or if someone else takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.

What if I miss a dose?
If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times. Do not take a double dose. Do not change the prescribed dose yourself unless your doctor tells you to.

What are the possible unwanted effects of XENICAL?
Along with its desired effects, a medicine may cause some unwanted effects. Tell your doctor as soon as possible if you do not feel well while you are taking XENICAL. The majority of unwanted effects related to the use of XENICAL result from its local action in your digestive system. These commonly include:

• urgent or increased need to open the bowels
• flatulence (wind) with discharge,
• oily discharge and oily or fatty stools.

These symptoms are generally mild, occur at the beginning of treatment, go away after a short period of time and are particularly experienced after meals containing high levels of fat. Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.

If you are concerned about these or notice other effects not mentioned on this web page you should inform your doctor about it.

How should XENICAL be stored?