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Xenical® (orlistat)

What is it

Xenical is an anti-obesity agent. XENICAL is used to help obese people lose weight and keep this weight off. It does not suppress your appetite or act on the brain. It works in the digestive system, where it blocks about one-third of the fat in the food you eat from being digested. Since fat contains more calories than other components in foods, cutting the fat that is digested by your body is an effective way to limit daily calories and lose weight. It is a potent, specific and long-acting inhibitor of gastrointestinal lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested. Your body therefore, cannot use this dietary fat as a source of energy and convert it to fat tissue. This will help you reduce your weight.

Xenical is indicated in the treatment of obesity in conjunction with a mildly hypocaloric diet.

 

Before you take it

Do not take Xenical if:

  • you are hypersensitive (allergic) to orlistat or any of the other ingredients of Xenical.

  • you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),

  • you have cholestasis (liver disorder).

You should not breast-feed while on Xenical, as it is not known whether Xenical passes into human milk. Xenical is not recommended for use during pregnancy.

Taking other medicines:

Weight loss may also affect the dose of medication taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other drugs you may be taking with your doctor. Losing weight may mean you need adjustments to the dose of these medications.

Xenical may modify the activity of anticoagulant drugs (e.g. warfarin). Your doctor may need to monitor your blood coagulation. Xenical may modify the activity of cyclosporin. Your doctor may need to monitor your blood levels more frequently than usual. Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctors advice in taking a well balanced diet rich in fruit and vegetables. Your doctor may suggest you take a multivitamin supplement.

Driving and using machines:

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

Use in Children:

Xenical is not intended to be used in children.

 

How to take it

The usual dose of Xenical is one 120mg capsule taken with each of the three main meals per day. It can be taken immediately before, during a meal or up to one hour after a meal. If you have the impression that the effect of Xenical is too strong or too weak, talk to your doctor or pharmacist.

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 lunchtime and one capsule at dinnertime. To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks. Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.

Tell your doctor if, for any reason, 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.

Duration of treatment:

Xenical should be prescribed for no longer than 2 years.

If you take more Xenical than you should:

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

If you forget to take Xenical:

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. If you have missed several doses, please inform your doctor and follow the advice given to you. Do not change the prescribed dose yourself unless your doctor tells you to.

 

Possible Side Effects

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. 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 a meal very high in fat, the possibility of gastrointestinal effects may increase. The more fat you eat, the more fat in your stools, and the more you will experience these dietary events. The frequency and onset of these dietary events varies from one person to another and depends on how much fat is consumed. They usually occur more frequently in the beginning of your program, and will gradually disappear as you develop new eating habits. Most importantly, you can control these dietary events when you control your fat intake. It is not XENICAL alone, but the excess fat that you eat while taking XENICAL that causes these events. Try not to exceed your daily fat allowance as calculated by your doctor or dietician.

Rare cases of allergic reactions have occurred with Xenical. The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), difficulty in breathing, nausea, vomiting and feeling unwell. Very rarely increases in liver enzyme levels have been reported. If you are concerned about these or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

 

Storing it

  • Keep out of the reach and sight of children. Do not store above 30 degrees centigrade.

  • Store in the original package container in order to protect from moisture.

  • Do not use the capsules after the expiry date, which is printed on the carton.

 

Further Information

For more information about this medicinal product, please contact your doctor or pharmacist.