PACKAGE LEAFLET: INFORMATION FOR THE USER
Xenical 120mg hard capsules

1. WHAT XENICAL IS AND WHAT IT IS USED FOR
Xenical is an anti-obesity agent. It does not suppress your appetite.
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.

2. BEFORE YOU TAKE XENICAL
Do not take XENICAL
- if you are allergic (hypersensitive) to orlistat or any of the other ingredients of XENICAL,
- if you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),
- if you have cholestasis (liver disorder)

Take special care with xenical:
Weight loss may also affect the dose of medicines 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.

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 a meal very high in fat, the possibility of gastrointestinal effects may increase.

Pregnancy and Breast-feeding
Taking xenical during pregnancy is not recommended.You should not breast-feed your infant during treatment with xenical as it is not known whether xenical passes into human milk.

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

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 savoury snacks.

4. POSSIBLE SIDE EFFECTS
Like all medicines, xenical can cause side effects, although not everybody gets them.Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking xenical.

These symptoms are generally mild, occur at the beginning of treatment, go away after some 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.

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), severe difficulty in breathing, nausea, vomiting and feeling unwell.

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE XENICAL
Keep out of the reach and sight of children.Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What XENICAL contains
The active substance is 120 mg orlistat
The other ingredients are microcrystalline cellulose, sodium starch glycollate, povidone, sodium lauryl sulphate and talc. The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.