Xenical

• Weight-loss medicine
• Blocks the absorption of fat from food
• Take with food
• Can cause diarrhoea with high-fat foods

Xenical (active substance: orlistat) is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested. Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body. Xenical is indicated in the treatment of obesity in conjunction with a low-calorie intake diet.

Always use Xenical exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose of Xenical is:

• Adults: one 120-mg capsule taken with each of the three main meals per day.

The capsule can be taken immediately before, during a meal or up to one hour after a meal. It should be swallowed with water.

Instructions for use

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. 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 Xenical exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily. Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5% of your body weight as measured at the start of the treatment.

If you take more or less Xenical than you should

If you take more capsules than you have been told to take, contact a doctor as you may need medical attention.

If you miss a dose, take it as soon as you remember provided this is within one hour of your last meal. If more time has passed, then skip the missed dose and continue with your regular dosing schedule. If you have missed several doses, please inform your doctor and follow the advice given to you.

Xenical is not suitable for everyone. Do not take this medicine if:

You are allergic (hypersensitive) to orlistat or any other ingredient in this medicine.
You have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract). You have cholestasis (liver disorder). You are breastfeeding. Xenical is not suitable for use in children.

When should Xenical be used with caution? Xenical should be used with extreme caution in the following situations:

Weight loss may affect the dose of medicines taken for other conditions (e.g., 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 the dose of these medicines.

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.

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

The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform your doctor whether you suffer from problems with your kidney.

Pregnancy and breastfeeding

Taking Xenical during pregnancy is not recommended.

You must not breastfeed your infant during treatment with Xenical. This is because it is not known if Xenical passes into breast milk.

Other medicines and Xenical

Xenical is known to interact with some medicines. Xenical may modify the activity of:

• Anticoagulant drugs (e.g., warfarin). Your doctor may need to monitor your blood coagulation.
• Ciclosporin. Co-administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin blood levels more frequently than usual.
• Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.
• Amiodarone. You may ask your doctor for advice.

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. Your doctor may suggest you take a multivitamin supplement.

Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic

drugs, thus leading to convulsions. Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when Xenical together with antiepileptic drugs.

For more warnings about the use of Xenical, please see the package leaflet.

Like all medicines, Xenical can cause side effects, although not everyone gets them. Tell your doctor or pharmacist 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 symptoms are generally mild, occur at the beginning of treatment 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.

Very common side effects (may affect more than 1 in 10 users)

• Headache.
• Abdominal pain/discomfort.
• Urgent or increased need to open the bowels.
• Flatulence (wind) with discharge.
• Oily discharge, oily or fatty stools.
• Liquid stools.
• Low blood sugar levels (experienced by some people with type 2 diabetes).

Common side effects (may affect up to 1 in 100 users)

• Rectal pain/discomfort.
• Soft stools.
• Incontinence (stools).
• Bloating (experienced by some people with type 2 diabetes).
• Tooth/gum disorder.
• Irregularity of menstrual cycle.
• Tiredness.

For a list of less common side effects, please see the package leaflet. Consult a doctor if the side effects are severe or if you experience side effects that are not listed on the leaflet.

The following ingredients are in this medicine:

The active substance is orlistat. Each capsule contains 120 mg of orlistat.
The other ingredients are cellulose microcrystalline (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulphate, talc. The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
The manufacturer of Xenical is:

Roche Pharma AG
Emil-Barrell-Str. 1
D-79639 – Grenzach-Wyhlen
Germany

Read the package leaflet before use.