XENICAL 120 mg HARD CAPSULES

2. What you need to know 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 through the digestive tract).
• If you have cholestasis (liver disorder).
• If you are breast-feeding

Warnings and precautions

Weight loss may also affect the dose of other medicines you are taking (e.g. high cholesterol or diabetes). Make sure you inform your doctor if you are taking these or other medicines. Weight loss may mean that you need a dose adjustment of these medicines.

To get the most benefit from Xenical, you should follow the nutrition program recommended by your doctor. As with any weight-control program, eating too much fat or calories can reduce the effect of weight loss.

This medicine may cause a change in your bowel habits, such as the presence of oily stools or fatty stools, due to the elimination of undigested fat in your stools. The possibility of this happening may increase if Xenical is taken with a high-fat diet. Additionally, your daily intake of fat should be distributed evenly among your three main meals, as taking Xenical with a very high-fat meal may increase the possibility of gastrointestinal effects.

In case of severe diarrhea, there may be a failure of oral contraceptives, so it is recommended to use an additional contraceptive method.

In patients with chronic kidney disease, the use of Orlistat may be associated with kidney stones. Inform your doctor if you have kidney problems.

This medicine contains less than 1 mmol sodium (23 mg) per capsule; it is essentially "sodium-free".

Children

Xenical is not indicated for use in children.

Taking XENICAL with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

This is important because using more than one medicine at the same time can increase or decrease their effect.

Xenical may alter the effect of:

• Anticoagulants (e.g. warfarin), so your doctor may need to monitor your blood coagulation.

• Ciclosporin. Concomitant administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.

• Iodine salts and/or levothyroxine. They may cause cases of hypothyroidism and/or alterations in the control of hypothyroidism.

• Amiodarone. Consult your doctor.

• AIDS medications.

• Medicines for depression, psychiatric disorders, or anxiety.

Xenical reduces the absorption of supplements of some fat-soluble nutrients, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's advice and take a balanced diet rich in fruits and vegetables. Your doctor may recommend a multivitamin supplement.

Orlistat may alter anticonvulsant treatment by decreasing the absorption of antiepileptic medicines, which may lead to the occurrence of convulsions. Consult your doctor if you think the frequency or severity of convulsions has changed while taking Xenical with antiepileptic medicines.

Xenical is not recommended for those taking acarbose (an anti-diabetic drug used for type 2 diabetes).

Taking XENICAL with food, drink, and alcohol

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

Pregnancy and breast-feeding

Xenical is not recommended during pregnancy.

You should not breast-feed your child during treatment with Xenical, as it is not known whether Xenical passes into breast milk.

Driving and using machines

Xenical has no known effect on the ability to drive or use machines.

3. How to take XENICAL

Follow your doctor's instructions exactly for taking Xenical. If you are unsure, ask your doctor or pharmacist.

The recommended dose of Xenical is one 120 mg capsule taken with each of the three main meals of the day. It can be taken immediately before, during, or up to one hour after the meal. The capsule should be taken with water.

Xenical should be taken with a calorie-controlled diet, which is rich in fruits and vegetables and contains, on average, 30% of calories from fat. Your daily intake of fat, carbohydrates, and protein should be distributed over three meals. This means you will usually take one capsule at breakfast, one at lunch, and one at dinner. To achieve optimal benefits, avoid eating foods that contain fat between meals, such as biscuits, chocolate, or salty snacks.

Xenical works only in the presence of fat from your diet. Therefore, you do not need to take Xenical if you miss a meal or if you have a meal without fat.

If for any reason you have not taken your medicine exactly as prescribed, tell your doctor. Otherwise, your doctor may think that this medicine is not effective or well-tolerated and may change your treatment unnecessarily.

Your doctor will stop the treatment with Xenical if, after 12 weeks, you have not lost at least 5% of your initial body weight.

Xenical has been studied in clinical trials for up to 4 years.

If you take more XENICAL than you should

If you take more capsules than your doctor has told you, or if someone else takes your medicine accidentally, contact your 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 it is within one hour of eating and then continue as before. Do not take a double dose to make up for forgotten doses. If you have missed several doses, please inform your doctor and follow the advice given.

Do not change the prescribed dose yourself unless your doctor tells you to.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you do not feel well while taking Xenical, tell your doctor or pharmacist as soon as possible.

Most of the unwanted effects related to the use of Xenical are a result of its local action on the digestive system. These symptoms are generally mild, occur at the beginning of treatment, and are more likely to occur after meals that are high in fat.

Normally, these symptoms disappear if you continue with the treatment and follow the recommended diet.

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

Headache, abdominal pain or discomfort, urgency or increased need to defecate, flatulence (gas) with fecal incontinence, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some patients with type 2 diabetes)

Common side effects (affect between 1 and 10 in 100 people)

Rectal pain or discomfort, soft stools, incontinence (fecal), bloating (experienced by some patients with type 2 diabetes), changes in teeth and gums, irregular menstrual cycle, fatigue.

The following side effects have also been reported, but their frequency cannot be estimated from the available data:

Allergic reactions. The main symptoms are: itching, rash, hives (raised areas of skin that are usually very itchy and may be pale or red), severe difficulty breathing, nausea, vomiting, and discomfort. Blisters on the skin (including blisters that burst). Diverticulitis. Rectal bleeding. Increases in liver enzyme levels may be detected in blood tests. Hepatitis (inflammation of the liver). The symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and sensitivity of the liver (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite. Stop taking Xenical if these symptoms appear and inform your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (developed by calcium oxalate that can cause kidney stones). See Chapter 2, Be especially careful with Xenical. Interactions with anticoagulants.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of XENICAL

Keep out of the sight and reach of children.

Blisters

Do not use this medicine after the expiry date stated on the pack.

Do not store above 25°C

Store in the original package and keep the blister in the outer packaging to protect from light and moisture.

Glass bottles

Do not use this medicine after the expiry date stated on the pack.

Do not store above 30°C

Keep the container tightly closed to protect from moisture

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xenical

• The active substance is orlistat. Each capsule contains 120 mg of orlistat.
• The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate (type A), povidone (E1201), sodium lauryl sulfate, and talc. The capsule shell is composed of gelatin, carmine (E132), titanium dioxide (E171), and edible ink.

Appearance of the product and pack contents

Xenical is turquoise-colored capsules with the inscription "XENICAL 120" and are supplied in blister packs and glass bottles containing 21, 42, and 84 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a

17498 Mesekenhagen

Germany

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.