PATIENT INFORMATION LEAFLET

XENICAL 120 mg Hard Capsules

Orlistat

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Xenical is a medication used to treat obesity. It acts on your digestive system by preventing the digestion of approximately one-third of the fat contained in the food you consume. Xenical binds to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fats you have ingested during a meal. The undigested fat cannot be absorbed and your body eliminates it.

Xenical is indicated for the treatment of obesity, in conjunction with a low-calorie diet.

Do not take XENICAL

• If you are allergic (hypersensitive) to orlistat or to any of the other components 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 breastfeeding.

Warnings and precautions

Weight loss may also affect the dose of medications you take for other conditions (e.g. high cholesterol or diabetes). Be sure to inform your doctor if you are taking these or other medications. Weight loss may mean that you need an adjustment in the dose of these medications.

To get the maximum benefit of Xenical, you must follow the nutrition program recommended by your doctor. As with any other weight control program, excessive consumption of fat and calories may reduce the effect on weight loss.

This medication may cause a harmless change in your bowel habits, such as the presence of fatty or greasy stools, due to the elimination of undigested fat through the stool. The likelihood of this occurring may increase if Xenical is taken with a diet high in fat. Additionally, your daily intake of fat should be distributed evenly among the three main meals, as taking Xenical with a meal very high in fat may increase the likelihood of gastrointestinal side effects.

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

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

Children

Xenical is not indicated for use in children.

Taking XENICAL with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

This is important as using more than one medication at the same time may increase or decrease its effect.

Xenical may modify the action of:

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

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

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

• Amiodarone. Consult your doctor.

• Medications for HIV/AIDS.

• Medications for depression, psychiatric disorders, or anxiety.

Xenical reduces the absorption of some fat-soluble supplements, 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 reducing the absorption of antiepileptic medications, which may lead to the appearance of seizures. Consult your doctor if you consider that the frequency or severity of seizures has changed when taking Xenical with antiepileptic medications.

Xenical is not recommended for those taking acarbose (anti-diabetic medication 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 breastfeeding

Xenical is not recommended during pregnancy.

You should not breastfeed your child during treatment with Xenical, as it is unknown whether Xenical passes into breast milk.

Driving and operating machinery

Xenical has no known effect on the ability to drive or operate machinery.

Follow exactly the administration instructions for Xenical as indicated by your doctor. If in doubt, consult 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 eating. The capsule should be taken with water.

Xenical should be taken with a calorie-controlled, well-balanced diet rich in fruits and vegetables, with approximately 30% of daily calories coming from fat. Your daily intake of fat, carbohydrates, and protein should be distributed over three meals. This means you will usually take a capsule at breakfast, another at lunch, and another at dinner. To achieve optimal benefits, avoid consuming foods high in fat between meals, such as cookies, chocolate, or salty snacks.

Xenical only acts in the presence of dietary fats. Therefore, you do not need to take Xenical if you do not take a main meal or if you take a meal that does not contain fat.

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

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

Xenical has been studied in clinical trials of up to 4 years' duration.

If you take more XENICAL than you should

If you take more capsules than your doctor has indicated, or if someone else accidentally ingests your medication, contact your doctor, pharmacist, or hospital as you may require medical attention.

If you forget to take XENICAL

If you forget to take your medication at any time, take it as soon as you remember, provided it is up to one hour after eating your meal, and then continue taking it at the usual intervals. Do not take a double dose to make up for missed doses. If you have missed several doses, please inform your doctor and follow their advice.

Do not change the prescribed dose without consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Most unwanted effects related to the use of Xenical are the result of its local action on the digestive system. These symptoms are generally moderate, occur at the beginning of treatment, and are mainly present after meals with high levels of fat.

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

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

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

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

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

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

Allergic reactions. The main symptoms are: itching, skin rash, hives (slightly elevated areas of skin that itch and are paler or redder than the surrounding skin), 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). Symptoms may include yellowing of the skin and eyes, itching, dark-colored urine, stomach pain, and liver tenderness (indicated by pain below the front part of the thoracic 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 may cause kidney stones). See Chapter 2, Be especially careful with Xenical. Interactions with anticoagulants.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnexo V*. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the sight and reach of children.

Blister Packs

Do not use this medication after the expiration date that appears on the packaging.

Do not store above 25 °C

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

Glass Bottles

Do not use this medication after the expiration date that appears on the packaging.

Do not store above 30 °C

Keep the container perfectly closed to protect it from moisture

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Xenical Composition

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

Product appearance and packaging contents

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for Manufacturing

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a

17498 Mesekenhagen

Germany

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Last review date of this leaflet

The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu/.