Xenical 120 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
XENICAL 120 mg hard capsules
Orlistat
Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Xenical is and what it is used for
- What you need to know before taking Xenical
- How to take Xenical
- Possible adverse effects
- How to store Xenical
- Contents of the pack and other information
1. What XENICAL is and what it is used for
Xenical is a medicine used to treat obesity. It acts on your digestive system, preventing about one-third of the fat contained in the food you eat from being digested. Xenical binds to enzymes in your digestive system (lipases), thereby preventing them from breaking down some of the fat you have consumed with your meal. Undigested fat cannot be absorbed and is eliminated from your body.
Xenical is indicated for the treatment of obesity, in conjunction with a low-calorie diet.
2. What you need to know before taking XENICAL
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 (inadequate absorption of nutrients through the digestive tract).
- If you have cholestasis (a liver disorder).
- If you are breastfeeding.
Warnings and precautions
Weight loss may also affect the dose of medications you are taking for other conditions (e.g., high cholesterol or diabetes). Make sure to inform your doctor if you are taking these or other medicines. Weight loss may mean that you require an adjustment in the dose of these medications.
To get the maximum benefit from Xenical, you must follow the nutritional program recommended by your doctor. As with any weight control program, excessive intake of fat and calories may reduce the weight loss effect.
This medicine may cause harmless changes in your bowel habits, such as oily or fatty stools, due to the excretion of undigested fat in the feces. The likelihood of this occurring may increase if Xenical is taken with a high-fat diet. In addition, your daily fat intake should be evenly distributed among the three main meals, since taking Xenical with a very high-fat meal may increase the possibility of gastrointestinal effects.
In case of severe diarrhea, oral contraceptives may become less effective; therefore, use of 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 medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, essentially “sodium-free.”
Children
Xenical is not indicated for use in children.
Taking XENICAL with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This is important because using more than one medicine at the same time may increase or decrease their effects.
Xenical may alter the action of:
- Anticoagulants (e.g., warfarin); therefore, your doctor may need to monitor your blood coagulation.
- Cyclosporine. Concomitant administration with cyclosporine is not recommended. Your doctor may need to monitor your cyclosporine plasma levels more frequently than usual.
- Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or impaired control of hypothyroidism may occur.
- Amiodarone. Consult your doctor.
- Medications for treating AIDS.
- Medications for depression, psychiatric disorders, or anxiety.
Xenical reduces the absorption of supplements of certain fat-soluble nutrients, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's advice and consume a balanced diet rich in fruit and vegetables. Your doctor may recommend taking a multivitamin supplement.
Orlistat may interfere with anticonvulsant treatment by reducing the absorption of antiepileptic drugs, which could lead to seizures. Consult your doctor if you notice any change in the frequency or severity of seizures while taking Xenical together with antiepileptic medications.
Xenical is not recommended for patients 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. Swallow the capsule with water.
Pregnancy and breastfeeding
It is not recommended to take Xenical during pregnancy.
You should not breastfeed while taking Xenical, as it is unknown whether Xenical passes into breast milk.
Driving and using machines
Xenical has no known effect on the ability to drive or operate machinery.
3. How to take XENICAL
Follow exactly the instructions for using Xenical as given 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 may be taken immediately before, during, or up to one hour after the meal. The capsule should be swallowed with water.
Xenical should be taken with a calorie-controlled, well-balanced diet rich in fruits and vegetables, in which approximately 30% of the calories come from fat. Your daily intake of fats, carbohydrates, and proteins should be distributed over three meals. This means that you will usually take one capsule at breakfast, another at lunch, and another at dinner. To achieve optimal benefits, avoid eating fat-containing foods between meals, such as biscuits, chocolate, or salty snacks.
Xenical works only in the presence of dietary fat. Therefore, you do not need to take Xenical if you skip a main meal or if you eat a meal that contains no fat.
If for any reason you have not taken your medicine exactly as prescribed, inform your doctor. Otherwise, your doctor may think that this medicine 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 body weight.
Xenical has been studied in clinical trials lasting up to 4 years.
If you take more XENICAL than you should
If you take more capsules than your doctor has prescribed, or if someone else accidentally takes your medicine, contact your doctor, pharmacist, or hospital, as you may require 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 after eating your meal, and then continue taking it at your usual intervals. 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 by your doctor.
Do not change the prescribed dose yourself unless your doctor tells you to do so.
If you have any questions 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 everyone 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 the result of its local action on the digestive system. These symptoms are usually mild, occur at the beginning of treatment, and appear mainly after meals 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 patients)
Headache, abdominal pain or discomfort, urgency or increased need to defecate, flatulence (gas) with fecal incontinence, oily 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 patients)
Rectal pain or discomfort, soft stools, incontinence (fecal), bloating (experienced by some patients with type 2 diabetes), dental and gingival disorders, menstrual irregularities, 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, skin rash, hives (slightly raised, itchy areas of skin that are paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and malaise. Skin blisters (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 under the front part of the rib cage on the right side), sometimes accompanied by loss of appetite. Stop taking Xenical if these symptoms occur and inform your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (caused by calcium oxalate, which may lead to kidney stones). See Section 2, Take special care with Xenical. Interactions with anticoagulants.
Reporting of side effects
If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through 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.
Blister packs
Do not use this medicine after the expiry date shown on the container.
Do not store above 25 °C.
Store in the original packaging and keep the blister in the outer container to protect it from light and moisture.
Glass bottles
Do not use this medicine after the expiry date shown on the container.
Do not store above 30 °C.
Keep the container tightly closed to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components are microcrystalline cellulose (E460), sodium carboxymethylstarch (type A), povidone (E1201), sodium lauryl sulfate, and talc. The capsule shell consists of gelatin, indigo carmine (E132), titanium dioxide (E171), and edible ink.
Appearance of the product and contents of the pack
Xenical is turquoise-coloured capsules with the imprint "XENICAL 120" and is supplied in blister packs and glass bottles containing 21, 42 and 84 capsules.
Only some 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 the most recent review of this leaflet
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.