Xenical (Zen-nik-al) is a medicine which is used in obesity. Xenical contains orlistat. It is supplied by Roche Products Limited.

The information in this Medicine Guide for Xenical varies according to the condition being treated and the particular preparation used.

We have information for a single preparation used in the treatment of obesity. The preparation name is shown in red below.

Xenical 120mg capsules

Form: Capsule

Regulated Information Patient Information Leaflet Summary of Product Characteristics

 

To get the most benefit from your medicine, take it exactly as prescribed. You should also take care to look after your medicine.

Xenical is used in the treatment of obesity. Xenical prevents your body from absorbing the fat from the food you eat. By reducing the amount of fat which is absorbed, Xenical can help you to lose weight more easily.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often to take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Xenical:

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Xenical:

If you are having problems taking this form of Xenical, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex and it is therefore essential that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

Suddenly stopping your medicine may cause your original condition to return. This is why you must speak to your prescriber if you are having any problems taking your medicine.

If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

The instructions on how you should keep your medicine are on the pharmacy label. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Xenical:

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Your prescriber will not give you this medicine if they know of any reasons why you must not take it. Sometimes it is necessary to prescribe this medicine with extra caution. For more information see the ‘Whether this medicine is suitable for you’ section.

If you have been prescribed this medicine you need to be aware of the side-effects that you could develop while taking this medicine. For more information see the 'Side-effects' section.

Xenical is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Xenical is not used in children.

Over time it is possible that Xenical can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Xenical has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who take Xenical

• influenza
• lowered blood sugar
• headaches
• infection of the upper respiratory tract
• stomach pain and discomfort
• flatulence
• oily, fatty or liquid stools
• oily discharge from the rectum
• passing stools more often than usual
• sudden urge to pass stools

Common: More than 1 in 100 people who take Xenical

• feeling anxious
• infection of the lower respiratory tract
• swelling of the stomach
• rectal pain and discomfort
• tooth or gum problems
• urinary tract infection
• irregular menstrual periods
• tiredness
• faecal incontinence
• soft stools
• distension of the stomach

The frequency of these side-effects is unknown

• diarrhoea - if diarrhoea is severe this may lead to a failure of oral contraceptives to work in people who are taking oral contraceptives. The use of an additional method of contraception is recommended
• increased risk of bone fractures
• abnormal laboratory test results
• bleeding from the rectum - you must tell your prescriber if you get any bleeding from the rectum
• gastrointestinal problems such as diverticulitis or pancreatitis
• skin problems
• liver problems
• hypersensitivity reactions such as itching, urticaria, skin rashes, angioedema, bronchospasm, or anaphylaxis
• kidney problems
• thyroid problems

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you have been prescribed this medicine you and your prescriber may need to think about whether you need to change any of your everyday activities. You must also discuss with your prescriber any other medicines and any complementary preparations you are taking.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Xenical:

The following types of medicine may interact with Xenical:

If you are taking Xenical and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Xenical:

If you have been prescribed Xenical you should only take something on the above list on the specific advice of your prescriber or pharmacist.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Xenical:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Xenical:

You need to make sure that there are enough of these vitamins in your diet. For more information contact your prescriber.

Alcohol can interact with certain medicines.

In the case of Xenical:

Taking this medicine could have an impact on your decisions relating to family planning, pregnancy and breast-feeding.

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Xenical:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Xenical, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Xenical:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Xenical contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Xenical before, do not take Xenical. Talk to your prescriber, pharmacist or nurse as soon as possible.