XENICAL contains the active ingredient orlistat.
XENICAL is used to treat people who are obese (BMI ( 30) or overweight (BMI ( 27) with other risk factors (eg high blood pressure, high cholesterol, high blood lipid profile).
Your Body Mass Index (BMI) is calculated by dividing your weight (in kg) by your height (in metres) squared.
XENICAL belongs to a group of medicines called lipase inhibitors.
These medicines work by targeting the absorption of dietary fat in your body rather than suppressing your appetite.
Dietary fats are large molecules that need to be broken down before they can be absorbed into the body. They are broken down by enzymes called lipases. That is, lipases play an important role in the digestion of dietary fat. When taken with a meal, XENICAL interferes with the activity of these enzymes. This allows about 30% of the fat eaten in the meal to pass through the gut undigested. Therefore, your body cannot store these excess calories as fatty tissue or use them as a source of energy. This helps you to reduce your weight by burning up fat that you are already carrying, maintain your lower weight and minimise any weight regain.
Losing even small amounts of weight and keeping it off produces additional health benefits for you, especially when you are at risk for other diseases such as heart disease and diabetes. XENICAL can also help to improve risk factors, such as high blood pressure, high cholesterol and high blood sugar. If these are not treated, they could lead to other diseases such as hypertension and diabetes.
Ask you pharmacist or doctor if you have any questions about obesity related risk factors.
XENICAL should be taken in conjunction with a well-balanced calorie-controlled diet and other appropriate measures such as exercise.
Ask your pharmacist or doctor if you have any questions or if you are not sure why XENICAL has been recommended for you.
XENICAL is not addictive.
Do not take XENICAL if:
1. you have had an allergic reaction to XENICAL (orlistat) or any ingredients listed at the end of this leaflet
2. your doctor has diagnosed that your uptake of essential nutrients is lower than it should be
3. you have certain pancreatic problems
4. you have had recent major surgery to your stomach or intestines
5. you have a blockage of your bile duct
6. if the packaging is torn or shows signs of tampering or the capsules do not look quite right
7. if the expiry date (EXP) printed on the pack has passed.
If you are not sure if you should be taking XENICAL, talk to your pharmacist or doctor.
Do not give XENICAL to children or adolescents under 18 years of age.
The safety and effectiveness in children have not been established.
Tell your pharmacist or doctor if:
1. you are pregnant or plan to become pregnant
2. you are breast-feeding or intend to breast-feed
3. you have vitamin deficiencies
4. you have kidney stones
5. you have any allergies to any other substances, such as foods, preservatives or dyes
6. you have peptic (stomach) ulcer disease
7. you receive long term treatment for mental or nerve disorders
8. you have symptomatic cholelithiasis (painful gall stones)
9. you have post surgical adhesions
10. you have an eating disorder
11. you take large doses of laxatives
12. you have significant heart, kidney, liver, gastrointestinal or endocrine disorders
13. you have any other health problems.
If you have not told your pharmacist or doctor about any of the above, tell them before you take any XENICAL.
Because weight loss has many beneficial effects, it may also affect the dose of medication taken for conditions such as high cholesterol or diabetes. Be sure to discuss these and other drugs you may be taking with your pharmacist or doctor. Losing weight may mean you need adjustments to these medications.
Tell your pharmacist or doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop. Some medicines and XENICAL may interfere with each other. These include:
These medicines may be affected by XENICAL. Your pharmacist or doctor will advise you.
Your pharmacist and doctor have more information on medicines to be careful with or avoid while taking XENICAL.
Ask your pharmacist or doctor if you are not sure about this list of medicines.
Follow all directions given to you by your pharmacist and doctor carefully.
They may differ from the information contained in this leaflet.
Take XENICAL exactly as your pharmacist or doctor has prescribed.
The recommended dose of XENICAL for adults over 18 years of age is one 120 mg capsule taken three times a day.
Taking more than the recommended dose will not provide an additional benefit.
It is also recommended that you take a daily multivitamin supplement containing vitamins A, D and E.
Use by people under 18 years of age is not recommended except on medical advice.
Swallow capsules whole with a glass of water.
Do not open the capsules and do not take any capsules that are damaged.
XENICAL should be taken with a well-balanced calorie - controlled diet that is rich in fruit and vegetables and contains an average of 30% calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over 3 main meals. To gain the most benefit, avoid eating food containing fat between meals, such as biscuits, chocolate or savoury snacks.
Look out for fats in foods by reading all food labels. Your fat intake may also be reduced by removing all fat from meat, skin from chicken and using non fat or low fat milk.
Be careful not to replace the fat in your diet with large quantities of other foods, such as sugar and alcohol.
For further dietary advice, refer to the NH&MRC website at http:/www.nhmrc.gov.au
Because increased exercise will help weight loss, it is advisable to follow a regular exercise program (eg walking, swimming). See your doctor before starting an exercise program.
If you are concerned that XENICAL is not working, talk to your pharmacist or doctor.
You will usually take 1 capsule with each of the 3 main meals per day. This means that you will usually take one capsule at breakfast, lunch and dinner. It can be taken during the meal or up to 1 hour after the meal is consumed.
XENICAL only works in the presence of dietary fat in your body. Therefore, if you miss a main meal or if you know that the meal contains no fat, then XENICAL need not be taken.
Continue taking XENICAL for as long as your pharmacist or doctor prescribes, for up to four years.
XENICAL should be taken every day to be effective.
Weight loss normally starts within 2 weeks and continues for 6 to 12 months on XENICAL treatment. XENICAL will then help you to maintain this new lower weight and help to prevent weight being regained.
The improvement in risk factors (such as reduction in high blood pressure, normalising blood sugar levels and lowering cholesterol levels) is usually observed within 1 month of starting therapy and has been maintained during the course of XENICAL treatment.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember provided this is within 1 hour of your last meal and then go back to taking it as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not double a dose to make up for one you have missed.
Immediately telephone your pharmacist or doctor or Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much XENICAL, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.
If you are not sure what to do, contact your pharmacist or doctor.
Tell all doctors, dentists and pharmacists who are treating you that you are taking XENICAL.
Tell your pharmacist or doctor if you become pregnant while taking XENICAL.
Tell your pharmacist or doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your pharmacist or doctor may think that it was not effective and change your treatment unnecessarily.
Tell your pharmacist or doctor if you feel the capsules are not helping your condition.
If you have high blood sugar or cholesterol levels, your doctor may ask you to have regular blood tests to monitor your blood sugar or blood cholesterol levels.
To gain the most benefit from XENICAL you should follow the nutrition program recommended to you by your doctor or pharmacist. As with any weight-control program, over-consumption of fat and calories may counteract any weight loss effect.
Do not give XENICAL to anyone else even if they have the same condition as you.
Do not take any other medicines whether they require a prescription or not without first telling your pharmacist or doctor.
People on a weight reduction diet may become deficient in some vitamins and minerals. To avoid this, you should follow your doctor's or pharmacist's advice in taking a well-balanced diet rich in fruit and vegetables. Because XENICAL works by preventing the absorption of some of the fat from the diet, it may affect absorption of some fat soluble nutrients. Although most people taking XENICAL will still have normal vitamin levels, you should take a multivitamin supplement containing fat-soluble vitamins. This supplement should be taken at least 2 hours before or after XENICAL, or at bedtime.
XENICAL can cause harmless changes in your bowel habits, such as fatty or oily stools. This is due to the removal of undigested fat in your faeces. The possibility of this happening will increase if XENICAL is taken with a diet high in fat. In addition, your daily intake of fat should be distributed over 3 main meals. If XENICAL is taken with any one meal very high in fat, the possibility of unwanted effects on the digestive system will increase.
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking XENICAL.
XENICAL helps most people who are overweight or obese but it may have unwanted side effects in a few.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
The majority of unwanted effects related to XENICAL use result from its local action in your digestive system.
Ask your pharmacist or doctor to answer any questions you may have.
Tell your pharmacist or doctor if you notice any of the following and they worry you:
Normally, these symptoms disappear if you continue treatment and keep to your recommended diet. These symptoms are generally mild, occur at the beginning of treatment, go away after a short period of time and are particularly experienced after meals containing high levels of fat.
Other side effects may also occur in some patients including:
Tell your pharmacist or doctor if you notice anything else that is making you feel unwell.
Ask your pharmacist or doctor if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Keep your capsules in the blister pack until it is time to take them.
If you take the capsules out of the packaging they will not keep well.
Keep the blister pack in a cool dry place where the temperature stays below 25 degrees C.
Do not store XENICAL, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills or other places where it may get hot, even for a short period.
Heat and dampness can destroy some medicines.
Keep XENICAL where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your pharmacist or doctor tells you to stop taking XENICAL, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.
XENICAL 120 mg capsules have a turquoise cap and body with "XENICAL Roche 120" printed in black ink.
XENICAL does not contain sucrose, gluten, tartrazine or any other azo dyes.
Active ingredient - orlistat
Inactive ingredients -
The capsule also contains:
The capsule shell contains:
The printing ink contains:
XENICAL capsules are available in blister packs containing 42 and 84 capsules.
XENICAL is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
4 - 10 Inman Road
Dee Why NSW 2099
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number:
This leaflet was prepared 5 February 2009.
The Xenical Plan - your free on-line support program
Your decision to take Xenical means you're already on your way to gaining control of your weight and improved health and wellbeing. To help you, we have developed the Xenical Plan website at www.xenical.com.au "http://www.xenical.com.au". The website includes extensive information, including healthy menus, dining out guide, BMI calculator, frequently asked questions... and more. You'll learn techniques to make successful weight management a reality, long term.
How to enrol in the Xenical Plan
Simply go to www.xenical.com.au "http://www.xenical.com.au" and register online using the barcode on your Xenical carton. Any information you provide us with will remain confidential.
The Xenical Plan complies with the National Privacy Principles and the Privacy Act to ensure that your personal information is protected from any misuse.
Roche collects and uses your personal information to enrol you in and administer the Xenical Plan. In accordance with the Privacy Act, you can gain access to your personal information. Your personal information may also be shared between Roche and its service providers. By providing Roche with your information, you consent to Roche and its service providers collecting that information (including health information) about you. If you do not consent, you should not provide your details to Roche. Unfortunately in this case Roche will not be able to enrol you in the Xenical Plan.
Roche also uses your information to tell you about other services offered by it. By enrolling in the Xenical Plan, you consent to Roche using your personal information for that purpose.
If you have any queries you can contact us via the website at www.xenical.com.au