orlistat: package leaflet

Choose the day you will start taking the capsules ahead of time. Before you start taking the capsules, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits. Keep a record of what you are eating in a food diary. Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.

Think about how much weight you want to lose and then set a target weight. A realistic goal is to lose between 5% to 10% of your starting weight. The amount of weight you lose may vary from week to week. You should aim to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week.

To help you reach your weight-loss goal you need to set two daily targets, one for calories and one for fat. For further advice see Further helpful information in section 6.

Taking alli

Adults 18 and over
- Take one capsule, three times a day.
- Take alli just before, during or up to one hour after meals. This usually means one capsule at breakfast, lunch and dinner. Make sure your three main meals are well balanced, reduced calorie, and lower-fat.

• If you miss a meal, or your meal contains no fat, do not take a capsule. alli does not work unless there is some fat in the meal.
• Swallow the capsule whole with water.
• Do not take more than 3 capsules a day.
• Eat lower-fat meals to reduce the chance of diet-related treatment effects (see section 4).
• Try to be more physically active before you start taking the capsules. Physical activity is an important part of a weight loss programme. Remember to check with your doctor first if you have not exercised before.
• Continue to be active while taking alli and after you stop taking it.

How long should I take alli for?

• alli should not be taken for more than six months.
• If you do not lose weight after taking alli for 12 weeks, see your doctor or pharmacist for advice. You may need to stop taking alli.
• Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits. People who lose weight and maintain the loss make lifestyle changes, which include changes to what they eat and how active they are.

If you take more alli than you should

Do not take more than 3 capsules a day.

If you have taken too many capsules, contact a doctor as soon as possible.

If you forget to take alli

If you miss taking a capsule:

• If it is less than an hour since your last main meal, take the missed capsule.
• If it is more than an hour since your last main meal, do not take the missed capsule. Wait and take the next capsule around your next main meal as usual.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the common side effects related to alli (for example, wind with or without oily spotting, sudden or more frequent bowel motions and soft stools) are caused by the way it works (see section 1). Eat lower-fat meals to help manage these diet-related treatment effects.

Serious side effects
It is not known how frequently these side effects occur

Severe allergic reactions
- Signs of a severe allergic reaction include: severe breathing difficulties, sweating, rash, itching, swollen face, rapid heart beat, collapse.

Stop taking the capsules. Get medical help immediately.

Other serious side effects
- Bleeding from the back passage (rectum)
- Diverticulitis (inflammation of the large intestine). Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation
- Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating towards the back, possibly with fever, nausea and vomiting
- Skin blistering (including blisters that burst)
- Severe stomach pain caused by gallstones.
- Hepatitis (inflammation of the liver). Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness(indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.
- Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones). See section 2, warnings and precautions.

Stop taking the capsules. Tell your doctor if you get any of these.

Very common side effects
These may affect more than 1 in 10 people
- Wind (flatulence), with or without oily spotting
- Sudden bowel motions
- Fatty or oily stools
- Soft stools


Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.

Common side effects
These may affect up to 1 in 10 people
- Stomach (abdominal) pain
- Incontinence (stools)
- Runny/liquid stools
- More frequent bowel motions
- Anxiety

Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.

Effects seen in blood tests
It is not known how frequently these effects occur (frequency cannot be estimated from the available data)
- Increases in the levels of some liver enzymes
- Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines  Tell your doctor that you are taking alli when you have a blood test.

Reporting of side effects
If you get 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Learn to deal with alli effects related to your diet or fat intake

The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body. Such effects typically occur within the first few weeks of using the capsules, before you may have learnt to limit the amount of fat in your diet. Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done.

You can learn to minimise the impact of diet-related treatment effects by following these guidelines:
- Start your lower-fat diet a few days, or even a week, before you begin taking the capsules.
- Find out more about how much fat your favourite foods typically contain, and the size of your portions. By familiarising yourself with portions you will be less likely to accidentally exceed your fat target.
- Distribute your fat allowance evenly across your meals for the day. Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes.
- Most users who experience these effects find that they can manage and control them by adjusting their diet.
Do not be concerned if you do not experience any of these problems. This does not mean that the capsules are not working.

- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Keep the container tightly closed to protect from moisture.
- The bottle contains two sealed canisters containing silica gel to keep the capsules dry. Keep the canisters in the bottle.
Do not swallow them.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What alli contains

The active substance is orlistat. Each hard capsule contains 60 mg of orlistat.
The other ingredients are:
- Capsule filling: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium laurilsulfate, talc.
- Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate, sorbitan monolaurate, black ink (shellac, iron oxide black (E172), propylene glycol).
- Capsule band: gelatin, polysorbate 80, indigo carmine (E132).

What alli looks like and contents of the pack

alli capsules have a turquoise cap and body, with a dark blue band round the middle, imprinted with "alli".

alli is available in pack sizes of 42, 60, 84, 90 and 120 capsules. Not all pack sizes may be available in all countries.

Marketing Authorisation Holder
Haleon Ireland Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford,
Ireland

Manufacturer
Haleon Germany GmbH, Barthstraße 4, 80339 München, Germany
Famar S.A, 48 KM Athens-Lamia,
190 11 Avlona, Greece

This leaflet was last revised in November 2024.

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

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FURTHER HELPFUL INFORMATION

Risk of being overweight

Being overweight will affect your health and increase your risk of developing serious health problems such as:
- High blood pressure
- Diabetes
- Heart disease
- Stroke
- Certain forms of cancer
- Osteoarthritis
Talk to your doctor about your risk of developing these conditions.

Importance of losing weight

Losing weight and maintaining weight loss, for example by improving your diet and increasing your physical activity, can help reduce the risk of serious health problems and help improve your health.

Helpful tips on your diet and your calorie and fat targets while taking alli

alli should be used along with a reduced calorie, lower-fat diet. The capsules work by preventing some of the fat you eat from being absorbed but you can still eat foods from all the main food groups. Although you should focus on the calories and fat that you eat, it is important to eat a balanced diet. You should choose meals which contain a range of different nutrients and learn to eat healthily for the long term.

Understanding the importance of calorie and fat targets

Calories are a measurement of the energy your body needs. They are sometimes called kilocalories or kcal. Energy may also be measured in kilojoules, which you may also see on food labels.
- The calorie target is the maximum number of calories you will eat each day. See the chart further on in this section.
- Your fat gram target is the maximum number of grams of fat you will eat in each meal. The fat gram target chart follows the information below on setting your calorie target.
- Controlling your fat target is essential because of the way the capsules work. Taking alli means your body will pass more fat through, and therefore may struggle to cope with eating as much fat as before. So by meeting your fat target, you will maximise weight loss results while minimising the risk of diet-related treatment effects.
- You should aim to lose weight gradually and steadily. Losing around 0.5 kg (1 lb) per week is ideal.

How to set your calorie target

The following table has been worked out so that it gives you a calorie target that is about 500 calories fewer per day than your body needs to maintain your current weight. That adds up to 3500 fewer calories per week, about the number of calories in 0.5 kg (1 lb) of fat.

Your calorie target alone should allow you to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week, without feeling frustrated or deprived.

Eating fewer than 1200 calories per day is not recommended.

You will need to know your activity level to set your calorie targets. The more active you are, the higher your calorie target.
- Low activity means you do little or no walking, climbing stairs, gardening, or other physical activity on a daily basis.
- Moderate activity means you burn around 150 calories per day in physical activity, for example, walking three kilometres (2 miles), gardening for 30 to 45 minutes, or running two kilometres (1.25 miles) in 15 minutes. Choose the level that most closely fits your daily routine. If you are unsure which level you are, choose Low activity.

Women
Low activity
Below 68.1 kg
Below 10 st 10 lb
1200 calories
68.1 kg to 74.7 kg
10 st 10 lb to 11 st 11 lb
1400 calories
74.8 kg to 83.9 kg
11 st 12 lb to 13 st 2 lb
1600 calories
84.0 kg and over
13 st 3 lb and over
1800 calories
Moderate activity
Below 61.2 kg
Below 9 st 9 lb
1400 calories
61.3 kg to 65.7 kg
9 st 9 lb to 10 st 4 lb
1600 calories
65.8 kg and over
10 st 5 lb and over
1800 calories

Men
Low activity
Below 65.7 kg
Below 10 st 4 lb
1400 calories
65.8 kg to 70.2 kg
10 st 5 lb to 11 st
1600 calories
70.3 kg and over
11 st 1 lb and over
1800 calories
Moderate activity
59.0 kg and over
9 st 4 lb and over
1800 calories

How to set your fat target

The following chart shows how to set your fat target based on the amount of calories you are allowed per day. You should plan to have three meals per day. If you have set a target of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your daily allowance for fat, snacks should contain no more than 3 g of fat.

Amount of calories you can eat per day
Maximum amount of fat allowed per meal
Maximum amount of fat allowed from snacks per day
12 g
3 g
15 g
3 g
17 g
3 g
19 g
3 g

Remember

• Stick to realistic calorie and fat targets as this is a good way of maintaining your weight loss achievements in the long-term.
• Write down what you eat in a food diary, including the calorie and fat content.
• Try to be more physically active before you start taking the capsules. Physical activity is an important part of a weight loss programme. Remember to check with your doctor first if you have not exercised before.
• Continue to be active while taking alli and after you stop taking it.

The alli weight loss programme combines the capsules with an eating plan and a wide range of resources to help you understand how to eat a reduced calorie, lower-fat diet and guidelines for becoming more active.

Xenical is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested.
Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body.

Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.

Do not take XENICAL
- if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Xenical,
- if you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),
- if you have cholestasis (liver disorder)
- if you are breast-feeding

Warnings and precautions
Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other medicines you may be taking with your doctor. Losing weight may mean you need adjustments to the dose of these medicines.

To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor. As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.

This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces. The possibility of this happening may increase if Xenical is taken with a diet high in fat. In addition your daily intake of fat should be distributed evenly over three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.

The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform your doctor whether you suffer from problems with your kidney.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Children
Xenical is not intended to be used in children.

Other medicines and Xenical
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.

Xenical may modify the activity of

• Anticoagulant drugs (e.g. warfarin). Your doctor may need to monitor your blood coagulation.

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

• Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.

• Amiodarone. You may ask your doctor for advice.

• Medicines to treat HIV.

• Medicines for depression, psychiatric disorders or anxiousness

Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor’s advice in taking a well balanced diet rich in fruit and vegetables. Your doctor may suggest you take a multivitamin supplement.

Orlistat may unbalance an anticonvulsant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions. Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.

Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).

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

Pregnancy and breast-feeding
Taking Xenical during pregnancy is not recommended.
You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk.

Driving and using machines

Xenical has no known effect on your ability to drive a car or operate machinery.

Always take Xenical exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day. It can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.

Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three meals. This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time. To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.

Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.

Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5 % of your body weight as measured at the start of treatment with Xenical.

Xenical has been studied in long-term clinical studies of up to 4 years duration.

If you take more XENICAL than you should
If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a 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 this is within one hour of your last meal, then continue to take it at the usual times. Do not take a double dose. If you have missed several doses, please inform your doctor and follow the advice given to you.
Do not change the prescribed dose yourself unless your doctor tells you to.

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

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

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenical.

The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system. These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat. Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.

Very common side effects (affects more than 1 user in 10)

Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).

Common side effects (affects 1 to 10 users in 100)

Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness.

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, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell. Skin blistering (including blisters that burst). Diverticulitis. Bleeding from the back passage (rectum). Increases in the levels of some liver enzymes may be found in blood tests. Hepatitis (inflammation of the liver). Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite. Stop Xenical if such symptoms occur and tell your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones). See Chapter 2, take special care with Xenical.
Effects on clotting with anti-coagulants.

Reporting of side effects
If you get 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 Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children

Blister packs
Do not use Xenical after the expiry date stated on the carton.
Do not store above 25 °C.
Store in original package and keep the blister in the outer carton in order to protect from light and moisture.

Glass bottles
Do not use Xenical after the expiry date stated on the bottle.
Do not store above 30 °C.
Keep container tightly closed in order to protect from moisture.

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

What XENICAL contains

• The active substance is orlistat. Each capsule contains 120 mg of orlistat.
• The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium laurilsulfate and talc. The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.

What XENICAL looks like and contents of the pack

Xenical capsules are turquoise with the imprint “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 Authorisation 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

This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.

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