Alli

Package leaflet: Information for the user

alli 60 mg hard capsules

orlistat
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor or pharmacist if you have not lost weight after taking alli for 12 weeks. You may need to stop taking alli.

Contents of this leaflet:

1. What alli is and what it is used for
   • Risks associated with being overweight
   • How alli works
2. What you need to know before taking alli
   • Do not take alli
   • Warnings and precautions
   • Other medicines and alli
   • alli with food and drink
   • Pregnancy and breastfeeding
   • Driving and using machines
3. How to take alli
   • Preparing to lose weight
   • Choose a start date
   • Decide your weight-loss goal
   • Set your calorie and fat intake goals
   • Taking alli
   • Adults aged 18 years and over
   • How long to take alli
   • If you take more alli than you should
   • If you forget to take alli
4. Possible side effects
   • Serious side effects
   • Very common side effects
   • Common side effects
   • Effects observed in blood tests
   • Learning to manage treatment-related effects associated with diet
5. How to store alli
6. Contents of the pack and other information
   • What alli contains
   • What alli looks like and contents of the pack
   • Marketing Authorisation Holder and Manufacturer
   • Other useful information

1. What alli is and what it is used for

alli 60 mg hard capsules (orlistat) is a peripherally-acting anti-obesity medication used for
weight loss in adults aged 18 years and over who are overweight, with a body mass index (BMI)
equal to or greater than 28. alli should be used in combination with a reduced-calorie, low-fat diet.
BMI is a way of assessing whether your weight is appropriate or if you are overweight for your height.
The table below will help you determine whether you are overweight and whether alli is suitable for you.
Find your height in the table. If your weight is below the value indicated for your height, do not take alli.

Risks associated with being overweight
Being overweight increases the risk of developing several serious health problems, such as diabetes and
cardiovascular diseases. These conditions may not cause obvious symptoms; therefore, you should
consult your doctor for a general health check-up.
How alli works
The active substance in alli (orlistat) has been studied to act on dietary fats in the digestive system.
This substance blocks the absorption of approximately one-quarter of the fat contained in meals. This unabsorbed fat is then eliminated from the body through the faeces (see section 4). It is therefore important to commit to following a low-fat diet to manage these effects. In this way, the effect of the capsules will support your efforts, helping you lose more weight than diet alone. For every 2 kg lost with diet alone, alli could help you lose up to an additional 1 kg.

2. What you need to know before taking alli

Do not take alli
If you are allergic to orlistat or to any of the other ingredients of this medicine (listed in
section 6).

• If you are pregnant or breastfeeding.
• If you are taking cyclosporine, a medicine used after organ transplants, for severe rheumatoid arthritis, and certain serious skin diseases.
• If you are taking warfarin or other medicines used to thin the blood.
• If you have cholestasis (a condition in which bile flow from the liver is blocked).
• If you have diagnosed problems with food absorption (chronic malabsorption syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking alli

• If you have diabetes, inform your doctor as you may need to adjust the dose of your anti-diabetic medicine.
• If you have kidney disease. Consult your doctor before taking alli if you have kidney problems. Use of orlistat may be associated with kidney stone formation in patients with chronic kidney disease.

Children and adolescents
This medicine must not be taken by children and adolescents under 18 years of age.
Other medicines and alli
alli may affect certain medicines you are taking.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take alli with these medicines:

• Cyclosporine: cyclosporine is used after organ transplants, for severe forms of rheumatoid arthritis, and in certain serious skin diseases.
• Warfarin or other medicines used to thin the blood.

Oral contraceptive pill and alli

• The oral contraceptive pill may be less effective in case of severe diarrhoea. Use an additional contraceptive method if you develop severe diarrhoea.

Take a multivitamin supplement every day if you are taking alli

• alli may reduce levels of certain vitamins absorbed by the body. The multivitamin supplement should contain vitamins A, D, E, and K. The multivitamin supplement should be taken before bedtime, at a different time from when you take alli, to help vitamin absorption.

Inform your doctor before taking alli if you are taking

• amiodarone, used for heart rhythm problems.
• acarbose (an anti-diabetic medicine used in the treatment of type 2 diabetes mellitus). alli is not recommended in people taking acarbose.
• a thyroid medicine (levotiroxine), as dose adjustment may be needed and the two medicines should be taken at different times of the day.
• a medicine for epilepsy, as any change in frequency or intensity of seizures should be discussed with your doctor.
• medicines for HIV treatment. It is important to consult your doctor before taking alli if you are on HIV medicines.
• medicines for depression, psychiatric disorders, or anxiety.

Inform your doctor or pharmacist when taking alli

• if you are taking medicine for high blood pressure, as dose adjustment may be needed.
• if you are taking medicine for high cholesterol, as dose adjustment may be needed.

alli with food and drink
alli should be taken in combination with a reduced-calorie and reduced-fat diet. Try to start the diet before beginning treatment. For information on how to set your calorie and fat intake goals, see Additional useful information in section 6.
alli can be taken immediately before, during, or within one hour after meals. Swallow the capsule with water. This generally means one capsule at breakfast, lunch, and dinner. If you skip a meal or eat a fat-free meal, do not take the capsule. alli does not work if the meal does not contain at least some fat.
If you eat a high-fat meal, do not take a higher than recommended dose. Taking the capsule with a meal high in fat may increase the likelihood of experiencing treatment-related gastrointestinal effects (see section 4). Make every effort to avoid any high-fat meals while taking alli.
Pregnancy and breastfeeding
Do not take alli if you are pregnant or breastfeeding.
Driving and using machines
It is unlikely that alli will affect your ability to drive or use machinery.
alli contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take alli

Getting ready to lose weight

1. 1. Choose a start date

Decide in advance the date when you will start taking the capsules. Before beginning to take the
capsules, start a reduced-calorie and low-fat diet and allow your body a few days to get used to the
new eating habits. Keep a record of what you eat in a food diary.
Such diaries are effective because they make you aware of what you eat and how much you eat,
providing a basis for introducing changes.

1. 2. Decide on your weight loss goal

Think about how many kilograms you would like to lose, then set a target weight. A realistic goal is to lose
between 5% and 10% of your initial weight. The amount of weight you lose may vary from week to
week. You should aim to lose weight gradually and steadily, about 0.5 kg per week.

1. 3. Set your calorie and fat intake goals

To help you reach your weight goal, you need to set two daily targets: one for calories and one for fat.
For further advice, please read Additional useful information in section 6.

Taking alli
Adults from 18 years of age and over

• Take one capsule three times a day.
• Take alli immediately before, during, or within one hour after meals. This generally means one capsule at breakfast, one at lunch, and one at dinner. Make sure your three main meals are well-balanced and low in calories and fat.
• If you skip a meal or eat a fat-free meal, do not take the capsule. alli does not work if the meal does not contain at least some fat.
• Swallow the capsule whole with water.
• Do not take more than 3 capsules per day.
• Eat low-fat meals to reduce the likelihood of experiencing treatment-related side effects associated with the diet (see section 4).
• Try to increase your physical activity before starting treatment with the capsules. Physical activity is an important part of a weight-loss programme. If you have never exercised before, remember to consult your doctor first.
• Continue exercising while taking alli and also after you stop taking it.

How long should you take alli

• alli must not be taken for longer than six months.
• If you have not lost weight after taking alli for 12 weeks, consult your doctor or pharmacist. It may be necessary to discontinue alli.
• Effective weight loss is not achieved simply by changing your eating habits for a short period and then returning to old habits. People who lose weight and maintain the weight loss change their lifestyles by modifying what they eat and increasing their level of physical activity.

If you take more alli than you should
Do not take more than 3 capsules per day.
If you have taken too many capsules, contact your doctor immediately.

If you forget to take alli
If you forget to take a capsule:

• If less than one hour has passed since your last meal, take the missed capsule.
• If more than one hour has passed since your last meal, do not take the missed capsule. Wait and take the next capsule with your next meal, as usual.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most of the side effects of alli (for example, increased intestinal gas with or without oily spotting, sudden or more frequent bowel movements, soft stools) are caused by the way it works (see section 1). Eat low-fat meals to help control these diet-related treatment effects.

Serious side effects
It is not known how often these side effects occur.
Severe allergic reactions

• Signs of a severe allergic reaction include: severe breathing difficulties, sweating, redness, itching, swelling of the face, rapid heartbeat, collapse. Stop taking the capsules immediately and seek urgent medical help.

Other serious side effects

• Rectal bleeding.
• Diverticulitis (inflammation of the large intestine). Symptoms may include abdominal pain, especially on the left side, possibly accompanied by fever and constipation.
• Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain, sometimes radiating to the back, possibly accompanied by fever, nausea, and vomiting.
• Blisters on the skin (including blisters that rupture).
• Severe abdominal pain caused by gallstones.
• Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark-colored urine, abdominal pain, and liver tenderness (indicated by pain under the front part of the rib cage on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (accumulation of calcium oxalate that may lead to kidney stone formation). See section 2, Warnings and precautions. Stop taking the capsules. If you experience any of these side effects, tell your doctor.

Very common side effects
May affect more than 1 in 10 people

• Increased intestinal gas, with or without oily spotting
• Sudden bowel movements
• Fatty or oily stools
• Soft stools

Tell your doctor or pharmacist if any of these side effects become severe or bothersome.

Common side effects
May affect up to 1 in 10 people

• Abdominal pain
• Faecal incontinence
• Loose stools
• More frequent bowel movements
• Anxiety

Tell your doctor or pharmacist if any of these side effects become severe or bothersome.

Effects observed in blood tests
It is not known how often these effects occur (frequency cannot be estimated from the available data)

• Increased levels of certain liver enzymes.
• Effects on blood coagulation in patients treated with warfarin or other blood-thinning medicines (anticoagulants). Inform your doctor that you are taking alli if you undergo blood tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects 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.

Learning to manage diet- or fat-related effects of alli
Most side effects are caused by the mechanism of action of the capsules and result from the fact that some dietary fat passes through the body undigested and is eliminated in the stools. These effects typically occur during the first weeks of treatment, before you become accustomed to limiting the amount of fat in your diet. These diet-related treatment effects may be a sign that you have consumed more fat than recommended.

You can learn to minimize the impact of diet-related treatment effects by following these rules:

• Start following a low-fat diet for a few days, or even a week, before beginning to take the capsules.
• Be more aware of how much fat is contained in your favourite foods and the portion sizes you eat. Becoming familiar with portion sizes will reduce the likelihood of accidentally exceeding your recommended fat intake.
• Distribute your daily allowance of fat evenly across your meals throughout the day. Do not save fat and calories to indulge later in a high-fat meal or dessert, as you might do with other weight-loss programmes.
• Most people who have experienced these side effects have found them manageable and controllable by adjusting their diet. Do not worry if you do not experience any of these problems. This does not mean that the capsules are not working.

5. How to store alli

• 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 on the bottle after the word “Exp”. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Keep the bottle tightly closed to protect the medicine from moisture.
• The bottle contains two sealed cylinders with silica gel to keep the capsules dry. Keep the cylinders inside the bottle. Do not swallow them.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What alli contains
The active substance is orlistat. Each hard capsule contains 60 mg of orlistat.
The other components are:

• Capsule contents: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, talc.
• Capsule cap: gelatin, indigotine (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, black ink (shellac, black iron oxide (E172), propylene glycol).
• Capsule band: gelatin, polysorbate 80, indigotine (E132).

Description of the appearance of alli and pack contents
alli capsules have turquoise body and cap, with a dark blue band in the centre, imprinted with "alli".
alli is available in packs of 42, 60, 84, 90 and 120 capsules. Not all pack sizes may be available in all countries.
Marketing Authorization Holder
Haleon Ireland Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Manufacturer
Famar S.A, 48 KM Athens-Lamia,190 11 Avlona, Greece
Haleon Germany GmbH, Barthstraße 4, 80339 Munich, Germany
More detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

ADDITIONAL USEFUL INFORMATION
Risks associated with being overweight
Being overweight affects health and increases the risk of developing serious health problems such as:

• High blood pressure
• Diabetes
• Cardiovascular diseases
• Stroke
• Some forms of cancer
• Osteoarthritis

Talk to your doctor about your personal risks of developing these conditions.
The importance of weight loss
Losing weight and maintaining weight loss, for example by improving your diet and increasing physical activity, can help reduce the risk of serious health problems and improve overall health.
Useful advice on diet and fat and calorie goals while taking alli
alli should be used in conjunction with a reduced-calorie and reduced-fat diet. The capsules work by preventing the absorption of part of the dietary fat ingested, but you can still eat foods from all the main food groups. Although you need to pay attention to the calories and fat you consume, it is important to follow a balanced diet. It is advisable to choose meals containing a variety of different nutrients and to learn how to eat properly in the long term.
Understanding the importance of fat and calorie goals
Calories are a measure of the energy required by the body. They are sometimes referred to as kilocalories or kcal. Energy can also be measured in kilojoules, which may also be listed on food labels.

• The calorie goal is the maximum number of calories you can consume in a day. Please refer to the table provided later in this section.
• The fat goal is the maximum number of grams of fat you can consume per meal. The fat table is provided after the information below on setting the calorie goal.
• Monitoring your fat intake is essential, given how the capsules work. When taking alli, your body will eliminate a higher amount of fat, and therefore you may experience difficulties managing high fat intake if you continue to eat as much fat as before. Therefore, adhering to the recommended fat goal will maximize weight loss results while minimizing the risk of treatment-related adverse effects associated with diet.
• You should aim to lose weight gradually and steadily. Ideally, aim to lose about 0.5 kg per week.

How to set your calorie goal
The table below has been designed to provide you with a daily calorie goal approximately 500 calories lower than the amount your body needs to maintain its current weight. This amounts to a total reduction of 3,500 calories per week, which corresponds to the amount of calories contained in 0.5 kg of fat.
By strictly following this calorie goal, you should achieve gradual and steady weight loss of about 0.5 kg per week, without feeling frustrated or unsatisfied.
It is not recommended to consume fewer than 1,200 calories per day.
To determine your calorie goal, you need to know your activity level. The more active you are, the higher your calorie goal will be.

• A low activity level means engaging in little or no physical activity such as walking, climbing stairs, gardening, or other daily physical activities.
• A moderate activity level means burning approximately 150 calories per day through physical activity, for example walking 3 km, gardening for 30–45 minutes, or running 2 km in 15 minutes. Choose the activity level that best matches your daily habits. If you are unsure of your level, choose a low activity level.

Women

Men

How to set your fat goal
The following table shows you how to set your fat goal based on your daily allowed calorie intake. You should plan to consume 3 meals per day. For example, if you have set a daily calorie goal of 1400 calories, the maximum amount of fat allowed per meal will be 15 g. To stay within your daily allowed fat intake, snacks should contain no more than 3 g of fat.

Reminders

• Set a realistic goal in terms of calories and fat intake, as this is a good way to maintain long-term weight loss achievements.
• Keep a record of what you eat in a food diary, including calorie and fat content.
• Try to increase your level of physical activity before starting to take the capsules. Physical activity is an important part of a weight-loss program. If you have never exercised before, remember to consult your doctor.
• Continue to stay active while taking alli and after stopping treatment.

The alli weight-loss program combines the capsules with a dietary plan and a wide range of resources to help you understand how to follow a reduced-calorie and reduced-fat diet, as well as guidelines to become more active.