Alli 60 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

alli 60 mg hard capsules

orlistat

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• If you do not lose weight after taking alli for 12 weeks, consult your doctor or pharmacist. You may need to stop taking alli.

Package leaflet contents

1. What alli is and what it is used for

   • Risks of being overweight
   • How alli works

2. What you need to know before taking alli

   • Do not take alli
   • Warnings and precautions
   • Use of alli with other medicines
   • Taking alli with food and drink
   • Pregnancy and breastfeeding
   • Driving and using machines

3. How to take alli

   • Preparing to lose weight
     • Choose your start date
     • Decide on your weight loss goal
     • Set your calorie and fat intake goals
   • Taking alli
     • Adults aged 18 and over
     • How long should you 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
   • Side effects observed in blood tests
   • Learn how to manage treatment-related effects associated with diet

5. Storage of alli

6. Package contents and other information

   • Composition of alli
   • What the product looks like and contents of the pack
   • Marketing authorization holder and manufacturer
   • More 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 over 18 years of age who are overweight, with a body mass index (BMI) of 28 or higher. alli should be used in combination with a low-calorie and low-fat diet.

BMI is a way of determining whether your weight is healthy or if you are overweight, taking your height into account. The table below will help you determine whether you are overweight and whether alli is suitable for you.

Check your weight in the following table. If your weight is below the weight shown next to your height, do not take alli.

Risks of being overweight

Being overweight increases the risk of developing various serious health problems, such as diabetes or heart disease. These conditions may not make you feel unwell, so you should see your doctor for a general check-up.

How alli works

The active ingredient in alli (orlistat) is designed to target the fat in your digestive system. It prevents about one-quarter of the fat you consume in your meals from being absorbed. This fat will be eliminated from your body in your stools (see section 4). Therefore, it is important that you follow a low-calorie and low-fat diet to manage these effects. If you do so, the action of the capsules will assist your efforts by helping you lose more weight than with diet alone. For every 2 kg you lose through diet alone, alli could help you lose up to an additional 1 kg.

2. What you need to know before starting to take 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, used after organ transplant, in severe rheumatoid arthritis, and in certain severe skin conditions.
• If you are taking warfarin or other anticoagulant medicines.
• If you have cholestasis (a condition in which bile flow from the liver is blocked).
• If you have been diagnosed by a doctor with malabsorption of food (chronic malabsorption syndrome).

Warnings and precautions

Consult your doctor or pharmacist before starting alli.

• If you have diabetes. Speak with your doctor about whether adjustment of your antidiabetic medication is needed.
• If you have any kidney disease. Talk to your doctor before taking alli if you have kidney problems. The use of orlistat may be associated with kidney stones in patients with chronic kidney disease.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Other medicines and alli

alli may affect certain medicines you take.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take alli together with the following medicines:

• Cyclosporine, used after organ transplantation, in severe rheumatoid arthritis, and in certain serious skin diseases.
• Warfarin or other anticoagulant medicines.

Use of oral contraceptives together with alli

• Oral contraceptives may become less effective if you experience severe diarrhoea. Use an additional contraceptive method if you have severe diarrhoea.

Take a multivitamin 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. It should be taken at bedtime, after you have finished taking alli for the day, to ensure proper absorption of the vitamins.

Consult your doctor before taking alli if you are taking:

• Amiodarone, used for heart rhythm problems.
• Acarbose (an antidiabetic medicine used to treat type 2 diabetes mellitus); the use of alli is not recommended in people taking acarbose.
• A thyroid medicine (levotiroxine), as it may be necessary to adjust the dose and to take your medicines at different times of the day.
• A medicine for epilepsy, since any change in the frequency and severity of seizures should be discussed with your doctor.
• Medicines for HIV. It is important that you consult your doctor before taking alli if you are receiving treatment for HIV.
• Medicines for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking alli:

• If you are taking any medicine for high blood pressure, as it may be necessary to adjust the dose.
• If you are taking any medicine for high cholesterol, as it may be necessary to adjust the dose.

Taking alli with food and drink

alli should be used in conjunction with a low-calorie and low-fat diet. Try to start this diet before beginning treatment. For information on how to set your calorie and fat goals, see More useful information in the blue pages of section 6.

You may take alli immediately before, during, or up to one hour after a meal. The capsule must be swallowed with water. This usually means taking one capsule with breakfast, one with lunch, and one with dinner. If you skip a meal or if the meal contains no fat, do not take the capsule. alli does not work if the meal contains no fat.

If you eat a high-fat meal, you should not take a higher dose than recommended. Taking a capsule with a meal that contains too much fat increases the likelihood of experiencing diet-related treatment effects (see section 4). You should make every effort to avoid high-fat meals while taking alli.

Pregnancy and lactation

Do not take alli during pregnancy or lactation.

Driving and operating machinery

It is unlikely that this will affect your ability to drive or operate machinery.

alli contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially

3. How to take alli

Preparing to lose weight

1. Choose your start date

Decide in advance the day you will begin using the capsules. Before starting to take the capsules, begin your low-calorie and low-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 are eating, and provide a basis for making changes.

1. Decide on your weight loss goal

Think about how much weight you want to lose and set yourself 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, at about 0.5 kg per week.

1. Set your calorie and fat goals

To help you achieve your weight loss goal, you need to set two daily targets—one for calories and one for fat. For more information, see Helpful information in the blue pages of section 6.

Taking alli

Adults aged 18 years or older

• 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 balanced and low in calories and fat.
• If you skip a meal or if your meal contains no fat, do not take a capsule. alli does not work unless the meal contains some fat.
• Swallow the capsule whole with water.
• Do not take more than three capsules a day.
• You may store your daily dose of alli in the blue pill organizer (Shuttle) included in this package.
• Eat low-fat meals to help reduce diet-related treatment effects (see section 4).
• Try to become more physically active before starting treatment. Physical exercise is an important part of weight loss programs. Remember to consult your doctor if you have not exercised before.
• Continue being physically active while taking alli and after stopping it.

How long should I take alli?

• alli should not be taken for longer than 6 months.
• If you have not lost weight after taking alli for 12 weeks, consult your doctor or pharmacist. You may need to stop taking alli.
• To be successful in losing weight, it is not enough to change your eating habits for a short period and then return to old habits. People who lose weight and maintain the weight loss make lifestyle changes, including changes in what they eat and how active they are.

If you take more than you should

Do not take more than three 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 forget to take a dose of alli:

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Most of the common adverse effects associated with the use of alli (for example, gas with or without oily spotting, or more frequent bowel movements and soft stools) are the result of its mechanism of action (see section 1). Eat low-fat foods to help manage these diet-related treatment effects.

Serious adverse effects

The frequency of these adverse effects is unknown

Severe allergic reactions

• Signs of a severe allergic reaction include: severe difficulty breathing, sweating, skin rash, itching, swelling of the face, rapid heartbeat, collapse.

Stop taking the capsules and seek immediate medical help.

Other serious adverse effects

• Rectal bleeding
• Diverticulitis (inflammation of the large intestine). Symptoms include pain in the lower abdomen, especially on the left side, possibly with fever and constipation.
• Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain, sometimes radiating to the back, possibly with fever, nausea, and vomiting.
• Blisters on the skin (including blisters that burst).
• Severe stomach pain caused by gallstones (stones in the gallbladder).
• Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark-colored urine, stomach pain, and tender liver (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (calcium oxalate deposition which may lead to kidney stones).

See section 2, take special care with alli.

Stop taking the capsules. Inform your doctor if you experience any of these effects.

Very common adverse effects

May affect more than 1 in 10 people

• Gas (flatulence) with or without oily spotting
• Sudden bowel evacuation
• Oily or fatty stools
• Soft stools

Inform your doctor or pharmacist if any of these adverse effects worsen or become bothersome.

Common adverse effects

May affect up to 1 in 10 people

• Stomach (abdominal) pain
• Fecal incontinence
• Watery or liquid stools
• More frequent bowel movements
• Anxiety

Inform your doctor or pharmacist if any of these adverse effects worsen or become bothersome.

Adverse effects observed in blood tests

Frequency of these effects is unknown (frequency cannot be estimated from available data)

• Increased levels of certain liver enzymes.
• Effects on blood coagulation in people taking warfarin or other anticoagulant medicines.

Inform your doctor that you are taking alli when having a blood test.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

Learn how to manage treatment-related effects associated with diet or fat intake

The most common adverse effects are caused by the mechanism of action of the capsules and occur due to the elimination of part of the dietary fat from the body. These effects typically occur during the first weeks of using the capsules, before you have learned to limit 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 diet-related treatment effects by following these basic guidelines:

• Start a low-fat diet a few days, or even a week, before beginning to take the capsules.
• Learn more about the fat content of your favorite meals and portion sizes. Becoming familiar with portion sizes will make it less likely that you accidentally exceed your fat intake goal.
• Distribute your fat allowance evenly across meals. Do not save up fat or calorie allowances to consume a high-fat meal or dessert later, as you may have done with other weight-loss programs.
• Most users who experience these effects find they can control and manage them by adjusting their diet.

Do not worry if you do not experience these issues. This does not mean that the capsules are not working.

5. Storage of alli

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Keep the container tightly closed to protect from moisture.
• The bottle contains two sealed cylinders with silica gel to keep the capsules dry. Keep the cylinders in the bottle. Do not ingest them.
• You may store your daily dose of alli in the blue dosette box (Shuttle) provided in the package. Discard any capsule that has been stored in the dosette box for more than one month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of alli

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, and talc.
• Capsule shell: Gelatin, indigo carmine (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, and black ink (Shellac, black iron oxide (E172), and propylene glycol).
• Band: Gelatin, polysorbate 80, and indigo carmine (E132).

Appearance of the product and contents of the pack

alli capsules have a turquoise-colored shell and body, with a band around the central area bearing the imprint "alli".

alli is available in packs containing 42, 60, 84, 90 and 120 capsules. Only certain pack sizes may be marketed.

Each pack includes a blue dosing tray (Shuttle) to carry the daily dose of alli.

Marketing Authorization Holder GlaxoSmithKline Dungarvan Limited, Knockbrack,
Dungarvan, Co. Waterford, Ireland

Manufacturer Famar S.A, 48 KM Athens-Lamia, 190 11 Avlona, Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

You may also visit the country-specific alli website for further information on the alli weight-loss programme.

Belgium/Belgique/Belgien

GlaxoSmithKline Consumer Healthcare s.a./n.v.

Tel/Tel: +32 10858600

www.alli.be

Lithuania

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00

[email protected] www.alli.lt

Te.: + 359 2 953 10 34

www.alli.bg

GlaxoSmithKline Consumer Healthcare Czech Republic s.r.o.

Tel: + 420 222 001 111

[email protected] www.alli.cz

Luxembourg/Luxemburg

GlaxoSmithKline Consumer Healthcare s.a./n.v. Belgique/Belgien

Tél/Tel: + 32 10858600

www.alli.be

Hungary
GlaxoSmithKline Kft. Consumer Healthcare
Tel.: + 36 1 225 5800

www.alliprogram.hu

Denmark

GlaxoSmithKline Consumer Healthcare ApS
Tel: +45 80 25 16 27

[email protected]
www.alliplan.dk

Malta

GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131

www.alli.com.mt

Germany

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,

Tel: 0049 (0) 180 3 63462554

www.alliprogramm.de

Netherlands

GlaxoSmithKline Consumer Healthcare BV Tel: +31800 4090005

[email protected] www.alli.nl

Estonia

GlaxoSmithKline Eesti OÜ
Tel: +372 6676 900

[email protected]

Norway

GlaxoSmithKline Consumer Healthcare Tel: +47 80 05 86 30

[email protected]

Spain

GlaxoSmithKline Consumer Healthcare, S.A.

Tel: + 34 900 816 705

www.alli.com.es

Poland

GlaxoSmithKline Consumer Healthcare Sp. z o.o.

Tel.: + 48 (0)22 576 96 00

www.alli.pl

France

GlaxoSmithKline Santé Grand Public Tel.: + 33 (0)1 39 17 80 00

Portugal

GlaxoSmithKline Consumer Healthcare Produtos para a Saúde e Higiene, Lda.

Tel: 800 784 695

[email protected]

Croatia GlaxoSmithKline d.o.o. Tel: +385 1 6051 999

www.alli.com.hr

Romania

GlaxoSmithKline Consumer Healthcare S.R.L.

Tel: + 40 21 302 8 208

www.alli.ro

Ireland

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Tel: + 353 (0)1 495 5000

www.alli.ie

Slovenia

GSK d.o.o., Ljubljana Tel: + 386 (0)1 280 25 00

www.alli.si

Iceland GlaxoSmithKline ehf. Tel: + 354 530 3700

Slovak Republic

GlaxoSmithKline Consumer Healthcare Slovakia s.r.o.
Tel: +421 (0)2 48 26 11 11
[email protected]
www.alli.sk

Italy

GlaxoSmithKline Consumer Healthcare S.r.l.

Tel: +39 02 38062020

www.alli.it

Finland
GlaxoSmithKline Oy
Consumer Healthcare
Tel: 080 077 40 80

[email protected]

• A. Papaellinas Ltd,
  24018, 1700
• +357 22 741 741
  www.alli.com.cy

Sweden

GlaxoSmithKline Consumer Healthcare Tel: 020-100579

[email protected] www.alliplan.se

Latvia

GlaxoSmithKline Latvia SIA Tel: +371 67312687

[email protected]

United Kingdom (NI)

GlaxoSmithKline Consumer Healthcare Tel: + 44 (0)800 171 2014 (Freephone) [email protected]

www.alli.com.lv www.alli.co.uk

Date of most recent review of this leaflet: July 2020

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

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ADDITIONAL USEFUL INFORMATION

Risks of being overweight

Being overweight affects your health and increases your risk of developing serious health problems such as:

• Hypertension
• Diabetes
• Heart disease
• Stroke
• Certain types of cancer
• Osteoarthritis

Talk to your doctor about your risk of developing these conditions.

Importance of weight loss

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

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

alli should be used in combination with a reduced-calorie and low-fat diet. The capsules work by preventing the absorption of some of the fat you eat, but you can still consume foods from all major food groups. While you should focus on the calories and fat you consume, it is important to maintain a balanced diet. You should choose meals containing a variety of nutrients and learn to eat healthily in the long term.

Understanding the importance of calorie and fat goals

Calories are a measure of the energy your body needs. They are sometimes referred to as kilocalories or kcal. Energy may also be measured in kilojoules, which you may have seen on nutritional labels.

• Your calorie goal is the maximum number of calories you should consume each day. See the table provided later in this section.

• Your fat gram goal is the maximum number of grams of fat you should consume per meal. The fat gram goal table has been developed based on the information below regarding setting your calorie goal.

• Controlling your fat intake is essential due to the mechanism of action of the capsules.

Taking alli means your body will eliminate more fat, making it more difficult to handle as much fat in meals as before. Therefore, by adhering to your fat goal, you will maximize weight loss results while minimizing the risk of diet-related treatment side effects.

• You should aim for gradual and steady weight loss. Ideally, lose about 0.5 kg per week.

How to set your calorie goal

The following table has been designed to provide you with a daily calorie goal that is approximately 500 calories less than the amount your body needs to maintain your current weight. This results in a weekly deficit of up to 3,500 calories, roughly equivalent to the number of calories in 0.5 kg of body fat.

Your calorie goal should allow you to lose weight gradually and steadily at a rate of about 0.5 kg per week without feelings of frustration or deprivation.

It is not recommended to consume fewer than 1,200 kcal per day.

You will need to determine your physical activity level to establish your calorie goals. The more active you are, the higher your calorie goal should be.

• Low activity means you never or almost never walk, climb stairs, garden, or engage in other physical activities daily.
• Moderate activity means burning 150 calories per day through physical activity. Examples of moderate activity include walking approximately three kilometers (2 miles), gardening for 30 to 45 minutes, or running two kilometers (1.25 miles) in 15 minutes. Choose the level that best matches your daily routine. If you are unsure which level applies to you, choose Low Activity.

Women

Men

How to set your fat goal

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

Remember

• Stick to realistic calorie and fat intake goals, as this is a way to maintain long-term weight loss achievements.
• Keep a food diary, recording everything you eat, including calorie and fat content.
• Try to become more physically active before starting the capsules. Physical activity is an important part of a weight loss program. Remember to consult your doctor if you have not exercised before.
• Continue being physically active while taking alli and after stopping it.

The alli program combines capsules with a meal plan and a wide range of resources that
will help you understand how to follow a low-calorie and low-fat diet, as well as guidelines for becoming more active.

The alli website (please go to the specific country website listed in the local representatives section shown above) will provide you with a variety of interactive tools, low-fat recipes, physical activity tips, and other helpful information to support a healthy lifestyle and help you achieve your weight loss goals.

Visit www.alli.com.es