ALLI 60 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

alli 60 mg hard capsules

orlistat

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not lose weight after taking alli for 12 weeks, talk to your doctor or pharmacist. You may need to stop taking alli.

Contents of the Package Leaflet

1. What is alli and what is it used for?
   • Risks of being overweight
   • How alli works
2. What you need to know before you take alli
   • Do not take alli
   • Warnings and precautions
   • Using alli with other medicines
   • Taking alli with food and drink
   • Pregnancy and breastfeeding
   • Driving and using machines
3. How to take alli
   • Preparation for weight loss
   • • Choose your start date
     • Decide on your weight loss goal
     • Set your calorie and fat targets.
   • Taking alli
   • • Adults aged 18 and over
     • How long should I take alli for?
     • 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 seen in blood tests
   • Learn how to control treatment effects related to diet
5. Storing alli
6. Package contents and further information
   • What is in alli
   • Appearance and package contents
   • Marketing authorisation holder and manufacturer
   • Further information

1. What is alli and what is it used for

alli 60 mg hard capsules (orlistat) is a weight loss medicine that works in the periphery to help with weight loss in adults aged 18 and over who are overweight, with a body mass index (BMI) of 28 or above. alli should be used in combination with a low-calorie, low-fat diet.

and fats.

Body mass index (BMI) is a way of measuring whether you are a healthy weight for your height. The table below will help you find out if you are overweight and if alli is right for you.

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

Risks of being overweight

Being overweight increases the risk of developing 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 stops about a quarter of the fat you eat from being absorbed. This fat will be removed from your body in your stools (see section 4). Therefore, it is important that you follow a low-calorie, low-fat diet to control these effects. If you do, the action of the capsules will help your weight loss efforts, helping you lose more weight than just with diet alone. For every 2 kg you lose just with diet, alli could help you lose up to 1 kg more.

2. What you need to know before you take alli

Do not take alli

If you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6).

• If you are pregnant or breastfeeding.
• If you are taking ciclosporin, used after an organ transplant, for severe rheumatoid arthritis and in certain severe skin conditions.
• If you are taking warfarin or other blood-thinning medicines.
• If you have cholestasis (a disease where bile flow from the liver is blocked).
• If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking alli.

• If you have diabetes. You may need to adjust your diabetes medicine.
• 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 should not take this medicine.

Other medicines and alli

alli can affect some medicines that you take.

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

Do not take alli with the following medicines:

• Ciclosporin, used after an organ transplant, for severe rheumatoid arthritis and in certain severe skin conditions.
• Warfarin or other blood-thinning medicines.

Taking the oral contraceptive pill with alli

• The oral contraceptive pill may be less effective if you get severe diarrhoea. Use an additional contraceptive method if you get severe diarrhoea.

Take a multivitamin every day if you are taking alli

• alli may reduce the levels of some vitamins absorbed by the body. The multivitamin should contain vitamins A, D, E and K. Take it before you go to bed, when you will not be taking alli, to make sure the vitamins are absorbed.

Talk to your doctor before taking alli if you are taking:

• Amiodarone, used for heart rhythm problems.
• Acarbose, (an anti-diabetic medicine used to treat type 2 diabetes mellitus) the use of alli is not recommended in people taking acarbose.
• A medicine for an underactive thyroid gland (levothyroxine) as you may need to adjust the dose and take your medicines at different times of the day.
• A medicine for epilepsy, as any changes in the frequency or severity of seizures should be discussed with your doctor.

Talk to your doctor while you are taking alli:

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

Taking alli with food and drink

alli should be used in combination with a low-calorie, low-fat diet. Try to start this diet before you start treatment. For information on how to set your calorie and fat targets, see Further informationin the blue pages of section 6.

You can take alli just before, during or up to one hour after a meal. The capsule should be swallowed with water. This usually means one capsule with breakfast, one with lunch and one with dinner. If you miss a meal or your meal does not contain fat, do not take a capsule. alli only works if the meal contains some fat.

If you eat a meal high in fat, do not take a higher dose than recommended. Taking a capsule with a meal high in fat increases the chance of getting treatment effects related to diet (see section 4). You should make every effort to avoid meals high in fat while taking alli.

Pregnancy and breastfeeding

Do not take alli during pregnancy or breastfeeding.

Driving and using machines

It is unlikely that alli will affect your ability to drive or use machines.

alli contains sodium

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

3. How to take alli

Preparation for weight loss

1. Choose your start date

Choose the day you will start using the capsules in advance. Before you start taking the capsules, start your low-calorie, 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. These diaries are effective because they make you aware of what you are eating, how much you are eating, and give you a basis for making changes.

1. Decide on your weight loss goal

Think about how much weight you want to lose and set a weight loss goal. 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 try to lose weight at a steady and gradual rate of about 0.5 kg per week.

1. Set your calorie and fat targets

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

Taking alli

Adults aged 18 and over

• Take one capsule, three times a day.
• Take alli just before, during or up to one hour after a meal. Normally, this means one capsule with breakfast, one with lunch and one with dinner. Make sure your three main meals are balanced and low in calories and fat.
• If you miss a meal or your meal does not contain fat, do not take a capsule. alli only works if the meal contains some fat.
• Swallow the capsule whole with water.
• Do not take more than three capsules a day.
• You can store your daily dose of alli in the blue pill box (Shuttle) included in this pack.
• Take low-fat meals to help reduce treatment effects related to diet (see section 4).
• Try to be more physically active before starting treatment. Physical exercise is an important part of weight loss programmes. Remember to talk to your doctor if you have not exercised before.
• Continue to be physically active while taking alli and after stopping it.

How long should I take alli for?

• Do not take alli for more than 6 months.
• If you do not lose weight after taking alli for 12 weeks, talk to your doctor or pharmacist. You may need to stop taking alli.
• To be successful in weight loss, it is not enough to eat differently for a short period and then go back to your old habits. People who lose weight and maintain weight loss make changes to their lifestyle, including changes to what they eat and how active they are.

and maintain weight loss make changes to their lifestyle, including changes to what they eat and how active they are.

If you take more alli 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 it is less than one hour since your last meal, take the missed dose.
• If it is more than one hour since your last meal, do not take the missed dose. Wait and take the next dose with your meal as usual.

If you have any other questions on 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 everybody gets them.

Most of the common side effects related to the use of alli (e.g. gas with or without oily spotting, or more frequent and softer stools) are a result of its mechanism of action (see section 1). Take low-fat foods to try to control these diet-related treatment effects.

Serious side effects

Frequency not known

Severe allergic reactions

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

Stop taking the capsules and seek medical help immediately.

Other serious side effects

• Rectal bleeding
• Diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain, 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 urine, abdominal pain and liver tenderness (indicated by pain under the front of the rib cage, on the right side), sometimes with loss of appetite
• Nephropathy due to oxalate (calcium oxalate deposits that can lead to kidney stones).

See section 2, be especially careful with alli.

Stop taking the capsules. Tell your doctor if you get any of these effects.

Very common side effects

May affect more than 1 in 10 people

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

Tell your doctor or pharmacist if any of these side effects get worse or are troublesome.

Common side effects

May affect up to 1 in 10 people

• Abdominal pain
• Incontinence (faecal)
• Fluid or liquid stools
• More frequent stools
• Anxiety

Tell your doctor or pharmacist if any of these side effects get worse or are troublesome.

Side effects seen in blood tests

Frequency not known

• Increased levels of some liver enzymes.
• Effects on blood clotting in people taking warfarin or other blood-thinning 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 how to control treatment effects related to diet

The most common side effects are caused by the mechanism of action of the capsules and occur because of the removal of some fat from the body. These effects usually happen during the first few weeks of taking the capsules, before you have learned to limit the amount of fat in your diet. These diet-related treatment effects can be a sign that you have eaten more fat than you should.

You can learn to minimise diet-related treatment effects by following these simple guidelines:

• Start a low-fat diet a few days, or even a week, before you start taking the capsules.
• Find out more about the fat content of your favourite foods, and the size of portions. If you get used to portion sizes, you will be less likely to accidentally exceed

your fat target.

• Distribute your daily fat allowance evenly across your meals to avoid taking a meal with a high fat content or a dessert, as you may have done with other weight loss programmes.
• Most people who get these effects find that they can control them and manage them by adjusting their diet.

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

5. Storing 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 blister 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 includes two sealed cylinders containing silica gel to keep the capsules dry. Keep the cylinders in the bottle. Do not swallow them.
• You can store your daily dose of alli in the blue pill box (Shuttle) included in the pack. Discard any capsule that has been stored in the pill 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 no longer required. This will help to protect the environment.

6. Package contents and further information

Composition of alli

The active ingredient is orlistat. Each hard capsule contains 60 mg of orlistat. The other ingredients are:

• Capsule content: Microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, and talc.
• Capsule shell: Gelatin, carmine indigo (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 carmine indigo (E132).

Appearance of the product and packaging content

The alli capsules have a turquoise-colored shell and body with a band around the central area printed with "alli".

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

Each pack includes a blue-colored pill box (Shuttle) to carry the daily dose of alli.

Marketing authorization holderGlaxoSmithKline Dungarvan Limited, Knockbrack,

Dungarvan, Co. Waterford, Ireland

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

You can also visit the alli website specific to your country for more information on the alli weight loss program.

België/Belgique/Belgien

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

Tel: + 32 10858600

www.alli.be

Lietuva

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

MagyarországGlaxoSmithKline Kft. Consumer Healthcare Tel.: + 36 1 225 5800

www.alliprogram.hu

Danmark

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

[email protected] www.alliplan.dk

Malta

GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131

www.alli.com.mt

Deutschland

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,

Tel: 0049 (0) 180 3 63462554

www.alliprogramm.de

Nederland

GlaxoSmithKline Consumer Healthcare BV Tel: +31800 4090005

[email protected] www.alli.nl

Eesti

GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900

[email protected]

Norge

GlaxoSmithKline Consumer Healthcare Tlf: + 47 80 05 86 30

[email protected]

España

GlaxoSmithKline Consumer Healthcare, S.A.

Tel: + 34 900 816 705

www.alli.com.es

Polska

GlaxoSmithKline Consumer Healthcare Sp. z o.o.

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

www.alli.pl

France

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

Portugal

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

Tel: 800 784 695

[email protected]

HrvatskaGlaxoSmithKline d.o.o. Tel:+385 1 6051 999

www.alli.com.hr

România

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

Slovenija

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

www.alli.si

ÍslandGlaxoSmithKline ehf. Sími: + 354 530 3700

Slovenská republika

GlaxoSmithKline Consumer Healthcare Slovakia s.

• o.

Tel: + 421 (0)2 48 26 11 11

[email protected] www.alli.sk

Italia

GlaxoSmithKline Consumer Healthcare S.r.l.

Tel: + 39 02 38062020

www.alli.it

Suomi/FinlandGlaxoSmithKline Oy Consumer Healthcare Puh/Tel: 080 077 40 80

[email protected]

• A. Papaellinas Ltd,

. . 24018, 1700

• +357 22 741 741

www.alli.com.cy

Sverige

GlaxoSmithKline Consumer Healthcare Tel: 020-100579

[email protected] www.alliplan.se

Latvija

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 last revision 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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MORE USEFUL INFORMATION

Risks of being overweight

Being overweight will affect your health and increase your risk of developing serious health problems such as:

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

Talk to your doctor about the risk of developing these diseases. Importance of weight loss

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

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

alli should be used with a low-calorie and low-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 you eat, it's also important to eat a balanced diet. You should choose meals that contain a range of different 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 called kilocalories or kcal. Energy can also be measured in kilojoules, which you may also have seen on nutrition labels.

• Your calorie goal is the maximum number of calories you will eat each day. See the table included later in this section.
• Your fat gram goal is the maximum number of grams of fat you will eat at

each meal. The fat gram goal table has been developed based on the information shown below on how to set your calorie goal.

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

Taking alli means that your body will eliminate more fat, and therefore it will be harder for you to handle as much fat in meals as before. Therefore, by sticking to your fat goal, you will maximize your weight loss results while minimizing the risk of treatment-related effects on your diet.

• You should aim to lose weight gradually and steadily. Ideally, you should lose around 0.5 kg per week.

How to set your calorie goal

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

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

It is not recommended to take less than 1200 kcal per day.

You will need to know your level of physical activity to set your calorie goals. The more active you are, the higher your calorie goal will be.

• Low activity means that you never or hardly ever walk, climb stairs, garden, or do other daily activities.
• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are 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 fits your daily routine. If you are unsure which level you are at, 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 have per day. You should plan to have three meals per day. If you have set a calorie goal of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your allocated amount of fat, snacks should not contain more than 3 g of fat.

Remember

• Stick to realistic calorie and fat goals, as this is a way to maintain long-term weight loss achievements.
• Write down what you eat in a food diary, including calorie and fat content.
• Try to be more physically active before starting to take 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 to be active while taking alli and after stopping treatment.

The alli program combines the 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 and guidelines for becoming more physically active.

The alli website (please refer to the country-specific website listed above) will provide you with a range of interactive tools, low-fat recipes, physical activity tips, and other useful information to help you have a healthy lifestyle and support you in achieving your weight loss goals.

Visit www.alli.com.es