alli 60 mg hard capsules

alli is used for weight loss in adults aged 18 and over who are overweight, and have a body mass index (BMI) of 28 or above. alli should be used along with a reduced calorie, lower-fat diet.

BMI is a way to find out if you have a healthy weight, or are overweight, for your height. The chart below will help you find out whether you are overweight and whether alli is right for you.

Find your height on the chart. If you weigh less than the weight shown for your height, do not take alli .

Height Weight Height Weight 1.50 m 63 kg 4 10 9 st 8 lbs 1.55 m 67.25 kg 5 0 10 st 3 lbs 1.60 m 71.75 kg 5 2 10 st 13 lbs 1.65 m 76.25 kg 5 4 11 st 9 lbs 1.70 m 81 kg 5 6 12 st 5 lbs 1.75 m 85.75 kg 5 8 13 st 2 lbs 1.80 m 90.75 kg 5 10 13 st 13 lbs 1.85 m 95.75 kg 6 0 14 st 10 lbs 1.90 m 101 kg 6 2 15 st 8 lbs

Risk of being overweight

Being overweight increases your risk of developing several serious health problems such as diabetes and heart disease. These conditions may not cause you to feel unwell so you should see your doctor for a general health check.

How alli works

The active ingredient (orlistat) in alli is designed to target fat in your digestive system. It stops about a quarter of the fat in your meals from being absorbed. This fat will pass out of the body in your stools. You may experience diet-related treatment effects (see Chapter 4). It is therefore important that you commit to a lower-fat diet to manage these effects. If you do, the action of the capsules will assist your efforts by helping you to lose more weight compared to dieting alone. For every 2 kg (4 lb) you lose from dieting alone, alli can help you lose 1 kg (2 lb) more.

Do not take alli

• If you are under 18.
• If you are pregnant or breast-feeding.
• If you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.
• If you are taking warfarin or other medicines used to thin the blood.
• If you are allergic (hypersensitive) to orlistat or any of the ingredients of alli: see Chapter 6 for further information.
• If you have cholestasis (condition where the flow of bile from the liver is blocked).
• If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.

Take special care with alli

If you have diabetes. Tell your doctor who may need to adjust your anti-diabetic medicine.

If you have kidney disease. Talk to your doctor before taking alli if you have problems with your kidneys. The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.

Taking other medicines

alli may affect some medicines you have to take.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take alli with these medicines

• Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.
• Warfarin or other medicines used to thin the blood.

The oral contraceptive pill and alli

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

Multivitamins and alli

• You should take a multivitamin, every day. alli can lower the levels of some vitamins absorbed by your body. The multivitamin should contain vitamins A, D, E and K. You should take the multivitamin at bedtime, when you will not be taking alli, to help ensure that the vitamins are absorbed.

Talk to your doctor before taking alli if you are taking

• amiodarone, used for heart rhythm problems.
• acarbose, used for diabetes.
• a thyroid medicine (levothyroxine) as it may be necessary to adjust your dose and take your medicines at different times of the day.
• a medicine for epilepsy as any changes in the frequency and severity of your convulsions should be discussed with your doctor.

Talk to your doctor or pharmacist when taking alli

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

Taking alliwith food and drink

alli should be used along with a reduced calorie, lower-fat diet. Try to start this diet before beginning treatment. For information on how to set your calorie and fat targets, see Further helpful information in the blue pages in Chapter 6.
Take alli just before, during or up to one hour after meals. This usually means one capsule at breakfast, lunch and dinner. 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.
If you eat a high-fat meal, do not take more than the recommended dose. Taking the capsule with a meal containing too much fat may increase your chance of getting diet-related treatment effects (see Chapter 4). Make every effort to avoid any high-fat meals while taking alli.

Pregnancy and breast-feeding

Do not take alli if you are pregnant or breast-feeding.

Driving and using machines

alli is unlikely to affect your ability to drive and use machines.

Preparing to lose weight

1. Choose your start date

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.

2. Decide on your weight loss goal

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.

3. 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 further advice see Further helpful information in the blue pages in Chapter 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.
• You can keep your daily dose of alli in the blue carry case (Shuttle) included in this pack.
• Eat lower-fat meals to reduce the chance of diet-related treatment effects (see Chapter 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 too much alli

Do not take more than 3 capsules a day.
If you take 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, alli 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 Chapter 1). Eat lower-fat meals to help manage these diet-related treatment effects.

Serious side effectsIt 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 yellow skin and eyes, itching, stomach pain and liver tenderness. Stop taking the capsules. Tell your doctor if you get any of these.

Very common side effectsThese may affect more than 1 in 10 people taking alli

• 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 effectsThese may affect up to 1 in 10 people taking alli

• 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 testsIt is not known how frequently these effects occur

• 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.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Learn to deal with diet-related treatment effects

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 out of the reach and sight of children.
• Do not use alli 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.
• You can also keep your daily dose of alli in the blue carry case (Shuttle) included in this pack. Discard any capsules stored in the carry case for more than one month.

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.

A blue carry case (Shuttle) is included in this pack for carrying your daily dose of alli.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Glaxo Group Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.

Manufacturer: Famar, 190 11 Avlona, Greece
Catalent UK Packaging Limited, Sedge Close, Headway, Great Oakley, Corby,Northamptonshire NN18 8HS, United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

You can also visit your country specific alli website for further information about the alli weight loss programme.

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2656 2900 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 2656 2900 www.alli.be www.alli.be

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Consumer Healthcare Tel. 36 1 225 5800 www.alli.bg www.alliprogram.hu Malta GlaxoSmithKline Malta Limited Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com www.alli.com.mt www.alli.cz

Danmark GlaxoSmithKline Consumer Healthcare AS Tlf 45 44 86 86 00 dk.infogsk.com Nederland GlaxoSmithKline Consumer Healthcare BV Tel 31 030 693 8780 info.nlchgsk.com

www.alliplan.dk www.alli.nl

Deutschland Norge

GlaxoSmithKline Consumer Healthcare GmbH Co. KG, Tel 0049 0 180 3 63462554 GlaxoSmithKline Consumer Healthcare Tlf 47 22 70 22 01 dk.infogsk.com

www.alliprogramm.de www.alliplan.no

Österreich GlaxoSmithKline Markenartikel GmbH Tel 0043 0 512 390 11040 Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 979 estoniagsk.com www.alliprogramm.at www.alli.gsk.ee

Polska GlaxoSmithKline Consumer Healthcare Sp. z o.o. Tel. 48 022 576 96 00 GlaxoSmithKline A.E.B.E. . 266, 152 32 30 210 68 82 100 www.alli.plwww.alli.gr

España GlaxoSmithKline Consumer Healthcare, S.A. Tel 34 902 014 400 www.alli.com.es Portugal GlaxoSmithKline Consumer Healthcare Produtos para a Saúde e Higiene, Lda. Tel 800201343 LIS.FI-CHgsk.com

France GlaxoSmithKline Santé Grand Public Tél. 33 01 39 17 80 00 www.alli.pt România GlaxoSmithKline Consumer Healthcare S.R.L. Tel 40 21 302 8 208

www.alliprogramme.fr www.alli.ro

Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 66 Ireland GlaxoSmithKline Consumer Healthcare Ireland Limited Tel 353 01 495 5000 www.alli.siwww.alli.ie

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

www.alli.sk

Italia GlaxoSmithKline Consumer Healthcare S.p.A. Tel 39 02 38062020 www.alli.it SuomiFinland GlaxoSmithKline Oy Consumer Healthcare PuhTel 358 010 30 30 100 Finland.tuoteinfogsk.com

www.alliplan.fi

.. , .. 24018, 1700 T. 357 22 741 741 Sverige GlaxoSmithKline Consumer Healthcare Tel 020 363 636 dk.infogsk.com

www.alli.com.cy www.alliplan.se

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline Consumer Healthcare Tel 44 0500 888 878 Freephone customer.relationsgsk.com

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

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

www.alli.lt

This leaflet was last approved in

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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 Below 61.2 kg Below 9 st 9 lb 1400 calories Moderate activity 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 59.0 kg and over 9 st 4 lb and over 1800 calories Moderate activity

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 1200 12 g 3 g 1400 15 g 3 g 1600 17 g 3 g 1800 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.

The alli website (please refer to your country specific website included in the list of local representatives above) provides you with a range of interactive tools, lower-fat recipes, physical activity tips and other useful information to help you lead a healthy life and to support you in meeting your weight loss goals, together with details of a weight loss programme which is individually tailored for you.

Visit