Patient leaflet - Alli (previously Orlistat GSK)
1. What alli is and what it is used for
-
– Risk of being overweight
-
– How alli works
2. What you need to know before you take alli
-
– Do not take alli
-
– Warnings and precautions
-
– Other medicines and alli
-
– alli with food and drink
-
– Pregnancy and breast-feeding
-
– 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 targets
-
– Taking alli
-
– Adults 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
-
– Effects seen in blood tests
-
– Learn to deal with diet-related treatment effects
-
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
-
– Further helpful information
1. What alli is and what it is used for alli 60 mg hard capsules (orlistat) is a peripherally acting antiobesity product which 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</p></td><td style="vertical-align:top;"><p>10 st 3 lbs</p></td></tr><tr><td style="vertical-align:top;"><p>1.60 m</p></td><td style="vertical-align:top;"><p>71.75 kg</p></td><td style="vertical-align:top;"><p>5' 2 | 10 st 13 lbs | |
| 1.65 m | 76.25 kg | 5' 4</p></td><td style="vertical-align:top;"><p>11 st 9 lbs</p></td></tr><tr><td style="vertical-align:top;"><p>1.70 m</p></td><td style="vertical-align:top;"><p>81 kg</p></td><td style="vertical-align:top;"><p>5' 6 | 12 st 5 lbs | |
| 1.75 m | 85.75 kg | 5' 8</p></td><td style="vertical-align:bottom;"><p>13 st 2 lbs</p></td></tr><tr><td style="vertical-align:bottom;"><p>1.80 m</p></td><td style="vertical-align:bottom;"><p>90.75 kg</p></td><td style="vertical-align:bottom;"><p>5' 10 | 13 st 13 lbs | |
| 1.85 m | 95.75 kg | 6' 0</p></td><td style="vertical-align:middle;"><p>14 st 10 lbs</p></td></tr><tr><td style="vertical-align:top;"><p>1.90 m</p></td><td style="vertical-align:top;"><p>101 kg</p></td><td style="vertical-align:top;"><p>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 substance (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 (see section 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 might help you lose up to 1 kg (2 lb) 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 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 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.
Warning and precautions
Talk to your doctor or pharmacist before taking 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.
Children and adolescents
This medicine must not be taken by children and adolescents under 18 years old.
Other medicines and alli
alli may affect some medicines you have to take.
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
-
– 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.
Take a multivitamin every day if you are taking alli
-
– 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, (an anti-diabetic medicine used to treat type 2 diabetes mellitus). alli is not
recommended for people taking acarbose.
-
– 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.
-
– medicines to treat 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 anxiousness.
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.
alli with 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 section 6.
alli can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water. 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 section 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.
alli contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take alli
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 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.
-
– 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 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.
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 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 howfrequently these effects occur (frequency cannot be estimatedfrom 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. Y ou can also report side effects directly via the national reporting system listed in 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.
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 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.
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.
6. Contents of the pack and other information
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
GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford,
Ireland
Manufacturer
Famar S.A, 48 KM Athens-Lamia,
190 11 Avlona, Greece
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.
| Belgie/Belgique/Belgien GlaxoSmithKline Consumer Healthcare s.a./n.v. Tel/Tel: + 32 10858600 | Lietuva GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 |
| Luxembourg/Luxemburg | |
| Etnrapw« rnakcoCMumKnaHH Kohctombp XenTKetp Ten.: + 359 2 953 10 34 | GlaxoSmithKline Consumer Healthcare s.a./n.v. Belgique/Belgien Tel/Tel: + 32 10858600 |
| www. alli. be | |
| Česká republika GlaxoSmithKline Consumer Healthcare Czech Republic s.r. o. Tel: + 420 222 001 111 | Magyarország GlaxoSmithKline Kft. Consumer Healthcare Tel.: + 36 1 225 5800 www. alliprogram. hu |
| Danmark GlaxoSmithKline Consumer Healthcare ApS Tlf: + 45 80 25 16 27 | Malta GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131 |
| Deutschland GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Tel: 0049 (0) 180 3 63462554 | Nederland GlaxoSmithKline Consumer Healthcare BV Tel: +31800 4090005 |
| Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 | Norge GlaxoSmithKline Consumer Healthcare Tlf: + 47 80 05 86 30 |
| www. alliplan. no | |
| EMdSa GlaxoSmithKline KaTavaXwTiicd npoiovTa YYEiaq EXXaq Movonpoawnn Avwvu |u.q ETaipeia | Österreich GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Tel: 0049 (0) 180 3 63462554 |
| A. Kq^iaiag 2, 152 32 XaXavöpi |
Tnk + 30 210 68 82 100
| España GlaxoSmithKline Consumer Healthcare, S.A. Tel: + 34 900 816 705 | Polska GlaxoSmithKline Consumer Healthcare Sp. z o.o. Tel.: + 48 (0)22 576 96 00 |
| France GlaxoSmithKline Santé Grand Public Tél.: + 33 (0)1 39 17 80 00 | Portugal GlaxoSmithKline Consumer Healthcare -Produtos para a Saude e Higiene, Lda. Tel: 800 784 695 apoio. consumidor@gsk. com |
| Hrvatska GlaxoSmithKline d.o.o. Tel:+385 1 6051 999 | Romania GlaxoSmithKline Consumer Healthcare S.R.L. Tel: + 40 21 302 8 208 |
| Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Tel: + 353 (0)1 495 5000 | Slovenija GSK d.o.o., Ljubljana Tel: + 386 (0)1 280 25 00 |
| Island GlaxoSmithKline ehf. Simi: + 354 530 3700 | Slovenská republika GlaxoSmithKline Consumer Healthcare Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 |
| Italia GlaxoSmithKline Consumer Healthcare S.r.l Tel: + 39 02 38062020 | Suomi/Finland GlaxoSmithKline Oy Consumer Healthcare Puh/Tel: 080 077 40 80 |
| Knnpog C. A. Papaellinas Ltd, T.0. 24018, 1700 AeuKrooia TnX. +357 22 741 741 | Sverige GlaxoSmithKline Consumer Healthcare Tel: 020–100579 |
| www. alli. com. cy | |
| Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 | United Kingdom (NI) GlaxoSmithKline Consumer Healthcare Tel: + 44 (0)800 171 2014 (Freephone) |
This leaflet was last revised in July 2020
Detailed information on this medicine is available on the European Medicines Agency web site:. -------------------------------------------------------------------------------------------------------------------
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 |
| 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.