1. What alli is and what it is used for

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.

• If you are allergic to orlistat or any of the 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

• 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.

• amiodarone, used for heart rhythm problems.
• acarbose, (an anti-diabetic drug 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.

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.

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

• 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 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 effects These 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 tests
It 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 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 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.

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 and Manufacturer
Marketing Authorisation Holder: Glaxo Group Limited, 980 Great West Road
Brentford, Middlesex, TW8 9GS, United Kingdom
Manufacturer: Famar, 190 11 Avlona, Greece

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.

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.

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.