Label: Information for the User

alli 60 mg Hard Capsules

orlistat

Read this label carefully before you start taking this medicine, because it contains important information for you.

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

alli 60 mg hard capsules (orlistat) is an anti-obesity medication with peripheral action that is used to lose weight in adults over 18 years old with overweight, with a body mass index (BMI) of 28 or higher. alli must be used in combination with a low-calorie and low-fat diet.

and.

The BMI is a way to know if you have a healthy weight or if you have overweight taking into account your height. The table that is included below will help you find out if you have overweight and if alli is suitable for you.

Consult your weight in the table below. If your weight is less than the weight that appears on the side of your height, do not take alli.

Risks of having overweight

Having 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 of alli (orlistat) is designed to target fat in your digestive system. It prevents about a quarter of the fat you take in meals from being absorbed. This fat will be eliminated from your body in the feces (see section 4). Therefore, it is essential that you follow a low-calorie and low-fat diet to control these effects. If you do, the action of the capsules will help you in your efforts, helping you to lose more weight than just with diet. For every 2 kg you lose just with diet, alli could help you lose up to 1 kg more.

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 certain severe skin conditions.
• If you are taking warfarin or other anticoagulant medicines.
• If you have cholestasis (a condition where bile flow from the liver is blocked).
• If you have chronic malabsorption syndrome diagnosed by a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take alli.

• If you have diabetes. Consult your doctor if necessary to adjust your antidiabetic medication.
• 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 may affect some medicines you take.

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

Do not take alli with the following medicines

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

Use of oral contraceptives with alli

• Oral contraceptives may be less effective if you have severe diarrhea. Use an additional contraceptive method if you have severe diarrhea.

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. and should be taken before going to sleep, when you will not be taking alli, to ensure that the vitamins are absorbed.

Consult your doctor before taking alli if you are taking

• Amiodarone, used for heart rhythm problems.
• Acarbosa, (an antidiabetic medicine used to treat type 2 diabetes) the use of alli is not recommended in people taking acarbosa.
• A thyroid medicine (levotiroxine) as it may be necessary to adjust the dose and take your medicines at different times of the day.
• An epilepsy medicine, as any change in the frequency and severity of seizures should be discussed with your doctor.
• Medicines for treating HIV. It is essential to 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 drinks

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

alli can be taken immediately before, during meals, or up to one hour after meals. The capsule should be swallowed with water. This usually means taking one capsule with breakfast, one with lunch, and one with dinner. If you do not eat a meal or if the meal does not contain fat, do not take the capsule. alli does not work if the meal does not contain some fat.

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

Pregnancy and breastfeeding

Do not take alli during pregnancy or breastfeeding.

Driving and operating machines

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

alli contains sodium

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

Preparation for Weight Loss

1. Choose Your Start Date

Choose the day you will start taking the capsules in advance. Before starting to take the capsules, begin a 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. These 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. Determine Your Weight Loss Goal

Think about how much weight you want to lose and set a weight 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 gradual and consistent rate of around 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 goals, one for calories and one for fat. For more information, seeMore Useful Informationin the blue pages of section 6.

How to Take Alli

Adults 18 Years or Older

• Take one capsule, three times a day.
• Take Alli just before, during, or up to one hour after meals. Normally, this means taking a capsule at breakfast, lunch, and dinner. Make sure your three main meals are balanced and low in calories and fat.

• If you miss a meal, or if your meal does not contain fat, do not take a capsule. Alli will not work unless 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) that comes with this package.
• Eat meals low in fat to help reduce the effects of the treatment related to diet (see section 4).
• Try to be 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 to be active while taking Alli and after stopping its use.

How Long Should I Take Alli?

• Alli should not be taken for more than 6 months.
• If you do not lose weight after taking Alli for 12 weeks, consult 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 of time and then return to old habits. People who lose weight and maintain the loss make changes to their lifestyle, including changes to what they eat and how active they are.

If You Take Too Much Alli

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 has been less than an hour since your last meal, take the missed dose.
• If it has been more than an 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 about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The majority of frequent side effects related to the use of alli (for example, gas with or without oily spots, or more frequent and soft stools) are the result of its mechanism of action (see section 1). Take low-fat foods to try to control these treatment-related side effects related to diet.

Severe side effects

The frequency of these side effects is unknown

Severe allergic reactions

• The signs of a severe allergic reaction include: severe difficulty breathing, sweating, skin rash, itching, facial swelling, rapid heart rate, collapse.

Stop taking the capsules and seek medical help immediately.

Other severe side effects

• Bleeding rectum
• Diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain (abdominal), 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 yellow skin and eyes, itching, dark urine, stomach and liver pain (indicated by pain below the front of the chest, on the right side), sometimes with loss of appetite
• Oxalate nephropathy (deposition of calcium oxalate that may lead to kidney stones). See section 2, be especially careful with alli.

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

Very frequent side effects

May affect more than 1 in 10 people

• Gas (flatulence) with or without oily spots.
• Emergency evacuation.
• Oily or greasy stools.
• Soft stools.

Inform your doctor or pharmacist if any of these side effects worsen or become complicated.

Frequent side effects

May affect up to 1 in 10 patients

• Abdominal pain (stomach)
• Fecal incontinence
• Fluid or liquid stools
• More frequent stools
• Anxiety

Inform your doctor or pharmacist if any of these side effects worsen or become complicated.

Side effects observed in blood tests

The frequency of these side effects is unknown (the frequency cannot be estimated from the available data)

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Learn to control alli-related diet or fat intake effects

The most common side effects are caused by the mechanism of action of the capsules and occur due to the elimination of part of the fat from the body. These effects typically occur during the first weeks of use of the capsules, before you have learned to limit the amount of fat in your diet. These treatment-related diet effects may be a sign that you have eaten more fat than you should.

You can learn to minimize treatment-related diet effects by following these basic guidelines:

• Start a low-fat diet a few days, or even a week, before starting to take the capsules.
• Find out more about the fat content of your favorite foods, and the portion size. If you familiarize yourself with the portions, you will be less likely to accidentally exceed your fat target.
• Distribute the fat limit evenly across meals throughout the day. Do not “save” fat and calorie intake and then take a high-fat meal or dessert, as you may have done with other weight loss programs.
• Most users who experience these effects find that they can control and manage them by adjusting their diet.

Do not worry if you do not experience these problems. That does not mean the capsules are not working.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25°C.
• Keep the container perfectly closed to protect it from moisture.
• The bottle includes two sealed cylinders containing silica gel to keep the capsules dry. Keep the cylinders in the bottle. Do not ingest them.
• You can store your daily dose of alli in the blue pill box (Shuttle) included in the container. Remove any capsule that has been stored in the pill box for more than one month.
• Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Active Ingredient Composition

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

• Capule content: Microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, and talc.

• Capule coating: Gelatin, indigo carmine (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, and black ink (Shellac, iron oxide black (E172), and propylene glycol).

• Band: Gelatin, polisorbate 80, and indigo carmine (E132).

Appearance of the Product and Contents of the Package

The alli capsules have a turquoise-colored body and cap with a band around the middle section with the impression "alli".

alli is available in packages of 42, 60, 84, 90, and 120 capsules. Some package sizes may not be available.

Each package includes a blue shuttle (pill box) to help you take your daily dose of alli.

Marketing Authorization Holder

GlaxoSmithKline Dungarvan Limited,

Knockbrack,

Dungarvan,

Co. Waterford,

Ireland

Manufacturer

Famar S.A, 48 KM Atenas-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 country-specific alli website for more information on the alli weight loss program.

Last Review Date: July 2020

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

MORE INFORMATION ON USE

Risks of Being Overweight

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

• Hypertension

• Diabetes

• Cardiac disease

• Stroke

• Certain types of cancer

• Osteoarthritis

Discuss the risk of developing these diseases with your doctor.

Importance of Weight Loss

Weight loss 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 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 is 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. Sometimes they are called Kilocalories or Kcal. Energy can also be measured in Kilojoules, which you may have seen in nutritional tables.

• The calorie goal is the maximum number of calories you will eat each day. See the table below for this information.

• Your fat goal is the maximum number of grams of fat you will eat in

each meal. The fat goal table has been drawn up based on the information below on how to set your calorie goal.

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

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

• You should aim to lose weight gradually and consistently. The ideal is to lose around 0.5 kg per week.

How to Set Your Calorie Goal

The following table has been designed so that it provides you with a calorie goal that is approximately 500 calories less than the number of calories your body needs to maintain your current weight. This means around 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 stable rate of 0.5 kg per week without feeling frustrated or deprived.

Do not 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 you never or almost never walk, climb stairs, garden, or engage in any other daily activity.

• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are walking about 3 kilometers (2 miles), working in the garden for 30 to 45 minutes, or running 2 kilometers (1.25 miles) in 15 minutes. Choose the level that best suits your daily routine. If you are unsure of which level you are in, 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 receive per day. You should plan to have three meals a day. If you have set a goal of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within the assigned amount of fat, snacks should not contain more than 3 g of fat

Remember

• Adjusting to realistic calorie and fat goals, as this is a way to maintain weight loss achievements in the long term.

• Record what you eat in a food diary, including the 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 it.

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 active.

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

Visitwww.alli.com.es