Alli 60 mg capsulas duras

Label: Information for the User

alli 60 mg Hard Capsules

Orlistat

Read this entire 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 your doctor or pharmacist. You may need to stop taking alli.

Label Content

1. What alli is and what it is used for
   • Risks of being overweight
   • How alli works
2. What you need to know before you start taking alli
   • Do not take alli
   • Warnings and precautions
   • Use of alli with other medicines
   • Taking alli with food and drinks
   • Pregnancy and breastfeeding
   • Driving and operating machines
3. How to take alli
   • Weight loss preparation
   • • Choose your start date
     • Determine your weight loss goal
     • Set your calorie and fat goals.
   • Taking alli
   • • Adults 18 years of age or older
     • How long should I take alli?
     • If I take more alli than I should
     • If I forget to take alli
4. Side effects
   • Severe side effects
   • Very common side effects
   • Common side effects
   • Side effects observed in blood tests
   • Learn to control treatment-related diet effects
5. Storage of alli
6. Contents of the pack and additional information
   • Composition of alli
   • Appearance of the product and contents of the pack
   • Marketing authorization holder and responsible manufacturer
   • Further information

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 in this medicine (listed in section 6).

• If you are pregnant or breastfeeding.
• If you are taking ciclosporin, used after an organ transplant, for severe 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 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 bedtime, 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 that you 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, or up to one hour after a meal. The capsule should be swallowed with water. This usually means taking a capsule with breakfast, another with lunch, and another 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 chances 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

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 your 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 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 with 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 with 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.

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 (stomach), especially on the left side, possibly with fever and constipation.

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 tenderness (indicated by pain under the front of the chest, on the right side), sometimes with loss of appetite
• Calcium 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.
• Explosive bowel movements
• 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 bowel movements
• 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 thenational 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 limit.

• Distribute the fat limit evenly across meals andfat and calorie intake to then take a meal with high fat content or a dessert, as you may have done with other weight loss programs.
• Most users who experience these effects find that they can control them 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.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This way, you will help protect the environment.

Composition of alli

The active ingredient is orlistat. Each hard 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 Propylenglycol).

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

Appearance of the product and contents of the pack

alli capsules have a turquoise-coloured body and cap with a band around the central area with the impression "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 shuttle to help you take your daily dose of alli.

Marketing Authorisation HolderGlaxoSmithKline Dungarvan Limited, Knockbrack,

Dungarvan, Co. Waterford, Ireland

Responsible for manufacturingFamar 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 authorisation holder.

You can also visit the country-specific alli website for more information on the alli weight loss programme.

België/Belgique/Belgien

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

Tél/Tel: + 32 10858600

www.alli.be

Lietuva

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00

info.lt@gsk.comwww.alli.lt

Te .: + 359 2 953 10 34

www.alli.bg

GlaxoSmithKline Consumer Healthcare Czech Republic s.r.o.

Tel: + 420 222 001 111

cz.info@gsk.comwww.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

scanda.consumer-relations @gsk.comwww.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

info.nlch@gsk.comwww.alli.nl

Eesti

GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900

[email protected]

Norge

GlaxoSmithKline Consumer Healthcare Tlf: + 47 80 05 86 30

scanda.consumer-relations @gsk.com

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 HealthcareProdutos 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.

r. 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

scanda.consumer-relations @gsk.com

C. A. Papaellinas Ltd,

. . 24018, 1700

T. +357 22 741 741

www.alli.com.cy

Sverige

GlaxoSmithKline Consumer Healthcare Tel: 020-100579

scanda.consumer-relations @gsk.comwww.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.lvwww.alli.co.uk

Fecha de la última revisión de este prospecto: julio de 2020

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

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MÁS INFORMACIÓN DE UTILIDAD

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

Speak with your doctor about the risk of developing these diseases.Importance of weight loss

Weight loss 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 targets 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 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 targets

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 target is the maximum number of calories you will eat each day. See the table below for this section.
• Your fat target is the maximum amount of fat you will eat in

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

• Controlling your fat target 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 target, you will maximise the weight loss results while minimising the risk of diet-related treatment effects.

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

How to set your calorie target

The following table has been designed so that it provides you with a calorie target that is approximately 500 calories less than the number of calories your body needs to maintain your current weight. This means you will be 3,500 calories less per week, approximately the number of calories in 0.5 kg of fat.

You will need to know your level of physical activity to set your calorie targets. The more active you are, the higher your calorie target 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 approximately three kilometres (2 miles), working in the garden for 30 to 45 minutes or running two kilometres (1.25 miles) in 15 minutes. Choose the level that best suits your daily routine. If you are unsure which level you are, choose Low Activity.

Women

Men

How to set your fat target

The following table shows how to set your fat target 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 target of 1,400 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 targets, as this is a way to maintain weight loss achievements in the long term.
• Keep a record of 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 programme. Remember to consult your doctor if you have not exercised before.
• Continue to be active while taking alli and after stopping it.

The alli programme 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 the guidelines for becoming more active.

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

Visitwww.alli.com.es