ALLI 60 mg HARD CAPSULES ORLISTAT

Introduction

Package Leaflet: Information for the User

alli 60 mg hard capsules

orlistat

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not lose weight after taking alli for 12 weeks, talk to your doctor or pharmacist. You may need to stop taking alli.

Contents of the pack

1. What is alli and what is it used for
   • Risks of being overweight
   • How alli works
2. What you need to know before you take alli
   • Do not take alli
   • Warnings and precautions
   • Using alli with other medicines
   • Taking alli with food and drink
   • Pregnancy and breast-feeding
   • Driving and using machines
3. How to take alli
   • Preparation for weight loss
   • • Choose your start date
     • Decide on your weight loss goal
     • Set your calorie and fat targets.
   • Taking alli
   • • Adults aged 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
   • Side effects found in blood tests
   • Learn how to control treatment effects related to diet
5. Storing alli
6. Contents of the pack and other information
   • What alli contains
   • Appearance and pack contents
   • Marketing authorisation holder and manufacturer
   • Further information

1. What is alli and what is it used for

alli 60 mg hard capsules (orlistat) is a weight loss medicine that works in the stomach to block the absorption of some of the fat in the food you eat. It is used to help you lose weight and maintain weight loss when used with a low-calorie and low-fat diet.

alli should be used in conjunction with a low-calorie and low-fat diet.

Your Body Mass Index (BMI) is a measure of whether you are a healthy weight for your height. The table below will help you find out if you are overweight and whether alli is suitable for you.

Check your weight against the table below. If your weight is lower than the weight next to your height, do not take alli.

Risks of being overweight

Being overweight increases your risk of developing 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 health check.

How alli works

The active ingredient in alli (orlistat) 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 your body in your stools (see section 4). It is therefore important that you follow a low-calorie and low-fat diet to control these effects. If you do, the action of the capsules will help your weight loss efforts, helping you to lose more weight than by dieting alone. For every 2 kg you lose by dieting alone, alli can help you lose up to 1 kg 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 an organ transplant, for severe rheumatoid arthritis and for some severe skin conditions.
• If you are taking warfarin or other blood thinning medicines.
• If you have cholestasis (a condition where bile flow from the liver is blocked).
• If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking alli.

• If you have diabetes. Your doctor may need to adjust your diabetic medication.
• If you have kidney problems. 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 old should not take this medicine.

Other medicines and alli

alli may affect some medicines that you take.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take alli with the following medicines

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

Taking the oral contraceptive pill with alli

• The oral contraceptive pill may be less effective if you get severe diarrhoea. Use a complementary contraceptive method if you get severe diarrhoea.

Take a multivitamin every day if you are taking alli

• alli may reduce the levels of some vitamins absorbed by your body. The multivitamin should contain vitamins A, D, E and K. Take it before you go to bed, when you will not be taking alli, to make sure 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 used to treat type 2 diabetes mellitus) the use of alli is not recommended in people taking acarbose.
• A medicine for an underactive thyroid gland (levothyroxine) as you may need to adjust the dose and take your medicines at different times of the day.
• A medicine for epilepsy, as any changes in the frequency or severity of fits should be discussed with your doctor.
• Medicines for HIV. It is important that you talk to your doctor before taking alli if you are receiving treatment for HIV.
• Medicines for depression, psychiatric disorders or anxiety.

Talk to your doctor or pharmacist while you are taking alli

• If you are taking any medicines for high blood pressure, as you may need to adjust the dose.
• If you are taking any medicines for high cholesterol, as you may need to adjust the dose.

Taking alli with food and drink

alli should be taken with a low-calorie and low-fat diet. Try to start this diet before you start treatment. For information on how to set your calorie and fat targets, see Further informationin the blue pages of section 6.

You can take alli just before, during or up to one hour after meals. The capsule should be swallowed with water. This usually means one capsule at breakfast, one at lunch and one at dinner. Make sure your three main meals are balanced and low in calories and fat.

If you miss a meal or your meal does not contain fat, do not take a capsule. alli only works in the presence of fat from a meal.

If you eat a meal very high in fat, do not take a higher dose of alli. Taking a capsule with a meal high in fat increases the chance of diet-related treatment effects (see section 4). You should make every effort to avoid meals high in fat while taking alli.

Pregnancy and breast-feeding

Do not take alli during pregnancy or breast-feeding.

Driving and using machines

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

alli contains sodium

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

3. How to take alli

Preparation for weight loss

1. Choose your start date

Choose the day you will start using the capsules in advance. Before you start taking the capsules, start 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 diaries are helpful because they make you aware of what you are eating, how much you are eating and provide a basis for making changes.

1. Decide on your weight loss goal

Think about how much weight you want to lose and set a weight loss target. A realistic target 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 steady and gradual rate of about 0.5 kg per week.

1. Set your calorie and fat targets

To help you reach your weight loss target, you need to set two daily targets, one for calories and one for fat. For more information, see Further informationin the blue pages of section 6.

Taking alli

Adults aged 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, one at lunch and one at dinner. Make sure your three main meals are balanced and low in calories and fat.

• If you miss a meal or your meal does not contain fat, do not take a capsule. alli only works in the presence of fat from a meal.
• 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) included in the pack.
• Eat low-fat meals to help reduce diet-related treatment effects (see section 4).
• Try to be more physically active before you start treatment. Exercise is an important part of weight loss programmes. Remember to talk to your doctor if you have not exercised before.
• Continue to be active while you are taking alli and after you stop taking it.

How long should I take alli for?

• Do not take alli for more than 6 months.
• If you do not lose weight after taking alli for 12 weeks, talk to 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 time and then go back to your old habits. People who lose weight and maintain weight loss make changes to their lifestyle, including changes to what they eat and how active they are.

If you take more alli than you should

Do not take more than three capsules a day.

If you have taken too many capsules, talk to a doctor as soon as possible.

If you forget to take alli

If you forget to take a dose of alli:

• If it is less than one hour since your last meal, take the missed dose.
• If it is more than one hour since your last meal, do not take the missed dose. Wait and take the next dose with your next meal as usual.

If you have any further questions on the use of this product, 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 the use of alli (for example, gas with or without oily spotting, or more frequent and looser stools) are caused by the way it works (see section 1). Eat low-fat meals to try to control these diet-related treatment effects.

Serious side effects

Frequency not known

Severe allergic reactions

• Signs of a severe allergic reaction include: severe difficulty breathing, sweating, rash, itching, swelling of the face, fast heart rate, collapse.

Stop taking the capsules and seek medical help immediately.

Other serious side effects

• Rectal bleeding
• Diverticulitis (inflammation of the large intestine). Symptoms include lower stomach (abdominal) pain, especially on the left side, 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.
• Hepatitis (inflammation of the liver). Symptoms can include yellowing of the skin and eyes, itching, dark urine, stomach pain and a sensitive liver (indicated by pain below the front of the rib cage, on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (a deposit of calcium oxalate that can lead to kidney stones). See section 2, be particularly careful with alli.

Stop taking the capsules. Tell your doctor if you get any of these effects.

Very common side effects

May affect more than 1 in 10 people

• Gas (flatulence) with or without oily spotting.
• Sudden bowel movements
• Oily or fatty stools
• Soft stools

Tell your doctor or pharmacist if any of these side effects get worse or are troublesome.

Common side effects

May affect up to 1 in 10 people

• Stomach pain (abdominal)
• Incontinence (faecal)
• Fluid or liquid stools
• More frequent stools
• Anxiety

Tell your doctor or pharmacist if any of these side effects get worse or are troublesome.

Side effects found in blood tests

Frequency not known

• Increased levels of some liver enzymes.
• Effects on blood clotting in people taking warfarin or other anticoagulant 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. 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 how to control diet-related treatment effects

The most common side effects are caused by the way the capsules work and are a result of the removal of some of the fat from your body. These effects usually occur in the first few weeks of taking the capsules, before you have learned to limit the amount of fat in your diet. These diet-related treatment effects can be a sign that you have eaten more fat than you should have.

You can learn how to minimise diet-related treatment effects by following these simple guidelines:

• Start a low-fat diet a few days or even a week before you start taking the capsules.
• Find out more about the fat content of your favourite foods and the size of portions. If you become familiar with portion sizes, you are less likely to accidentally exceed your fat target.
• Distribute your daily fat allowance evenly across your meals throughout the day. Do not ‘save up’ your fat allowance and then eat a meal high in fat or have a fatty dessert, as you may have done with other weight loss programmes.
• Most people 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. This does not mean that the capsules are not working.

5. Storing 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 blister 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 the capsules from moisture.
• The bottle contains two sealed cylinders containing silica gel to keep the capsules dry. Keep the cylinders in the bottle. Do not swallow them.
• You can store your daily dose of alli in the blue pill box (Shuttle) included in the pack. Discard any capsule that has been stored in the pill box for more than one month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of alli

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

• Capsule content: Microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, and talc.
• Capsule shell: Gelatin, carmine indigo (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, and black ink (Shellac, black iron oxide (E172), and Propylene Glycol).
• Band: Gelatin, polysorbate 80, and carmine indigo (E132).

Appearance of the Product and Container Content

The alli capsules have a turquoise-colored shell and body with a band around the central area printed with "alli".

alli is available in packs of 42, 60, 84, 90, and 120 capsules. Not all pack sizes may be marketed.

Each pack includes a blue pill box (Shuttle) to carry the daily dose of alli.

Marketing Authorization Holder

GlaxoSmithKline Dungarvan Limited,

Knockbrack,

Dungarvan,

Co. Waterford,

Ireland

Manufacturer

Famar S.A, 48 KM Athens-Lamia,

190 11 Avlona, Greece

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

You can also visit the alli website specific to your country for more information about the alli weight loss program.

Date of Last Revision of this Leaflet: July 2020

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

MORE USEFUL INFORMATION

Risks of Being Overweight

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

• Hypertension
• Diabetes
• Heart disease
• Stroke
• Certain types of cancer
• Osteoarthritis

Talk to your doctor about the risk of developing these diseases.

Importance of Weight Loss

Losing weight 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 Goals While Taking alli

alli should be used with a low-calorie, 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 essential 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. They are sometimes called kilocalories or kcal. Energy can also be measured in kilojoules, which you may also have seen on nutrition labels.

• Your calorie goal is the maximum number of calories you will eat each day. See the table included later in this section.
• Your fat gram goal is the maximum number of grams of fat you will eat at each meal. The fat gram goal table has been developed based on the information shown below on how to set your calorie goal.

Controlling your fat goal is essential due to the mechanism of action of the capsules.

• Taking alli means your body will eliminate more fat, and it will be more challenging to handle as much fat in meals as before. Therefore, by sticking to your fat goal, you will maximize your weight loss results while minimizing the risk of treatment-related effects on your diet.

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

How to Set Your Calorie Goal

The following table has been designed to provide you with a calorie goal that is approximately 500 calories less than your body needs to maintain your current weight. This is equivalent to up to 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 steady rate of 0.5 kg per week without feelings of frustration or deprivation.

It is not recommended to take less than 1200 kcal per day.

You will need to know your physical activity level to set your calorie goals. The more active you are, the higher your calorie goal will be.

• Low activity means you never or hardly ever walk, climb stairs, garden, or do other daily activities.
• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are walking approximately three kilometers (2 miles), gardening for 30 to 45 minutes, or running two kilometers (1.25 miles) in 15 minutes. Choose the level that best fits your daily routine. If you are unsure which level you are at, 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 have per day. You should plan to have three meals per day. If you have set a calorie goal of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your assigned fat amount, snacks should not contain more than 3 g of fat.

Remember

• Stick to realistic calorie and fat goals, as this is a way to maintain long-term weight loss achievements.
• Write down what you eat in a food diary, including calorie and fat content.
• Try to be more physically active before starting to take the capsules. Physical activity is an essential 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, low-fat diet and guidelines for becoming more physically active.

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

Visit www.alli.com.es