ORLILOSS 60 mg HARD CAPSULES

Introduction

Leaflet:information for the user

Orliloss 60 mg hard capsules

orlistat

Read the entire leaflet carefullybefore starting to take thismedication, as it contains important informationfor you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the leaflet

1. What is Orliloss and what is it used for
2. What you need to know before taking Orliloss
3. How to take Orliloss
4. Possible side effects

5 Conservation of Orliloss

1. Package contents and additional information

1. What is Orliloss and what is it used for

Orlistat is used to lose weight in adults over 18 years of age with overweight, with a body mass index (BMI) of 28 or higher. Orlistat should be used in combination with a low-calorie and low-fat diet.

BMI is a way to determine if you have a healthy weight or if you are overweight, considering your height. The table included below will help you determine if you are overweight and if this medication is suitable for you. Check your weight in the following table. If your weight is lower than the weight listed next to your height, do not take this medication.

Risks of being overweight

Being 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 Orliloss works

The active ingredient of Orliloss (orlistat) is designed to target the fat in your digestive system. It prevents about a quarter of the fat you eat from being absorbed. This fat will be eliminated from your body in the stool. You may experience treatment-related effects (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 to lose more weight than just with diet. For every 2 kg you lose just with diet, Orliloss can help you lose 1 kg more.

2. What you need to know before taking Orliloss

Do not take Orliloss:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6),
• if you are pregnant or breastfeeding,
• if you are taking cyclosporin, used after an organ transplant, in cases of severe rheumatoid arthritis, and in certain severe skin conditions,
• if you are taking warfarin or other anticoagulant medications,
• if you have cholestasis (a disease where the flow of bile from the liver is blocked),
• if you have food absorption problems (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Orliloss.

If you have diabetes. Consult your doctor if you need to adjust your antidiabetic medication.

• If you have any kidney disease. Talk to your doctor before taking this medication if you have kidney problems. The use of orlistat may be associated with kidney stones in patients with chronic kidney disease.

Childrenandadolescents

Children and adolescents under 18 years of age should not take this medication.

Other medications and Orliloss

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

Orliloss may affect some medications you take.

Do not take Orliloss with the following medications:

• cyclosporin, used after an organ transplant, in cases of severe rheumatoid arthritis, and in certain severe skin conditions,
• warfarin or other anticoagulant medications.

Use of oral contraceptives with Orliloss:

• oral contraceptives may be less effective if you suffer from severe diarrhea. Use an additional contraceptive method if you suffer from severe diarrhea.

Multivitamin complexes and Orliloss:

• it is recommended to take a multivitamin complex every day since this medication may reduce the levels of some vitamins absorbed by the body. The multivitamin complex should contain vitamins A, D, E, and K. You should take it before bedtime, when you will no longer take Orliloss, to ensure that the vitamins are absorbed.

Consult your doctor before taking orlistat if you are taking:

• amiodarone, used for heart rhythm problems,
• acarbose (an antidiabetic medication used to treat type 2 diabetes mellitus). Orliloss is not recommended for people taking acarbose,
• a medication for the thyroid (levothyroxine), as it may be necessary to adjust the dose and take the medications at different times of the day,
• a medication for epilepsy, as any change in the frequency and severity of seizures should be discussed with your doctor,
• medications for depression, psychiatric disorders, or anxiety,
• medications to treat HIV. It is essential that you consult your doctor before taking Orliloss if you are receiving treatment for HIV.

Consult your doctor or pharmacist while taking Orliloss:

• if you are taking any medication for high blood pressure, as it may be necessary to adjust the dose,
• if you are taking any medication for high cholesterol, as it may be necessary to adjust the dose.

Taking Orlilosswith food and drinks

Orliloss 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, see "More useful information" in section 6.

You can take Orliloss immediately before, during, or up to one hour after a meal. The capsule should be swallowed with water. This usually means 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. This medication does not work if the meal does not contain some fat.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Orliloss during pregnancy or breastfeeding.

Driving and using machines

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

Orliloss contains sodium

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

3. How to take Orliloss

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist.

Preparation for weight loss

1. Choose your start date

Choose the day you will start using the capsules in advance. Before starting to take 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 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. Decide on 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 constant rate of about 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, see "More useful information" in section 6.

Taking OrlilossAdults 18 years or older

• take one capsule, three times a day,
• take Orliloss just before, during, or up to one hour after meals. Normally, this means one capsule with breakfast, one with lunch, and one with dinner. Make sure your three main meals are balanced and low in calories and fat,
• swallow the capsule whole with water,
• do not take more than three capsules per day.

Eat low-fat meals to help reduce treatment-related effects related to diet (see section 4).

Try to be more physically active before starting treatment. Exercise is an essential part of weight loss programs. Remember to consult your doctor if you have not exercised before.

Continue to be active while taking Orliloss and after stopping it.

How long should I take Orliloss?

• Orliloss should not be taken for more than 6 months,
• to be successful in weight loss, it is not enough to eat differently for a short period and then return to old habits. People who lose weight and maintain weight loss make lifestyle changes, including modifications to what they eat and how active they are.

If you take more Orlilossthan you should

Do not take more than three capsules per day.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take OrlilossIf you forget to take a dose of Orliloss:

Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most frequent side effects related to the use of Orliloss (e.g., gas with or without oily spots, or more frequent and soft stools) are the result of its mechanism of action (see section 1). Eat low-fat foods to try to control these treatment-related effects related to diet.

Severe side effects

The frequency with which these side effects occur is not known.

Severe allergic reactions

Signs of a severe allergic reaction include: severe difficulty breathing, sweating, skin rash, itching, swelling of the face, rapid heartbeat, and collapse.

Stop taking the capsules and seek immediate medical attention.

Other severe side effects

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

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

Very common side effects(may affect more than 1 in 10 people)

• gas (flatulence) with or without oily spots,
• sudden evacuation,
• oily or fatty stools,
• soft stools.

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

Common side effects(may affect up to 1 in 10 people)

• stomach pain (abdominal),
• incontinence (fecal),
• fluid or liquid stools,
• more frequent stools,
• anxiety.

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

Side effects observed in blood tests(the frequency with which these side effects occur is not known)

• increased levels of some liver enzymes,
• effects on blood coagulation in people taking warfarin or other anticoagulant medications.

Tell your doctor that you are taking Orliloss when you have a blood test.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.

Learn to control treatment-related effects related to diet

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 using the capsules, before you have learned to limit the amount of fat in your diet. These treatment-related effects related to diet may be a sign that you have eaten more fat than you should.

You can learn to minimize treatment-related effects related to diet 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 size of the portions. If you become familiar with the portions, you will be less likely to accidentally exceed your fat goal,
• distribute your fat limit evenly in meals throughout the day. Do not "save" fat and calorie intake to 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 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.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Orliloss

Keepthis medicationout of sight and reach of children.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Do not use this medication after the expiration date stated on the box and label after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Orliloss Composition

The active ingredient is orlistat. Each hard capsule contains 60 mg of orlistat.

The other ingredients are:

Capsule content: microcrystalline cellulose Ph 112, sodium carboxymethyl starch (type A) potato, hydrophobic colloidal silica, and sodium lauryl sulfate.

Capsule body: gelatin, indigo carmine (E132), and titanium dioxide (E171).

Product Appearance and Package Contents

Orliloss hard capsules have a light blue body and cap.

Orliloss 60 mg hard capsules are supplied in PVC/PVDC/Al blister packs of 42, 84, and 120 hard capsules and in HDPE bottles with a PE cap containing 42 and 84 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Lek, S.A.

Ul Domaniewska 50 C

02-672 Warsaw

Poland

Date of the Last Revision of this Leaflet: April 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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 OrlilossOrliloss 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 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. Sometimes they are called kilocalories or kcal. Energy can also be measured in kilojoules, which you may also have seen in nutritional tables.

• Your calorie goal is the maximum number of calories you will eat each day. See the chart included later in this section.
• Your fat goal is the maximum number of grams of fat you will eat at each meal. The fat goal chart 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 Orliloss means that your body will eliminate more fat, and therefore it will be more challenging to handle as much fat in meals as before. Therefore, by adjusting 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 steadily. 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 its current weight. This assumes 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 stable 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 level of physical activity to establish your calorie goals. The more active you are, the higher your calorie goal will be.

• Low activity means that you never or almost never walk, climb stairs, garden, or engage in other daily activities.
• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are walking approximately three kilometers, gardening for 30 to 45 minutes, or running two kilometers 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 chart 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 a day. If you have set a goal of 1,400 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

• Adjust to realistic calorie and fat goals, as it 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 with your doctor if you have not exercised before,
• Continue to be active while taking Orliloss and after stopping treatment.