Leaflet:information for the user

Orliloss 60 mg hard capsules

orlistat

Read this leaflet carefully before you start taking thismedicine,because it contains important informationfor you.

Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience side effects, consult your doctor or pharmacist,even if they are 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.

1.What isOrlilossand what it is used for

2.What you need to knowbeforestarting totakeOrliloss

3.How to takeOrliloss

4.Possible side effects

5Storage ofOrliloss

6.Contents of the pack and additional information

Orlistat is used to lose weight in adults over 18 years old 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.

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 this medication is suitable for you. Check 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 this medication.

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 Orliloss works

The active ingredient of Orliloss (orlistat) is designed to target the fat in your digestive system. Prevents about a quarter of the fat you take in meals 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 to follow a low-calorie and low-fat diet to control those 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, Orliloss can help you lose 1 kg more.

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 ciclosporin, used after an organ transplant, for severe rheumatoid arthritis and certain severe skin conditions,
• if you are taking warfarin or other anticoagulant medications,
• 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 Orliloss.

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 this medication 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 medication.

Other medications and Orliloss

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

Orliloss may affect some medications you take.

Do not take Orliloss with the following medications:

• ciclosporin, used after an organ transplant, for severe rheumatoid arthritis and certain severe skin conditions,
• warfarin or other anticoagulant medications.

Use of oral contraceptives with Orliloss:

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

Multi-vitamin complexes and Orliloss:

• it is recommended to take a multi-vitamin complex every day since this medication may reduce the levels of some vitamins absorbed by the body. The multi-vitamin complex should contain vitamins A, D, E, and K. Take it before going to sleep, when you will not 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,
• acarbosa (an antidiabetic medication used to treat type 2 diabetes). Orlistat is not recommended for people taking acarbosa,
• a thyroid medication (levotiroxine) since the dose may need to be adjusted and take your medications at different times of the day,
• an antiepileptic medication, since any change in seizure frequency and severity should be discussed with your doctor,
• medications for depression, psychiatric disorders, or anxiety,
• medications to treat HIV.It is important to 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 the dose may need to be adjusted,
• if you are taking any medication for high cholesterol, as the dose may need to be adjusted.

Orliloss intake with 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 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. This medication 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 effects related to the diet (see section 4). You should make every effort to avoid meals high in fat while taking Orliloss.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you 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 lactation.

Driving and operating machines

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

Orliloss contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

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

Weight Loss Preparation

1. Choose your start date

Choose the day you will start using 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.

2. Decide 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 around 0.5 kg per week.

3. 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.

Orliloss Intake
Adults 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 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. Orliloss does not work unless the meal contains some fat,
• swallow the capsule whole with water,
• do not take more than three capsules a day.

Take 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 Orliloss and after stopping its use.

How long should I take Orliloss?

• Orliloss should not be taken for more than 6 months,
• if you do not lose weight after taking this medication for 12 weeks, consult your doctor or pharmacist. You may need to stop taking it,
• 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 modifications to what they eat and how active they are.

If you take more Orliloss than you should

Do not take more than three capsules a day.

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

If you forgot to take Orliloss
If you forgot to take a dose of Orliloss:

• 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.

Do nottakeadosedoubletocompensateforthedosesmissed.

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 Orliloss (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 with which these side effects occur 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, and collapse.

Stop taking the capsules and seek medical help immediately.

Other severe side effects

• Rectal bleeding,
• diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain (abdominal), 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,
• skin blisters (including blisters that burst),
• intense stomach pain caused by gallstones (stones in the gallbladder)
• hepatitis (inflammation of the liver). Symptoms may include yellow skin and eyes, itching, dark-colored urine, stomach and liver pain (indicated by pain below the front of the chest cavity on the right side), sometimes with loss of appetite.
• nephrotoxicity by oxalate (deposition of calcium oxalate that may 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 side effects.

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

• gas (flatulence) with or without oily spots,
• sudden 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 people)

• abdominal pain (stomach),
• incontinence (fecal),
• 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 with which these side effects occur is unknown)

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

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

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Learn to control treatment-related side effects related to diet

The most common side effects are caused by the mechanism of action of the capsules and occur typically 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 side effects related to diet may be a sign that you have eaten more fat than you should.

You can learn to minimize treatment-related side 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 familiarize yourself with the portions, you will be less likely to accidentally exceed your fat target,
• distribute the fat limit evenly 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 side 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 that the capsules are not working.

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 Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

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

Keepthis medicationout of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect it from light and moisture.

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

Themedicinesshouldnotbethrownintothedrainsorintothetrash.DepositthepackagingandthemedicinesthatyoudonotneedattheSIGREpoint of the pharmacy. If in doubt, ask your pharmacisthowtodisposeofthepackagingandthemedicinesthatyoudonotneed. Bydoingso,youwillhelptoprotecttheenvironment.

Composition of Orliloss

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

The other components are:

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

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

Appearance of the product and contents of the package

Orlilosshard capsules have a blue light-colored body and cap.

Orliloss60 mg hard capsules are supplied in PVC/PVDC/Al blister packs containing 42, 84 and 120capsules and in HDPE bottles with PE caps containing 42 and 84 hard capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Lek, S.A.

Ul Domaniewska 50 C

02-672 Warsaw

Poland

Last revision date of this leaflet: April 2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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.

Talk to 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 objectives while taking Orliloss
Orlilossshould 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 objectives

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 objective is the maximum number of calories you will eat each day. See the table that is included later in this section.
• Your fat objective is the maximum number of grams of fat you will eat in each meal. The fat objective table has been drawn up following the information shown below on how to set your calorie objective.
• Controlling your fat objective is essential because of the mechanism of action of the capsules. Taking Orliloss means that your body will eliminate more fat, and therefore it will be more difficult for you to manage as much fat in meals as before. Therefore, by adjusting to your fat objective, you will maximize the results of weight loss while minimizing the risk of treatment-related side effects related to diet.
• 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 objective

The following table has been designed so that it provides you with a calorie objective 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 objective should allow you to lose weight at a gradual and stable rate of 0.5 kg per week without feelings of frustration or deprivation.

Do not take less than 1200 Kcal per day.

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

• Low activity means that you never or almost never walk, climb stairs, practice gardening or other daily activity.
• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are walking approximately three kilometers, working in the garden for 30 to 45 minutes or running two kilometers in 15 minutes. Choose the level that best suits your daily routine. If you are unsure of which level you are, choose Low activity.

Women

Men

How to set your fat objective

The following table shows how to set your fat objective 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 objectives 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 with your doctor if you have not exercised before,
• Continue to be active while taking Orliloss and after stopping it.