OrliLoss 60 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orliloss 60 mg hard capsules

orlistat

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

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated 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.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse 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 Orliloss is and what it is used for

2. What you need to know before taking Orliloss

3. How to take Orliloss

4. Possible side effects

5. Storage of Orliloss

6. Contents of the pack and other information

1. What Orlistat is and what it is used for

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

BMI is a way of determining whether you have a healthy weight or are overweight, taking into account your height. The table included below will help you determine if you are overweight and whether this medicine is suitable for you. Check your weight in the table below. If your weight is below the weight shown next to your height, do not take this medicine.

Height	Weight
1.50 m	63 kg
1.55 m	67.25 kg
1.60 m	71.75 kg
1.65 m	76.25 kg
1.70 m	81 kg
1.75 m	85.75 kg
1.80 m	90.75 kg
1.85 m	95.75 kg
1.90 m	101 kg

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 in Orliloss (orlistat) is designed to target fat in your digestive system. It prevents about one-quarter of the fat from your meals from being absorbed. This unabsorbed fat is then eliminated from your body in the faeces. You may experience treatment-related effects (see section 4). Therefore, it is important that you follow a low-calorie and low-fat diet to help control these effects. If you do, the action of the capsules will assist your efforts by helping you lose more weight than with diet alone. For every 2 kg you lose with diet alone, Orliloss may help you lose an additional 1 kg.

2. What you need to know before taking Orliloss

Do not take Orliloss:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or breastfeeding,
• if you are taking cyclosporine, used after organ transplant, in cases of severe rheumatoid arthritis, and in certain serious skin conditions,
• if you are taking warfarin or other anticoagulant medicines,
• if you have cholestasis (a condition in which the flow of bile from the liver is blocked),
• if you have a diagnosed problem with food absorption (chronic malabsorption syndrome).

Warnings and precautions

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

If you have diabetes: consult your doctor about whether adjustment of your antidiabetic medication is needed.

• If you have any kidney disease: speak with your doctor before taking this medicine if you have kidney problems. Use of orlistat may be associated with kidney stones in patients with chronic kidney disease.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Other medicines and Orliloss

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

Orliloss may affect certain medicines you are taking.

Do not take Orliloss together with the following medicines:

• cyclosporine, used after organ transplant, in cases of severe rheumatoid arthritis, and in certain serious skin conditions,
• warfarin or other anticoagulant medicines.

Use of oral contraceptives together with Orliloss:

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

Multivitamin supplements and Orliloss:

• it is recommended to take a multivitamin supplement every day, as this medicine may reduce the levels of certain vitamins absorbed by the body. The multivitamin supplement should contain vitamins A, D, E, and K. It should be taken at bedtime, when you will no longer be taking Orliloss, to ensure proper absorption of the vitamins.

Consult your doctor before taking orlistat if you are taking:

• amiodarone, used for heart rhythm problems,
• acarbose (an antidiabetic medicine used to treat type 2 diabetes mellitus). Orliloss is not recommended for people taking acarbose,
• a thyroid medicine (levotiroxine), as dose adjustment may be needed and you may need to take your medicines at different times of the day,
• a medicine for epilepsy, as any change in frequency or severity of seizures should be discussed with your doctor,
• medicines for depression, psychiatric disorders, or anxiety,
• medicines to treat HIV. It is important 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 medicine for high blood pressure, as dose adjustment may be needed,
• if you are taking any medicine for high cholesterol, as dose adjustment may be needed.

Taking Orliloss with food and drink

Orliloss should be used together with a low-calorie and low-fat diet. Try to start this diet before beginning treatment. For information on how to set your calorie and fat intake goals, see "More useful information" in section 6.

Orliloss may be taken 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 skip a meal or if the meal contains no fat, do not take the capsule. This medicine does not work if the meal contains no fat.

If you eat a meal high in fat, do not take a higher dose than recommended. Taking a capsule with a meal that is very high in fat increases the likelihood of experiencing treatment-related side effects (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 medicine.

Do not take Orliloss during pregnancy or breastfeeding.

Driving and using machines

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

Orliloss contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., essentially “sodium-free”.

3. How to take Orliloss

Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Preparing to lose weight

1. Choose your start date

Decide in advance the day you will start taking the capsules. Before beginning to take the capsules, start your low-calorie and low-fat diet and allow your body a few days to adjust to your new eating habits. Keep a record of what you are eating in a food diary. Food diaries are effective because they make you aware of what and how much you are eating, and provide a basis for making changes.

2. Decide on your weight loss goal

Think about how much weight you want to lose and set yourself a target weight. 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 aim to lose weight gradually and steadily, at about 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 targets: one for calories and one for fat. For further information, see "Useful additional information" in section 6.

Taking Orliloss
Adults aged 18 years and over

• take one capsule three times a day,
• take Orliloss just before, during, or up to one hour after meals. This usually means one capsule at breakfast, lunch, and dinner. Make sure your three main meals are balanced and low in calories and fat,
• if you skip a meal or if your meal contains no 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 per day.

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

Try to become 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 stay physically active while taking Orliloss and after stopping it.

How long should you take Orliloss?

• Orliloss should not be taken for longer than 6 months,
• if you have not lost weight after taking this medicine for 12 weeks, consult your doctor or pharmacist. You may need to stop taking it,
• successful weight loss requires more than just changing your eating habits temporarily and then returning to old habits. People who lose weight and maintain the loss make lifestyle changes, including changes in what they eat and their level of physical activity.

If you take more Orliloss than you should

Do not take more than three capsules per day.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Most of the common adverse effects associated with the use of Orliloss (such as gas with or without oily spotting, increased frequency of bowel movements, or soft stools) are the result of its mechanism of action (see section 1). Follow a low-fat diet to help manage these diet-related treatment effects.

Serious adverse effects

The frequency of occurrence of these adverse effects is unknown.

Severe allergic reactions

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

Stop taking the capsules and seek immediate medical help.

Other serious adverse effects

• Rectal bleeding,
• Diverticulitis (inflammation of the large intestine). Symptoms include lower 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,
• Skin blistering (including blisters that burst),
• Severe stomach pain caused by gallstones,
• Hepatitis (liver inflammation). Symptoms may include yellowing of the skin and eyes, itching, dark-colored urine, stomach pain, and a tender liver (indicated by pain under the front part of the rib cage on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (calcium oxalate deposition which may lead to kidney stones). See section 2, take special care with Orliloss.

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

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

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

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

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

• Stomach (abdominal) pain,
• Incontinence (fecal),
• Loose or liquid stools,
• More frequent bowel movements,
• Anxiety.

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

Adverse effects observed in blood tests (frequency unknown)

• Increased levels of certain liver enzymes,
• Effects on blood coagulation in people taking warfarin or other anticoagulant medicines.

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

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

Learn to manage diet-related treatment effects

The most common adverse effects are caused by the mechanism of action of the capsules and occur due to the elimination of some fat from the body. These effects typically occur during 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 may be a sign that you have consumed more fat than recommended.

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

• Start a low-fat diet a few days, or even a week, before beginning to take the capsules,
• Learn more about the fat content of your favorite meals and portion sizes. Becoming familiar with portion sizes makes it less likely that you will accidentally exceed your fat intake goal,
• Distribute your fat allowance evenly across meals throughout the day. Do not “save” fat and calorie intake for a high-fat meal or dessert later, as you may have done with other weight-loss programs,
• Most users who experience these effects find 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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Orliloss

Keep this medicine out of the 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 medicine after the expiry date stated on the carton and label after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orliloss

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

The other components are:

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

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

Appearance of the product and contents of the pack

Orliloss hard capsules have a light blue body and cap.

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

Parque Norte Business Park

Roble Building

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 most recent revision of this leaflet: April 2022

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

ADDITIONAL USEFUL INFORMATION

Risks of being overweight

Being overweight affects your health and increases your risk of developing serious health problems such as:

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

Talk to your doctor about your risk of developing these conditions.

Importance of weight loss

Losing weight 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 overall health.

Useful tips on diet and your calorie and fat goals while taking Orliloss
Orliloss should be used in combination with a low-calorie and low-fat diet. The capsules work by preventing the absorption of some of the fat you eat, but you can still consume foods from all major food groups. While you should focus on the calories and fats you consume, it is important to maintain a balanced diet. You should choose meals containing a variety of 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 referred to as kilocalories or kcal. Energy can also be measured in kilojoules, which you may have seen on nutritional labels.

• Your calorie goal is the maximum number of calories you should consume each day. See the table included later in this section.
• Your fat gram goal is the maximum number of grams of fat you should consume per meal. The fat gram goal table has been designed based on the information provided below on setting your calorie goal.
• Controlling your fat intake is essential due to the mechanism of action of the capsules. Taking Orliloss means your body will eliminate more fat, making it more difficult to handle high-fat meals as before. Therefore, by adhering to your fat goal, you will maximize weight loss results while minimizing the risk of diet-related treatment side effects.
• You should aim for gradual and steady weight loss. Ideally, lose about 0.5 kg per week.

How to set your calorie goal

The following table has been designed to provide you with a daily calorie goal approximately 500 calories below the amount your body needs to maintain your current weight. This results in a weekly deficit of up to 3,500 calories, roughly equivalent to the number of calories in 0.5 kg of body fat.

Your calorie goal should allow you to lose weight gradually and steadily at a rate of about 0.5 kg per week, without feelings of frustration or deprivation.

It is not recommended to consume fewer than 1,200 kcal per day.

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

• Low activity means you never or almost never walk, climb stairs, garden, or engage in other physical activity daily.
• Moderate activity means burning 150 calories per day through physical activity. Examples of moderate activity include 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 applies to you, select Low activity.

Women

Low activity	Less than 68.1 kg	1,200 calories
68.1 kg to 74.7 kg	1,400 calories
74.8 kg to 83.9 kg	1,600 calories
84.0 kg and above	1,800 calories
Moderate activity	Less than 61.2 kg	1,400 calories
61.3 kg to 65.7 kg	1,600 calories
65.8 kg and above	1,800 calories

Men

Low activity	Less than 65.7 kg	1,400 calories
65.8 kg to 70.2 kg	1,600 calories
70.3 kg and above	1,800 calories
Moderate activity	59.0 kg and above	1,800 calories

How to set your fat goal

The following table shows how to set your fat goal based on the number of calories you can consume each day. You should plan to have three meals per day. If, for example, your goal is 1,400 calories per day, the maximum amount of fat allowed per meal would be 15 g. To stay within your allotted fat amount, snacks should not contain more than 3 g of fat.

Calorie amount you can consume per day	Maximum amount of fat allowed per meal	Maximum amount of fat from snacks allowed per day
1,200 calories	12 g	3 g
1,400 calories	15 g	3 g
1,600 calories	17 g	3 g
1,800 calories	19 g	3 g

Remember

• Stick to realistic calorie and fat intake goals, as this is a way to maintain long-term weight loss achievements,
• Record what you eat in a food diary, including calorie and fat content,
• Try to become 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 being physically active while taking Orliloss and after stopping it.