BEACITA 60 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Beacita 60 mg Hard Capsules

orlistat

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

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

• Keep this leaflet, 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 not listed in this leaflet. See section 4.
• If you do not lose weight after taking Beacita for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Beacita.

Contents of the Package Leaflet

1. What is Beacita and what is it used for
2. What you need to know before taking Beacita
3. How to take Beacita
4. Possible side effects
5. Storage of Beacita
6. Package Contents and Additional Information

1. What is Beacita and what is it used for

Beacita 60 mg hard capsules (orlistat) is a peripheral-acting anti-obesity medication used to aid in weight loss in adults over 18 years of age with overweight, with a body mass index (BMI) of 28 or higher. Beacita should be used in combination with a low-calorie and low-fat diet.

Body Mass Index (BMI) is a way to determine if you have a healthy weight or if you are overweight, considering your height. The table below will help you find out if you are overweight and if Beacita 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 Beacita.

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 Beacita works

The active ingredient of Beacita (orlistat) is designed to target 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 your feces (see section 4). Therefore, it is essential that you follow a low-calorie and low-fat diet to control these diet-related treatment 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, Beacita could help you lose up to 1 kg more.

2. What you need to know before taking Beacita

Do not take Beacita

? If you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6).

? If you are pregnant or breastfeeding.

? If you are taking ciclosporin, used after organ transplantation, 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 bile flow from the liver is blocked).

? If you have problems with food absorption (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Beacita.

? If you have diabetes. Consult your doctor if you need to adjust your anti-diabetic medication.

? If you have any kidney disease. Talk to your doctor before taking Beacita 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 of age should not take this medicine.

Other medicines and Beacita

Beacita may affect some medicines you take.

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

Do not take Beacita with the following medicines.

? Ciclosporin, used after organ transplantation, in cases of severe rheumatoid arthritis, and in certain severe skin conditions.

? Warfarin or other anticoagulant medications.

Use of oral contraceptives with Beacita

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

Take a multivitamin every day if you are taking Beacita

? Beacita may reduce the levels of some vitamins absorbed by the body. The multivitamin complex should contain vitamins A, D, E, and K, and you should take it before bedtime, when you will not be taking Beacita, to ensure that the vitamins are absorbed.

Consult your doctor before taking Beacita if you are taking

? Amiodarone, used for heart rhythm problems.

? Acarbose (an anti-diabetic medication used to treat type 2 diabetes mellitus). The use of Beacita is not recommended in people taking acarbose.

? A medicine for the thyroid (levothyroxine), as it may be necessary to adjust the dose and take your medicines at different times of the day.

? A medicine for epilepsy, 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 Beacita if you are receiving treatment for HIV.

? Medicines for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking Beacita

? 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 Beacita with food, drinks, and alcohol

Beacita 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 Additional Useful Informationin section 6.

Beacita can 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. Make sure your three main meals are balanced and low in calories and fat.

If you take a meal with high fat content, do not take a higher dose than recommended.

Taking a capsule with a meal that contains too much fat increases the chances of suffering from diet-related treatment effects (see section 4). You should make every effort to avoid meals with high fat content while taking Beacita.

Pregnancy and breastfeeding

Do not take Beacita during pregnancy or breastfeeding.

Driving and using machines

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

Beacita contains sodium

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

3. How to take Beacita

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

Preparation for weight loss

1. Choose your start date

Choose in advance the day you will start using the capsules. 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 Additional Useful Informationin section 6.

Taking Beacita

Adults 18 years or older

? Take one capsule, three times a day.

? Take Beacita immediately 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.

? If you miss a meal or if your meal does not contain fat, do not take a capsule. Beacita does not work unless the meal contains some fat.

? Swallow the capsule whole with water.

? Do not take more than three capsules per day.

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

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

? Continue to be active while taking Beacita and after stopping it.

How long should Beacita be taken

? Beacita should not be taken for more than 6 months.

? If you do not lose weight after taking Beacita for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Beacita.

? 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 Beacita than you should

Do not take more than three capsules per day.

? If you have taken too many capsules, contact a doctor as soon as possible.

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 medicine and the amount ingested.

If you forget to take Beacita

If you forget to take a dose of Beacita:

? If it has been less than one hour since your last meal, take the missed capsule.

? If it has been more than one hour since your last meal, do not take the missed capsule. Wait and take the next capsule with the next meal as usual.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Severe side effects

The frequency of these side effects is not known.

Severe allergic reactions

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

? Stop taking the capsules and seek immediate medical attention.

Other severe side effects

? Rectal bleeding.

? Diverticulitis (inflammation of the large intestine). Symptoms include pain in the lower abdomen, 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, Warnings and precautions.

? 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 bowel movements.

? Oily or fatty stools.

? Soft stools.

? Inform 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.

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

Effects observed in blood tests

The frequency of these effects is not known (frequency cannot be estimated from available data)

? Increase in some liver enzyme levels.

? Effects on blood coagulation in people taking warfarin or other anticoagulant medications.

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

Learn to control diet-related treatment 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 body's fat. 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 diet-related treatment effects can be a sign that you have eaten more fat than you should.

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 starting to take the capsules.

? Find out more about the fat content of your favorite foods and portion sizes. If you become familiar with portion sizes, you will be less likely to accidentally exceed your fat goal.

? Distribute your fat limit evenly across meals throughout the day. Do not "save" fat 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 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. Storage of Beacita

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofBeacita

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

Capsule filling:microcrystalline cellulose PH 112, sodium carboxymethyl starch (type A) (derived from potato starch), hydrophobic colloidal silica, sodium lauryl sulfate.

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

Product Appearance and Package Contents

Beacita capsules have a light blue body and cap.

Beacita 60 mg hard capsules are available in package sizes of 42 and 84 capsules.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

Or

Rontis Hellas Medical and Pharmaceutical Products S.A.

p.o. BOX 3012 Larisa Industrial Area

41004 Larisa

Greece

Date of Last Revision of the Leaflet: October 2020

Other Sources of Information

Detailed information about this medication 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 Beacita

Beacita 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 fats 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 gram goal is the maximum number of grams of fat you will eat at each meal. The fat gram 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 Beacita means that your body will eliminate more fat, and therefore, it will be more difficult 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 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 its current weight. This means 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 1,200 kcal per day.

You will need to know your physical activity level 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 of your level, 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 the assigned amount of fat, snacks should not contain more than 3 g of fat.

Remember:

? Adjusting to realistic calorie and fat goals 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 Beacita and after stopping treatment.