BEACITA 60 mg Hard Capsule

Зміст інструкції

1. BEACITA 60 mg hard capsules
   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. How to store BEACITA
   6. Package Contents and Further Information
2. BEACITA 120 mg hard capsules
   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. How to store BEACITA
   6. Contents of the pack and other information

BEACITA 60 mg hard capsules

Orlistat
Generic medicine

Read this leaflet carefully before you start taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not lose weight after taking BEACITA for 12 weeks, ask your doctor or pharmacist for advice. It may be necessary to stop taking BEACITA.

Contents of this leaflet:

• 1. What BEACITA is and what it is used for
• 2. What you need to know before you take BEACITA
• 3. How to take BEACITA
• 4. Possible side effects
• 5. How to store BEACITA
• 6. Contents of the pack and other information

1. WHAT IS BEACITA AND WHAT IS IT USED FOR

BEACITA is used for weight loss in adults aged 18 years and over who are overweight, with a body mass index (BMI) equal to or greater than 28. BEACITA must be used in association with a low-calorie, low-fat diet. The BMI is a way to assess whether your weight is right or whether you are overweight for your height. The table below will help you find out if you are overweight and if BEACITA is suitable for you. Find your height in the table. If your weight is lower than that indicated for your height, do not take BEACITA

Risks associated with being overweight
Being overweight increases the risk of developing several serious health problems, such as diabetes and cardiovascular diseases. These conditions may not cause you obvious discomfort, so you should consult your doctor for a general check-up of your health status.

How BEACITA works
The active ingredient of BEACITA (orlistat) has been studied to act on fats at the level of the digestive system. This substance blocks the absorption of approximately one quarter of the fats present in meals. These fats are thus eliminated from the body with the stool. You may experience treatment effects associated with the diet (see section 4). It is therefore important to commit to following a low-fat diet to control these effects. In this way, the effect of the capsules will support your commitment, helping you to lose more weight than diet alone. For every 2 kg lost with diet alone, BEACITA can help you lose 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, a medicine used after organ transplants, for severe rheumatoid arthritis and some severe skin diseases
• If you are taking warfarin or other medicines used to thin the blood
• If you suffer from cholestasis (a condition in which the flow of bile from the liver is blocked)
• If you suffer from problems with food absorption (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking BEACITA.

• If you suffer from diabetes, tell your doctor that they may need to adjust the dose of your anti-diabetic medicine.
• If you suffer from kidney disease. Consult your doctor before taking BEACITA if you have kidney problems. The use of orlistat may be associated with the formation of kidney stones in patients suffering from chronic kidney disease.

Children and adolescents
This medicine should not be taken by children and adolescents under 18 years of age.

Other medicines and BEACITA
BEACITA can affect some medicines that you must take.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Do not take BEACITA with these medicines

• Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and in some severe skin diseases.
• Warfarin or other medicines used to thin the blood. The oral contraceptive pill and BEACITA The oral contraceptive pill may be less effective in case of severe diarrhoea. Use an additional contraceptive method if you develop severe diarrhoea.

Multivitamin preparations and BEACITA
You must take a multivitamin preparation every day. BEACITA can reduce the levels of some
vitamins absorbed by the body. The multivitamin preparation must contain vitamins A, D, E and

• K. You must take the multivitamin preparation before bedtime, at a different time from when you take BEACITA, to promote the absorption of vitamins

Tell your doctor or pharmacist before taking BEACITA if you are taking

• amiodarone, used for heart rhythm problems;
• taking BEACITA is not recommended for patients taking acarbose (antidiabetic medicine used for type 2 diabetes mellitus);
• a medicine for the thyroid (levothyroxine), as it may be necessary to adjust the dose and take the two medicines at different times of the day;
• a medicine for epilepsy, as any change in the frequency and intensity of seizures should be discussed with your doctor.
• medicines to treat HIV. It is important that you consult your doctor before taking BEACITA if you are being treated for HIV;
• medicines for depression, psychiatric illnesses or anxiety.

Tell your doctor or pharmacist when you take BEACITA

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

BEACITA with food and drink
BEACITA should be taken in conjunction with a low-calorie and low-fat diet. Try to
start the diet before starting treatment. For information on how to set your goals in
terms of calories and fats, read the Further informationsection in Section 6.
Take BEACITA immediately before, during or within one hour of meals. This generally means
one capsule with breakfast, lunch and dinner. If you skip a meal or eat a meal that contains no fat,
do not take the capsule. BEACITA does not work if the meal does not contain at least some fat.
If you eat a meal high in fat, do not take a higher dose than recommended. Taking the
capsule with a meal containing too much fat can increase the likelihood of developing side effects of
the diet-related treatment (see section 4). Make every possible effort to avoid any
meal containing a lot of fat while taking BEACITA.

Pregnancy and breastfeeding
Do not take BEACITA if you are pregnant or breastfeeding.

Driving and operating machinery
It is unlikely that BEACITA will affect your ability to drive or operate machinery.

3. How to take BEACITA

Prepare to lose weight
Choose a start date
Choose in advance the date on which you will start taking the capsules. Before starting to take the
capsules, begin a low-calorie and low-fat diet and give your body a few days to
adjust to the new eating habits. Record what you eat in a food diary. These
diaries are effective because they make you aware of what you eat and how much you eat,
providing you with the basis for making changes.
Decide on your weight loss goal
Think about how many kilograms you want to lose and then set a weight target. A realistic goal is to lose
between 5% and 10% of your initial weight. The amount of weight you can lose may vary from week to
week. You should aim to lose weight at a gradual and steady rate of about 0.5 kg per week.
Set your goals in terms of calories and fats
To help you achieve your weight target, you need to set two daily goals,
one for calories and one for fats. For more advice, read the paragraph “ Further useful information”
in section 6

Taking BEACITA
Adults aged 18 years and over

• Take one capsule, three times a day.
• Take BEACITA immediately before, during or within one hour of meals. This generally means one capsule at breakfast, one at lunch and one at dinner. Make sure that your three main meals are well-balanced, and low in calories and fats
• If you skip a meal, or if you consume a meal that does not contain fats, do not take the capsule. BEACITA does not work if the meal does not contain at least some fats.
• Swallow the capsule whole with water.
• Do not take more than 3 capsules a day. Consume low-fat meals to reduce the likelihood of developing side effects associated with the diet (see section 4).

Try to increase your physical activity before starting treatment with the capsules.
Physical activity is an important part of a weight loss program. If you have never done
physical activity, remember to have a check-up with your doctor first.
Continue to exercise while taking BEACITA and also after you have stopped taking it.

How long you should takeBEACITA

• BEACITA should not be taken for more than six months.
• If you do not lose weight after taking BEACITA for 12 weeks, ask your doctor or pharmacist for advice.
• You may need to stop treatment with BEACITA.
• Effective weight loss is not achieved just by eating differently for a short period of time and then returning to old eating habits. People who lose weight and maintain the loss change their lifestyles, changing what they eat and their level of physical activity.

If you take more BEACITA than you should
Do not take more than 3 capsules a day.

• If you have taken too many capsules, contact your doctor as soon as possible.

If you forget to take BEACITA
If you have forgotten to take a capsule:

• If less than one hour has passed since your last meal, take the forgotten capsule.
• If more than one hour has passed since your last meal, do not take the forgotten capsule. Wait and take the next capsule near your next meal, as usual

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most of the side effects of BEACITA (for example, presence of intestinal gas with or
without oily leakage, sudden or more frequent bowel movements and soft stools) are caused by the
mechanism by which it works (see section 1). Consume low-fat meals to
help control these treatment effects associated with the diet.

Serious side effects(frequency of these side effects 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, collapse. Stop taking the capsules. Seek immediate medical attention. Other serious side effects
• anal (rectal) bleeding
• diverticulitis (intestinal inflammation). Symptoms may include abdominal pain, especially on the left, possibly accompanied by fever and constipation
• pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating to the back, possibly accompanied by fever, nausea and vomiting.
• blisters on the skin (including blisters that break)
• severe abdominal pain caused by gallstones
• hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain and liver tenderness (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite
• oxalates nephropathy (calcium oxalate build-up that can form kidney stones) which can lead to kidney failure. See section 2 Warnings and precautions.

Stop taking the capsules. If you experience any of these effects, see your doctor.

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

• presence of intestinal gas (flatulence), with or without oily leakage
• sudden bowel movements
• fatty or oily stools
• soft stools
• oily leakage
• low blood sugar levels (manifested in some patients with type 2 diabetes)
• upper respiratory tract infection
• influenza
• headache.

Tell your doctor or pharmacist if any of these effects becomes serious or bothersome.
Common side effects (may affect up to 1 in 10 people)

• abdominal (stomach) pain
• rectal/discomfort pain
• swelling (manifested by some subjects with type 2 diabetes)
• dental/gum problems
• fatigue
• incontinence (faeces)
• watery/liquid stools
• more frequent bowel movements
• anxiety
• urinary tract infection
• lower respiratory tract infection.

Tell your doctor or pharmacist if any of these effects becomes serious or bothersome.
Effects on blood tests (frequency with which they occur is not known)

• increased levels of certain liver enzymes
• effects on blood clotting in patients taking warfarin or other anticoagulants.

Tell your doctor that you are taking BEACITA while undergoing blood tests.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

Learning to control treatment effects associated with the diet
Most side effects are caused by the mechanism by which the capsules work and
result from the fact that some of the fats pass through the body and are eliminated as such in the
faeces. These effects typically occur within the first few weeks of treatment, before getting
used to limiting the amount of fat in the diet. These treatment effects associated with the
diet can be a sign that you have eaten more fat than you should have.
You can learn to minimize the impact of treatment effects associated with the diet by observing
these rules:

• Start following a low-fat diet for a few days, or even a week, before starting to take the capsules.
• Be more aware of how much fat your favorite foods contain and the portion sizes you eat. By familiarizing yourself with portions, you will be less likely to accidentally exceed the set amount of fat.
• Distribute your fat ration evenly throughout the meals of the day. Do not save fat and calories to then indulge in a high-fat meal or a dessert, as you might do following other weight loss programs.
• Most subjects who have experienced these effects have found them manageable and controllable by adjusting their diet.
• Do not worry if you do not experience any of these problems. This does not mean that the capsules are not working.

5. How to store BEACITA

• Keep this medicine out of the sight and reach of children.
• Do not store at temperatures above 25°C. Store in the original package to protect the medicine from light and moisture.
• Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Further Information

What BEACITA contains

• The active ingredient is orlistat. Each hard capsule contains 60 mg of orlistat.
• The other ingredients are: Capsule content: microcrystalline cellulose PH112, sodium starch glycolate (type A), anhydrous colloidal silica, sodium lauryl sulfate; Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).

Description of the appearance of BEACITA and package contents
BEACITA capsules have blue caps and bodies.

Package size
Blisters: 42, 60, 84 90 and 120 capsules.
Bottles: 42 and 84 capsules.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Aurobindo Pharma (Italia) – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
Pharmaceutical Works POLPHARMA SA - 19 Pelplińska Street - 83-200 Starogard Gdański (Poland)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Portugal Orlistato Actavis
Austria Beacita 60 mg Hard Capsules
Bulgaria Beacita
Czech Republic Beacita 60 mg
Denmark Beacita 60 mg
Hungary Beacita
Italy Beacita
Malta Beacita
Sweden Beacita
United Kingdom Orlistat 60 mg Capsules, hard

OTHER USEFUL INFORMATION
Risks associated with overweight
Being overweight affects your health and increases the risk of developing serious health problems
such as:

• High blood pressure
• Diabetes
• Heart disease
• Stroke
• Some forms of cancer
• Osteoarthritis Talk to your doctor about your personal risks of developing these problems.

The importance of losing weight
Losing weight and maintaining the loss, for example by improving your diet and increasing physical activity,
can help reduce the risk of major health problems and improve your health itself.

Useful tips on diet and fat and calorie targets when taking
BEACITA
BEACITA must be used in conjunction with a low-calorie and low-fat diet. The capsules work by preventing the absorption of some of the fat ingested with the diet, but you can
continue to eat foods from all the main food groups. Although it is necessary to focus
on the calories and fats you eat, it is still important to follow a balanced diet. It is
advisable to choose meals that contain a variety of different nutrients and learn to
eat correctly in the long term.

Understanding the importance of fat and calorie targets
Calories are a measure of the energy the body needs. They are sometimes called
kilocalories or kcal. Energy can also be measured in kilojoules, which can also be shown
on food labels

• The calorie target is the maximum number of calories you can consume in a day. See the table further on in this paragraph.
• The fat target in grams is the maximum number of grams of fat you can consume per meal. The fat table is shown after the information below on defining the calorie target.
• Keeping your fat target under control is essential, given how the capsules work. When taking BEACITA, your body will eliminate more fat, and therefore may have difficulty managing it if you eat the same amount of fat as before. Therefore, by respecting the predefined fat target, you will be able to achieve the best results in terms of weight loss, minimizing the risk of side effects of the treatment associated with the diet.
• You should try to lose weight gradually and steadily. Ideally, you should lose about 0.5 kg per week.

How to set the calorie target
The following table has been developed to give you a calorie target that is about 500 calories lower than
what your body needs to maintain your current weight. This is a total of 3500
fewer calories per week, which is the amount of calories contained in 0.5 kg of fat.
Only by respecting the calorie target should you be able to lose weight at a gradual and
steady rate of about 0.5 kg per week, without feeling frustrated or dissatisfied.
It is not advisable to consume less than 1200 calories per day.
To set your calorie target you need to know your activity level. The more active you are,
the higher the calorie target

• A low level of activity means doing little or no activity such as walking, climbing stairs, gardening or other daily physical activities.
• A moderate level of activity means burning about 150 calories per day in physical activity, for example walking three kilometers, gardening for 30-45 minutes or running two kilometers in 15 minutes. Choose the activity level that best suits your daily habits. If you are unsure of your level, choose a low activity level

Women
Men

How to set the fat target
The following table shows you how to set your fat target based on the amount of
calories allowed per day. You should plan to consume 3 meals a day. For example, if
you have set a calorie target of 1400 calories per day, the maximum amount of fat allowed per
meal will be 15 g. To respect the allowed daily amount of fat, snacks should not
contain more than 3 g of fat.
Remember:

• Set a realistic calorie and fat target, as this is a good way to maintain your achieved weight goals in the long term.
• Keep a record of what you eat in a food diary, including the calorie and fat content.
• Try to increase your level of physical activity before starting to take the capsules. Physical activity is an important part of a weight loss program. If you have never exercised before, be sure to consult your doctor.
• Continue to stay active while taking BEACITA and after stopping treatment.

The BEACITA weight loss program combines the capsules with a dietary plan and a wide range
of resources to help you understand how to follow a low-calorie and low-fat diet, as well
as guidelines for becoming more active.

BEACITA 120 mg hard capsules

Orlistat
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BEACITA is and what it is used for
• 2. What you need to know before you take BEACITA
• 3. How to take BEACITA
• 4. Possible side effects
• 5. How to store BEACITA
• 6. Contents of the pack and other information

1. WHAT IS BEACITA AND WHAT IS IT USED FOR

BEACITA is a medication used to treat obesity. It acts on the digestive system by blocking the
digestion of approximately one-third of the fats ingested during a meal.
BEACITA acts on the enzymes of the digestive system (lipases) and blocks their action on some of the
fats consumed during the meal. Undigested fats cannot be absorbed and are eliminated
from the body.
BEACITA is indicated for the treatment of obesity in association with a low-calorie diet.

2. What you need to know before taking BEACITA

Do not take BEACITA

• if you are allergic to orlistat or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from chronic malabsorption syndrome (insufficient absorption of nutrients from the digestive system),
• if you suffer from cholestasis (liver alteration),
• if you are breastfeeding.

Warnings and precautions
Weight loss can also affect the dose of medicines taken to treat other conditions (such as hypercholesterolemia or diabetes). Make sure to inform your doctor about these or other medicines you may already be taking. Weight loss may require an adjustment of the doses of these medicines.
To obtain the best results with BEACITA, you must follow the dietary advice given to you by your doctor. As with any weight control program, excessive consumption of fats and calories can reduce any weight loss effect.
The medicine may cause changes in your bowel habits, such as fatty or oily stools due to the elimination of undigested fats in your stools. The likelihood of these events occurring may increase if BEACITA is taken with a high-fat diet. In addition, the daily intake of fats must be distributed equally in the three main meals, as if BEACITA is taken at the same time as a very fatty meal, the likelihood of gastrointestinal effects occurring may increase.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraceptives that may occur in case of severe diarrhea.
The use of orlistat may be associated with the formation of kidney stones in patients suffering from chronic kidney disease. Inform your doctor if you have kidney problems.

Children and adolescents
BEACITA is not recommended for the treatment of children and adolescents under 18 years of age.

Other medicines and BEACITA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. This is very important because taking multiple medicines at the same time can enhance or reduce the effectiveness of the medicines.
BEACITA may alter the activity of:

• acarbose.BEACITA is not recommended in patients taking acarbose(an antidiabetic drug used to treat type 2 diabetes mellitus).
• anticoagulant drugs (e.g. warfarin). Your doctor may need to check your blood coagulation.
• cyclosporine (a medicine used to reduce the activity of your immune system). The simultaneous administration of BEACITA with cyclosporine is not recommended. However, if such use is unavoidable, your doctor may need to check your blood levels of cyclosporine more frequently than usual.
• iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.
• amiodarone (a medicine used to treat irregular heartbeat). Ask your doctor for advice.
• medicines for the treatment of HIV; - medicines for depression, psychiatric illnesses or anxiety. BEACITA reduces the absorption of some fat-soluble nutrients administered in addition to the diet, in particular beta-carotene and vitamin E. You should therefore follow your doctor's instructions, taking a well-balanced diet rich in fruits and vegetables. Your doctor may suggest that you take a multivitamin supplement.

Orlistat may disrupt treatment with anticonvulsants by decreasing the absorption of antiepileptic drugs and therefore causing seizures. Contact your doctor if you feel that the frequency and/or severity of seizures have changed while taking BEACITA simultaneously with antiepileptic drugs.
Orlistat should be used with caution in patients treated with antidepressants and antipsychotics (including lithium).

BEACITA with food and drink
BEACITA can be taken immediately before, during a meal or up to one hour after the meal.
The capsule should be swallowed with water.

Pregnancy and breastfeeding
The use of BEACITA is not recommended during pregnancy.
Since it is not known whether BEACITA is secreted in human breast milk, you should not breastfeed during treatment with BEACITA.

Driving and using machines
BEACITA has no known effects on the ability to drive vehicles or use machines.

3. How to take BEACITA

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Dosage:
The recommended dose of BEACITA is one 120 mg capsule to be taken with each of the three main
meals daily. The capsule can be taken immediately before, during or up to one hour after the meal. The
capsule must be swallowed with water.
General information:
BEACITA must be taken with a well-balanced, low-calorie diet, rich in fruit and vegetables, containing
an average of 30 % of calories derived from fats. The daily intake of fats, carbohydrates and proteins
should be distributed over the three main meals. This means that you will generally need to take one
capsule at breakfast, one at lunch and one at dinner. For optimal results, it is important to avoid
eating foods containing fats between main meals, such as biscuits, chocolate and savoury snacks.
BEACITA only works in the presence of fats consumed with the diet. Therefore, if you skip a main
meal or if you consume a meal that does not contain fats, it is not necessary to take BEACITA.
Inform your doctor if, for any reason, you have not taken the medicine exactly as prescribed.
Otherwise, the doctor may think that the medicine is not effective or is not well tolerated and
may therefore decide to change therapy, without this being really necessary.
The doctor will stop the treatment with BEACITA after 12 weeks if you have not lost at least 5 % of
the body weight recorded at the beginning of the therapy with BEACITA.
BEACITA has been studied in long-term clinical studies lasting up to 4 years.

If you take more BEACITA than you should
If you take more capsules than you have been prescribed or if another person accidentally takes your
medicine, contact a doctor, pharmacist or go to a hospital, as medical intervention may be
necessary.

If you forget to take BEACITA
If you forget to take the medicine, take it as soon as you remember, provided this is within one hour of
your last meal, and then continue to take it as prescribed. Do not take a double dose to make up for a
forgotten dose. If you have forgotten to take it several times, inform your doctor and follow their
instructions.
Do not change the prescribed dose unless your doctor has told you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor or pharmacist as soon as possible if you experience any disorders during treatment with
BEACITA.
Most of the side effects related to the use of BEACITA are a direct consequence
of its local action on the digestive system. These symptoms are generally mild, appear
at the beginning of treatment and occur particularly after meals with a high fat content.
Normally these symptoms disappear with the continuation of therapy and if the prescribed diet is followed.

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

• Headache
• upper respiratory tract inflammation
• abdominal discomfort/pain
• urgent or increased need to defecate
• flatulence (gas)
• flatulence (gas) with passage of stool
• oily stools
• fatty/oily stools
• liquid stools
• increased stool frequency
• influenza
• low blood sugar levels (observed in some patients with type 2 diabetes).

Common side effects (affecting 1 to 10 in 10 people)

• lower respiratory tract inflammation
• rectal pain/discomfort
• soft stools
• faecal incontinence (inability to control bowel movements)
• swelling (manifested by some patients with type 2 diabetes)
• dental/gum problems
• urinary tract infection
• irregular menstrual cycle
• fatigue
• anxiety.

The following side effects have also been reported but their frequency cannot be
evaluated from the available data:

• allergic reactions. The main symptoms are itching, skin rashes, hives (small raised lesions paler or more intense in color than the surrounding skin, accompanied by itching), severe difficulty breathing, nausea, vomiting and feeling unwell. If you experienceany of these symptoms, seek immediate medical attention.
• rectal bleeding
• increases in certain liver enzyme levels may be detected in blood tests
• diverticulitis (the most common symptom is abdominal pain. Cramps, nausea, vomiting, fever, chills, or changes in bowel habits may also occur).
• calculi
• hepatitis (inflammation of the liver). Symptoms include yellowing of the skin and eyes, itching, dark urine, stomach pain and liver tenderness (indicated by pain in the right side of the chest), sometimes with loss of appetite.
• blistering rashes (including burning rashes)
• effects on coagulation in association with anticoagulants
• pancreatitis (inflammation of the pancreas)
• oxalate nephropathy (formed by calcium oxalate which can cause kidney stones). See paragraph 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store BEACITA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BEACITA contains

• The active ingredient is orlistat. Each hard capsule contains 120 mg of orlistat.
• The other ingredients are: Capsule content: microcrystalline cellulose PH112, sodium starch glycolate (type A), anhydrous colloidal silica, sodium lauryl sulfate; Capsule coating: gelatin, titanium dioxide (E171), indigo carmine (E132).

Description of the appearance of BEACITA and contents of the pack
BEACITA capsules are blue and are available in blisters containing 21, 42, 84 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
Pharmaceutical Works POLPHARMA SA - 19 Pelplińska Street - 83-200 Starogard Gdański (Poland)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Portugal Orlistato Actavis
Bulgaria Beacita
Czech Republic Beacita 120 mg
Denmark Beacita 120 mg
Hungary Beacita
Italy Beacita
Sweden Beacita
United Kingdom Orlistat 120 mg Capsules, hard

This leaflet was last approved on.