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BEACITA 60MG CAPSULES HARD

Active substance(s): ORLISTAT

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Package leaflet: Information for the user
Beacita 60mg Capsules, hard
Orlistat
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
If you do not lose weight after taking Beacita for 12 weeks, see your doctor or pharmacist for
advice. You may need to stop taking Beacita.
What is in 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 Beacita is and what it is used for

Beacita is used for weight loss in adults aged 18 and over who are overweight, and have a body mass
index (BMI) of 28 or above. Beacita should be used along with a reduced calorie, lower-fat diet.
BMI is a way to find out if you have a healthy weight, or are overweight, for your height. The chart
below will help you find out whether you are overweight and whether Beacita is right for you. Find
your height on the chart. If you weigh less than the weight shown for your height, do not take Beacita .
Height
1.50 m
1.55 m
1.60 m
1.65 m
1.70 m
1.75 m
1.80 m
1.85 m
1.90 m

Weight
63 kg
67.25 kg
71.75 kg
76.25 kg
81 kg
85.75 kg
90.75 kg
95.75 kg
101 kg

Height
4' 10''
5' 0''
5' 2''
5' 4''
5' 6''
5' 8''
5' 10''
6' 0''
6' 2''

Weight
9st 8lbs
10st 3lbs
10st 13lbs
11st 9lbs
12st 5lbs
13st 2lbs
13st 13lbs
14st 10lbs
15st 8lbs

Risk of being overweight
Being overweight increases your risk of developing several serious health problems such as diabetes
and heart disease. These conditions may not cause you to feel unwell so you should see your doctor
for a general health check.
How Beacita works
The active ingredient (orlistat) in Beacita is designed to target fat in your digestive system. It stops
about a quarter of the fat in your meals from being absorbed. This fat will pass out of the body in your
stools. You may experience diet-related treatment effects (see section 4). It is therefore important that
you commit to a lower-fat diet to manage these effects. If you do, the action of the capsules will assist
your efforts by helping you to lose more weight compared to dieting alone. For every 2 kg (4 lb) you
lose from dieting alone, Beacita can help you lose 1 kg (2 lb) more.
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2.

What you need to know before you take 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 breast-feeding
if you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and
some severe skin conditions
if you are taking warfarin or other medicines used to thin the blood
if you have cholestasis (condition where the flow of bile from the liver is blocked)
if you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Beacita
If you have diabetes. Tell your doctor who may need to adjust your anti-diabetic medicine.
If you have kidney disease. Talk to your doctor before taking Beacita if you have problems with your
kidneys. The use of orlistat may be associated with kidney stones in patients suffering from chronic
kidney disease.
Children and adolescents
This medicine must not be taken by children and adolescents under 18 years old.
Other medicines and Beacita
Beacita may affect some medicines you have to take.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Do not take Beacita with these medicines
ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some
severe skin conditions.
warfarin or other medicines used to thin the blood.
The oral contraceptive pill and Beacita
The oral contraceptive pill may be less effective if you get severe diarrhoea. Use an extra method of
contraception if you get severe diarrhoea.
Multivitamins and Beacita
You should take a multivitamin, every day. Beacita can lower the levels of some vitamins absorbed by
your body. The multivitamin should contain vitamins A, D, E and K. You should take the
multivitamin at bedtime, when you will not be taking Beacita , to help ensure that the vitamins are
absorbed.
Talk to your doctor or pharmacist before taking Beacita if you are taking
amiodarone, used for heart rhythm problems;
acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus). Beacita is not
recommended for people taking acarbose;
a thyroid medicine (levothyroxine) as it may be necessary to adjust your dose and take your
medicines at different times of the day;
a medicine for epilepsy as any changes in the frequency and severity of your convulsions should
be discussed with your doctor.
medicines to treat HIV. It is important that you consult your doctor before taking Beacita if you are
receiving treatment for HIV.
medicines for depression, psychiatric disorders or anxiousness.
Talk to your doctor or pharmacist when taking Beacita
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if you are taking a medicine for high blood pressure as it may be necessary to adjust your dose;
if you are taking a medicine for high cholesterol as it may be necessary to adjust your dose.

Beacita with food and drink
Beacita should be used along with a reduced calorie, lower-fat diet. Try to start this diet before
beginning treatment. For information on how to set your calorie and fat targets, see ‘Further helpful
information’ in section 6.
Beacita can be taken immediately before, during a meal or up to one hour after a meal. This usually
means one capsule at breakfast, lunch and dinner. The capsule should be swallowed with water. If you
miss a meal, or your meal contains no fat, do not take a capsule. Beacita does not work unless there is
some fat in the meal.
If you eat a high-fat meal, do not take more than the recommended dose. Taking the capsule with a
meal containing too much fat may increase your chance of getting diet-related treatment effects (see
section 4). Make every effort to avoid any high-fat meals while taking Beacita
Pregnancy and breast-feeding
Do not take Beacita if you are pregnant or breast-feeding.
Driving and using machines
Beacita is unlikely to affect your ability to drive and use machines.
3.

How to take Beacita

Preparing to lose weight
Choose your start date
Choose the day you will start taking the capsules ahead of time. Before you start taking the capsules,
begin your reduced calorie, lower-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. Food diaries are effective, because they
make you aware of what you are eating, how much you eat, and give you the basis to make changes.
Decide on your weight loss goal
Think about how much weight you want to lose and then set a target weight. A realistic goal is to lose
between 5% to 10% of your starting weight. The amount of weight you lose may vary from week to
week. You should aim to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week.
Set your calorie and fat targets
To help you reach your weight-loss goal you need to set two daily targets, one for calories and one for
fat. For further advice see ‘Further helpful information’ in section 6.
Taking Beacita
Adults 18 and over
Take one capsule, three times a day.
Take Beacita 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 well balanced, reduced
calorie, and lower-fat.
If you miss a meal, or your meal contains no fat, do not take a capsule. Beacita does not work
unless there is some fat in the meal.
Swallow the capsule whole with water.
Do not take more than 3 capsules a day.
Eat lower-fat meals to reduce the chance of diet-related treatment effects (see section 4).
Try to be more physically active before you start taking the capsules. Physical activity is an important
part of a weight loss programme. Remember to check with your doctor first if you have not exercised
before.
Continue to be active while taking Beacita and after you stop taking it.

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How long should Beacita be taken for
Beacita should not be taken for more than six months.
If you do not lose weight after taking Beacita for 12 weeks, see your doctor or pharmacist for
advice.
You may need to stop taking Beacita
Successful weight loss is not just about eating differently for a short period of time before
reverting to your old habits. People who lose weight and maintain the loss make lifestyle
changes, which include changes to what they eat and how active they are.
If you take more Beacita than you should
Do not take more than 3 capsules a day.
If you take too many capsules, contact a doctor as soon as possible.
If you forget to take Beacita
If you miss taking a capsule:
If it is less than an hour since your last main meal, take the missed capsule.
If it is more than an hour since your last main meal, do not take the missed capsule. Wait and
take the next capsule around your next main 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 everybody gets them.
Most of the common side effects related to Beacita (for example, wind with or without oily spotting,
sudden or more frequent bowel motions and soft stools) are caused by the way it works (see section 1).
Eat lower-fat meals to help manage these diet-related treatment effects.
Serious side effects (it is not known how frequently these side effects occur)
Severe allergic reactions
signs of a severe allergic reaction include: severe breathing difficulties, sweating, rash, itching,
swollen face, rapid heart beat, collapse.
Stop taking the capsules. Get medical help immediately.
Other serious side effects
bleeding from the back passage (rectum)
diverticulitis (inflammation of the large intestine). Symptoms may include lower stomach
(abdominal) pain, particularly on the left side, possibly with fever and constipation.
pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain
sometimes radiating towards the back, possibly with fever, nausea and vomiting.
skin blistering (including blisters that burst)
severe stomach pain caused by gallstones
hepatitis (inflammation of the liver). Symptoms can include yellow skin and eyes, itching, dark
coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib
cage on your right hand side), sometimes with loss of appetite.
oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones) that may
lead to kidney failure. See section 2, warnings and precautions.
Stop taking the capsules. Tell your doctor if you get any of these.
Other side effects
Very common side effects (may affect more than 1 in 10 people)
wind (flatulence), with or without oily spotting
sudden bowel motions
fatty or oily stools
soft stools
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oily discharge
low blood sugar levels (experienced by some people with type 2 diabetes)
upper respiratory infection
influenza
headache.
Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.
Common side effects (may affect up to 1 in 10 people)
stomach (abdominal) pain
rectal pain/discomfort
bloating (experienced by some people with type 2 diabetes)
tooth/gum disorder
tiredness
incontinence (stools)
runny/liquid stools
more frequent bowel motions
anxiety
urinary trect infection
lower respiratory infection.
Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.
Effects seen in blood tests (it is not known how frequently these effects occur)
increases in the levels of some liver enzymes
effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant)
medicines.
Tell your doctor that you are taking Beacita when you have a blood test.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Learn to deal with diet-related treatment effects
The most common side effects are caused by the way the capsules work and result from some of the
fat being passed out of your body. Such effects typically occur within the first few weeks of using the
capsules, before you may have learnt to limit the amount of fat in your diet. Such diet-related
treatment effects may be a signal that you have eaten more fat than you should have done.
You can learn to minimise the impact of diet-related treatment effects by following these guidelines:
Start your lower-fat diet a few days, or even a week, before you begin taking the capsules.
Find out more about how much fat your favourite foods typically contain, and the size of your
portions. By familiarising yourself with portions you will be less likely to accidentally exceed
your fat target.
Distribute your fat allowance evenly across your meals for the day. Do not “save up” fat and
calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on
other weight loss programmes.
Most users who experience these effects find that they can manage and control them by
adjusting their diet.
Do not be concerned 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 above 25°C. Store in original package in order to protect from light and moisture.
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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 throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Beacita contains
The active substance is orlistat. Each hard capsule contains 60 mg of orlistat.
The other ingredients are:
capsule filling: microcrystalline cellulose PH112, sodium starch glycolate (type A), sillica
colloidal anhydrous, sodium laurilsulfate;
capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
What Beacita looks like and contents of the pack
Beacita capsules have a light blue cap and body.
Package size:
Blister packs: 42, 60, 84, 90 and 120 capsules. Not all pack sizes may be marketed.
Marketing authorisation holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Pharmaceutical Works POLPHARMA SA
19 Pelplińska Street
83-200 Starogard Gdański
Poland
This leaflet was last approved in November 2015
If you would like a leaflet with larger text, please contact 01271 385257.

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK

FURTHER HELPFUL INFORMATION
Risk of being overweight
Being overweight will affect your health and increase your risk of developing serious health problems
such as:
High blood pressure
Diabetes
Heart disease
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Stroke
Certain forms of cancer
Osteoarthritis
Talk to your doctor about your risk of developing these conditions.
Importance of losing weight
Losing weight and maintaining weight loss, for example by improving your diet and increasing your
physical activity, can help reduce the risk of serious health problems and help improve your health.
Helpful tips on your diet and your calorie and fat targets while taking Beacita
Beacita should be used along with a reduced calorie, lower-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 that you eat, it is important to eat a balanced diet.
You should choose meals which contain a range of different nutrients and learn to eat healthily for the
long term.
Understanding the importance of calorie and fat targets
Calories are a measurement of the energy your body needs. They are sometimes called kilocalories or
kcal. Energy may also be measured in kilojoules, which you may also see on food labels.
The calorie target is the maximum number of calories you will eat each day. See the chart
further on in this section.
Your fat gram target is the maximum number of grams of fat you will eat in each meal. The fat
gram target chart follows the information below on setting your calorie target.
Controlling your fat target is essential because of the way the capsules work. Taking Beacita
means your body will pass more fat through, and therefore may struggle to cope with eating as
much fat as before. So by meeting your fat target, you will maximise weight loss results while
minimising the risk of diet-related treatment effects.
You should aim to lose weight gradually and steadily. Losing around 0.5 kg (1 lb) per week is
ideal.
How to set your calorie target
The following table has been worked out so that it gives you a calorie target that is about 500 calories
fewer per day than your body needs to maintain your current weight. That adds up to 3500 fewer
calories per week, about the number of calories in 0.5 kg (1 lb) of fat.
Your calorie target alone should allow you to lose weight at a gradual, steady pace of about 0.5 kg
(1 lb) per week, without feeling frustrated or deprived.
Eating fewer than 1200 calories per day is not recommended.
You will need to know your activity level to set your calorie targets. The more active you are, the
higher your calorie target.
“Low activity” means you do little or no walking, climbing stairs, gardening, or other physical
activity on a daily basis.
“Moderate activity” means you burn around 150 calories per day in physical activity, for
example, walking three kilometres (2 miles), gardening for 30 to 45 minutes, or running two
kilometres (1.25 miles) in 15 minutes. Choose the level that most closely fits your daily routine.
If you are unsure which level you are, choose “low activity”.
Women
Low activity

Moderate activity

below 68.1 kg
68.1 kg to 74.7 kg
74.8 kg to 83.9 kg
84.0 kg and over
below 61.2 kg
61.3 kg to 65.7 kg

below 10 st 10 lb
10 st 10 lb to 11 st 11 lb
11 st 12 lb to 13 st 2 lb
13 st 3 lb and over
below 9 st 9 lb
9 st 9 lb to 10 st 4 lb
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1200 calories
1400 calories
1600 calories
1800 calories
1400 calories
1600 calories

65.8 kg and over

10 st 5 lb and over

1800 calories

below 65.7 kg
65.8 kg to 70.2 kg
70.3 kg and over
59.0 kg and over

below 10 st 4 lb
10 st 5 lb to 11 st
11 st 1 lb and over
9 st 4 lb and over

1400 calories
1600 calories
1800 calories
1800 calories

Men
Low activity

Moderate activity

How to set your fat target
The following chart shows how to set your fat target based on the amount of calories you are allowed
per day. You should plan to have three meals per day. If you have set a target of 1400 calories per day,
for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your daily
allowance for fat, snacks should contain no more than 3 g of fat.
Amount of calories
you can eat per day
1200
1400
1600
1800

Maximum amount of fat
allowed per meal
12 g
15 g
17 g
19 g

Maximum amount of fat
allowed from snacks per day
3g
3g
3g
3g

Remember:
Stick to realistic calorie and fat targets as this is a good way of maintaining your weight loss
achievements in the long-term.
Write down what you eat in a food diary, including the calorie and fat content.
Try to be more physically active before you start taking the capsules. Physical activity is an
important part of a weight loss programme. Remember to check with your doctor first if you
have not exercised before.
Continue to be active while taking Beacita and after you stop taking it.
The Beacita weight loss programme combines the capsules with an eating plan and a wide range of
resources to help you understand how to eat a reduced calorie, lower-fat diet and guidelines for
becoming more active.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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