ALLI 60 мг Капсулы

Содержание инструкции

1. alli 60 mg hard capsules
   1. What alli is and what it is used for
   2. What you need to know before taking alli
   3. How to take alli
   4. Possible side effects
   5. How to store alli
   6. Content of the packs and other information

alli 60 mg hard capsules

orlistat

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 doctor or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor or pharmacist if you do not lose weight after taking alli for 12 weeks. It may be necessary to stop taking alli.

Contents of this leaflet:

• 1. What alli is and what it is used for
• Risks associated with overweight
• How alli works
• 2. What you need to know before you take alli
• Do not take alli
• Warnings and precautions
• Other medicines and alli
• alli with food and drink
• Pregnancy and breastfeeding
• Driving and using machines
• 3. How to take alli
• Prepare to lose weight
• Choose a start date
• Decide on your weight loss goal
• Set your goals in terms of calories and fats
• Taking alli
• Adults 18 years and over
• How long you should take alli
• If you take more alli than you should
• If you forget to take alli
• 4. Possible side effects
• Serious side effects
• Very common side effects
• Common side effects
• Effects observed in blood tests
• Learning to manage the effects of treatment associated with the diet
• 5. How to store alli
• 6. Contents of the pack and other information
• What alli contains
• Description of the appearance of alli and contents of the pack
• Marketing authorisation holder and manufacturer
• Other useful information

1. What alli is and what it is used for

alli 60 mg hard capsules (orlistat) is a peripherally acting anti-obesity drug that is used to
lose weight in adults aged 18 years and over who are overweight, with a body mass index (BMI) equal to or greater than 28. alli must be used in association with a low-calorie and low-fat diet.
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 discover if you are overweight and if alli is suitable for you.
Find your height in the table. If your weight is lower than that indicated for your height, do not
take alli .
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, therefore you should
consult your doctor for a general check-up of your health status.
How alli works
The active ingredient of alli (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 feces (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, alli may help you lose up to 1 kg more.

2. What you need to know before taking alli

Do not take alli
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 cyclosporine, a medicine used after organ transplants, for severe rheumatoid arthritis and some severe skin diseases.
• If you are taking warfarin or other medicines that are 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 alli

• 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 a kidney disease. Consult your doctor before taking alli 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 the age of 18 years.

Other medicines and alli
alli can affect some medicines that you are taking.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take alli with these medicines

• Cyclosporine: cyclosporine is used after organ transplants, for severe forms of rheumatoid arthritis and in some severe skin diseases.
• Warfarin or other medicines to thin the blood.

The oral contraceptive pill and alli

• The oral contraceptive pill may be less effective in case of severe diarrhea. Use an additional contraceptive method if you develop severe diarrhea.

Take a multivitamin preparation every day if you take alli

• alli can reduce the levels of some vitamins absorbed by the body. The multivitamin preparation should contain vitamins A, D, E and K. The multivitamin preparation should be taken before bedtime, at a time different from when you take alli, to promote the absorption of vitamins.

Tell your doctor before taking alli if you are taking

• amiodarone, used for heart rhythm problems.
• acarbose (a medicine for diabetes used in the treatment of type 2 diabetes mellitus). alli is not recommended in people taking acarbose.
• a medicine for the thyroid (levothyroxine), as the dose may need to be adjusted and the two medicines taken 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 for the treatment of HIV. It is important to consult your doctor before taking alli if you are taking medicines for HIV
• medicines for depression, psychiatric disorders or anxiety.

Tell your doctor or pharmacist when you take alli

• if you are taking a medicine for high blood pressure, as the dose may need to be adjusted.
• if you are taking a medicine for high cholesterol, as the dose may need to be adjusted.

alli with food and drink
alli 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 on the blue pages of section 6.
alli can be taken immediately before, during or within one hour after meals. The capsule must be
swallowed with water. This generally means one capsule with breakfast, lunch and dinner. If
you skip a meal or consume a meal that does not contain fat, do not take the capsule. alli does not work if
the meal does not contain at least some fat.
If you consume a meal with a lot of fat, do not take a higher dose than recommended. Taking the
capsule with a meal containing too much fat may increase the likelihood of developing side effects of the
diet (see section 4). Make every effort to avoid any
meal containing a lot of fat while taking alli.

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

Driving and using machines
It is unlikely that alli will affect your ability to drive or operate machinery.

alli contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take alli

Get ready to lose weight

• 1.Choose a start date

Choose in advance the date you will start taking the capsules. Before you begin taking the
capsules, start a low-calorie, low-fat diet and give your body a few days to
adjust to the new eating habits. Keep a food diary of what you eat. These diaries are effective
because they make you aware of what and how much you eat, providing you with a basis for making changes.

• 2.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 starting 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.

• 3.Set your goals in terms of calories and fat

To help you reach your weight target, you need to set two daily goals, one for calories and one for fat.
For more advice, read the Further useful informationsection on the blue pages in section 6.
Taking alli

Adults aged 18 years and over

• Take one capsule, three times a day.
• Take alli 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 your three main meals are well-balanced, and low in calories and fat.
• If you skip a meal, or if you eat a meal that contains no fat, do not take the capsule. alli does not work if the meal contains at least some fat.
• Swallow the capsule whole with water.
• Do not take more than 3 capsules a day.
• You can keep your daily dose of alli in the blue portable case (shuttle) contained in this pack.
• Eat low-fat meals to reduce the likelihood of developing treatment 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 exercised before, remember to have a check-up with your doctor first.
• Continue to exercise while taking alli and also after you have stopped taking it.

How long you should take alli

• alli should not be taken for more than six months.
• If you have not lost weight after taking alli for 12 weeks, ask your doctor or pharmacist for advice. It may be necessary to stop alli.
• 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 alli than you should
Do not take more than 3 capsules a day.
➔ If you have taken too many capsules, seek medical advice immediately.

If you forget to take alli
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 everybody gets them.
Most of the side effects of alli (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
The frequency with which these side effects occur is not known.

Serious allergic reactions

• Signs of a serious allergic reaction include: severe difficulty breathing, sweating, redness, itching, swelling of the face, fast heartbeat, collapse. ➔ Stop taking the capsules. Seek immediate medical attention.

Other serious side effects

• Anal bleeding.
• Diverticulitis (inflammation of the large intestine). Symptoms may include abdominal pain, especially on the left side, 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 open).
• 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 under the front of the rib cage on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (accumulation of calcium oxalate which can lead to kidney stone formation). See section 2, warnings and precautions. ➔ Stop taking the capsules. If you experience any of these effects, tell your doctor.

Very common side effects

May affect more than 1 in 10 people

• Presence of intestinal gas, with or without oily leakage
• Sudden bowel movements
• Greasy or oily stools
• Soft stools ➔ Tell your doctor or pharmacist if any of these effects become severe or worrying.

Common side effects

May affect up to 1 in 10 people

• Abdominal pain
• Faecal incontinence
• Liquid stools
• More frequent bowel movements
• Anxiety ➔ Tell your doctor or pharmacist if any of these effects becomes severe or worrying.

Side effects observed in blood tests

The frequency with which these side effects occur is not known (the frequency cannot be estimated on

the basis of available data)

• Increased levels of certain liver enzymes.
• Effects on blood coagulation in patients treated with warfarin or other blood-thinning medicines (anticoagulants). ➔ Tell your doctor that you are taking alli if you are undergoing blood tests.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system listed in Annex V . By reporting side effects you can
help provide more information on the safety of this medicine.
Learning to manage alli’s effects associated with diet or fat intake
Most side effects are caused by the way the capsules work and
result from some of the fat passing through your body and being eliminated in your
stools. These effects typically occur within the first few weeks of treatment, before you have gotten
used to limiting the amount of fat in your 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 you start taking the capsules.
• Be more aware of how much fat is in your favorite foods and the portion sizes you eat. By becoming familiar with portions, you are less likely to accidentally exceed your fat allowance.
• Spread your fat ration evenly across the different meals of the day. Do not save up fat and calories for a high-fat meal or treat, as you might do with other weight loss programs.
• Most people 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 alli

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack and the bottle after the wording “Exp”. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Keep the bottle tightly closed to protect the medicine from moisture.
• The bottle contains two sealed cylinders containing silica gel to keep the capsules dry. Keep the cylinders in the bottle. Do not ingest them.
• You can store the daily dose of alli in the blue portable case (shuttle) contained in the package. Discard any capsules stored for more than one month in the portable case.
• 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. Content of the packs and other information

What alli contains
The active ingredient is orlistat. Each hard capsule contains 60 mg of orlistat.
The other ingredients are:

• Capsule content: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, talc.
• Cap: gelatin, indigotine (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, black ink (shellac, black iron oxide (E172), propylene glycol).
• Capsule band: gelatin, polysorbate 80, indigotine (E132).

Description of the appearance of alli and pack contents
alli capsules have turquoise caps and bodies, with a dark blue band in the middle, on which is imprinted
"alli".
alli is available in packs of 42, 60, 84, 90 and 120 capsules. Not all pack sizes may be
available in all countries.
A blue portable case (shuttle) is included in this pack to carry your daily dose of
alli.

Marketing Authorisation Holder
GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland

Manufacturer
Famar S.A, 48 KM Athens-Lamia,
190 11 Avlona, Greece
For further information on this medicinal product, please contact the local representative of the
marketing authorisation holder.
For more information on the alli weight loss program, you can also visit the specific website for your country.

België/Belgique/Belgien
GlaxoSmithKline Consumer Healthcare s.a./n.v.
Tél/Tel: + 32 10858600
www.alli.be

Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
[email protected]
www.alli.lt

България
ГлаксоСмитКлайн Консюмър Хелткеър
Teл.: + 359 2 953 10 34
www.alli.bg

Luxembourg/Luxemburg
GlaxoSmithKline Consumer Healthcare s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 10858600
www.alli.be

Česká republika
GlaxoSmithKline Consumer Healthcare Czech
Republic s.r.o.
Tel: + 420 222 001 111
[email protected]
www.alli.cz

MagyarországGlaxoSmithKline Kft.
Consumer Healthcare
Tel.: + 36 1 225 5800
www.alliprogram.hu

Danmark
GlaxoSmithKline Consumer Healthcare ApS
Tlf: + 45 80 25 16 27
scanda.consumer-relations @gsk.com
www.alliplan.dk

Malta
GlaxoSmithKline (Malta) Limited
Tel: + 356 21 238131
www.alli.com.mt

Deutschland
GlaxoSmithKline Consumer Healthcare
GmbH & Co. KG,
Tel: 0049 (0) 180 3 63462554
www.alliprogramm.de

Nederland
GlaxoSmithKline Consumer Healthcare BV
Tel: +31800 4090005
[email protected]
www.alli.nl

Eesti
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
[email protected]
www.alli.gsk.ee

Norge
GlaxoSmithKline Consumer Healthcare
Tlf: + 47 80 05 86 30
scanda.consumer-relations @gsk.com
www.alliplan.no

Ελλάδα
GlaxoSmithKline A.E.B.E.
Λ. Κηφισίας 266, 152 32 Χαλάνδρι
Τηλ: + 30 210 68 82 100
www.alli.gr

Österreich
GlaxoSmithKline Consumer Healthcare GmbH &
Co. KG,
Tel: 0049 (0) 180 3 63462554
www.alliprogramm.at

España
GlaxoSmithKline Consumer Healthcare, S.A.
Tel: + 34 900 816 705
www.alli.com.es

Polska
GlaxoSmithKline Consumer Healthcare Sp. z o.o.
Tel.: + 48 (0)22 576 96 00
www.alli.pl

France
GlaxoSmithKline Santé Grand Public
Tél.: + 33 (0)1 39 17 80 00

Portugal
GlaxoSmithKline Consumer Healthcare – Produtos
para a Saúde e Higiene, Lda.
Tel: 800 784 695
[email protected]

www.alli.pt
Hrvatska
GlaxoSmithKline d.o.o.
Tel:+385 1 6051 999
www.alli.com.hr

România
GlaxoSmithKline Consumer Healthcare S.R.L.
Tel: + 40 21 302 8 208
www.alli.ro

Ireland
GlaxoSmithKline Consumer Healthcare
(Ireland) Limited
Tel: + 353 (0)1 495 5000
www.alli.ie

Slovenija
GSK d.o.o., Ljubljana
Tel: + 386 (0)1 280 25 00
www.alli.si

Ísland
GlaxoSmithKline ehf.
Sími: + 354 530 3700

Slovenská republika
GlaxoSmithKline Slovakia s. r. o.
Tel: + 421 (0)2 48 26 11 11
[email protected]
www.alli.sk

Italia
GlaxoSmithKline Consumer Healthcare S.r.l.
Tel: + 39 02 38062020
www.alli.it

Suomi/FinlandGlaxoSmithKline Oy
Consumer Healthcare
Puh/Tel: 080 077 40 80
scanda.consumer-relations @gsk.com
www.alliplan.fi

Κύπρος

• C. A. Papaellinas Ltd, Τ.Θ. 24018, 1700 Λευκωσία Tηλ. +357 22 741 741

www.alli.com.cy

Sverige
GlaxoSmithKline Consumer Healthcare
Tel: 020-100579
scanda.consumer-relations @gsk.com
www.alliplan.se

Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
[email protected]
www.alli.com.lv

United Kingdom
GlaxoSmithKline Consumer Healthcare
Tel: + 44 (0)800 171 2014 (Freephone)
[email protected]
www.alli.co.uk
More detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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FURTHER 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
• Cardiovascular diseases
• 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 your physical activity, can help reduce the risk of major health problems and improve your health itself.
Useful tips on diet and goals in terms of fats and calories while taking alli
alli 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 still continue to eat foods from all the main food groups. Although you need to focus on the calories and fats you eat, it is important to still follow a balanced diet. You should 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 goals
Calories are a measure of the energy your 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 goal is the maximum number of calories you can consume in a day. See the table later in this section.
• The fat goal 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 goal.
• Keeping your fat goal under control is essential, considering how the capsules work. When taking alli, 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 goal, you will be able to achieve the maximum result in terms of weight loss, minimizing the risk of side effects of 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 your calorie goal
The following table has been developed to give you a calorie goal that is approximately 500 calories lower than what your body needs to maintain your current weight. This is a total of 3500 calories less per week, which is the amount of calories contained in 0.5 kg of fat.
Only by respecting the calorie goal 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 goal, you need to know your activity level. The more active you are, the higher your calorie goal will be.

• 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 a 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 your fat goal
The following table shows you how to set your fat goal based on the amount of calories you are allowed per day. You will need to plan for 3 meals a day. For example, if you have set a calorie goal 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 goal, as this is a good way to maintain your achieved weight goals in the long term.
• Keep a food diary, including 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 alli and after stopping treatment.

The alli weight loss program combines the capsules with a diet 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.
The alli website (refer to the specific website for your country included in the list of local representatives above) provides a range of interactive tools, low-fat recipes, exercise tips and other useful information to help you lead a healthy life and support you in achieving your weight loss goals.
Visit www.alli.it