60 mg hard capsules 
Orlistat

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

– Save this information, you may need to read it again.

– If you need further information or advice, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– Contact a doctor or pharmacist and ask for advice if you do not lose weight after taking Alli for 12 weeks. You may need to stop taking Alli.

In this leaflet you will find information about: 
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. Contents of the packaging and other information 

1. What Alli is and what it is used for

Alli is used for weight loss in adults 18 years and older, who are overweight and have a BMI ( body mass index ) of 28 or more. Alli should be used with a calorie-reduced, low-fat diet.

BMI is a way to find out if you have a healthy weight or if you are overweight for your height. Using the table below, you can find out if you are overweight and if you can use alli.

Find your height in the table. If you weigh less than the weight indicated for your height, do not take Alli.

Length Weight
150 cm 63 kg
155 cm 67.25 kg
160 cm 71.75 kg
165 cm 76.25 kg
170 cm 81 kg
175 cm 85.75 kg
180 cm 90.75 kg
185 cm 95.75 kg
190 cm 101 kg

The risk of being overweight

Being overweight increases the risk of developing serious health problems such as diabetes and heart disease. These conditions may not make you feel bad, so you should have a general health check-up with a doctor.

How Alli works

The active substance (orlistat) in alli is designed to target the fat in the digestive system. It prevents about a quarter of the fat in a meal from being absorbed by the body. This fat disappears from the body with the stool (see section 4). It is therefore important that you eat a low-fat diet to deal with these effects. If you do, the capsules will help you lose more weight compared to a diet program alone. For every 2 kg that you lose from diet alone, Alli can make you lose up to another 1 kg.

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 ciclosporin used after organ transplants, for severe rheumatoid arthritis and certain serious skin conditions.

If you are taking warfarin or other medicines used to thin the blood.

• If you have bile stasis (a condition in which the bile flow from the liver is blocked).

• If your doctor has diagnosed you with food intake (chronic malabsorption syndrome).

Warnings and cautions

Talk to your doctor or pharmacist before taking alli.

• If you have diabetes. Talk to your doctor who may need to adjust your medicine for diabetes.

• If you have kidney disease. Talk to your doctor before taking Alli if you have kidney problems. The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.

Children and young people

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

Other medicines and alli

alli may affect certain medicines that you have to take.

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

  • Ciclosporin: Ciclosporin is used after organ transplants, for severe rheumatoid arthritis and certain serious skin conditions.
  • Warfarin or other medicines used to thin the blood.

Birth control pills and Alli

  • Birth control pills can have a reduced effect if you have severe diarrhea. Use an extra method of contraception if you have severe diarrhea.

Take a multivitamin every day if you are taking alli

  • You should take a multivitamin every day. Alli can make the body absorb less of certain vitamins. The multivitamin preparation should contain vitamins A, D, E, and K. To be sure that the vitamins will be taken up, you should take the multivitamin preparation at bedtime and not at the same time as Alli.

Talk to your doctor before taking Alli if you are taking

  • amiodarone, which is used for heart rhythm problems.
  • acarbose (a diabetes medicine used to treat type 2 diabetes mellitus ). alli is not recommended for people taking acarbose.
  • Thyroid drugs (levothyroxine) as it may be necessary to adjust dose one and take your drugs at different times of the day.
  • Some medicine for epilepsy as any changes in the frequency and severity of seizures should be discussed with your doctor.
  • Medicines for the treatment of HIV. It is important that you talk to your doctor before taking alli if you are being treated for HIV at the same time.
  • Medicines for depression, mental disorders or anxiety

Talk to your doctor or pharmacist when taking alli

  • If you are taking any medicine for high blood pressure, dose one may need to be adjusted.
  • If you are taking any medicine for high cholesterol, dose one may need to be adjusted.

alli with food and drink

alli should be used with a calorie-reduced, low-fat diet. Try to start with such a diet before starting treatment. More information on determining your calorie and fat goals can be found on the blue pages in section 6, Other Useful Information.

alli can be taken just before, during or up to 1 hour after a meal. The capsule should be swallowed whole with water. This usually means 1 capsule at breakfast, lunch and dinner. If you skip a meal, or if the meal does not contain any fat, do not take any capsule. alli does not work unless there is some fat in the meal.

Do not take more than the recommended dose even if you eat a high-fat meal. Taking the capsule with a high-fat meal increases the risk of diet-related effects (see section 4). Always try to avoid high-fat meals when taking alli.

Pregnancy and breastfeeding

Do not take alli if you are pregnant or breast-feeding.

Driving and using machines

It is unlikely that alli would affect your ability to drive or use machines.

3. How to take alli

Plan your weight loss

1. Select the start date

Decide in advance which day you will start taking the capsules. Before you start taking the capsules, start with your low-calorie, low-fat diet, and allow your body to adapt to your new eating habits for a few days. Write down what you eat in a food diary. Food diaries are effective because you become aware of what you are eating and how much you are eating and give yourself something to start from when you make changes.

2. Set a goal for your weight loss

Think about how much you want to lose weight and then set a target weight. A realistic goal is to reduce by between 5% and 10% of your starting weight. Weight loss may vary from week to week. You should strive for a gradual, stable weight loss of about 0.5 kg per week.

Set goals for calories and fat

To help you reach your weight loss goal, you need to set two daily goals, one for calories and one for fat. Read more on the blue pages under section 6, Other useful information.

To take alli

Adults, 18 years and older

• Take 1 capsule 3 times a day.

• Take alli just before, during, or up to 1 hour after meals. This usually means 1 capsule at breakfast, lunch, and dinner. Make sure your 3 main goals have good balance, reduced calorie content, and low-fat content.

• If you skip a meal, or if the meal does not contain any fat, do not take any capsule. alli 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.

• You can store your daily dose of alli in the blue case (shuttle) included in the package.

• Eat low-fat meals to reduce the risk of diet-related treatment effects (see section 4).

Try to become more physically active before you start taking the capsules. Physical activity is an important part of a weight loss program. Remember to check with your doctor first, if you have not exercised before.

• Continue exercising when you take alli and when you have stopped taking it.

How long should I take alli?

  • alli should not be taken for more than 6 months.
  • If you do not lose weight after taking alli for 12 weeks, contact your doctor or pharmacist for advice. You may need to stop taking alli.
  • Successful weight loss is not just about eating differently for a short period of time and then returning to your old habits. People who lose weight and maintain the reduction change their lifestyle, which means that they change their diet and exercise habits

If you take more Alli 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 alli

If you forget to take a capsule:

Take the forgotten capsule if less than an hour has passed since your last main meal.

Do not take the forgotten capsule if more than an hour has passed since your last main meal. Wait and take the next capsule to your next main meal as usual.

If you have any further questions on the use of this product, 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 with alli (for example, gases with or without oily secretion, sudden or frequent bowel movements and soft stools) are caused by the way the medicine works (see section 1). You can manage these diet-related effects by eating low-fat meals.

Serious side effects are

It is not known how often these side effects occur

Severe allergic reactions

Signs of a severe allergic reaction include severe difficulty breathing, sweating, rash, itching, swelling of the face, rapid pulse, collapse.

→ Stop taking the capsules. Seek medical attention immediately.

Other serious side effects are

  • Bleeding from the rectum ( rectum ).
  • Diverticulitis ( inflammation of the colon). Symptoms may include pain in the lower abdomen, especially on the left side, possibly with fever and constipation.
  • Pancreatitis ( inflammation of the pancreas). The symptoms can be severe stomach pain that sometimes radiates to the back, possibly with fever, nausea, and vomiting.
  • Skin blisters (including blisters that are missing).
  • 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 tenderness in the liver (felt as pain on the right side below the chest), sometimes even with the loss of appetite.
  • Oxalate nephropathy (accumulation of calcium oxalate which may lead to kidney stones ). See section 2, warnings, and precautions.

→ Stop taking the capsules. Tell your doctor if you get any of these side effects.

Very common side effects are

These can occur in more than 1 in 10 users

  • Gases ( flatulence ) with or without oily excretion.
  • Sudden bowel movements.
  • Oily or oily stools.
  • Soft stools.

→ Tell your doctor or pharmacist if any of these side effects get worse or worse.

Common side effects are

These can occur in up to 1 in 10 users

  • Stomach pain (abdominal pain).
  • Incontinence (stool).
  • Flowing/liquid stools.
  • More common stools.
  • Concern.

→ Tell your doctor or pharmacist if any of these side effects get worse or worse.

Effects seen in blood tests

It is not known how often these side effects occur (occurs in an unknown number of users)

  • The increased amount of certain liver enzymes.
  • Effects on blood coagulation in people taking warfarin or other blood-thinning medicines ( anticoagulants ).

→ Tell your doctor that you take alli when you leave a blood test.

Learn to deal with the effects of alli that are related to diet or fat intake

The most common side effects are caused by the way the capsules work and are due to some of the fast disappearing from the body. Such effects usually occur during the first few weeks of using the capsules, before you may have learned to limit the amount of fat in your diet. Such diet-related treatment effects can be a signal that you have eaten more fat than you should.

You can learn to minimize the impact of diet-related treatment effects by following the advice below:

  • Start eating a low-fat diet for a few days, or even a week, before you start taking the capsules.
  • Find out how much fat your favorite food usually contains and how large portions you eat. By keeping track of the portions, you are less likely to accidentally exceed your fat target.
  • Distribute your fat ratio evenly over today’s meals. Do not “save” fat and calorie rations and revel in a high-fat meal or dessert that you may have done with other weight loss programs.
  • Most users who experience these effects find that they can manage and control them by changing their diet.

Do not worry if you do not experience any of these problems. This does not mean that the capsules do not work.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 carton and can after “EXP”. The expiration date is the last day of the specified month.
  • Do not store above 25 ° C.
  • Close the package tightly. Moisture sensitive.
  • The jar contains 2 sealed containers with silica gel that keep the capsules dry. Store the containers in the jar. Do not swallow them.
  • You can also store your daily dose of alli in the blue case (shuttle) included in the package. Discard capsules that have been stored in the case for more than 1 month.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

Other ingredients are:

Capsule contents: Microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium lauryl sulfate, talc.

Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), sodium lauryl sulfate, sorbitan monolaurate, black ink (shellac, black iron oxide (E172), propylene glycol).

Capsule band: gelatin, polysorbate 80, indigo carmine (E132).

What the medicine looks like and contents of the pack

alli capsules have a turquoise capsule cover with a dark blue band around the middle, marked with “alli”.

alli is available in pack sizes of 42, 60, 84, 90 and 120 capsules. Some pack sizes may not be marketed in all countries.

A blue case (shuttle) is included in the package so you can take your daily dose of alli.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline Dungarvan Limited,

Knockbrack, Dungarvan, Co. Waterford,

Ireland

Manufacturer:

Famar SA, 48 KM Athens-Lamia,

190 11 Avlona, ​​Greece

Contact the representative of the marketing authorization holder to find out more about this medicine.

You can also visit the alli website for your particular country for more information on alli weight loss programs.

Belgium / Belgique / BelgienGlaxoSmithKline Consumer Healthcare sa / nvTel: + 32 10858600www.alli.be LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.comwww.alli.lt
BulgariaGlaxoSmithKlein Consumer SheltersTel .: + 359 2 953 10 34www.alli.bg Luxembourg / LuxemburgGlaxoSmithKline Consumer Healthcare sa / nvBelgium / BelgiumTel: + 32 10858600www.alli.be
Czech RepublicGlaxoSmithKline sroTel: + 420 222 001 111gsk.czmail@gsk.comwww.alli.cz HungaryGlaxoSmithKline Kft.Consumer HealthcareTel .: + 36 1 225 5800www.alliprogram.hu
DenmarkGlaxoSmithKline Consumer Healthcare A / STel: + 45 80 25 16 27scanda.consumer-relations@gsk.comwww.alliplan.dk MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131www.alli.com.mt
GermanyGlaxoSmithKline Consumer Healthcare GmbH & Co. KG.Tel: 0049 (0) 180 3 63462554www.alliprogramm.de The NetherlandsGlaxoSmithKline Consumer Healthcare BVTel: + 31 (0) 30 693 8780info.nlch@gsk.comwww.alli.nl
EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.comwww.alli.gsk.ee NorwayGlaxoSmithKline Consumer HealthcareTel: + 47 80 05 86 30scanda.consumer-relations@gsk.comwww.alliplan.no
GreeceGlaxoSmithKline AEBEΛ. 26ηφισίας 266, 152 32 .αλάνδρι:Ηλ: + 30 210 68 82 100www.alli.gr AustriaGlaxoSmithKline Consumer Healthcare GmbH& Co. KGTel: 0049 (0) 180 3 63462554www.alliprogramm.at
SpainGlaxoSmithKline Consumer Healthcare, SATel: + 34 900 816 705www.alli.com.es PolandGlaxoSmithKline Consumer Healthcare Sp. z ooTel .: + 48 (0) 22 576 96 00www.alli.pl
FranceGlaxoSmithKline General Public HealthTel .: + 33 (0) 1 39 17 80 00www.alliprogramme.fr PortugalGlaxoSmithKline Consumer Healthcare – Products for Saudi Arabia and Hygiene, Lda.Tel: 800 784 695apoio.consumidor@gsk.comwww.alli.pt
CroatiaGlaxoSmithKline dooTel: +385 1 6051 999www.alli.com.hr RomaniaGlaxoSmithKline Consumer Healthcare SRLTel: + 40 21 302 8 208www.alli.ro
IrelandGlaxoSmithKline Consumer Healthcare (Ireland) LimitedTel: + 353 (0) 1 495 5000www.alli.ie SloveniaGSK doo, LjubljanaTel: + 386 (0) 1 280 25 00www.alli.si
IcelandGlaxoSmithKline ehf.Phone: + 354 530 3700 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.comwww.alli.sk
ItalyGlaxoSmithKline Consumer Healthcare SpATel: + 39 02 38062020www.alli.it Suomi / FinlandGlaxoSmithKline OyConsumer HealthcarePuh / Tel: 080 077 40 80scanda.consumer-relations@gsk.comwww.alliplan.fi
ΚύπροςCA Papaellinas Ltd,Τ.Θ. 24018, 1700 ΛευκωσίαTηλ. +357 22 741 741www.alli.com.cy
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.comwww.alli.com.lv United KingdomGlaxoSmithKline Consumer HealthcareTel: + 44 (0) 800 171 201 (Freephone)customer.relations@gsk.comwww.alli.co.uk

This leaflet was last modified on 11/26/2018

Other sources of information

Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

OTHER USEFUL INFORMATION

The risk of being 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 risks of developing these conditions.

The importance of weight loss

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 improve your health.

Useful tips on diet and your calorie and fat goals when taking alli

alli should be used with a calorie-reduced, low-fat diet. The capsules work by preventing some of the fat you eat from being absorbed by your body, but you can still eat foods from all major food groups. Even if you have to think about how many calories and how much fat you eat, it is important that you eat a well-balanced diet. You should choose meals that contain several different nutrients and learn to eat healthy in the long run.

Understand the importance of goals for calories and fat

Calories are a measure of the energy that the body needs. They are sometimes called kilocalories or kcal. Energy can also be measured in kilojoules, which you can sometimes see on food labels.

• Your calorie goal is the maximum number of calories you can eat per day. See the table later in this section.

• Your target for fat grams is the maximum number of grams of fat you can eat at each meal. The table of fat gram goals can be found after the information below on how to determine your goal for calories.

• It is important that you control your fat intake with regard to the way the capsules work. When you take alli, it means that more fat passes out of the body, which therefore has to struggle to cope with the fact that you eat as much fat as before. So if you follow your goal for fat, you will get the best possible weight loss results while reducing the risk of diet-related treatment effects.

• You should strive for a gradual and even weight loss. A reduction of about 0.5 kg per week is ideal.

Here’s how to set your goal for calories

The table below has been developed so that you get a goal for calories that is about 500 calories less per day than the body needs to maintain your current weight. There will be 3,500 fewer calories per week, about as many calories as there are in 0.5 kg of fat.

With your calorie goal alone, you should be able to get a gradual, stable weight loss of about 0.5 kg a week without feeling frustrated or finding it difficult.

You should not eat less than 1,200 calories a day.

You need to know your activity level to be able to set a goal for your calories. The more active you are, the higher your calorie goal will be.

  • Low activity means that you walk to a very small extent or not at all, walk upstairs, work in the garden, or engage in other daily physical activities.
  • Moderate activity means that you burn about 150 calories per day during physical activity, for example walking three kilometers, engaging in gardening for 30 to 45 minutes, or running two kilometers in 15 minutes. Choose the level that best fits your daily routines. If you are unsure of your level, choose the low activity.

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

Low activity Under 65.7 kg 1,400 calories
  65.8 kg to 70.2 kg 1,600 calories
  70.3 kg and more 1,800 calories
Moderate activity 59.0 kg and more 1,800 calories

How to set your goal for fat

The table below shows how to set your fat goal based on the number of calories you are allowed to eat per day. You should eat three meals a day. For example, if you have set a goal of 1,400 calories per day, the maximum amount of fat per meal will be 15 g. In order to stay within your daily fat ratio, snacks must not contain more than 3 g of fat.

Number of calories you can eat per day Max. amount of fat per meal Max. amount of fat from snacks per day
1 200 12 g 3 g
1 400 15 g 3 g
1 600 17 g 3 g
1 800 19 g 3 g

Remember

  • Stick to realistic calorie and fat goals, as it is a great way to maintain your weight loss in the long run.
  • Write down what you eat in a food diary, including 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 program. Remember to check with your doctor first, if you have not exercised before.
  • Keep exercising when you take alli and when you have stopped taking it.

The alli weight loss program combines the capsules with a diet and many different resources to help you understand how to eat a low-calorie, low-fat diet along with good advice on how to become more active.

On the alli website (the website for your particular country is listed in the list of local representatives above) you will find many different interactive tools, low-fat recipes, tips on physical activity, and other useful information to help you live a healthier life and achieve your weight loss goals.

Muhammad Nadeem

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