PACKAGE LEAFLET: INFORMATION FOR THE USER

Orlistat 60ma hard capsules Orlistat    ^u

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.

•    If you have any further questions or require any further advice, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    You must talk to your doctor or pharmacist if you do not lose weight after taking Orlistat for 12 weeks. You may need to stop taking Oriistat.

In this leaflet:

1.    What Oriistat is and what it is used for

2.    What you need to know before you take Oriistat

3.    How to take Oriistat

4.    Possible side effects

5.    How to store Oriistat

6.    Contents of the pack and other information

1. WHAT ORLISTAT IS AND WHAT IT IS USED FOR

Oriistat 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. Oriistat should be used aiong 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 Orlistat 60 mg Capsules is right for you. Find your height on the chart. If you weigh less than the weight shown for your height, do not take Orlistat 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 Orlistat works

The active ingredient (oriistat) in Oriistat 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, Oriistat can help you lose 1 kg (2 lb) more. You must talk to a doctor or pharmacist if you do not lose weight after taking Oriistat for 12 weeks. You may need to stop taking Oriistat.

Height	Weight	Height	Weight
1.50 m	63 kg	4’ 10”	9st8lbs
1.55 m	67.25 kg	5’ 0”	10st 3lbs
1.60 m	71.75 kg	5’2”	10st 13lbs
1.65 m	76.25 kg	5’4”	11 st 9lbs
1.70 m	81 kg	5’6”	12st 5lbs
1.75 m	85.75 kg	5’8”	13st 2lbs
1.80 m	90.75 kg	5’ 10”	13st 13lbs
1.85 m	95.75 kg	6’ 0”	14st 10lbs
1.90 m	101 kg	6’2”	15st 8lbs

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORLISTAT Do not take ORLISTAT

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

•    If you are pregnant or breast-feeding

•    If you are taking cidosporin, used after organ transplants, tor severe rheumatoid arthritis and some severe skin conditions

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

•    If you are allergic (hypersensitive) to Orlistat or any of the ingredients of Orlistat (see section 6 for further information)

•    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.

Take special care with ORLISTAT (WARNINGS AND PRECAUTIONS)

Talk to your doctor or pharmacist before taking Oriistat:

•    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 Oriistat if you have problems with your kidneys. The use of oriistat 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 ORLISTAT

Oriistat 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.

Do not take Oriistat with these medicines

•    cidosporin: cidosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.

•    Warfarin or other medicines used to thin the blood.

•    Acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus). Oriistat is not recommended for people taking Acarbose.

The oral contraceptive pill and Orlistat 60 mg Capsules

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 Orlistat 60 ma Capsules

You should take a multivitamin, every day. Orlistat 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 Orlistat, to help ensure that the vitamins are absorbed.

Talk to your doctor or pharmacist before taking Orlistat if you are taking

•    amiodarone, used for heart rhythm problems;

•    acarbose, (an anti-diabetic drug used to treat type 2 diabetes mellitus). Orlistat 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 Orlistat if you are receiving treatment for HIV.

•    medicines for depression, psychiatric disorders or anxiousness. It is important that you consult your doctor before taking Orlistat if you are receiving treatment for depression, mood or anxiety disorders.

Talk to vour doctor or pharmacist when taking Orlistat ;    • 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.

ORLISTAT with food and drink

Orlistat 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.

Orlistat can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water. This usually means one capsule at breakfast, lunch and dinner. If you miss a meal, or your meal contains no fat, do not take a capsule. Orlistat does not work unless there is some fat in the meal.lf 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 Oriistat Capsules.

Pregnancy, breast-feeding and fertility Do not take Orlistat if you are pregnant or breast-feeding.

Studies do not indicate harmful effects with respect to fertility.

Driving and using machines

No effect on ability to drive or use machines has been observed.

3. HOW TO TAKE ORLISTAT Preparing to lose weight

1. 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.

2.    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.

3.    Set vour 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 ORLISTAT

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults 18 and over The recommended dose is:

•    Take one capsule, three times a day.

•    Take Oriislat 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. Oriistat 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 Oriistat and after you stop taking it.

How long should ORLISTAT be taken

•    Oriistat should not be taken for more than six months.

•    if you do not lose weight after taking Orlistat for 12 weeks, see your doctor or pharmacist for advice. You may need to stop taking Orlistat Capsules.

• 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 ORLISTAT than you should

Do not take more than 3 capsules a day.

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

If you forget to take ORLISTAT

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.

Do not take a double dose to make up for a forgotten dose.

If you stop taking ORLISTAT

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 Orlistat Capsules (for example, wind with or without oijy 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 heartbeat, collapse.

Stop taking the Orlistat. 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 yellowing 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). See Section 2, Take special care with Oriistat (warnings and precautions).

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

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

•    Wind (flatulence), with or without oily spotting

•    Sudden bowel motions

•    Oily discharge, fatty or oily stools

•    Soft stools.

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

•    Incontinence (stools)

•    Runny/liquid stools

•    More frequent bowel motions

•    Anxiety

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 Orlistat when you have a blood test.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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 nave 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 leam 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in https://yellowcard.mhra.aov.uk/. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ORLISTAT

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

Do not store above 25°C. Store in original package in order to protect 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 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 Orlistat contains

The active substance is Orlistat. Each hard capsule contains 60 mg of Oriistat. The other ingredients are:

capsule filling: microcrystalline cellulose (E460), sodium starch glycolate (type A), sillica colloidal anhydrous, sodium

laurilsulfate;

capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).

What Orlistat looks like and contents of the pack

Oriistat 60 mg Capsules have a brightly blue cap and body.

Oriistat 60 mg Capsules are available in blister packs and bottles containing 42,60,84,90 and 120 capsules. Not all pack types and sizes may be marketed.

Marketing Authorisation Holder;

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED

This leaflet was last revised in 08/2016

Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency (MHRA) web site: http://www.mhra.qov.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

•    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 nealth problems and help improve your health.

Helpful tips on your diet and your calorie and fat targets while taking Orlistat 60 mg Capsules

Orlistat 60 mg Capsules 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 leam to eat healthily tor 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 Orlistat 60 mg Capsules means your body will pass more fat through, and therefore may struggle to cope with eating as much tat 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 (f 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.

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 faking Orlistat 60 mg Capsules and after you stop faking it.