Leaflet: information for the user

Linestat 60 mg hard capsules

Orlistat

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

Ifyou experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

• If you do not lose weight after taking Linestat for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Linestat.

1. What Linestat is and what it is used for

2. What you need to know before you start taking Linestat

3. How to take Linestat

4. Possible side effects

5. Storage of Linestat

6. Contents of the pack and additional information

Linestat is used for weight loss in adults over 18 years old with overweight, with a body mass index (BMI) of 28 or higher. Linestat must be used in combination with a low-calorie and low-fat diet.

The BMI is a way to know if you have a healthy weight or if you have overweight, taking into account your height. The table below will help you find out if you have overweight and if this medication is suitable for you.

Consult your weight in the table below. If your weight is less than the weight that appears on the side of your height, do not take this medication.

Risks of having overweight

Having overweight increases the risk of developing various serious health problems, such as diabetes or heart disease. These conditions may not make you feel unwell, so you should see your doctor for a general check-up.

How Linestat works

The active ingredient of Linestat (orlistat) is designed to target the fat in your digestive system. It prevents about a quarter of the fat you take in meals from being absorbed. This fat will be eliminated from your body in the feces. You may experience treatment-related effects (see section 4). Therefore, it is essential that you follow a low-calorie and low-fat diet to control these effects. If you do, the action of the capsules will help you in your efforts, helping you to lose more weight than just with diet. For every 2 kg you lose just with diet, Linestat can help you lose 1 kg more.

Do not takeLinestat:

• if you are allergic to orlistat or any of the other components of this medication (listed in section 6),
• if you are pregnant or breastfeeding,
• if you are taking ciclosporina, used after organ transplantation, for severe rheumatoid arthritis and certain severe skin conditions,
• if you are taking warfarin or other anticoagulant medications,
• if you have cholestasis (a condition where bile flow from the liver is blocked),
• if you have malabsorption problems (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLinestat.

• If you have diabetes. Consult your doctor if necessary to adjust your antidiabetic medication.

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

Children and adolescents

Children and adolescents under 18 years old should not take this medication

TakingLinestatwith other medications

Linestat may affect some medications you take.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Linestat with the following medications:

• Ciclosporina, used after organ transplantation, for severe rheumatoid arthritis and certain severe skin conditions.
• Warfarin or other anticoagulant medications.

Use of oral contraceptives with Linestat:

• Oral contraceptives may be less effective if you experience severe diarrhea. Use an additional contraceptive method if you experience severe diarrhea.

Multi-vitamin complexes and Linestat:

• It is recommended to take a multi-vitamin complex daily since this medication may reduce the levels of certain vitamins absorbed by the body. The multi-vitamin complex should contain vitamins A, D, E, and K. Take it before bedtime, when you will not be taking Linestat to ensure that the vitamins are absorbed.

Consult your doctor before taking Linestat if you are taking:

• Amiodarone, used for heart rhythm problems,
• Acarbosa (an antidiabetic used to treat type 2 diabetes mellitus) the use of Linestat is not recommended in people taking acarbosa,
• A thyroid medication (levotiroxine) as it may be necessary to adjust the dose and take your medications at different times of the day,
• An antiepileptic medication, as any change in seizure frequency and severityshould be discussed with your doctor.

-Medications for HIV treatment. It is essential to consult your doctor before taking Linestat if you are receiving HIV treatment.

-Medications for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking Linestat:

• Ifyou are taking any medication for high blood pressure, as it may be necessary to adjust the dose.
• If you are taking any medication for high cholesterol, as it may be necessary to adjust the dose.

TakingLinestatwith food and drinks

Linestatshould be used in conjunction with a low-calorie and low-fat diet. Try to start this diet before starting treatment. For information on how to set your calorie and fat goals, see “More useful information”, in section 6.

You can takeLinestatimmediately before, during, or up to one hour after a meal. The capsule should be swallowed with water. This usually means taking a capsule with breakfast, another with lunch, and another with dinner. If you do not eat a meal or if the meal does not contain fat, do not take the capsule. This medication does not work if the meal does not contain some fat.

If you eat a meal high in fat, do not take a higher dose than recommended. Taking a capsule with a meal that contains too much fat increases the likelihood of experiencing treatment-related diet effects (see section 4). You should make every effort to avoid eating meals high in fat while takingLinestat.

Pregnancy and breastfeeding

Do not take Linestat during pregnancy or breastfeeding.

Driving and operating machines

It is unlikely thatLinestatwill affect your ability to drive or operate machines.

Linestat contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially “sodium-free”.

Preparation for Weight Loss

1. Choose Your Start Date

Choose the day you will start taking the capsules in advance. Before starting to take the capsules, begin your low-calorie and low-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. These food diaries are effective because they make you aware of what you are eating, how much you are eating, and provide a basis for making changes.

2. Decide Your Weight Loss Goal

Think about how much weight you want to lose and set a weight goal. A realistic goal is to lose between 5% and 10% of your initial weight. The amount of weight you lose may vary from week to week. You should try to lose weight at a gradual and consistent rate of around 0.5 kg per week.

3. Set Your Calorie and Fat Goals

To help you achieve your weight loss goal, you need to set two daily goals, one for calories and one for fat. For more information, see “More Useful Information”in section 6.

Linestat Dosage

Adults 18 years or older

• Take one capsule, three times a day.
• TakeLinestatjust before, during, or up to one hour after meals. Normally, this means taking a capsule at breakfast, lunch, and dinner. Make sure your three main meals are balanced and low in calories and fat.
• If you miss a meal, or if your meal does not contain fat, do not take a capsule.Linestatdoes not work unless the meal contains some fat,
• Swallow the capsule whole with water,
• Do not takemore than three capsules per day.
• Take meals low in fat to help reduce diet-related side effects of the treatment (see section 4).
• Try to be more physically active before starting treatment. Physical exercise is an important part of weight loss programs. Remember to consult with your doctor if you have not exercised before.
• Continue to be active while taking Linestat and after stopping its use.

How Long Should I Take Linestat?

• Linestatshould not be taken for more than 6 months.
• If you do not lose weight after taking this medication for 12 weeks, consult your doctor or pharmacist. You may need to stop taking it.
• To be successful in weight loss, it is not enough to eat differently for a short period of time and then return to old habits. People who lose weight and maintain the loss make changes to their lifestyle, including modifications to what they eat and how active they are.

What If I Take MoreLinestatThan I Should?

Do not take more than three capsules per day.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

What If I Forget to Take Linestat?

If you forget to take a dose of Linestat:

• Ifit has been less than one hour since your last meal, take the missed dose.
• If it has been more than one hour since your last meal, do not take the missed dose. Wait and take the nextdose with your meal as usual.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of frequent side effects related to the use ofLinestat(for example, gas with or without oily spots, or more frequent and soft stools) are the result of its mechanism of action (see section 1). Take low-fat foods to try to control these treatment-related side effects related to diet.

Severe side effects

The frequency of these side effects is unknown.

Severe allergic reactions

-the signs of a severe allergic reaction include: severe difficulty breathing, sweating,skin rash, itching, facial swelling, rapid heart rate, and collapse.

Stop taking the capsules and seek medical help immediately.

Other severe side effects

• Rectal bleeding,
• diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain (abdominal), especially on the left side, possibly with fever and constipation,
• pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain, sometimes radiating to the back, possibly with fever, nausea, and vomiting,
• skin blisters (including blisters that burst),
• severe stomach pain caused by gallstones (stones in the gallbladder),
• hepatitis (inflammation of the liver). Symptoms may include yellow skin and eyes, itching, dark urine, stomach and liver tenderness (indicated by pain below the front part of the thoracic cage on the right side), sometimes with loss of appetite.
• oxalate nephropathy (deposition of calcium oxalate that may lead to kidney stones). See section 2, be especially careful with Linestat.

Stop taking the capsules. Inform your doctor if you experience any of these side effects.

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

• gas (flatulence) with or without oily spots,
• sudden evacuation,
• oily or greasy stools,
• soft stools,

Inform your doctor or pharmacist if any of these side effects worsen or become complicated.

Common side effects(may affect up to 1 in 10 patients)

• abdominal pain,
• incontinence (fecal),
• fluid or liquid stools,
• more frequent stools,
• anxiety,

Inform your doctor or pharmacist if any of these side effects worsen or become complicated.

Side effects observed in blood tests(the frequency of these side effects is unknown)

• increased levels of some liver enzymes,
• effects on blood coagulation in people taking warfarin or other

anticoagulant medications.

Inform your doctor that you are takingLinestatwhen a blood test is performed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Learn to control treatment-related side effects related to diet

The most common side effects are caused by the mechanism of action of the capsules and occur typically during the first weeks of use of the capsules, before you have learned to limit the amount of fat in your diet. These treatment-related side effects related to diet may be a sign that you have eaten more fat than you should.

You can learn to minimize treatment-related side effects related to diet by following these basic guidelines:

• Start a low-fat diet a few days, or even a week, before starting to take the capsules.
• Find out more about the fat content of your favorite foods, and the portion size. If you familiarize yourself with the portions, you will be less likely to accidentally exceed your fat limit.
• Distribute the fat limit evenly throughout the day. Do not “save” fat and calorie intake and then take a high-fat meal or dessert, as you may have done with other weight loss programs.
• Mostusers who experience these side effects find that they can control them and manage them by adjusting their diet.

Do not worry if you do not experience these problems. That does not mean that the capsules are not working.

?Keepthis medicationout of the sight and reach of children.

?Do not store at a temperature above 25ºC.

?Store in the original packaging to protect it from light and humidity.

?Do not use this medication after the expiration date that appears on the box and labelafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Linestat

• The active principle is orlistat. Each hard capsule contains 60 mg of orlistat.
• The other componentsare:

Content of the capsule: microcrystalline cellulose,sodium carboxymethyl starch (type A) from potato, anhydrous colloidal silica and sodium lauryl sulfate.

Body of the capsule: gelatin, indigo carmine (E132) and titanium dioxide (E171).

Appearance of the product and contents of the package

Linestat 60 mg hard capsules have a blue light-colored body and cap.

Linestat 60 mg hard capsules are available in packages of 42, 84 and 120 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Teva Pharma S.L.U.

C/Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for Manufacturing

Pharmaceutical Works POLPHARMA SA

Pelplinska 19

83-200 Starogard Gdanski

Poland

or

RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.

P.O. BOX 3012 Larisa Industrial Area,

Larisa, 41004 Greece

Last review date of this leaflet: January 2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

MORE INFORMATION ON USE

Risks of being overweight

Being overweight will affect your health and increase your risk of developing serious health problems such as:

• Hypertension
• Diabetes
• Cardiac disease
• Cerebral hemorrhage
• Certain types of cancer
• Osteoarthritis

Discuss the risk of developing these diseases with your doctor.

Importance of weight loss

Weight loss and maintaining weight loss, for example by improving your diet and increasing physical activity, can help you reduce the risks of serious health problems and improve your health.

Useful tips on your diet and calorie and fat goals while taking Linestat

Linestat should be used with a low-calorie and low-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 you eat, it is important to eat a balanced diet. You should choose meals that contain a range of different nutrients and learn to eat healthily in the long term.

Understanding the importance of calorie and fat goals

Calories are a measure of the energy your body needs. Sometimes they are called Kilocalories or Kcal. Energy can also be measured in Kilojoules, which you may have seen in nutritional tables.

• Your calorie goal is the maximum number of calories you will eat each day. See the table below for this information.
• Your fat goal is the maximum number of grams of fat you will eat each meal. The fat goal table has been drawn up based on the information below on how to set your calorie goal.
• Controlling your fat goal is essential because of the mechanism of action of the capsules. Taking Linestat means that your body will eliminate more fat, and therefore it will be more difficult to manage as much fat in meals as before. Therefore, by adjusting to your fat goal, you will maximize weight loss results while minimizing the risk of treatment-related diet effects.
• You should aim to lose weight gradually and consistently. The ideal is to lose around 0.5 kg per week.

How to set your calorie goal

The following table has been designed to provide you with a calorie goal that is approximately 500 calories less than the number of calories your body needs to maintain your current weight. This means around 3,500 calories less per week, approximately the number of calories in 0.5 kg of fat.

Your calorie goal should allow you to lose weight at a gradual and stable rate of 0.5 kg per week without feelings of frustration or deprivation.

Do not take less than 1200 Kcal per day.

You will need to know your level of physical activity to set your calorie goals. The more active you are, the higher your calorie goal will be.

• Low activity means that you never or almost never walk, climb stairs, garden or engage in any other daily activity.
• Moderate activity means burning 150 calories per day in physical activity. Examples of moderate activity are walking approximately three kilometers, working in the garden for 30 to 45 minutes or running two kilometers in 15 minutes. Choose the level that best suits your daily routine. If you are unsure of which level you are on, choose Low activity.

Women

Men

How to set your fat goal

The following table shows how to set your fat goal based on the number of calories you can receive per day. You should plan to have three meals a day. If you have set a goal of 1,400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within the assigned amount of fat, snacks should not contain more than 3 g of fat.

Remember

• Adjusting to realistic calorie and fat goals is a way to maintain weight loss achievements in the long term.
• Record what you eat in a food diary, including calorie and fat content.
• Try to be more physically active before starting to take the capsules. Physical activity is an important part of a weight loss program. Remember to consult your doctor if you have not exercised before.

Continuebeing active while taking Linestat and after stopping it.