Linestat 60 MG 120 Capsules (Orlistat)

Linestat is used for weight loss in overweight adults aged 18 years and over with a body mass index (BMI) of 28 or higher. Linestat should be used in combination with a diet low in calories and fat.

BMI is a way to tell if you are a healthy weight or overweight based on your height. The table below will help you find out if you are overweight and if this medicine is right for you.

Check your weight in the table below. If your weight is less than the weight listed next to your height, do not take this medicine.

Risks of being overweight

Being overweight increases the risk of developing a number of serious health problems, such as diabetes or heart disease. These conditions may not make you feel sick, so you should see your doctor for a general checkup.

How Linestat works

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

Do not take Linestat :

• if you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or lactating,
• if you are taking ciclosporin, used after organ transplantation, in severe rheumatoid arthritis and in certain serious skin conditions,
• if you are taking warfarin or other anticoagulant medicines,
• if you have cholestasis (a disease 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 Cautions

Talk to your doctor or pharmacist before taking Linestat.

• If you have diabetes. Check with your doctor if your antidiabetic medication needs to be adjusted.

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

children and adolescents

Children and adolescents under 18 years of age should not take this medicine.

Taking Linestat with other medicines

Linestat can affect some medicines you take.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Linestat together with the following medicines:

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

Use of oral contraceptives together with Linestat:

• Oral contraceptives may be less effective if you have severe diarrhoea. Use an additional method of contraception if you have severe diarrhoea.

Multivitamin complexes and Linestat:

• It is recommended to take a multivitamin every day as this medicine can reduce the levels of some vitamins absorbed by the body. The multivitamin should contain vitamins A, D, E and K. You should take it at bedtime, when you are no longer taking Linestat to ensure that the vitamins are absorbed.

Talk to your doctor before taking Linestat if you are taking:

• Amiodarone, used for heart rhythm problems,
• Acarbose (an antidiabetic used to treat type 2 diabetes mellitus) Linestat is not recommended for use in people taking acarbose,
• A thyroid medicine (levothyroxine) as it may be necessary to adjust the dose and take your medicines at different times of the day,
• An epilepsy medication, as any changes in the frequency and severity of seizures should be discussed with your doctor.

- Medicines to treat HIV. It is important to talk to your doctor before taking Linestat if you are being treated for HIV.

- Medicines for depression, psychiatric disorders or anxiety.

Talk to your doctor or pharmacist while you are taking Linestat:

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

Taking Linestat with food and drink

Linestat should be used in conjunction with a diet low in calories and fat. Try to start this diet before starting treatment. For information on how to set your calorie and fat goal, see “ More Helpful Information ” in Section 6.

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

If you eat a high-fat meal, you should not take more than the recommended dose. Taking a capsule with a meal that contains too much fat increases the chance of diet-related treatment effects (see section 4). You should make every effort to avoid high-fat foods while you are taking Linestat.

Pregnancy and lactation

Do not take Linestat during pregnancy or lactation.

Driving and using machines

Linestat is unlikely to affect your ability to drive or use machines.

Linestat contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, ie essentially 'sodium-free'.

preparation to lose weight

1. Choose your start date

Choose the day you will start using the capsules in advance. Before you start taking the capsules, start your low-calorie, low-fat diet and give your body a few days to adjust to your new eating habits. Keep track of what you are eating in a journal. These food diaries are effective because they make you aware of what you're eating, how much you're eating, and give you the basis for making changes.

2. Decide your weight loss goal

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

3. Set your calorie and fat goals

To help you reach 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 socket

Adults 18 years or older

• Take one capsule, three times a day.
• Take Linestat just before, during, or up to one hour after meals. Normally this means one 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 is fat-free, skip a capsule. Linestat does not work unless the food contains some fat,
• Swallow the capsule whole with water,
• Do not take more than three capsules a day.
• Take low-fat meals to help reduce diet-related effects of 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 check with your doctor if you have not exercised before.
• Continue to be active while you are taking Linestat and after you stop using it.

For how long should I take Linestat?

• Linestat should not be taken for more than 6 months.
• If you do not lose weight after taking this medicine for 12 weeks, talk to your doctor or pharmacist. You may have to stop taking it.
• To be successful in losing weight, 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 it make lifestyle changes, including changes in what they eat and how active they are.

If you take more Linestat than you should

Do not take more than three capsules a day.

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

If you forget to take Linestat

If you forget to take a dose of Linestat:

• If it is less than an hour since your last meal, take the missed dose.
• If it is more than an hour since your last meal, skip the missed dose. Wait and take the next dose with food as usual.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the common side effects associated with the use of Linestat (for example gas with or without oily spots, or more frequent bowel movements and loose stools) are the result of its mechanism of action (see section 1). Eat low-fat foods to try to control these diet-related effects of treatment.

serious side effects

It is not known how often these side effects occur.

severe allergic reactions

- signs of a serious allergic reaction include: severe difficulty breathing, sweating, rash, itching, swelling of the face, rapid heartbeat and collapse.

Stop taking the capsules and seek medical help immediately.

Other serious side effects

• rectal bleeding,
• diverticulitis (inflammation of the large intestine). Symptoms include lower stomach (abdominal) pain, 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 bursting blisters),
• severe stomach pain caused by gallstones (bladder stones),
• hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark colored urine, stomach pain and tender liver (indicated by pain under the front of the rib cage on the right side), sometimes with loss of appetite.
• oxalate nephropathy (deposition of calcium oxalate which can lead to kidney stones). See section 2, take special care with Linestat.

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

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

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

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

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

• stomach (abdominal) pain
• incontinence (faecal),
• fluid or liquid stools,
• more frequent bowel movements
• anxiety,

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

Side effects seen in blood tests (it is not known how often these effects occur)

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

              anticoagulant medications.

Tell your doctor that you are taking Linestat when you have a blood test.

Reporting of adverse 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 communicate them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaram.es .

By reporting side effects you can help provide more information on the safety of this medicine.

Learn how to manage diet-related effects of treatment

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

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

• Start a low-fat diet a few days, or even a week, before you start taking the capsules.
• Find out more about the fat content of your favorite foods, and their serving sizes. By becoming familiar with serving sizes, you'll be less likely to accidentally exceed your fat goal.
• Distribute the fat allowance evenly at meals throughout the day. Don't "save" fat and calories for a high-fat meal or dessert later, as you may have done with other weight-loss programs.
• Most users who experience these effects find that they can be controlled and managed by adjusting their diet.

Don't worry if you don't experience these problems. That does not mean that the capsules are not working.

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

? Do not store at temperatures above 25ºC.

? Store in the original package in order to protect from light and moisture.

? Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of down the drain or in the trash. Deposit the containers and medications that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you don't need. This way you will help to protect the environment.

Composition of Linestat

• The active substance is orlistat. Each hard capsule contains 60 mg orlistat.
• The other components are:

Capsule contents : microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, colloidal anhydrous silica and sodium lauryl sulphate.

Capsule body : gelatin, indigo carmine (E132) and titanium dioxide (E171).

What the product looks like and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Manager

Marketing Authorization Holder

Teva Pharma SLU

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

28108 Alcobendas, Madrid (Spain)

responsible for manufacturing

Pharmaceutical Works POLPHARMA SA

Pelplinska 19

83-200 Starogard Gdański

Poland

either

RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS SA

PO BOX 3012 Larisa Industrial Area,

Larissa, 41004 Greece

Date of last revision of this leaflet: January 2022

Updated detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

MORE USEFUL INFORMATION

Risks of being overweight

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

• Hypertension
• Diabetes
• Heart disease
• Stroke
• certain types of cancer
• Osteoarthritis

Talk to your doctor about the risk of developing these diseases.

Importance of losing weight

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

Helpful advice about your diet and your calorie and fat goals while you are taking Linestat

Linestat should be used with a diet low in calories and fat. The capsules work by preventing some of the fat you eat from being absorbed, but you can still eat foods from all the major food groups. Although you should focus on the calories and fat you eat, it is important to eat a balanced diet. You must choose foods that contain a range of different nutrients and learn to eat healthily for the long term.

Understand the importance of targeting calories and fat

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 you may have also seen in nutrition tables.

• The calorie goal is the maximum number of calories you will eat each day. See the chart later in this section.
• Your fat gram goal is the maximum number of fat grams you will eat at each meal. The Fat Grams Goal Chart has been developed following the information below on how to set your calorie goal.
• Controlling the target fat is essential due to the mechanism of action of the capsules. Taking Linestat means that your body is going to burn more fat, and therefore it will be harder for you to handle as much fat at meals as before. So by sticking to your target fat, you will maximize weight loss results while minimizing the risk of diet-related treatment effects.
• You should aim to lose weight gradually and steadily. The ideal is to lose around 0.5 kg a week.

How to set your calorie goal

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

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

It is not recommended to take less than 1200 Kcal a 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 rarely or never walk, climb stairs, garden, or do other daily activities.
• Moderate activity means burning 150 calories a day in physical activity. Examples of moderate activity are walking about two miles, gardening for 30 to 45 minutes, or running a mile in 15 minutes. Choose the level that best fits your daily routine. If you're not sure what level you're at, choose Low Activity.

Women

Men

How to set your fat goal

The chart below shows how to set your fat goal based on the number of calories you can take in per day. You should plan to have three meals a day. If you've set a goal of 1,400 calories a day, for example, the maximum amount of fat allowed per meal would be 15g. To stay within the allotted amount of fat, appetizers must not contain more than 3 g of fat.

remember

• Stick to realistic calorie and fat goals, as this is one way to maintain your weight loss gains in the long term.
• Record 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 program. Remember to check with your doctor if you have not exercised before.

Continue to be active while you are taking Linestat and after you stop taking it.

Leaflet Linestat 60 MG 120 Capsules