Elimens 60 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Elimens 60 mg hard capsules

Orlistat

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

• Always follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• If you do not lose weight after taking Elimens for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Elimens.

Contents of the leaflet

1. What Elimens is and what it is used for

2. What you need to know before taking Elimens

3. How to take Elimens

4. Possible side effects

5. Storage of Elimens

6. Contents of the pack and other information

1. What Elimens is and what it is used for

Elimens is used for weight loss in adults over 18 years of age who are overweight, with a body mass index (BMI) of 28 or higher. Elimens should be used in combination with a low-calorie, low-fat diet.

BMI is a way of determining whether you have a healthy weight or are overweight, taking your height into account. The table included below will help you determine whether you are overweight and whether Elimens is suitable for you.

Check your weight in the table below. If your weight is below the weight shown next to your height, do not take Elimens.

Height	Weight
1.50 m	63 kg
1.55 m	67.25 kg
1.60 m	71.75 kg
1.65 m	76.25 kg
1.70 m	81 kg
1.75 m	85.75 kg
1.80 m	90.75 kg
1.85 m	95.75 kg
1.90 m	101 kg

Risks of being overweight

Being 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 Elimens works

The active ingredient in Elimens (orlistat) is designed to target fat in your digestive system. It prevents about one-quarter of the fat you consume in meals from being absorbed. This fat will be eliminated from your body in the stools (see section 4). Therefore, it is important that you follow a low-calorie and low-fat diet to manage these effects. If you do so, the action of the capsules will assist your efforts by helping you lose more weight than with diet alone. For every 2 kg you lose with diet alone, Elimens may help you lose up to an additional 1 kg.

2. What you need to know before taking Elimens

Do not take Elimens

• If you are allergic to orlistat or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are taking cyclosporine, 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 condition in which bile flow from the liver is blocked).
• If you have a diagnosed problem with food absorption (chronic malabsorption syndrome).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Elimens.

• If you have diabetes. Consult your doctor about whether adjustment of your antidiabetic medication is needed.

• If you have kidney disease. Speak with your doctor before taking Elimens if you have kidney problems. Use of orlistat may be associated with kidney stones in patients with chronic kidney disease.

Children and adolescents

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

Taking Elimens with other medicines

Elimens may affect certain medicines you are taking.

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

Do not take Elimens together with the following medicines:

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

Use of oral contraceptives together with Elimens

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

Take a multivitamin every day if you are taking Elimens

• Elimens may reduce levels of certain vitamins absorbed by the body. The multivitamin supplement should contain vitamins A, D, E, and K. Take it at bedtime, after you have finished taking Elimens for the day, to ensure proper absorption of the vitamins.

Consult your doctor before taking Elimens if you are taking:

• Amiodarone, used for heart rhythm problems.
• Acarbose (an antidiabetic medicine used to treat type 2 diabetes mellitus). The use of Elimens is not recommended in people taking acarbose.
• A thyroid medicine (levotiroxine), as dose adjustment may be needed and the medicines should be taken at different times of the day.
• A medicine for epilepsy, as any change in frequency or severity of seizures should be discussed with your doctor.
• Medicines for HIV. It is important that you consult your doctor before taking Elimens if you are receiving treatment for HIV.
• Medicines for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking Elimens

• If you are taking any medicine for high blood pressure, as dose adjustment may be needed.
• If you are taking any medicine for high cholesterol, as dose adjustment may be needed.

Taking Elimens with food and drink

Elimens should be used together with a low-calorie, low-fat diet. Try to start this diet before beginning treatment. For information on how to set your calorie and fat goals, see Useful additional information in section 6.

You may take Elimens immediately before, during, or up to one hour after a meal. Swallow the capsule with water. This usually means one capsule with breakfast, one with lunch, and one with dinner. If you miss a meal or if the meal contains no fat, do not take the capsule. Elimens does not work if the meal contains no fat.

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

Pregnancy and breastfeeding

Do not take Elimens during pregnancy or while breastfeeding.

Driving and using machines

It is unlikely that Elimens will affect your ability to drive or operate machinery.

Elimens contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; i.e., essentially “sodium-free”.

3. How to take Elimens

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Preparation for weight loss

1. Choose your start date

Decide in advance the day on which you will begin using the capsules. Before starting to take the capsules, begin your low-calorie and low-fat diet and allow your body a few days to adjust to your new eating habits. Keep a record of what you eat in a diary. 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.

1. Decide on your weight loss goal

Think about how much weight you want to lose and set yourself a target weight. 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 aim to lose weight gradually and steadily at a rate of about 0.5 kg per week.

1. Set your calorie and fat goals

To help you achieve your weight loss goal, you need to set two daily targets: one for calories and one for fat. For further information, see Useful additional information in the blue pages of section 6.

Taking Elimens

Adults aged 18 years or older

• Take one capsule three times a day.
• Take Elimens 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 balanced and low in calories and fat.
• If you skip a meal or if your meal contains no fat, do not take a capsule. Elimens does not work unless the meal contains some fat.
• Swallow the capsule whole with water.
• Do not take more than three capsules per day.
• Eat low-fat meals to help reduce diet-related treatment effects (see section 4).
• Try to become more physically active before starting treatment. Physical exercise is an important part of weight loss programs. Remember to consult your doctor if you have not exercised before.
• Continue being physically active while taking Elimens and after stopping it.

How long should I take Elimens?

• Elimens should not be taken for longer than 6 months.
• If you have not lost weight after taking Elimens for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Elimens.
• To be successful in losing weight, it is not enough to change your eating habits temporarily and then return to old habits. People who lose weight and maintain the weight loss make lifestyle changes, including modifications in what they eat and how active they are.

If you take more Elimens than you should

Do not take more than three capsules per day.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Elimens

If you forget to take a dose of Elimens:

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

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Most of the common adverse effects associated with the use of Elimens (for example, flatulence with or without oily spotting, or more frequent bowel movements and soft stools) are the result of its mechanism of action (see section 1). Follow a low-fat diet to help manage these treatment-related effects related to dietary fat intake.

Serious adverse effects

Frequency unknown

Severe allergic reactions

• Signs of a severe allergic reaction include: severe difficulty breathing, sweating, skin rash, itching, swelling of the face, rapid heartbeat, collapse.

Stop taking the capsules and seek immediate medical help.

Other serious adverse effects

• Rectal bleeding.
• Diverticulitis (inflammation of the large intestine). Symptoms include lower 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.
• Blisters on the skin (including blisters that burst).
• Severe stomach pain caused by gallstones (stones in the gallbladder).
• Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and tender liver (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (calcium oxalate deposition which may lead to kidney stones). See section 2, take special care with Elimens.

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

Very common adverse effects

May affect more than 1 in 10 people

• Flatulence (wind), with or without oily spotting.
• Sudden bowel evacuation.
• Oily or fatty stools.
• Soft stools.

Inform your doctor or pharmacist if any of these adverse effects worsen or become troublesome.

Common adverse effects

May affect up to 1 in 10 people

• Stomach (abdominal) pain.
• Faecal incontinence.
• Loose or liquid stools.
• More frequent bowel movements.
• Anxiety.

Inform your doctor or pharmacist if any of these adverse effects worsen or become troublesome.

Adverse effects observed in blood tests

Frequency unknown (frequency cannot be estimated from the available data)

• Increased levels of certain liver enzymes.
• Effects on blood clotting in people taking warfarin or other anticoagulant medicines.

Inform your doctor that you are taking Elimens when having a blood test.

Learn how to manage diet- or fat-related effects of Elimens

The most common adverse effects are caused by the mechanism of action of the capsules and occur due to the excretion of some dietary fat from the body. 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 treatment-related effects may be a sign that you have consumed more fat than you should.

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

• Start a low-fat diet a few days, or even a week, before beginning the capsules.
• Learn more about the fat content of your favourite meals and portion sizes. Becoming familiar with portion sizes will make it less likely that you accidentally exceed your fat intake goal.
• Distribute your fat allowance evenly across meals throughout the day. Do not "save" fat or calorie intake for a high-fat meal or dessert later, as you may have done with other weight-loss programmes.
• Most users who experience these effects find they can control and manage them by adjusting their diet.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Elimens

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused or expired medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Elimens

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

• The other components are:

  • Capsule contents: Microcrystalline cellulose PH 112, sodium carboxymethylstarch (type A) (from potato), colloidal anhydrous silica, and sodium lauryl sulfate.
  • Capsule shell: Gelatin, indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Elimens capsules are bright blue hard capsules containing white powder or slightly compacted agglomerated powder.

• PVC-PVDC/Aluminum blister packs containing 42 and 84 hard capsules.
• HDPE bottles with tamper-evident closure, featuring a "push-fit" tamper-evident cap and containing a fine-pore silica gel desiccant. The bottle contains 42 or 84 hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

PHARMACEUTICAL WORKS POLPHARMA SA

19 Pelplinska Street,

83–200 Starogard Gdanski, POLAND

or

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area – Larisa, 41004 – GREECE

Date of the most recent revision of this leaflet: October 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

ADDITIONAL USEFUL INFORMATION

Risks of being overweight

Being overweight affects your health and increases your risk of developing serious health problems such as:

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

Talk to your doctor about your risk of developing these conditions.

Importance of weight loss

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

Useful tips about your diet and your calorie and fat goals while taking Elimens

Elimens should be used in combination with a reduced-calorie and reduced-fat diet. The capsules work by preventing the absorption of some of the fat you eat, but you can still consume foods from all major food groups. While you should focus on the calories and fat you consume, it is important to maintain a balanced diet. You should choose meals containing a variety of 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. They are sometimes referred to as kilocalories or kcal. Energy can also be measured in kilojoules, which you may have seen on nutritional labels.

• Your calorie goal is the maximum number of calories you should consume each day. See the table included later in this section.
• Your fat gram goal is the maximum number of grams of fat you should consume per meal. The fat gram goal table has been designed based on the calorie goal information provided below.
• Monitoring your fat intake is essential due to the mechanism of action of the capsules. Taking Elimens means your body will eliminate more fat, making it harder to handle large amounts of fat in meals as before. Therefore, by adhering to your fat goal, you will maximize weight loss results while minimizing the risk of diet-related treatment side effects.
• You should aim for gradual and steady weight loss. Ideally, lose about 0.5 kg per week.

How to set your calorie goal

The following table has been designed to provide you with a calorie goal approximately 500 calories less than what your body needs to maintain your current weight. This results in a weekly deficit of up to 3,500 calories, roughly equivalent to the number of calories in 0.5 kg of body fat.

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

It is not recommended to consume fewer than 1,200 kcal per day.

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

• Low activity means you never or almost never walk, climb stairs, garden, or engage in other daily physical activities.
• Moderate activity means burning 150 calories per day through physical activity. Examples of moderate activity include walking approximately three kilometers (2 miles), gardening for 30 to 45 minutes, or running two kilometers (1.25 miles) in 15 minutes.

Choose the level that best matches your daily routine. If you are unsure which level applies to you, choose Low Activity.

Women

Low activity	Less than 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 above	1,800 calories
Moderate activity	Less than 61.2 kg	1,400 calories
61.3 kg to 65.7 kg	1,600 calories
65.8 kg and above	1,800 calories

Men

Low activity	Less than 65.7 kg	1,400 calories
	65.8 kg to 70.2 kg	1,600 calories
	70.3 kg and above	1,800 calories
Moderate activity	59.0 kg and above	1,800 calories

How to set your fat goal

The following table shows how to set your fat goal based on the number of calories you can consume per day. You should plan to have three meals per day. If, for example, you have set a goal of 1,400 calories per day, the maximum amount of fat allowed per meal would be 15 g. To stay within your allotted amount of fat, snacks should contain no more than 3 g of fat.

Calorie amount you can consume per day	Maximum amount of fat allowed per meal	Maximum amount of fat from snacks allowed per day
1,200 calories	12 g	3 g
1,400 calories	15 g	3 g
1,600 calories	17 g	3 g
1,800 calories	19 g	3 g

Remember

• Stick to realistic calorie and fat intake goals, as this is a way to maintain long-term weight loss achievements.
• Keep a food diary, recording everything you eat, including calorie and fat content.
• Try to become more physically active before starting the capsules. Physical activity is an important part of a weight loss program. Remember to consult your doctor if you have not exercised previously.

Continue staying physically active while taking Elimens and after stopping it.