Leaflet: information for the user

normofit 60 mg hard capsules

orlistat

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 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 normofit for 12 weeks, consult your doctor or pharmacist. You may need to stop taking normofit.

1. What is normofit and what it is used for

2. What you need to know before starting to take normofit

3. How to take normofit

4. Possible side effects

5. Storage of normofit

6. Contents of the pack and additional information

normofit is used for weight loss in adults over 18 years old with overweight, with a body mass index (BMI) of 28 or higher. normofit 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 that is included below will help you find out if you have overweight and if normofit is suitable for you.

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

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 bad, so you should see your doctor for a general check-up.

How normofit works

The active ingredient of normofit (orlistat) is designed to target the fat in your digestive system. Prevents about a quarter of the fat you take in meals from being absorbed. This fat will be eliminated from your body in the stool. 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 those 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, normofit can help you lose 1 kg more.

Do not take Normofit

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Normofit.

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 Normofit 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 should not take this medication.

Taking Normofit with Other Medications

Normofit 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 Normofit with the following medications

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

Use of Oral Contraceptives with Normofit

• 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 Normofit

• It is recommended to take a multi-vitamin complex daily as Normofit may reduce the levels of some vitamins absorbed by the body. The multi-vitamin complex should contain vitamins A, D, E, and K. and should be taken before bedtime, when you will not be taking Normofit, to ensure that the vitamins are absorbed.

Consult your doctor before taking Normofit if you are taking

• Amiodarone, used for heart rhythm problems.
• Acarbosa, (an antidiabetic medication used to treat type 2 diabetes) the use of Normofit is not recommended in people taking acarbosa.
• A medication for the thyroid (levotiroxine) as it may be necessary to adjust the dose and take your medications at different times of the day.
• A medication for epilepsy, as any change in the frequency and severity of seizures should be discussed with your doctor.
• Medications for HIV. It is essential to consult your doctor before taking Normofit if you are receiving treatment for HIV.
• Medications for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking Normofit

• If you 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.

Taking Normofit with Food and Drinks

Normofit should 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, seeMore Useful Information, in section 6.

Normofit can be taken immediately 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. Normofit does not work if the meal does not contain some fat.

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

Pregnancy and Lactation

Do not take Normofit during pregnancy or lactation.

Driving and Operating Machines

It is unlikely that Normofit will affect your ability to drive or operate machines.

Normofit contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it 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 a 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.

1. Determine 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.

1. 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, seeMore Useful Informationin section 6.

Normofit Dosage

Adults 18 Years or Older

• Take one capsule, three times a day.
• Take normofit just 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. normofit will not work unless the meal contains some fat.
• Swallow the capsule whole with water.
• Do not take more than three capsules per day.
• Take low-fat meals to help reduce the effects of the treatment related to diet (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 normofit and after stopping its use.

How Long Should I Take Normofit?

• normofit should not be taken for more than 6 months.
• If you do not lose weight after taking normofit for 12 weeks, consult with your doctor or pharmacist. You may need to stop taking normofit.
• 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.

If You Take More Normofit 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, consult a doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Normofit

If you forget to take a dose of normofit:

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

Do not take a double dose to compensate for the missed doses.

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

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

The majority of frequent side effects related to the use of normofit (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, collapse.

Stop taking the capsules and seek medical help immediately.

Other severe side effects

• Bleeding rectum
• Diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain (stomach), 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 yellow skin and eyes, itching, dark urine, stomach and liver pain (indicated by pain under the front of the chest, 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 normofit.

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

Very frequent side effects

May affect more than 1 in 10 people taking normofit

• Gas (flatulence) with or without oily spots.
• Emergency evacuation
• Oily or greasy stools
• Soft stools

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

Frequent side effects

May affect up to 1 in 10 patients taking normofit

• Abdominal pain (stomach)
• Fecal incontinence
• 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 taking normofit when you have a blood test.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 due to the elimination of part of the fat from the body. These side effects typically occur 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 target.
• Distribute the fat limit evenly throughout the meals throughout the day. Do not “save”

fat and calorie intake to then take a high-fat meal or dessert, as you may have done with other weight loss programs.

• Most users 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.

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

Do not use this medication after the expiration date that appears on the packaging and in the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at 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 normofit

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

- The other components are:

- Filling of the capsule: microcrystalline cellulose PH 112, sodium starch glycolate type A, colloidal anhydrous silica, sodium lauryl sulfate.

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

Appearance of the product and contents of the package

Normofit capsules have a light blue body and cap.

Normofit is available in packages of 42, 84 or 120 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Responsible for manufacturing:

Pharmaceutical Works POLPHARMA S.A.

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

Last review date of this leaflet: June 2023

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 USEFULNESS

Risks of having overweight

Having 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

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

Weight loss and maintaining weight loss, for example by improving your diet and increasing your 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 objectives while taking normofit

Normofit should be used with a low-calorie and low-fat diet. The capsules work by preventing part 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 objectives

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

How to set your calorie objective

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

Your calorie objective 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 objectives. The more active you are, the higher your calorie objective will be.

Choose the level that best suits your daily routine. If you are not sure which level you are in, choose Low Activity.

Women

Men

How to set your fat gram objective

The following table shows how to set your fat gram objective 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 calorie objective of 1400 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 objectives 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.
• Continue to be active while taking normofit and after stopping it.