NORMOFIT 60 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

normofit 60 mg hard capsules

orlistat

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect 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.

Contents of the Package Leaflet

1. What is normofit and what is it used for
2. What you need to know before you start taking normofit
3. How to take normofit
4. Possible side effects
5. Storage of normofit
6. Contents of the pack and further information

1. What is normofit and what is it used for

normofit is used to help with weight loss in adults aged 18 and over who are overweight, with a body mass index (BMI) of 28 or more. normofit should be used in combination with a low-calorie, low-fat diet.

Body mass index (BMI) is a way of measuring whether you are a healthy weight for your height. The table below will help you find out if you are overweight and if normofit is suitable for you.

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

Risks of being overweight

Being overweight increases the risk of developing 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 normofit works

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

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

Do not take normofit

• If you are allergic to orlistat or any of the other ingredients of normofit (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are taking ciclosporin, used after an organ transplant, for severe rheumatoid arthritis, and for certain severe skin conditions.
• If you are taking warfarin or other anticoagulant medicines.
• If you have cholestasis (a disease where bile flow from the liver is blocked).
• If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take normofit.

If you have diabetes. Consult your doctor if you need to adjust your anti-diabetic 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 of age should not take this medicine.

Taking normofit with other medicines

normofit may affect some medicines you are taking.

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

Do not take normofit with the following medicines

• Ciclosporin, used after an organ transplant, for severe rheumatoid arthritis, and for certain severe skin conditions.
• Warfarin or other anticoagulant medicines.

Use of oral contraceptives with normofit

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

Multivitamin complexes and normofit

• It is recommended to take a multivitamin complex every day since normofit may reduce the levels of some vitamins absorbed by the body. The multivitamin complex should contain vitamins A, D, E, and K, and you should take it 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.
• Acarbose, (an anti-diabetic medicine used to treat type 2 diabetes mellitus) the use of normofit is not recommended in people taking acarbose.
• A medicine for the thyroid (levothyroxine) as you may need to adjust the dose and take your medicines at different times of the day.
• A medicine for epilepsy, as any change in the frequency and severity of seizures should be discussed with your doctor.
• Medicines for HIV. It is important that you consult your doctor before taking normofit if you are receiving treatment for HIV.
• Medicines for depression, psychiatric disorders, or anxiety.

Consult your doctor or pharmacist while taking normofit

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

Taking normofit with food and drink

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

You can take normofit 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. 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 does not work unless the meal contains some fat.

If you take a meal with a high fat content, do not take a higher dose than recommended. Taking a capsule with a meal that contains too much fat increases the chances of suffering from treatment-related effects (see section 4). You should make every effort to avoid meals with high fat content while taking normofit.

Pregnancy and breastfeeding

Do not take normofit during pregnancy or breastfeeding.

Driving and using machines

It is unlikely that normofit will affect your ability to drive or use machines.

normofit contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”

3. How to take normofit

Preparation for weight loss

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 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. Decide on 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 steady 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 goals, one for calories and one for fat. For more information, see More useful informationin section 6.

Taking normofit

Adults aged 18 and over

• Take one capsule, three times a day.
• Take normofit just before, during, or up to one hour after meals. Normally, this means one capsule with breakfast, one with lunch, and one with 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 does 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 treatment-related effects (see section 4).
• Try to be more physically active before starting treatment. Exercise is an important part of weight loss programs. Remember to consult your doctor if you have not exercised before.
• Continue to be active while taking normofit and after stopping it.

How long should I take normofit for?

• normofit should not be taken for more than 6 months.
• If you do not lose weight after taking normofit for 12 weeks, consult 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 and then go back to old habits. People who lose weight and maintain weight loss make lifestyle changes, including changes in 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take normofit

If you forget to take a dose of normofit:

• If it is less than one hour since your last meal, take the missed dose.
• If it is more than one 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 make up for missed doses.

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

4. Possible side effects

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

Most common side effects related to the use of normofit (e.g. gas with or without oily spots, or sudden bowel movements) are the result of its mechanism of action (see section 1). Take low-fat foods to try to control these treatment-related effects.

Serious side effects

Frequency not known

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 medical help immediately.

Other serious side effects

• Rectal bleeding
• Diverticulitis (inflammation of the large intestine). Symptoms include lower abdominal pain, 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.
• Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and liver tenderness (indicated by pain under the front of the rib cage, on the right side), sometimes with loss of appetite.
• Oxalate nephropathy (calcium oxalate deposits that can 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 effects.

Very common side effects

May affect more than 1 in 10 people taking normofit

• Gas (flatulence) with or without oily spots.
• Sudden bowel movements
• Oily or fatty stools
• Soft stools

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

Common side effects

May affect up to 1 in 10 people taking normofit

• Abdominal pain
• Incontinence (fecal)
• Fluid or liquid stools
• More frequent bowel movements
• Anxiety

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

Side effects observed in blood tests

Frequency not known

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

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

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

Learn to control treatment-related effects

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 effects usually occur during the first few weeks of using the capsules, before you have learned to limit the amount of fat in your diet. These treatment-related effects can be a sign that you have eaten more fat than you should.

You can learn to minimize treatment-related effects 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 the size of the portions. If you become familiar with portions, you will be less likely to accidentally exceed your fat goal.
• Distribute your fat limit evenly across meals throughout the day. Do not “save”

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

• Most users who experience these effects find that they can control them and manage them by adjusting their diet.

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

5. Storage of normofit

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 on the blister after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of normofit

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

• The other ingredients are:
• Filler: microcrystalline cellulose PH 112, sodium starch glycolate (type A), hydrophobic colloidal silica, sodium lauryl sulfate.
• Body of the capsule: gelatin, titanium dioxide (E171), carmine indigo (E132).

Appearance of the product and pack contents

normofit capsules have a light blue body and cap.

normofit is available in packs of 42, 84, or 120 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

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

Date of the last revision of this leaflet:June 2023

Detailed information on this medicinal product 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 weight loss

Losing weight 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 goals while taking normofit

normofit 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 fats you eat, it is essential 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. They are sometimes called Kilocalories or Kcal. Energy can also be measured in Kilojoules, which you may also have seen in nutrition tables.

• Your calorie goal is the maximum number of calories you will eat each day. See the chart included later in this section.
• Your fat goal is the maximum number of grams of fat you will eat at each meal. The fat goal chart has been developed based on the information shown below on how to set your calorie goal.
• Controlling your fat goal is essential due to the mechanism of action of the capsules. Taking normofit means that your body will eliminate more fat, and therefore it will be more challenging to handle as much fat in meals as before. Therefore, by adjusting to your fat goal, you will maximize your weight loss results while minimizing the risk of treatment-related effects on your 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 goal

The following table has been designed to provide you with a calorie goal that is approximately 500 calories less than your body needs to maintain its current weight. This means up to 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.

It is not recommended to take less than 1200 Kcal per day.

You will need to know your physical activity level 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 other daily activities.
• Moderate activity means burning 150 calories per day in 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 fits your daily routine. If you are unsure which level you are at, choose Low Activity.

Women

Men

How to set your fat goal

The following chart shows how to set your fat goal based on the number of calories you can have per day. You should plan to have three meals per day. If you have set a goal of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within the allocated amount of fat, snacks should not contain more than 3 g of fat.

Remember

• Stick to realistic calorie and fat goals, as this is a way to maintain long-term weight loss achievements.
• Write down 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 essential part of a weight loss program. Remember to consult with your doctor if you have not exercised before.
• Continue to be active while taking normofit and after stopping it.