Beacita 60 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Beacita 60 mg hard capsules
orlistat
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- If you do not lose weight after taking Beacita for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Beacita.
Contents of the leaflet
- What Beacita is and what it is used for
- What you need to know before taking Beacita
- How to take Beacita
- Possible side effects
- How to store Beacita
- Contents of the pack and other information
1. What Beacita is and what it is used for
Beacita 60 mg hard capsules (orlistat) is a peripherally-acting anti-obesity medication used for weight loss in adults over 18 years of age who are overweight, with a body mass index (BMI) of 28 or higher. Beacita 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 Beacita is suitable for you.
Check your weight in the table below. If your weight is less than the weight shown next to your height, do not take Beacita.
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 visit your doctor for a general check-up.
How Beacita works
The active substance in Beacita (orlistat) is designed to target fat in your digestive system. It prevents about one-quarter of the fat you consume in your meals from being absorbed. This fat will be eliminated from your body in your 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 through diet alone, Beacita could help you lose an additional 1 kg.
2. What you need to know before taking Beacita
Do not take Beacita
? 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 diagnosed problems with food absorption (chronic malabsorption syndrome).
Warnings and precautions
Talk to your doctor or pharmacist before starting Beacita.
? If you have diabetes. Consult your doctor about whether adjustment of your antidiabetic medication may be necessary.
? If you have any kidney disease. Speak with your doctor before taking Beacita if you have kidney problems. 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 must not take this medicine.
Other medicines and Beacita
Beacita 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 Beacita 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 Beacita
? 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 Beacita
? Beacita may reduce levels of certain vitamins absorbed by the body. The multivitamin supplement should contain vitamins A, D, E, and K, and should be taken at bedtime, after your last dose of Beacita, to ensure proper absorption of the vitamins.
Consult your doctor before taking Beacita if you are taking
? Amiodarone, used for heart rhythm problems.
? Acarbose (an antidiabetic medicine used to treat type 2 diabetes mellitus). The use of Beacita is not recommended in people taking acarbose.
? A thyroid medicine (levotiroxine), as it may be necessary to adjust the dose and take your medicines at different times of day.
? A medicine for epilepsy, as any change in frequency or severity of seizures should be discussed with your doctor.
? Medicines for treating HIV. It is important that you consult your doctor before taking Beacita if you are receiving treatment for HIV.
? Medicines for depression, psychiatric disorders, or anxiety.
Talk to your doctor or pharmacist while taking Beacita
? If you are taking any medicine for high blood pressure, as dose adjustment may be necessary.
? If you are taking any medicine for high cholesterol, as dose adjustment may be necessary.
Taking Beacita with food, drinks, and alcohol
Beacita should be used in combination with a reduced-calorie, low-fat diet. Try to start this diet before beginning treatment. For information on setting your calorie and fat intake goals, see Useful additional information in section 6.
Beacita may be taken just 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. Do not take the capsule if you skip a meal or if the meal contains no fat. Beacita does not work if the meal contains no fat.
Do not take a higher than recommended dose if you eat a high-fat meal.
Taking a capsule with a meal 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 Beacita.
Pregnancy and breastfeeding
Do not take Beacita during pregnancy or while breastfeeding.
Driving and using machines
It is unlikely that Beacita will affect your ability to drive or use machines.
Beacita contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.
3. How to take Beacita
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Preparation for weight loss
- Choose your start date
Decide in advance the day you will begin taking the capsules. Before starting 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 and how much you are eating, and provide a basis for making changes.
- 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, about 0.5 kg per week.
- 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 more information, see Useful additional information in section 6.
Taking Beacita
Adults aged 18 years or older
• Take one capsule three times a day.
• Take Beacita 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. Beacita 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 first if you have not exercised before.
• Continue to stay active while taking Beacita and after stopping it.
How long Beacita should be taken
• Beacita should not be taken for longer than 6 months.
• If you do not lose weight after taking Beacita for 12 weeks, consult your doctor or pharmacist. You may need to stop taking Beacita.
• Successful weight loss requires more than just changing your eating habits temporarily and then returning to old habits. People who lose weight and maintain the loss make lifestyle changes, including modifications to their diet and physical activity levels.
If you take more Beacita 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, stating the name of the medicine and the amount ingested.
If you forget to take Beacita
If you forget to take a dose of Beacita:
• If less than one hour has passed since your last meal, take the missed capsule.
• If more than one hour has passed since your last meal, do not take the missed capsule. Wait and take the next capsule 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, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Most of the common adverse effects associated with the use of Beacita (for example, flatulence with or without oily spotting, increased frequency of defecation, and soft stools) are the result of its mechanism of action (see section 1). Follow a low-fat diet to help manage these diet-related treatment effects.
Serious adverse effects
The frequency of these adverse effects is unknown.
Severe allergic reactions
? Signs of a severe allergic reaction include: severe difficulty breathing, sweating, skin rash, itching, facial swelling, 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 pain in the lower abdomen, 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-coloured 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, Warnings and precautions.
?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
? Gas (flatulence) with or without oily spotting.
? Sudden bowel evacuation.
? Oily or fatty stools.
? Soft stools.
?Tell 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.
? Incontinence (fecal).
? Loose or liquid stools.
? More frequent bowel movements.
? Anxiety.
?Tell your doctor or pharmacist if any of these adverse effects worsen or become troublesome.
Effects observed in blood tests
Frequency unknown (frequency cannot be estimated from the available data)
? Increase in levels of certain liver enzymes.
? Effects on blood clotting in people taking warfarin or other anticoagulant medicines.
?Inform your doctor that you are taking Beacita when having a blood test.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
Learn how to manage diet-related treatment effects
The most common adverse effects are caused by the mechanism of action of the capsules and occur due to the elimination of some 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 diet-related treatment effects may be a sign that you have consumed more fat than you should.
You can learn to minimize diet-related treatment effects by following these basic guidelines:
? Start a low-fat diet a few days, or even a week, before beginning to take the capsules.
? Learn more about the fat content of your favourite foods and portion sizes. Becoming familiar with portion sizes will make it less likely that you accidentally exceed your fat intake goal.
? Distribute your daily fat allowance evenly across meals throughout the day. Do not “save” fat and 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 that the capsules are not working.
5. Storage of Beacita
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. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Beacita
- The active substance is orlistat. Each hard capsule contains 60 mg of orlistat.
- The other components are:
Capsule filling: microcrystalline cellulose PH 112, sodium carboxymethylstarch (type A) (derived from potato starch), colloidal anhydrous silica, sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
Appearance of the product and contents of the pack
Beacita capsules have a light blue body and cap.
Beacita 60 mg hard capsules are available in pack sizes of 42 and 84 capsules.
Marketing Authorization Holder
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Tel.: 91 630 86 45
Fax: 91 630 26 64
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
41004 Larisa
Greece
Date of the most recent review of the package leaflet: October 2020
Other sources of information
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 the risk of developing these diseases.
Importance of weight loss
Losing weight and maintaining weight loss, for example by improving your diet and increasing physical activity, can help reduce the risks of serious health problems and improve your overall health.
Useful tips about your diet and calorie and fat goals while taking Beacita
Beacita should be used in combination with a reduced-calorie, low-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 information provided below on setting your calorie goal.
• Controlling your fat intake is essential due to the mechanism of action of the capsules. Taking Beacita means your body will eliminate more fat, making it more difficult to handle high-fat meals as before. Therefore, by adhering to your fat intake 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, aim to 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 that is approximately 500 calories less than the amount your body needs to maintain your current weight. This results in a deficit of up to 3,500 calories per week, 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 physical activities daily.
• “Moderate activity” means burning 150 calories per day through physical activity. Examples of moderate activity include walking approximately three kilometers, gardening for 30 to 45 minutes, or running two kilometers 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, your goal is 1,400 calories per day, the maximum amount of fat allowed per meal would be 15 g. To stay within the allotted amount of fat, snacks should not contain 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 before.
• Continue being physically active while taking Beacita and after stopping it.