60 mg capsules, hard
orlistat
1. What Beacita is and what it is used for
Beacita is used for weight loss in adults 18 years and older, who are overweight and have a BMI ( body mass index ) of 28 or more.
Beacita should be used with a low-calorie, low-fat diet.
BMI is a way to find out if you have a healthy weight or if you are overweight for your height. Using the table below, you can find out if you are overweight and if you can use Beacita.
Find your height in the table. If you weigh less than the weight indicated for your height, do not take Beacita.
| Length | Weight |
| 150 cm | 63 kg |
| 155 cm | 67.25 kg |
| 160 cm | 71.75 kg |
| 165 cm | 76.25 kg |
| 170 cm | 81 kg |
| 175 cm | 85.75 kg |
| 180 cm | 90.75 kg |
| 185 cm | 95.75 kg |
| 190 cm | 101 kg |
The risk of being overweight
Being overweight increases the risk of developing serious health problems such as diabetes and heart disease. These conditions may not make you feel bad, so you should have a general health check-up with a doctor.
How Beacita works
The active ingredient (orlistat) in Beacita is designed to target the fat in the digestive system. It prevents about a quarter of the fat in a meal from being absorbed by the body. This fat disappears from the body with the stool. You may experience diet-related treatment effects (see section 4). It is therefore important that you eat a low-fat diet to deal with these effects. If you do, the capsules will help you lose more weight compared to a diet program alone. For every 2 kg that you lose from diet alone, Beacita can make you lose another 1 kg.
Orlistat contained in Beacita may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Beacita
Do not use Beacita
- If you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or breastfeeding.
- If you are taking ciclosporin, which is used after organ transplants, for severe rheumatoid arthritis and certain serious skin conditions.
- If you are taking warfarin or other medicines used to thin the blood.
- If you have bile stasis (a condition in which the bile flow from the liver is blocked).
- If your doctor has diagnosed you with food intake (chronic malabsorption syndrome).
Warnings and cautions
Talk to your doctor or pharmacist before using Beacita
- If you have diabetes.
- If you have kidney disease. Talk to your doctor before taking Beacita if you have kidney problems. The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.
Children and young people
This medicine must not be taken by children and adolescents under 18 years of age.
Other medicines and Beacita
Beacita may affect some medicines that you have to use.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Beacita with these medicines
- Ciclosporin: Ciclosporin is used after organ transplants, for severe rheumatoid arthritis and certain serious skin conditions.
- Warfarin or other medicines used to thin the blood.
Birth control pills and Beacita
- Birth control pills can have a reduced effect if you have severe diarrhea. Use an extra method of contraception if you have severe diarrhea.
Multivitamins and Beacita
.
- You should take a multivitamin every day. Beacita can make the body absorb less of certain vitamins. The multivitamin preparation should contain vitamins A, D, E, and K. To be sure that the vitamins will be absorbed, you should take the multivitamin preparation at bedtime and not at the same time as Beacita.
Talk to your doctor before taking Beacita if you are taking
- amiodarone, which is used for heart rhythm problems.
- acarbose (a medicine used to treat type 2 diabetes mellitus ). Beacita is not recommended for people taking acarbose.
- thyroid medication (levothyroxine) as it may be necessary to adjust dose one and take your medication at different times of the day.
- any medicine for epilepsy as any changes in the frequency and severity of seizures should be discussed with your doctor.
- any medicine for HIV. It is important that you consult your doctor before using Beacita if you are being treated for HIV.
- medicines for depression, mental disorders, or anxiety.
Talk to your doctor or pharmacist when taking Beacita
- If you are taking any medicine for high blood pressure, dose one may need to be adjusted.
- If you are taking any medicine for high cholesterol, dose one may need to be adjusted.
Beacita with food and drink
Beacita should be used with a low-calorie, low-fat diet. Try to start with such a diet before starting treatment. For more information on determining your calorie and fat goals, see Other Useful Information in Section 6.
Beacita can be taken just before, during, or up to 1 hour after meals. This usually means 1 capsule at breakfast, lunch, and dinner. The capsule should be swallowed with water. If you skip a meal, or if the meal does not contain any fat, do not take any capsule. Beacita does not work if there is not a little fat in the meal.
Do not take more than the recommended dose even if you eat a high-fat meal. Taking the capsule with a high-fat meal increases the risk of diet-related effects (see section 4). Always try to avoid high-fat meals when taking Beacita.
Pregnancy and breastfeeding
Do not take Beacita if you are pregnant or breast-feeding.
Driving and using machines
Beacita is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Beacita
Plan your weight loss
Select start date
Decide in advance which day you will start taking the capsules. Before you start taking the capsules, start with your low-calorie, low-fat diet, and allow your body to adapt to your new eating habits for a few days. Write down what you eat in a food diary. Food diaries are effective because you become aware of what you are eating and how much you are eating and give yourself something to start from when you make changes.
Set a goal for your weight loss
Think about how much you want to lose weight and then set a target weight. A realistic goal is to reduce by between 5% and 10% of your starting weight. Weight loss may vary from week to week. You should strive for a gradual, stable weight loss of about 0.5 kg per week.
Set goals for calories and fat
To help you reach your weight loss goal, you need to set two daily goals, one for calories and one for fat. Read more on the blue pages under section 6, Other useful information.
Using Beacita
Adults, 18 years and older
- Take 1 capsule 3 times a day.
- Take Beacita just before, during, or up to 1 hour after meals. This usually means 1 capsule at breakfast, lunch, and dinner. Make sure your 3 main goals have good balance, reduced calorie content, and low-fat content.
- If you skip a meal, or if the meal does not contain any fat, do not take any capsule. Beacita does not work if there is not a little fat in the meal.
- Swallow the capsule whole with water.
- Do not take more than 3 capsules a day.
Eat low-fat meals to reduce the risk of diet-related treatment effects (see section 4).
Try to become 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 first, if you have not exercised before.
Keep exercising when you take Beacita and when you stop taking it.
How long should I take Beacita?
- Beacita should not be taken for more than 6 months.
- If you do not lose weight after taking Beacita for 12 weeks, contact your doctor or pharmacist for advice. You may need to stop taking Beacita.
- Successful weight loss is not just about eating differently for a short period of time and then returning to your old habits. People who lose weight and maintain the reduction change their lifestyle, which means that they change their diet and exercise habits.
If you use more Beacita than you should
Do not take more than 3 capsules a day.
If you forget to use Beacita
If you forget to take a capsule:
- Take the forgotten capsule if less than an hour has passed since your last main meal.
- Do not take the forgotten capsule if more than an hour has passed since your last main meal. Wait and take the next capsule to your next main meal as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Beacita can cause side effects, although not everybody gets them.
Most of the common side effects with Beacita (for example, gases with or without oily secretions, sudden or frequent bowel movements, and soft stools) are caused by the way the medicine works (see section 1). You can manage these diet-related effects by eating low-fat meals.
Serious side effects are (It is not known how frequently these side effects are occurring)
Severe allergic reactions
- Signs of a severe allergic reaction include severe difficulty breathing, sweating, rash, itching, swelling of the face, rapid pulse, collapse.
Stop taking the capsules. Seek medical attention immediately.
Other serious side effects are
- Bleeding from the rectum ( rectum )
- Diverticulitis ( inflammation of the colon). Symptoms may include pain in the lower abdomen, especially on the left side, possibly with fever and constipation
- Pancreatitis ( inflammation of the pancreas). The symptoms can be severe stomach pain that sometimes radiates to the back, possibly with fever, nausea, and vomiting
- Skin blisters (including blisters that are missing)
- Severe abdominal pain caused by gallstones
- Hepatitis ( inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain, and tenderness in the liver (felt as pain on the right side below the chest), sometimes even with a loss of appetite.
- Oxalate nephropathy (accumulation of calcium oxalate which may lead to kidney stones ). See section 2, warnings, and precautions.
Stop taking the capsules. Tell your doctor if you get any of these side effects.
Other side effects are
Very common side effect is (can occur in more than 1 in 10)
- Gases ( flatulence ) with or without oily excretion.
- Sudden bowel movements
- Oily or oily stools
- Soft stools
- Oily intestinal emptying
- Low blood sugar (in patients with type 2 diabetes )
- Upper respiratory tract infection
- Influenza
- Headache
Tell your doctor or pharmacist if any of these side effects get worse or worse.
Common side effects are (may affect up to 1 in 10)
- Abdominal pain (abdominal pain)
- Rectal pain / discomfort
- Stretched abdomen (experienced in some people with type 2 diabetes )
- Tooth/gum problems
- Fatigue
- Incontinence (stool)
- Flowing/liquid stools
- More common stools
- Concern
- Urinary tract infection
- Lower respiratory tract infection
Tell your doctor or pharmacist if any of these side effects get worse or worse.
Effects were seen in blood tests (it is not known how often these side effects occur)
- An increased amount of certain liver enzymes.
- Effects on blood coagulation in people taking warfarin or other blood-thinning medicines ( anticoagulants ).
Tell your doctor that you are taking Beacita when you leave a blood test.
Learn how to manage diet-related treatment effects
The most common side effects are caused by the way the capsules work and are due to some of the fast disappearing from the body. Such effects usually occur during the first few weeks of using the capsules, before you may have learned to limit the amount of fat in your diet. Such diet-related treatment effects can be a signal that you have eaten more fat than you should.
You can learn to minimize the impact of diet-related treatment effects by following the advice below:
- Start eating a low-fat diet for a few days, or even a week, before you start taking the capsules.
- Find out how much fat your favorite food usually contains and how large portions you eat. By keeping track of your portions, you are less likely to accidentally exceed your fat target.
- Distribute your fat ratio evenly over today’s meals. Do not “save” fat and calorie rations and revel in a high-fat meal or dessert that you may have done with other weight loss programs.
- Most users who experience these effects find that they can manage and control them by changing their diet.
- Do not worry if you do not experience any of these problems. This does not mean that the capsules do not work.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Beacita
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store in the original package. Sensitive to light. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. date. respectively EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is orlistat. One hard capsule contains 60 mg of orlistat.
- Other ingredients are Capsule contents: microcrystalline cellulose PH112, sodium starch glycolate (type A), colloidal anhydrous silica, sodium lauryl sulfate. Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
What the medicine looks like and the contents of the pack
Beacita capsules have a light blue upper and lower parts.
Pack sizes:
Blister packs: 42, 60, 84, 90, and 120 capsules.
Jars: 42 and 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavigurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Pharmaceutical Works POLPHARMA SA
19 Pelplińska Street
83-200 Starogard Gdański
Poland