BEACITA "60 MG HARD CAPSULES"84 CAPSULES IN AL/PVC/PVDC BLISTER"

Name
BEACITA 60 mg hard capsules
Orlistat


What is it and what is it used for?
BEACITA is a peripherally acting anti-obesity medicine used for weight loss in adults aged 18 years and over who are overweight, with a body mass index (BMI) of 28 or more. BEACITA should be used in combination with a reduced calorie, lower fat diet.

BMI is a way to assess whether you're at a healthy weight or overweight for your height. The table below will help you determine if you're overweight and whether BEACITA is right for you.

Risks associated with being overweight
Being overweight increases your risk of developing several serious health problems, such as diabetes and cardiovascular disease. These conditions may not cause any obvious problems, so you should consult your doctor for a general health check.

How BEACITA works
The active ingredient in BEACITA (orlistat) has been studied to act on fats in the digestive system.
This substance blocks the absorption of about a quarter of the fat in your meals. These fats are then eliminated from your body in your stool (see section 4). It is therefore important to commit to a low-fat diet to manage these effects. This way, the effect of the capsules will support your efforts, helping you lose more weight than with diet alone. For every 2 kg lost through diet alone, BEACITA could help you lose up to 1 kg more.


What you need to know before taking the medicine
Do not take 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, a drug used after organ transplants, for severe forms of rheumatoid arthritis and some serious skin diseases.
- If you are taking warfarin or other medicines used to thin the blood.
- If you suffer from cholestasis (a condition where the flow of bile from the liver is blocked).
- If you suffer from problems absorbing food (chronic malabsorption syndrome)
- diagnosed by a doctor.


Warnings and precautions
Talk to your doctor or pharmacist before taking BEACITA.
- If you have diabetes, tell your doctor as he or she may need to adjust the dose of your antidiabetic medicine.
- If you suffer from kidney disease. Talk to your doctor before taking BEACITA if you have kidney problems.
The use of orlistat may be associated with the formation of kidney stones in patients with chronic kidney disease.

Children and adolescents
This medicine should not be taken by children and adolescents under 18 years of age.


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

Most of the side effects of BEACITA (for example, gas with or without oily discharge, sudden or more frequent bowel movements, and soft stools) are caused by the way it works (see section 1). Eat low-fat meals to help manage these diet-related treatment effects.

Serious side effects It is not known how often these side effects occur.

Severe allergic reactions
- Signs of a serious allergic reaction include: severe difficulty breathing, sweating, rash, itching, swelling of the face, rapid heartbeat, collapse.
Stop taking the capsules. Seek medical help immediately.

Other serious side effects
- Anal (rectal) bleeding
Diverticulitis (inflammation of the intestines). Symptoms may include abdominal pain, especially on the left side, possibly accompanied by fever and constipation.
- Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain, sometimes radiating to the back, possibly accompanied by fever, nausea, and vomiting.
- Blisters on the skin (including blisters that break)
- 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 liver tenderness (indicated by pain below the front of the rib cage on the right side of the hand), sometimes with loss of appetite.
- Oxalate nephropathy (calcium oxalate buildup that can form kidney stones).
See section 2 Warnings and precautions.
Stop taking the capsules. If you experience any of these effects, contact your doctor.

Very common side effects
They can affect more than 1 in 10 people
- Presence of intestinal gas (flatulence), with or without oily discharge
- Sudden intestinal discharge
- Fatty or oily stools
- Soft stools.
Tell your doctor or pharmacist if any of these effects become serious or worrying.

Common side effects
They can affect up to 1 in 10 people
- Abdominal (stomach) pain
- Incontinence (feces)
- Watery/liquid stools
- More frequent bowel movements
- Anxiety
- Urinary tract infection.
Tell your doctor or pharmacist if any of these effects become serious or worrying.

Effects on blood tests
The frequency with which they occur is not known (frequency cannot be estimated from the available data)
- Increased levels of some liver enzymes
- Effects on blood clotting in patients taking warfarin or other anticoagulants.
Tell your doctor that you are taking BEACITA while you are having blood tests.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.