ALLI "60 MG HARD CAPSULE - ORAL USE - BOTTLE (HDPE)"84 CAPSULES"

Name
Alli 60 mg hard capsules
Orlistat


What it is and what it is used for
Alli 60 mg hard capsules (orlistat) 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. alli should be used in combination with a reduced calorie, lower fat diet.

BMI is a way to assess whether you are at a healthy weight or overweight for your height. The table below will help you find out if you are overweight and if alli is right for you.

Find your height in the table. If your weight is less than what is listed for your height, do not take alli.

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

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


What you need to know before taking the medicine
Do not take alli:
- 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 medicine used after organ transplants, for severe 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 with food absorption (chronic malabsorption syndrome) diagnosed by a doctor.


Warnings and precautions
Talk to your doctor or pharmacist before taking alli:
- if you suffer from diabetes, tell your doctor as he may need to adjust the dose of your anti-diabetic medicine.
- if you have kidney disease. Consult your doctor before taking alli 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 side effects of alli (for example, gas with or without oily spotting, sudden or more frequent bowel movements, and soft stools) are caused by the way it works (see section 1). Eat lower-fat meals to help control 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 bleeding.
- Diverticulitis (inflammation of the large intestine). 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 that sometimes radiates 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 under the front of the rib cage on the right side), sometimes with loss of appetite.
- Oxalate nephropathy (build-up of calcium oxalate which may lead to kidney stones). See section 2, warnings and precautions.
• Stop taking the capsules. If you experience any of these effects, tell your doctor.

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

Common side effects
They can affect up to 1 in 10 people
- Abdominal pain
- Fecal incontinence
- Loose stools
- More frequent bowel movements
- Anxiety
• Tell your doctor or pharmacist if any of these effects become serious or worrying.

Effects observed in blood tests
It is not known how often these effects occur (frequency cannot be estimated from the available data)
- Increased levels of some liver enzymes.
- Effects on blood clotting in subjects treated with warfarin or other medicines that thin the blood (anticoagulants).
• Tell your doctor that you are taking alli if you have any blood tests.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.

Learn to manage the effects of alli associated with diet or fat intake
Most side effects are caused by the way the capsules work and result from some of the fat passing through your body and being passed as such in your stool. These effects typically occur within the first few weeks of treatment, before you have become accustomed to limiting the amount of fat in your diet. These diet-related treatment effects may be a sign that you have eaten more fat than you should.

You can learn to minimize the impact of diet-related treatment effects by following these rules:
- start following a low-fat diet for a few days, or even a week, before starting to take the capsules;
- be more aware of how much fat is in your favorite foods and the size of the portions you eat. By becoming familiar with portion sizes, you will be less likely to accidentally exceed your fat goal;
- distribute your fat intake evenly throughout the day. Don't save fat and calories and then indulge in a high-fat meal or dessert, as you might do with other weight-loss programs;
- most subjects who experienced these effects found them manageable and controllable by adjusting their diet.
Don't worry if you don't have any of these problems. This doesn't mean the capsules don't work.