Alli (Orlistat) 60 mg 120 cápsulas duras

1. NAME OF THE MEDICINAL PRODUCT
alli 60 mg hard capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 60 mg of orlistat.
For the full list of excipients, see section 6.1 of the package insert.

3. PHARMACEUTICAL FORM
hard capsule
The capsule has a dark blue central band and a turquoise body and cap with the inscription "there".

4. CLINICAL DATA

4.1 Therapeutic indications
alli is indicated for weight loss in overweight adults (body mass index, BMI, ≥28 kg/m2) and should be taken in combination with a slightly hypocaloric, low-fat diet.

4.2 Posology and method of administration

Posology

Adults
The recommended treatment dose is one 60 mg capsule three times a day. No more than three 60 mg capsules should be taken in 24 hours.
Diet and exercise are important parts of a weight loss program. It is recommended that you start a diet and exercise program before starting treatment with alli.
While taking orlistat, the patient should follow a nutritionally balanced, slightly hypocaloric diet in which approximately 30% of calories come from fat (for example, on a 2,000 kcal/day diet this equates to <67 g fat). ). The daily intake of fat, carbohydrates and protein should be spread over the three main meals.
The diet and exercise program should be continued when alli treatment is stopped.
Treatment should not exceed 6 months.
If patients are unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or pharmacist. It may be necessary to stop treatment.

special populations
Elderly patients (> 65 years).
Limited data are available on the use of orlistat in elderly patients. However, since orlistat absorption is minimal, no dose adjustment is required in this population.

LEAFLET