anti-obesity agent with peripheral action.
OLEOFIN is indicated for the long-term treatment of obese patients (BMI* ≥ 30) or with severe overweight (BMI* ≥ 28 kg/m2) with risk factors such as type II diabetes, hyperlipidemia and hypertension associated with a moderate hypocaloric diet.
Treatment with orlistat of non-diabetic patients should only be initiated if diet alone has previously produced a weight decrease of at least 2.5 kg in a period of 4 consecutive weeks. Treatment with orlistat should be suspended after 12 weeks in patients who have not lost at least 5% of their body weight compared to the weight at the beginning of treatment.
* BMI = Body Mass Index = Weight in kg / (Height in m)2
Dosage and Mode of Administration
The recommended dose of OLEIFIN is one capsule with each main meal (breakfast, lunch, and dinner), taken immediately before, during, or up to one hour after the meal. If the meal is not taken or does not contain any fat (e.g., a snack such as skimmed yogurt or fruit), the OLEOFIN dose may be omitted. The therapeutic benefits (including weight control and reduced risk factors) are maintained with long-term administration.
The patient should follow a nutritionally balanced and moderately hypocaloric diet, with 30% of calories from fats. The diet should be rich in fruits and vegetables. The daily intake of fats, carbohydrates, and proteins should be distributed among the three main meals.
At doses higher than 120 mg three times a day, no better results have been obtained. In fecal fat determinations, the effect of OLEOFIN is observed as soon as 24-48 hours after administration. After therapy discontinuation, the fecal fat content usually returns to baseline levels within 48-72 hours.
Since there is no experience on the use of orlistat for periods longer than two years, treatment with this drug should not exceed this period.
Hepatic or Renal Failure: No dose adjustment is required.
Children and Adolescents Younger than 18 Years of Age: The safety and efficacy in children and adolescents younger than 18 years of age have not been established.
OLEOFIN is contraindicated in patients with chronic malabsorption syndrome or cholestasis, as well as in patients with known hypersensibility to orlistat or any other component of the product. It is also contraindicated in women during lactation.
packages containing 30 capsules.