Odistad 120

OTC

Indications:

Conjunction with a mildly hypocaloric diet for the treatment of obese patients as well as to reduce the risk for weight regain subsequent to initial loss in patients with a body mass index (BMI) ≥ 30 kg/m², or overweight patients (BMI ≥ 28 kg/m²) with associated risk factors (e.g., hypertension, diabetes mellitus, hyperlipidemia).

Dosage:

Management of obesity and weight regain in adults: one 120 mg capsule three times a day with each main meal containing fat. Dosage exceeding three times daily does not provide additional benefit.

Safety and efficacy in children younger than 18 years of age have not been established.

No dosage adjustment is necessary in elderly and in individuals with hepatic and/ or renal impairment.

Usage:

Take Odistad 120 with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of Odistad 120 should be omitted.

Known hypersensitive to any of the active substance or excipients.

Chronic malabsorption syndrome or cholestasis.

Concurrent treatment with ciclosporin.

Pregnancy and breast-feeding.

Concurrent treatment with warfarin or other anticoagulants.

Common: Gastrointestinal disturbances, including faecal urgency and incontinence, flatulence, and fatty stools or discharge (should limit fat in meals).

Rare: Headache, anxiety, fatigue, rectal bleeding, and menstrual irregularities.

• The possibility of experiencing gastrointestinal symptoms may increase when orlistat is taken with an individual meal or a diet high in fat.
• Orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K). For this reason, a multivitamin supplement should be taken at bedtime.
• Patients who are taking a medicinal product for diabetes should consult a doctor before starting treatment with orlistat, in case it is necessary to adjust the dose of the antidiabetic medicinal product.
• Weight loss may be accompanied by an improvement in blood pressure and cholesterol levels. Patients who are taking a medicinal product for hypertension or hypercholesterolaemia should consult a doctor when taking orlistat, in case it is necessary to adjust the dose of these medicinal products.
• Patients who are taking amiodarone should consult a doctor before starting treatment with orlistat.
• Cases of rectal bleeding have been reported in patients taking orlistat.
• The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
• Use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.
• Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are coadministered. Patients taking levothyroxine should consult a doctor before starting treatment with orlistat, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted.
• Patients taking an antiepileptic medicinal product should consult a doctor before starting treatment with orlistat, as they should be monitored for possible changes in the frequency and severity of convulsions. If this occurs, consideration could be given to administering orlistat and antiepileptic medicinal products at different times.
• Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV.
• Odistad 120 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Orlistat is not recommended for use during pregnancy and breastfeeding.