Odistad 120

OTC

Indications

Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients as well as to reduce the risk for weight regain in patients with a body mass index (BMI) greater or equal to 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:
The recommended dose of Odistad 120 is one 120 mg capsule three times a day with each main meal containing fat.

Usage

• The capsule should be taken 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 orlistat should be omitted.
• Dosage exceeding three times daily have not been shown to provide additional benefit.
• If patients have been unable to lose weight after 12 weeks of treatment with orlistat, they should consult their doctor or pharmacist. It may be necessary to discontinue treatment.

Remarks

• Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme are started before beginning treatment with orlistat.
• The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat.
• The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
• The diet and exercise programme should continue to be followed when treatment with orlistat is stopped.
• The safety and effectiveness beyond 4 years have not been determined at this time.
• Safety and efficacy in children younger than 18 years of age have not been established.
• There are limited data on the use of orlistat in the elderly. The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied. However, as orlistat is minimally absorbed, no dosage adjustment is necessary in elderly and in individuals with hepatic and/or renal impairment.

• 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:

• Influenza,
• Hypoglycemia,
• Anxiety,
• Headache,
• Respiratory infection,
• Abdominal pain/discomfort, oily spotting from the rectum, flatus with discharge, faecal urgency, fatty/oily stool, flatulence, liquid
• stools, oily evacuation, increased defecation,
• Rectal pain/discomfort, soft stools, faecal incontinence, abdominal distension, tooth disorder, gingival disorder,
• Urinary tract infection,
• Menstrual irregularity,
• Fatigue.

• Patients should be advised to adhere to the dietary recommendations they are given. The possibility of experiencing gastrointestinal symptoms may increase when orlistat is taken with an individual meal or a diet high in fat.
• Treatment with 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.
• As weight loss may be accompanied by improved metabolic control in diabetes, 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.
• Medicinal products for hypertension or hypercholesterolaemia: 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. If this occurs, the patient should consult a doctor.
• The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
• Patients with kidney disease should consult a doctor before starting treatment with orlistat, as the 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.
• Patients should consult a physician before taking orlistat concomitantly with antiretroviral medications. 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.