Description

Compound:

Each hard gelatin capsule contains:

Orlistat – 120 mg.

Auxiliary components: Avicel PH 101, sodium starch glycolate, sodium lauryl sulfate, povidone, talc.

Properties:

Orlistat is a potent, long-acting, specific inhibitor of gastrointestinal lipases. It exhibits therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with lipase in the stomach and pancreas. Thus, the inactivated enzyme is not available to hydrolyze fats in the form of triglycerides into absorbable free fatty acids and monoglycerides.

Indications:

Prescribed in combination with a hypocaloric diet for the treatment of obesity. Patients with a body mass index (BMI) greater than or equal to 30 kg/m, or overweight patients (BMI > 28 kom) with associated risk factors. Treatment with Orlistat should be discontinued after 12 weeks if patients are unable to lose at least 5% of body weight measured at the start of therapy.

Mode of application:

Adults: The recommended dose is 1 120 mg capsule, swallowed with a small amount of liquid immediately before, during or 1 hour after each main meal. If a meal is skipped or does not contain fat, the dose of Orlistat should be skipped. The patient should be on a nutritionally balanced, slightly hypocaloric diet containing approximately 30% fat calories. A diet rich in fruits and vegetables is recommended. Daily intake of fats, carbohydrates and proteins should be divided into three main meals. Doses higher than 120 mg 3 times daily showed no additional effect. The effect of Orlistat leads to an increase in fecal fat within 24-48 hours after administration. After cessation of therapy, fecal fat content usually returns to pre-treatment levels within 48 to 72 hours.

Special Populations: The effect of Orlistat has not been studied in patients with hepatic and/or renal impairment, children and the elderly.

Contraindications:

Hypersensitivity to the active substance or any of the excipients. Chronic malabsorption syndrome. Cholestasis. Lactation.

Precautionary measures:

In cases of severe liver damage, which have been rarely reported with the use of Orlistat, stop using the drug and contact your healthcare provider if they develop characteristic signs and symptoms, including itching, yellow eyes or skin, dark spots on the skin, light-colored stools, or loss of appetite. In clinical trials, weight loss with Orlistat was less in patients with type II diabetes than in patients without diabetes. While taking it, careful monitoring of antidiabetic drug treatment may be required. The combined use of Orlistat with cyclosporine is not recommended. Patients should be advised to adhere to dietary nutrition. If Orlistat is taken with a high-fat meal, the likelihood of developing a rectal bleeding reaction may increase. Women who take tablet contraceptives should be warned that if frequent loose stools occur during the course of treatment with Orlistat, additional barrier protection is required, since the effect of hormonal drugs against this background is reduced. Coagulation parameters should be monitored in patients receiving concomitant oral anticoagulants. The drug should be used with caution in patients with chronic kidney disease and/or volume depletion, thyroid disease. Patients with epilepsy: Orlistat may impair anticonvulsant treatment by reducing the absorption of antiepileptic drugs, leading to seizures.

Side effects:

From the gastrointestinal tract: abdominal pain, flatulence, diarrhea, frequent trips to the toilet. The most unpleasant ones are: the release of undigested fat from the rectum at any time, the passage of gases with a small amount of feces, and fecal incontinence. Sometimes there is damage to the gums and teeth. Infectious diseases. Observed: influenza, infections of the lower and upper respiratory tract, urinary tract. Metabolism: Decrease in blood glucose concentration below 3.5 mmol/l. From the psyche and nervous system: Headaches and anxiety. From the reproductive system: Irregular cycle.

Pregnancy and lactation: caution should be exercised when prescribing to pregnant women. Since Orlistat is known to be excreted in breast milk, it is contraindicated during breastfeeding.

Storage:

Store at a temperature not exceeding 25C, in a dry place away from children.