Orlistat - 120 mg 30 Capsules

It is prescribed in combination with a lowcalorie diet for the treatment of obesity.

Patients with a body mass index (BMI) greater than or equal to 30 kg / m2, or overweight patients (BMI> 28 com) with associated risk factors. Orlistat treatment should be discontinued after 12 weeks if patients cannot lose at least 5% of the body weight measured at the beginning of therapy.

Trad ename: Orlistat

* Composition: Each hard gelatin capsule contains:

Orlistat — 120mg.

* Auxiliary components: Avisel 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, forming a covalent bond with lipase in the stomach and pancreas. Thus, the inactivated enzyme is not available for hydrolyzing triglyceride fats to absorbable free fatty acids and monoglycerides.

* Indications: It is prescribed in combination with a lowcalorie diet for the treatment of obesity. Patients with a body mass index (BMI) grea than or equal to 30 kg / m2, or overweight patients (BMI> 28 com) with associated risk factors. Orlistat treatment should be discontinued after 12 weeks if patients cannot lose at least 5% of the body weight measured at the beginning of therapy.

* Mode of application: Adults: the recommended dose is 1 capsule 120 mg, 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% of the calories of fat. A diet rich in fruits and vegetables is recommended. Your daily intake of fat, carbohydrates, and protein should be spread over your three main meals. Doses above 120 mg 3 times a day have shown no additional effect. The effect of Orlistat leads to an increase in fecal fat within 24-48 hours after ingestion. After stopping therapy, faecal fat usually returns to pretreatment levels, within 48-72 hours.

Special populations: the effect of Orlistat o patients with hepatic and / or renal insufficiency, children and the elderly has not been studied.

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

* Precautions: In cases of severe liver damage, which have rarely been reported with Orlistat, discontinue use of the drug and consult your doctor 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 Il diabetes than in patients without diabetes. It may require careful monitoring of treatment with antidiabetic drugs when taken. The combined use of Orlistat with cyclosporine is not recommended. Patients should be advised to adhere to a dietary diet. If Orlistat is taken with a high fat meal, the likelihood of a rectal bleeding reaction may increase. Women who take pill contraceptives should be warned that if during the course of treatment with Orlistat there is frequent loose stools, additional barrier protection is required, since the effect of hormonal drugs against this background decreases. 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. For patients with epilepsy: Orlistat may impair the quality of anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, resulting in seizures.

additional barrier protection is required, since the effect of hormonal agents 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. For patients with epilepsy: Orlistat may impair the quality of anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, leading to seizures. additional barrier protection is required, since the effect of hormonal agents 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. For patients with epilepsy: Orlistat may impair the quality of anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, resulting in seizures. diseases of the thyroid gland. For patients with epilepsy: Orlistat may impair the quality of anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, resulting in seizures. diseases of the thyroid gland. For patients with epilepsy: Orlistat may impair the quality of anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, resulting in seizures.

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

* Pregnancy and lactation: care should be tak when prescribing to pregnant women. Since

Orlistat is known to be excreted in breast milk, it is contraindicated for breastfeeding.

* Storage: Store at a temperature not exceeding 25C, in a dry place protected from children.

* Packaging: The cardboard box contains 1-3 blisters of 10 capsules each, paper instructions.