Regimex 120 mg 30 tablets

Trade name:

Regimax

Composition:

Each hard gelatin capsule contains:

Orlistat – 120mg.

Auxiliary components:

purified talc, microcrystalline cellulose powder PH 101, polyvinylpyrrolidone 1<30, titanium oxide, purified water.

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:

For the treatment of obese patients with a body mass index (BMI) greater than or equ 30 kg / m, overweight (BMI> 28 kg / m with associated risk factors). 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:

For adults, the recommended dose is 1 capsule 120 mg, with water immediately before, during or within 1 hour after each main meal. If a meal is skipped or does not contain fat, the dose of orlistat should be excluded. The patient should follow a balanced, moderately hypocaloric diet containing approximately 30% fat calories. A diet rich in fruits and vegetables is recommended. The intake of fats, carbohydrates and proteins should be divided into three main meals. Doses above 120 mg 3 times a day have no additional effect. Orlistat leads to an increase in fecal fat within 24-48 hours after ingestion. After stopping therapy, the fecal fat content usually returns to pretreatment levels, within 48-72 hours.

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

Contraindications:

Hypersensitivity to the active substance or any of the excipients. Chronic malabsorption syndrome. Cholestasis. Breast-feeding.

Precautions:

in the case of severe liver damage, which has rarely been reported with Orlistat, stop using the drug and contact your doctor if characteristic signs and symptoms develop, 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 joint administration of Orlistat with cyclosporine is not recommended. Patients should be advised to adhere to dietary recommendations. If Orlistat is taken with a high fat meal, the likelihood of a rectal bleeding reaction may increase. In the case of severe and / or persistent symptoms, prescribing physicians should conduct further research. 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. Patients with epilepsy: Orlistat can interfere with the absorption of anticonvulsants, antiepileptic drugs, which leads to 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 ta when prescribing to pregnant women. Sinc Orlistat is known to be excreted in breast milk, it is contraindicated for breastfeeding.

Storage:

Store at a temperature not exceeding 30C, in a dry place protected from children.

Packaging:

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