Orsoten Slim, 60mg capsules, 42pcs

Composition

Active ingredient:

orsoten semi-finished product-granules – 112.8 mg, in terms of orlistat-60 mg (auxiliary substance of semi-finished product-granules microcrystalline cellulose).

Auxiliary substances:

microcrystalline cellulose – 22.20 mg.

Solid gelatin Capsules No. 3:

Capsule body:

titanium dioxide (E 171) – 0.58 mg, gelatin-28.22 mg.

Capsule cap:

titanium dioxide (e171) – 0.19 mg, yellow iron oxide (E172) – 0.04 mg, gelatin-18.97 mg

Pharmacological action

Orsoten is a drug that interferes with the absorption of fats by the body.

The active ingredient of the drug Orsoten is orlistat, which, when ingested in the stomach, as well as directly in the duodenum, binds lipases (natural enzymes that break down fats).

As a result, fat entering the body with food is not decomposed and absorbed, but is removed from it with feces.

You will feel the effect of Orsoten within 24 hours, a maximum of 48, after you start taking it.

The drug itself is almost not absorbed and breaks down into substances that are neutral for the human body, which are also excreted by the intestines.

The field of application of this drug is the fight against excess weight, including in people whose extra pounds are caused by diabetes.

Indications

Weight loss in overweight adults (over 18 years of age) (body mass index BMI ≥ 28 kg/m2).

It is used only in combination with a moderate hypocaloric diet with low-fat food.

Use during pregnancy and lactation

There are no clinical data on the use of orlistat during pregnancy, so the drug Orsoten ® slim should not be used during pregnancy.

Since it is not known whether orlistat is excreted in breast milk, Orsoten slim should not be used during breastfeeding.

Contraindications

• Hypersensitivity to orlistat or to any of the components of the drug;
• glucose-galactose malabsorption syndrome;
• cholestasis;
• concomitant therapy with cyclosporine;
• age up to 18 years.

Side effects

Adverse reactions to orlistat were mainly observed from the gastrointestinal tract and were caused by an increased amount of fat in the stool. Usually, the observed adverse reactions are mild and transient.

The occurrence of these phenomena was observed at the initial stage of treatment during the first 3 months (but not more than one case). With prolonged use of orlistat, the number of cases of side effects decreases.

There are: flatulence accompanied by discharge from the rectum, urge to defecate, greasy/oily stools, oily discharge from the rectum, loose stools, soft stools, inclusions of fat in the feces (steatorrhea), pain/discomfort in the abdomen, increased defecation, pain/discomfort in the rectum, imperative urge to defecate, fecal incontinence, tooth and gum damage; hypoglycemia in patients with type 2 diabetes, headache, anxiety flu, fatigue, upper respiratory tract infections, urinary tract infections, dysmenorrhea, rarely: allergic reactions (e. g. pruritus, rash, urticaria, angioedema, bronchospasm, anaphylaxis); very rarely — diverticulitis, cholelithiasis, hepatitis (possibly severe), bullous rash, increased levels of hepatic transaminases and alkaline phosphatase.

Interaction

Patients receiving warfarin or other anticoagulants and orlistat may experience a decrease in prothrombin levels, an increase in the international normalization factor (INR), which leads to changes in hemostatic parameters.

Interactions with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, nifedipine GITS, nifedipine delayed release, sibutramine, furosemide, captopril, atenolol, glibenclamide or ethanol were not observed.

Increases the bioavailability and hypolipidemic effect of pravastatin, increasing its plasma concentration by 30%. Weight loss can improve the metabolism of diabetic patients, so it is necessary to reduce the dose of oral hypoglycemic agents. Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E. K). If a multivitamin is recommended, then they should be taken no earlier than 2 hours after taking orlistat or before bedtime.

With simultaneous use of orlistat and cyclosporine, a decrease in the level of cyclosporine concentration in blood plasma was noted, so it is recommended to determine the level of cyclosporine concentration in blood plasma more often.

In patients receiving amiodarone, more careful clinical monitoring and ECG monitoring should be carried out, since cases of a decrease in the level of amiodarone concentration in blood plasma have been described.

How to take, course of use and dosage

Inside,1 capsule (60 mg) three times a day, washed down with water, immediately before, during or within 1 hour after each meal.

If the meal was missed or the food did not contain fat, the use of orlistat should be skipped.

Within 24 hours, you can take no more than three capsules of 60 mg of Orsoten® slim.

Duration of treatment

The course of treatment should not exceed 6 months. If no weight loss occurs after 12 weeks of using Orsoten® slim (no more than 5% of the initial weight), the patient should consult a doctor to decide whether further use is appropriate.

Diet and exercise are an important component of a weight loss program. It is recommended to start a dietary program and exercise before starting therapy with Orsoten slim.

While using Orsoten ® slim, the patient should receive a moderately hypocaloric diet with a balanced nutrient content, in which approximately 30% is fat (for example, with a caloric content of 2000 kcal per day, the food should contain no more than 67 grams of fat). Your daily intake of fat, carbohydrates, and protein should be divided between the three main meals. The diet and exercise program should be continued even after the use of Orsoten ® slim is discontinued.

Elderly patients

Data on the use of orlistat in the elderly are limited.

Patients with impaired liver and kidney function

The effects of orlistat in individuals with impaired liver and/or kidney function have not been studied, but given that the absorption of orlistat is minimal, no dose adjustment is required in the elderly and in individuals with impaired liver and/or kidney function.

Overdose

Symptoms: when using orlistat at a dose of 800 mg once and at a dose of up to 400 mg three times a day, daily, for 15 days, both in patients with normal body weight and in patients with obesity, significant adverse reactions were not detected. When using orlistat 240 mg three times a day for 6 months, there was no increase in the frequency of adverse reactions.

Most reports of orlistat overdose in the post-marketing period either do not contain specific information about adverse reactions, or describe adverse reactions that do not differ from those observed with the recommended doses of orlistat.

Treatment: in case of overdose, consult a doctor. In case of significant overdose of orlistat, it is recommended to monitor the patient for 24 hours. Based on human and animal studies, all systemic effects of orlistat due to lipase inhibition are usually rapidly reversible.

Special instructions

Patients should be advised to adhere to the dietary recommendations they have received. The likelihood of gastrointestinal side effects is higher if a single meal or diet as a whole is characterized by a high fat content.

Treatment with Orsoten® slim may result in impaired absorption of fat-soluble vitamins (A, D, E, and K). For this reason, a multivitamin should be taken before bedtime.

Since weight loss can be associated with improved metabolic control in patients with diabetes mellitus, those who receive hypoglycemic drugs should consult their doctor before starting the use of Orsoten® slim and, if necessary, adjust the dose of hypoglycemic agents.

Weight loss can be accompanied by an improvement in blood pressure indicators and a decrease in cholesterol concentration.

Patients taking medications for hypertension or hypercholesterolemia should consult their doctor when using Orsoten ® slim and, if necessary, adjust the dose of these medications. Patients taking amiodarone should consult their doctor before starting therapy with Orsoten slim.

Rectal bleeding has been reported in patients treated with orlistat. If this phenomenon occurs, the patient should consult a doctor.

It is recommended to use an additional method of contraception to prevent possible ineffectiveness of oral contraceptives in the event of severe diarrhea.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

The drug Orsoten ® slim has no effect on driving vehicles and working with technical devices that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Orlistat

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults

Indications

Overeating, Obesity, Diet Error