Orsoten Slim, 60 mg capsules 42 pcs

Orsotene is a drug whose action prevents the absorption of fats by the body.

The active ingredient of the drug Orsothen is Orlistat, which, when entering the stomach and also directly into the duodenum, binds lipase (natural enzymes that break down fat).

As a result, fat entering the body with food is not broken down and absorbed, and is excreted with feces.

You will feel the effects of Orsothen in 24 hours and maximum 48 hours after taking it.

The drug itself is almost not absorbed and breaks down into substances neutral for the human body, which are also excreted with the help of the intestine.

The area of application of this drug is the fight against excess weight, including people whose excess weight is caused by diabetes.

Indications

Reducing body weight in adults (over 18 years) with excessive body weight (BMI ≥ 28 kg/m2).

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

Active ingredient

Composition

Active substance:

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

Auxiliary substances:

Cellulose microcrystalline – 22.20 mg.

Card gelatin capsules № 3:

Capsule body:

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

Capsule cap:

Titanium dioxide (E 171) – 0.19 mg, iron oxide yellow (E172) – 0.04 mg, gelatin – 18.97 mg.

How to take, the dosage

Orally, 1 capsule (60 mg) three times daily with water immediately before, during, or within 1 h after each meal.

If a meal is missed or if the meal was fat-free, Orlistat should be skipped.

No more than three 60 mg capsules of Orsoten® Slim can be taken within 24 hours.

The duration of treatment

The course of treatment should not exceed 6 months. If after 12 weeks of using Orsoten® Slim the reduction of body weight has not occurred (not more than 5% of the initial weight), the patient should consult the physician to decide whether further use is advisable.

Diet and exercise are an important component of a weight loss program. It is recommended that a dietary and exercise program be initiated prior to initiating therapy with Orsotene® Slim.

When using Orsothen® Slim, the patient should receive a moderately hypocaloric diet with a balanced content of nutrients, in which approximately 30% are fats (for example, if the caloric content is 2000 kcal per day, the food should not contain more than 67 grams of fat). The daily intake of fats, carbohydrates, and protein should be distributed among the three main meals. The diet and exercise program should be continued even after the use of Orsoten® Slim is discontinued.

Patients in the elderly

There are limited data on the use of Orlistat in the elderly.

Patients with impaired hepatic and renal function

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

Interaction

In patients receiving warfarin or other anticoagulants and Orlistat, there may be decreased prothrombin levels, increased international normalization ratio (INR), resulting in changes in hemostatic parameters.

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

Limits the bioavailability and hypolipidemic effect of pravastatin by increasing its plasma concentration by 30%. Reducing body weight may improve metabolism in patients with diabetes mellitus, due to which it is necessary to reduce the dose of oral hypoglycemic agents. Treatment with orlistat can potentially impair absorption of fat-soluble vitamins (A, D, E. K). If taking multivitamins is recommended, they should not be taken earlier than 2 hours after taking orlistat or before going to bed.

With simultaneous use of orlistat and cyclosporine, a decrease in plasma levels of cyclosporine has been noted, and therefore more frequent determination of plasma levels of cyclosporine is recommended.

In patients receiving amiodarone, clinical monitoring and ECG monitoring should be performed more carefully, since there have been described cases of decreased plasma amiodarone concentrations.

Special Instructions

Patients should be advised to follow the dietary recommendations they receive. The likelihood of gastrointestinal side effects is higher if a single meal or the diet as a whole is high in fat.

The treatment with Orsothen® Slim may lead to impair the absorption of fat-soluble vitamins (A, D, E and K). For this reason multivitamins should be taken before going to bed.

As weight loss may be accompanied by improved metabolic control in patients with diabetes mellitus, those who are taking hypoglycemic drugs should consult a physician before starting Orsothen® Slim and, if necessary, adjust the dose of hypoglycemic agents.

The decrease in body weight may be accompanied by an improvement in blood pressure and a decrease in cholesterol concentrations.

Patients taking medications for arterial hypertension or hypercholesterolemia should consult a physician when using Orsotene® Slim and adjust the dose of these medications, if necessary. Patients taking amiodarone should consult a physician before starting therapy with Orsotene® Slim.

In patients using Orlistat, cases of rectal bleeding have been described. If this occurs, the patient should consult a physician.

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraceptives if severe diarrhea occurs.

Impact on ability to drive vehicles and other mechanisms requiring increased concentration

The drug Orsothen® Slim has no effect on driving vehicles and operating technical devices requiring increased concentration and rapid psychomotor reaction.

Contraindications

Side effects

Adverse reactions to orlistat have mainly been reported in the gastrointestinal tract and have been caused by increased amounts of fat in the feces. Usually the observed adverse reactions are mild and transient.

The occurrence of these phenomena was observed in the initial phase of treatment during the first 3 months (but not more than one case). With prolonged use of orlistat, the incidence of adverse events decreases.

There are cases of: flatulence accompanied by rectal discharge, urge to defecate, greasy/oily stools, oily rectal discharge, liquid stools, soft stools, inclusions of fat in the stool (steatorrhea), pain/feeling of discomfort in the abdomen, frequent defecation, pain/discomfort in the rectum, imperative defecation urges, stool incontinence, dental and gum damage; hypoglycemia in patients with type 2 diabetes, headache, anxiety, flu, fatigue, upper respiratory tract infections, urinary tract infections, dysmenorrhea, rare: Allergic reactions (e.g. itching, rash, urticaria, angioneurotic edema, bronchospasm, anaphylaxis); very rare: diverticulitis, cholelithiasis, hepatitis (possibly severe), bullous rash, increased liver transaminases and ALP levels.

Overdose

Symptoms: no significant adverse reactions were found in both normal weight and obese patients when orlistat was administered in a dose of 800 mg once and up to 400 mg three times a day, daily, for 15 days. When using orlistat 240 mg three times daily for 6 months, no increase in the incidence of adverse reactions was noted.

The majority of reports of orlistat overdose in the post-marketing period either lack specific adverse reactions or describe adverse reactions that do not differ from those observed with the recommended doses of orlistat.

Treatment: In case of overdose, medical consultation is necessary. In case of a significant overdose of orlistat it is recommended to monitor the patient for 24 hours. Based on data from human and animal studies, all systemic effects of orlistat due to lipase inhibition are generally rapidly reversible.

Pregnancy use

There are no clinical data on the use of Orlistat during pregnancy, therefore Orsothen® Slim should not be used during pregnancy.

If it is unknown whether orlistat is excreted into the breast milk, Orsothen® Slim should not be used during breastfeeding.

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