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

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

Use only in combination with a moderate hypocaloric diet with low fat content.

Pharmacological effect

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 it enters the stomach, as well as directly into the duodenum, binds lipases (natural enzymes that break down fats).

As a result, fat that enters the body with food does not undergo breakdown and absorption, but is excreted from the body with feces.

You will feel the effect of Orsoten within 24 hours, maximum 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 through the intestines.

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

Special instructions

Patients should be instructed to adhere to the dietary recommendations they receive. The likelihood of side effects from the gastrointestinal tract is higher if a particular meal or diet as a whole is characterized by a high fat content.

Treatment with Orsoten® slim may impair the absorption of fat-soluble vitamins (A, D, E and K). For this reason, multivitamins should be taken before bed.

Since weight loss may be accompanied by improved metabolic control in patients with diabetes mellitus, those receiving hypoglycemic drugs should consult a doctor before using Orsoten® Slim and, if necessary, adjust the dose of hypoglycemic drugs.

Weight loss may be accompanied by an improvement in blood pressure and a decrease in cholesterol concentrations.

Patients taking medications for hypertension or hypercholesterolemia should consult a 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.

Cases of rectal bleeding have been reported in patients using orlistat. If this phenomenon occurs, the patient should consult a doctor.

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

Impact on the ability to drive vehicles and other mechanisms that require increased concentration

The drug Orsoten® slim does not affect driving or operating technical devices that require increased concentration and speed of psychomotor reactions.

Active ingredient

Orlistat

Composition

Active ingredient:

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

Excipients:

microcrystalline cellulose – 22.20 mg.

Hard gelatin capsules No. 3:

Capsule body:

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

Capsule cap:

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

Pregnancy

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

Since it is unknown 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 in the gastrointestinal tract and were caused by an increased amount of fat in the feces. Typically observed adverse reactions are mild and transient.

The appearance of these phenomena was observed at the initial stage of treatment during the first 3 months (but not more than one case). With long-term use of orlistat, the incidence of side effects decreases.

There are: flatulence accompanied by rectal discharge, urge to defecate, greasy/oily stools, oily rectal discharge, loose stools, soft stools, inclusions of fat in the stool (steatorrhea), pain/discomfort in the abdomen, increased frequency of bowel movements, pain/discomfort in the rectum, urge to defecate, fecal incontinence, dental damage and gums; hypoglycemia in patients with type 2 diabetes, headache, anxiety, flu, fatigue, upper respiratory tract infections, urinary tract infections, dysmenorrhea, rarely: allergic reactions (eg itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis); very rarely – diverticulitis, cholelithiasis, hepatitis (possibly severe), bullous rash, increased levels of liver transaminases and alkaline phosphatase.

Interaction

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

No interactions were observed with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, nifedipine GITS, sustained-release nifedipine, sibutramine, furosemide, captopril, atenolol, glibenclamide, or ethanol.

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

When taking orlistat and cyclosporine simultaneously, a decrease in the level of cyclosporine concentration in the blood plasma was observed, therefore it is recommended to determine the level of cyclosporine concentration in the blood plasma more often.

Patients receiving amiodarone should undergo more careful clinical observation and ECG monitoring, because Cases of decreased plasma amiodarone concentrations have been described.

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, no significant adverse reactions were detected in both patients with normal body weight and in obese patients. When using orlistat 240 mg three times a day for 6 months, no increase in the frequency of adverse reactions was noted.

Most post-marketing reports of orlistat overdose either lack specific information about adverse reactions or describe adverse reactions that are not different from those observed with 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 data from human and animal studies, all systemic effects of orlistat due to lipase inhibition are usually quickly reversible.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

KRKA dd Novo Mesto, Slovenia