Orsoten slim - official instructions for use. The reverse side of the drug Orsoten: side effects and contraindications to the use of Orsoten diet pills

They have become very popular, not only among athletes, but also among ordinary people who are trying to lose weight. One such drug is Orsoten. This tool is aimed at blocking the absorption of fats by the body, as a result of which a person begins to lose hated kilograms.

The active component of this drug is orlistat, which has a binding effect on lipases responsible for the breakdown of fats. As a result of this action, the fat that enters the body is not broken down and absorbed, but is excreted from it along with the feces.

Orsoten reviews are mostly positive, since the effect of this drug begins after 24 hours, and its active components are not absorbed into the blood and do not affect the processes occurring in other organs and tissues. It is also excreted from the body naturally after 1-2 days.

The peculiarity of this drug is also that its administration is possible even with a disease such as diabetes mellitus. As a rule, with it, most weight loss products are contraindicated due to the presence of a high sugar content in the tablets. But Orsoten does not have it, so for the category of people with diabetes, this drug is completely safe.

Orsoten is commercially available in only one form - in capsules. And in order to achieve the maximum effect from its reception, it is necessary to take this remedy only in combination with and.

It is worth noting that there are two versions of this drug on sale - Orsoten and Orsoten Slim. In their composition, they are almost the same. The only difference is in the dosage. Just Orsoten contains 120 mg of the active ingredient orlistat, and Orsoten slim only 60 mg.

Most weight loss drugs contain subitromine, which is not approved by dietitians, as it affects the receptors in the brain, and therefore the entire central nervous system. Orsoten also contains orlistat, which is not a psychotropic substance and causes fewer side effects.

The mechanism of action for this is as follows. When the drug enters the stomach and duodenum, it begins to block the production of lipase, which promotes the breakdown, absorption and deposition of fats in the subcutaneous tissue.

This action leads to the fact that fats that enter the stomach along with food are not digested and are immediately sent to the intestines. And already through it they are excreted from the body, so to speak, in an undigested form.

However, it is worth noting that the effectiveness of Orsoten can only be observed when following a low-calorie diet. After all, this drug is intended to help a person lose weight, but he will not do it instead of him.

If you drink alcoholic beverages and eat a large amount of fatty foods while taking Orsoten, then there is a high risk of developing digestive disorders. This can cause severe diarrhea and fatty stools, which can lead to incontinence.

It is also worth noting that Orsoten does not affect the absorption of carbohydrates, including simple ones. If during it you eat food rich in simple carbohydrates, it will be converted into fat and deposited in the subcutaneous tissue. And this process, unfortunately, cannot be prevented by this drug.

Contraindications to the use of Orsoten

Orsoten is designed specifically for people suffering from excess weight. Like any drug, Orsoten has its contraindications.
It is not recommended to be taken by people who have an individual intolerance to any component that is part of this remedy. It is also contraindicated in persons suffering from cholestasis and chronic malabsorption syndrome.

In addition, this drug has age restrictions. It should not be taken by people under the age of majority. Also, its reception is not recommended for women who are at the stage of pregnancy and lactation, since the effect of Orsoten on this category of persons has not been fully studied.

Like any drug, Orsoten also has side effects. They are observed most often in the initial stages of taking the drug, then their intensity decreases and over time they completely disappear.

The most common side effect is the appearance of excess fat in the stool. However, you should not be afraid of it, because, given the effect of this drug (removal of fats), this phenomenon is absolutely normal.

But along with this side effect, there may be other unpleasant symptoms. For example, diarrhea and fecal incontinence, which brings severe discomfort to a person's life. Flatulence and pain in the entire digestive tract (stomach, intestines) may also occur.

While taking Orsoten, the risk of developing an infection, the appearance of fatigue and even menstrual irregularities increases. There is also a category of people in whom taking this drug caused allergic reactions and impaired liver function.

If you have already decided to resort to the help of this drug, then you should follow some recommendations that will help lead to an improvement in the effectiveness of Orsoten.

1. Before starting the reception, do not be lazy and go to the doctor's appointment. This is necessary not only in order to get approval from him, but also in order for him to determine the amount of really extra pounds that you have, and determine the dosage in which this drug should be taken. It is not recommended to do this on your own, as you may make an incorrect calculation. And besides, Orsoten Slim contains only 60 mg of orlistat, which in this amount may simply be insufficient for the treatment of obesity. Strictly adhere to all recommendations received from doctors and be sure to follow a diet. If you do not do this, then buying Orsoten will be a waste of money.
2. Taking this drug causes a deterioration in the absorption of fat-soluble vitamins A, E, K and D. And in order to avoid the appearance of their deficiency in the body, taking Orsoten must certainly be accompanied by vitamin complexes, which are very easy to purchase at any pharmacy. You should also take multivitamins immediately before bedtime, when the main effect of the drug has already ended or has decreased to a minimum.
3. If you have a disease such as diabetes, a visit to a specialist is simply necessary. After all, these people, as a rule, receive special treatment that can affect the effectiveness of Orsoten. Therefore, it may be necessary to adjust the dosages of drugs or replace them. The same applies to those people who have problems with blood pressure and high cholesterol in the blood. Orsoten can affect their level, and not in the best way. If you are taking any special medications, then you should tell your doctor about the additional intake of Orsoten. perhaps he will also make some adjustments to your treatment.
4. Taking Orsoten can affect the effectiveness of hormonal drugs, so while taking it, you need to take care of additional methods of contraception in order to avoid unwanted pregnancy.

Orsoten has many advantages over other drugs that allegedly help fight excess weight. Firstly, its main component (orlistat) acts only on the gastrointestinal tract and does not affect other internal organs and systems, since it does not have the ability to penetrate into the blood and spread through the blood vessels throughout the body. As a result, a person taking this drug will not experience various side effects associated with the functioning of the nervous system and kidneys.

Secondly, it is this drug that nutritionists consider the best and most effective. They recommend it to be taken by people who have been unsuccessfully struggling with excess weight for a long time. Moreover, they also appoint it to those who have already achieved their goal and want to keep the achieved results as long as possible.

Thirdly, this remedy belongs to the group of drugs, which means that it prevents the development of many diseases that often occur against the background of weight loss. Therefore, taking Orsoten, you can not worry that you may develop glucose intolerance, hypercholesterolemia or arterial hypertension.

Based on this, we can conclude that Orsoten is a completely safe and unique drug for weight loss. However, it is still necessary to consult a doctor before taking it.

How is Orsoten taken for weight loss?

Orsoten application should occur according to the attached instructions for the drug. As a rule, take it three times a day, 1 capsule. A single dosage of the drug is determined individually by the doctor, but it should not exceed 120 mg.

This drug should be taken with plenty of water. And it should be only drinking purified water, and in no case tea, soda or milk. It is recommended to take Orsoten immediately before the main meal. The capsule can be drunk with meals, after it is not recommended.

If it suddenly happened that you forgot to take the drug, then the next time you take it, in no case should you increase the dosage. This can lead to severe diarrhea and other side effects.

Despite the fact that the drug removes fats and their large consumption is not recommended, it is impossible to completely exclude fats from the diet. They must be present at every meal. Treatment with Orsoten can occur for a long time, but not more than two years.

We remind you that Orsoten is a drug intended for. That is, it is advisable to take it only if your body mass index (BMI) exceeds 30.

Calculating BMI is very easy. To do this, you need to divide your weight in kilograms by your height in meters squared. If your BMI is less than 27, then you should not use Orsoten, as it is still a medicine and can provoke the development of serious health problems.

The dosage of the drug should be selected individually in each case, and therefore you still have to consult a specialist, especially if you are also taking other medications aimed at combating high cholesterol or diabetes.

In addition, it is important to understand that if you do not follow the daily routine and eat right, then you will not achieve the desired result from taking the drug. It will just get into your body and just as easy to get out of it.

Physical activity is also very important during this period. However, you do not need to overdo it with them. Ideal for "light" sports, such as hiking or home fitness.

Also, do not forget about taking vitamin complexes, since when taking Orsoten, as mentioned above, the absorption of fat-soluble vitamins worsens. And they are very important for the normal functioning of the body.

Deficiency of these vitamins can lead to various disorders in the body, as well as to the deterioration of the hair. Therefore, if you want to not only lose weight, but also maintain your health and beauty, go to the pharmacy for vitamins!

Video about Orthosene for weight loss

Someone calls these yellowish-white capsules a wonderful salvation from fats and extra pounds, and someone scares them with stories about how terrible this drug is with its effect on the body.

Indeed, Orsoten diet pills are one of the latest developments in the field of nutrition, which, when taken regularly, removes fat from the body day by day. And with them melt and extra pounds. You can easily lose up to 5 kg per month, and this is not the limit. In fact, Orsoten has both its advantages and disadvantages.

The benefits of the drug

Today, it can be said without exaggeration that the market is full of all kinds of weight loss products - both natural and synthetic. But Orsoten did not get lost among them: more and more people who have tried this drug are satisfied and leave a lot of the most positive feedback. What is it: promotion of another brand? PR? In fact, the mechanism of action of Orsoten is simple but effective. The mass of advantages distinguishes it from all other means.

• First of all, the active substance in the composition of Orsoten (orlistat) performs all its functions exclusively within the gastrointestinal tract. In this regard, it practically does not penetrate into the blood and does not spread throughout the body. The result - no side effects associated with disorders in the functioning of the kidneys and the nervous system, losing weight will not be experienced.
• Secondly, it is Orsoten that nutritionists recommend to those who need long-term control of body weight. This may be the usual weight loss, its maintenance at the desired level, or the prevention of its re-addition.
• Thirdly, Orsoten for weight loss is a drug. When losing weight, it prevents the development of diseases that usually increase against the background of weight loss. Therefore, you can absolutely not be afraid of either hypercholesterolemia, or impaired glucose tolerance, or hyperinsulinemia, or arterial hypertension, or diabetes mellitus - the usual companions of weight loss.

After reviewing this list of Orsoten benefits, there will be no doubt that the drug is actually very unique.

How do Orsoten tablets work?

The effectiveness of Orsoten in getting rid of extra pounds is dictated by the active ingredient in its composition - orlistat. This is a drug that is used in medicine and nutrition specifically for weight loss. It is it that, getting into the gastrointestinal tract, does all the necessary work there:

• blocks the activity of lipase - an enzyme that processes fats;
• as a result, fats are not absorbed by the body, as they remain undigested by lipase;
• the body begins to use the already existing fat, including visceral, stored "in reserve";
• no fat in the body - no extra pounds.

The mechanism of action of Orsoten is very simple, but it is in this simplicity that he is ingenious. Affecting a minimum of processes occurring in the body, it causes minimal damage to it.

Indications for the use of the drug

Like any other drug, Orsoten must be prescribed by a specialist: it is not a home remedy for self-medication. Indications for its use can be:

• obesity with BMI> 30 kg / m 2;
• if the treatment of any disease requires urgent or simply mandatory weight loss.

Often, Orsoten is prescribed along with hypoglycemic drugs, as well as a low-calorie diet, if the person who is losing weight has type II diabetes. There is nothing wrong with this, such a neighborhood is only beneficial to the body.

Orsoten for weight loss - instructions for use

The instructions for using Orsoten are simple and will not require much time and effort from you. If you decide to use it, a few rules for you should become unshakable and golden.

1. Before using it, be sure to consult with a specialist: your doctor or nutritionist.
2. Orlistat is taken three times a day, one capsule (a single dose should not exceed 120 mg - this is the weight of the capsule).
3. Each capsule should be taken with a glass of plain water.
4. It is better to take the drug immediately before the main meal, you can - during meals, in extreme cases - an hour after eating, but not later.
5. If for some reason a meal or capsule is missed, it is impossible to increase its dose in the next dose of the medicine.
6. In this case, be sure to include a small amount of fat in each meal.
7. Therapy can last up to two years.

Only by following the instructions exactly, you can hope that Orsoten will work and help you get the desired forms.

Contraindications and side effects

Despite the fact that orlistat does not affect the internal organs and systems of the body, a number of problems can still arise if it is used improperly. Anyone who decides to lose weight with Orsoten should definitely know When should you not take it at all?

• chronic malabsorption (loss of nutrients by the body);
• cholestasis (serious problems in the gallbladder);
• age up to 18 years;
• pregnancy;
• lactation;
• individual intolerance to Orlistat in particular or Orsoten in general.

Complications can also arise in the following cases:

• with the wrong dosage;
• when ignoring the instructions for use;
• if the diet is not followed: fats should enter the body no more than 30% of all calories per day, and should be distributed over different meals (breakfast, lunch, dinner).

Of the side effects in the study of the drug, the following points were noted.

• Disorders in the work of the stomach

Since orlistat affects the gastrointestinal tract, it is he who becomes the affected area if Orsoten did not suit the body as a means for losing weight. If you do not follow a diet that limits daily fat intake, you can upset the work of the gastrointestinal tract, although the reactions may be quite mild. There may be flatulence, involuntary oily discharge, urge to defecate, sometimes - its frequency, loose stools, soft, fatty or oily stools, fats in the feces, discomfort in the abdomen or in the rectum. Very rarely, lesions of the oral cavity (teeth and gums), hypoglycemia, cholelithiasis, diverticulitis can occur.

• CNS disorders

The nervous system practically does not suffer even with an increased dosage. The maximum that can appear is an inexplicable feeling of anxiety and incomprehensible headaches.

• allergic reactions

The skin is an indicator of the work of the gastrointestinal tract, therefore, various skin rashes can be observed: urticaria, rash, itching, angioedema. The lungs can also react with bronchospasm or anaphylaxis.

• Other

When taking Orsoten, it should be borne in mind that you may experience a feeling of fatigue, flu-like syndrome, dysmenorrhea (pain in the lower abdomen during the menstrual cycle), infections of the upper respiratory tract or urinary tract.

In any case, if your condition or disease is indicated in the above mentioned list of contraindications, you need to consult both your doctor and a nutritionist. If it is not possible to take a consultation from them, it is better to refuse to take Orsoten, since it is first a drug, and only then a means for losing weight. Therefore, in the presence of contraindications or the occurrence of any side effects, a less effective, but more gentle and safe method for losing weight should be found.

Means for weight loss Orsoten: reviews of doctors

The best nutritionists and doctors of other specialties were not slow to express their opinion about the new weight loss drug, which everyone is talking about so noisily and publicly today. What are their reviews?

First of all, all, as one, note the unique ability of Orsoten diet pills not to affect the central nervous system, unlike many other drugs of this kind.

Secondly Orsoten's medicinal focus can reassure anyone in its absolute safety. Like any other drug, it has been certified and approved for this market. Not all weight loss products today can boast of such an advantage.

There are also doctors who still argue that you can’t deprive your body of fat for a long time, and therefore, after a month of such a hunger strike on Orsoten, it’s better to take a break after all.

Orsoten- an unusual drug for weight loss, which has both its opponents and hostile opponents. In any case, all organisms are so different that for some, these capsules will be a real salvation, which will lead to the coveted figure on the scales. And they will not care that fat will be excreted from the body in such an unusual and not very pleasant way. And for some, this method of losing weight will be completely unacceptable, both in terms of aesthetics and based on physical data.

To minimize the risk of side effects, the surest option would be to seek the advice of a specialist who can prescribe Orsoten as a drug.

Remember: weight loss and health should go hand in hand, not against each other. It is quite possible that it is Orsoten who will help you make this a reality.

Orsoten: instructions for use and reviews

Catad_pgroup Weight loss products

Orsoten slim - official instructions for use

Registration number: LP-000301-180216

Trade name: Orsoten® slim

International non-proprietary or grouping name: orlistat

Dosage form: capsules

Composition per capsule

Active substance:

Orsoten, semi-finished granules 112.80 mg contains orlistat 60.00 mg

[Excipient of the semi-finished product-granules: microcrystalline cellulose 52.80 mg];

Excipients:

Cellulose microcrystalline 22.20 mg

Composition of hard gelatin capsules 1:

Frame: titanium dioxide (E171) 0.58 mg, gelatin 28.22 mg

Lid: titanium dioxide (E171) 0.19 mg, gelatin 18.97 mg, iron dye yellow oxide (E172) 0.04 mg 1 "Capsugel", Belgium.

Description

No. 3 hard gelatin capsules, white capsule body, light yellow capsule cap. Capsule contents: microgranules or a mixture of powder and microgranules of white or almost white color.

The presence of compacted agglomerates is allowed, which easily crumble when pressed.

Pharmacotherapeutic group: gastrointestinal lipase inhibitor

ATC Code: A08AB01

Pharmacological properties

Pharmacodynamics

Orlistat is a potent long-acting specific inhibitor of gastrointestinal lipases. It exhibits its therapeutic activity in the lumen of the stomach and small intestine, forming a covalent bond with the active serine site of gastric and pancreatic lipases. An inactivated enzyme loses its ability to hydrolyze dietary fats (triglycerides) into absorbable free fatty acids and monoglycerides. Undigested triglycerides are not absorbed, which leads to a decrease in the number of calories absorbed by the body and to a decrease in body weight. The therapeutic effect of the drug is thus carried out without absorption into the systemic circulation. In clinical studies, orlistat, taken daily at a dose of 60 mg 3 times a day, blocks the absorption of approximately 25% of the fats included in the daily diet.

Along with a decrease in body weight, with long-term use of orlistat at a dose of 60 mg, there is a decrease in such indicators as waist circumference, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in blood plasma. After 6 months of therapy with orlistat at a dose of 60 mg, the average concentration of total cholesterol in blood plasma decreases by an average of 2.4%, LDL cholesterol - by 3.5%.

Waist circumference after 6 months of taking the drug decreases, on average, by 4.5 cm.

Pharmacokinetics

Suction

Absorption of the drug is minimal.

breeding

About 97% of the ingested dose of the drug is excreted through the intestines, 83% of this amount is unchanged.

The excretion of orlistat and its metabolites by the kidneys is less than 2% of the dose taken. The drug is completely eliminated after 3-5 days. Elimination of orlistat is similar in both normal weight volunteers and obese patients.

Indications for use

Reducing excess body weight in adult patients (over 18 years of age) with a body mass index (BMI) of more than 28 kg/m2. It is used only in combination with a moderately hypocaloric diet containing no more than 30% of daily calories in the form of fats.

Contraindications

Hypersensitivity to orlistat or to any of the components of the drug;

Syndrome of chronic malabsorption;

cholestasis;

Simultaneous use of cyclosporine;

Simultaneous use of indirect anticoagulants (warfarin);

Simultaneous use of sitagliptin;

Pregnancy and the period of breastfeeding;

Age up to 18 years.

Use during pregnancy and during breastfeeding

The drug Orsoten Slim should not be used during pregnancy due to the lack of reliable clinical data confirming the safety of its use. It has not been established whether orlistat passes into breast milk, and therefore, the use of Orsoten Slim during breastfeeding is not recommended.

Dosage and administration

For adult patients, the recommended dose of Orsoten Slim is 60 mg (1 capsule) 3 times a day with each main meal in combination with a moderately low-calorie, low-fat diet. The capsule should be taken immediately before meals, during meals or no later than 1 hour after meals with water. If a meal is skipped or if the food does not contain fat, then Orsoten Slim can be skipped.

During the day, you can take no more than 3 capsules of Orsoten Slim. Orsoten Slim should only be taken at recommended doses. Treatment is recommended for no more than 6 months. It is recommended to discuss the results of weight loss with your doctor. If after 12 weeks of using the drug Orsoten® slim there is no decrease in body weight (that is, a decrease in body weight is less than 5% of the original), a doctor's consultation is necessary to decide whether to continue taking the drug.

Side effect

Adverse reactions (HP) when taking the drug Orsoten Slim, as a rule, are observed from the gastrointestinal tract (GIT) and are due to the pharmacological action of the drug.

very often ≥ 1/10

often ≥ 1/100 to< 1/10

infrequently from ≥ 1/1000 to< 1/100

rarely ≥ 1/10,000 to< 1/1000

rarely< 1/10000

frequency unknown - cannot be estimated from the available data.

Below is the frequency of HP from various organs and systems.

Clinical studies investigating the use of orlistat at a dose of 60 mg lasting from 18 to 24 months established HP from the gastrointestinal tract, which were generally mild and reversible. Usually they appeared at the beginning of treatment. Eating a low-fat diet reduces the chance of these reactions occurring.

From the gastrointestinal tract:

very often: oily discharge from the rectum, passing gases with some discharge, imperative urge to defecate, steatorrhea;

often: abdominal pain, fecal incontinence, loose stools, increased bowel movements.

As a rule, these HPs are weakly expressed and transitory. They occur in the early stages of treatment (in the first 3 months of therapy), and most patients had no more than one episode of such reactions.

Post-registration studies

During the post-marketing use of orlistat, the following HPs were noted, the frequency of which is unknown:

From the side of the hematopoietic organs: a decrease in the concentration of prothrombin and an increase in the international normalized ratio (MHO) in blood plasma in patients who took orlistat simultaneously with indirect anticoagulants.

From the gastrointestinal tract: minor bleeding from the rectum, diverticulitis.

From the skin and subcutaneous tissue: bullous rash.

From the immune system: hypersensitivity reactions, including pruritus, skin rash, urticaria, angioedema, bronchospasm and anaphylaxis.

From the side of the liver and biliary tract: cholelithiasis, hepatitis, increased activity of "liver" transaminases and alkaline phosphatase in blood plasma.

Overdose

When using orlistat at a dose of 800 mg once and at a dose of up to 400 mg 3 times a day daily for 15 days, both in persons with normal body weight and in patients with obesity, no significant HP was detected. When using orlistat at a dose of 240 mg 3 times a day for 6 months, there was no increase in the frequency of dose-dependent HP. In most cases of orlistat overdose reported in the post-registration period, indications of HP are either absent, or they are similar to those that may be after taking the recommended doses of the drug.

In case of an overdose, a doctor's consultation is necessary. With a significant overdose of orlistat, observation of the patient for 24 hours is recommended. According to preclinical and clinical studies, systemic effects associated with lipase inhibition are usually rapidly reversible.

Interaction with other drugs

Cyclosporine

Several drug interaction studies of ciclosporin, when co-administered with orlistat, have reported a decrease in plasma ciclosporin concentrations. Potentially, this may lead to a decrease in the immunosuppressive efficacy of the latter. Simultaneous use of the drug Orsoten Slim and cyclosporine is contraindicated.

Indirect anticoagulants

With the simultaneous use of warfarin or other oral anticoagulants with Orsoten® Slim, MHO values ​​\u200b\u200bmay change.

Fat soluble vitamins

Taking Orsoten Slim can potentially impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene).

Acarbose

Given the lack of studies studying pharmacokinetic interactions, it is not recommended to use the drug Orsoten Slim simultaneously with acarbose.

Amiodarone

With simultaneous use with orlistat, a decrease in the concentration of amiodarone in the blood plasma was noted after a single dose. The clinical significance of this effect in patients taking amiodarone is unclear. Simultaneous use of the drug Orsoten Slim and amiodarone is possible only on the recommendation of a doctor.

Lack of interaction

Orlistat does not interact with amitriptyline, phenytoin, fluoxetine, sibutramine, phentermine, atorvastatin, pravastatin, fibrates, biguanides, digoxin, nifedipine, losartan, and ethanol.

special instructions

Diet and exercise are an essential part of a weight loss program. It is recommended to start a dietary program and exercise before starting Orsoten Slim therapy.

While taking Orsoten® Slim, it is necessary to adhere to a fractional, balanced, moderately hypocaloric diet, with a fat content of not more than 30% of the daily calorie intake (for example, with a diet of 2000 kcal / day, fat intake should be no more than 66 g / day). You should follow the received recommendations on diet and physical activity, both during and after discontinuation of the drug.

The use of the drug Orsoten® slim leads to an increase in the fat content in the feces already 24-48 hours after the start of administration. After discontinuation of the use of the drug Orsoten Slim, the fat content in the feces usually returns to its original level within 48-72 hours.

Eating a low-fat diet reduces the likelihood of HP from the gastrointestinal tract.

Orlistat has the potential to impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene). In the vast majority of patients treated with orlistat during four-year clinical studies, the concentrations of vitamins A, D, E, K and beta-carotene were within normal limits. For preventive purposes, it is recommended to take multivitamins at night.

Since weight loss is usually accompanied by an improvement in carbohydrate metabolism, patients with type 2 diabetes should consult a doctor before starting therapy with Orsoten® Slim and, if necessary, adjust the dose of hypoglycemic drugs.

Weight loss during treatment may be accompanied by a decrease in blood pressure and the concentration of total cholesterol in the blood plasma. Patients taking antihypertensive or lipid-lowering drugs should consult a doctor and, if necessary, adjust the dose of these drugs. No interactions have been observed between oral contraceptives and orlistat in clinical studies. However, orlistat may indirectly reduce the bioavailability of oral contraceptives, which may lead to unwanted pregnancies. It is recommended to use additional methods of contraception in case of acute diarrhea.

Patients suffering from kidney disease should consult a doctor, as hyperoxaluria and nephropathy may develop.

Patients taking amiodarone, warfarin, or other oral anticoagulants should also consult a physician before starting orlistat therapy, as changes in the MHO are possible.

Patients should stop taking Orsoten Slim and consult a doctor if symptoms occur: icteric coloration of the sclera or skin, pruritus, dark urine and loss of appetite.

Influence on the ability to drive vehicles and mechanisms

The drug Orsoten Slim does not affect the ability to drive vehicles and mechanisms.

Release form

Capsules, 60 mg.

21 capsules in a blister pack made of a combined PVC / PVDC material and aluminum foil.

2 or 4 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging. Keep out of the reach of children.

Shelf life

Do not use after the expiration date.

Holiday conditions

Released without a prescription.

Manufacturer:

KRKA-RUS LLC, 143500, Russia, Moscow region, Istra, st. Moscow, d. 50

Representative office of JSC Krka, d.d., Novo mesto in the Russian Federation / Organization accepting consumer claims:

125212, Moscow, Golovinskoe shosse, house 5, building 1.

Orsoten slim (active substance orlistat) is a drug for the correction of overweight, which is an inhibitor of gastrointestinal lipases. It is necessary to immediately make a reservation that orsoten slim is not a dietary supplement, as they write about it on a number of Internet forums: it is a real drug from the Slovenian pharmaceutical company Krka, the closest relative of orsoten (the difference between them is only in the content of the active substance: 60 mg vs 120 mg). Orsoten slim differs from the notorious sibutramine in a much smaller number of adverse reactions. The therapeutic activity of the hero drug of this article is manifested exclusively in the bowels of the stomach and small intestine, where orlistat interacts with gastric and pancreatic lipases, inactivating the latter to such an extent that they lose their ability to break down dietary fat (triglycerides) into easily absorbed free fatty acids. and monoglycerides. And since triglycerides are not absorbed in the gastrointestinal tract, a certain calorie deficit develops, which, in turn, has a positive effect on body weight control. Orsoten slim at a dose of 60 mg 3 times a day blocks the absorption of about a quarter of the total dietary fat consumed. The therapeutic effect of the drug is limited only to the gastrointestinal tract, which is an undoubted advantage, since the absence of a systemic component in its action reduces the likelihood of adverse reactions. The pharmacological activity of orsoten slim leads to the fact that the fat content in the small intestine increases 24-48 hours after oral administration (because fat is no longer absorbed). After discontinuation of the drug, the fat content returns to its initial values ​​in 48-72 hours. Therapy with orsoten slim will only be effective in combination with lifestyle and dietary modifications (daily aerobic exercise and a low-calorie diet with limited saturated animal fats). Orsoten slim will do little without getting rid of the bad habits: in this case, continuing to abuse the unhealthy patient risks getting indigestion.

Moreover, it is necessary to limit not only fats, but also “fast” carbohydrates, since they are readily transformed into body fat. The weight loss associated with taking Orsoten Slim is also accompanied by other positive phenomena, such as a decrease in the level of total and “bad” cholesterol (low density lipoprotein), a decrease in waist circumference. If, after three months of regular pharmacotherapy with orsoten slim, the weight stubbornly continues to remain the same or decreases by less than 5%, it is necessary to consult a doctor to decide on the advisability of further treatment. It is important that the patient should begin to “diet” and exercise even before the start of the drug course, without stopping to follow a healthy lifestyle after it ends. The diet during treatment should include no more than 30% fat. The daily intake of the three main nutrients - proteins, fats and carbohydrates - should be evenly distributed between breakfast, lunch and dinner. The effects of orsoten slim in patients with renal and hepatic insufficiency have not been studied enough, however, given the minimal absorption of the drug in the gastrointestinal tract, dose adjustment in such patients is not required. The doctor should warn the patient about the increased risk of side effects when consuming a high-fat diet. Therapy with orsoten slim may lead to impaired absorption of fat-soluble vitamins. In this regard, vitamins A, D, E and K are recommended to be taken before bedtime. Taking the drug by patients with diabetes mellitus is often accompanied by an improvement in metabolic control, which may necessitate the correction of hypoglycemic drugs. Getting rid of excess body fat may be accompanied by normalization of blood pressure, and, therefore, the ability to reduce the dose of antihypertensive drugs taken.

Pharmacology

Long-acting lipase inhibitor of the gastrointestinal tract. The therapeutic activity of orlistat is realized in the lumen of the stomach and small intestine and consists in the formation of a covalent bond with the active serine site of gastric and pancreatic lipases. An enzyme thus inactivated loses its ability to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. Undigested triglycerides are not absorbed and the resulting calorie deficit can have a positive effect on weight control. Orlistat at a dose of 60 mg 3 times / day blocks the absorption of approximately 25% of dietary fat. The therapeutic effect of orlistat is realized without its systemic absorption. The effect of orlistat leads to the fact that the concentration of fat in the contents of the intestine increases already 24-48 hours after its use inside. After discontinuation of orlistat, the concentration of fat in the contents of the intestine usually returns to baseline after 48-72 hours.

In adult patients with a BMI ≥28 kg/m2, orlistat 60 mg three times a day is effective in combination with a hypocaloric, low-fat diet. In this case, the main weight loss occurs during the first 6 months of treatment.

The decrease in body weight caused by the use of orlistat at a dose of 60 mg 3 times / day is accompanied by another beneficial effect: a decrease in the concentration of total cholesterol, LDL cholesterol, as well as a decrease in waist circumference.

Pharmacokinetics

Suction

Studies in volunteers with normal and overweight have shown that the degree of absorption of orlistat is minimal. The concentration of unchanged orlistat in plasma is below the limit of quantification (below 5 ng / ml) 8 hours after oral administration of orlistat at a dose of 360 mg. In general, when used in therapeutic doses, the determination of unchanged orlistat in plasma is sporadic, and its concentration is extremely low (less than 10 ng / ml or 0.02 μmol / l), and there are no signs of cumulation, which indicates a minimal degree of absorption.

Distribution

V d cannot be determined because orlistat is absorbed to a minimal extent and has no established systemic pharmacokinetics. The binding of orlistat to plasma proteins is more than 99% (mainly with lipoproteins and albumins). Orlistat can penetrate erythrocytes to a minimal extent.

Metabolism

The metabolism of orlistat occurs mainly in the walls of the stomach and small intestine.

breeding

Approximately 97% of the dose is excreted through the intestines, 83% of this amount is in the form of unchanged orlistat. The cumulative renal excretion of all orlistat-containing substances is less than 2% of the administered dose. The time to reach full excretion (through the intestines and kidneys) is from 3 to 5 days.

Release form

Hard gelatin capsules, size No. 3, white body, light yellow cap; the contents of the capsules are microgranules or a mixture of powder and microgranules of white or almost white color; the presence of caked agglomerates is allowed, which easily crumble when pressed.

Excipient semi-finished product-granules: microcrystalline cellulose.

Excipients: microcrystalline cellulose - 22.2 mg.

The composition of hard gelatin capsules No. 3: capsule body - titanium dioxide (E171) - 0.58 mg, gelatin - 28.22 mg; capsule cap - titanium dioxide (E171) - 0.19 mg, iron oxide yellow (E172) - 0.04 mg, gelatin - 18.97 mg.

21 pcs. - cellular contour packings (2) - packs of cardboard.
21 pcs. - cellular contour packings (4) - packs of cardboard.

Dosage

Take orally 60 mg (1 caps.) 3 times / day, immediately before, during or within 1 hour after each meal. Capsules are washed down with water.

If a meal is skipped or the meal did not contain fat, the use of orlistat should be skipped.

Within 24 hours, you can take no more than 3 capsules of 60 mg of the drug Orsoten ® slim.

The course of treatment should not exceed 6 months.

If after 12 weeks of using Orsoten ® slim, weight loss does not occur (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.

During the use of the drug Orsoten ® slim, the patient should receive a moderately hypocaloric diet with a balanced content of nutrients, in which approximately 30% is fat (for example, at a calorie content of 2000 kcal / day, the food should contain no more than 67 g of fat). Daily intake of fats, carbohydrates and protein should be distributed between the three main meals. The diet and exercise program should continue after Orsoten Slim is discontinued.

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

The effects of orlistat in persons with impaired liver and/or kidney function have not been studied, however, given that the absorption of orlistat is minimal, dose adjustment in elderly patients and in patients with impaired liver and/or kidney function is not required.

Overdose

When using orlistat at a dose of 800 mg once and at a dose of up to 400 mg 3 times / day, daily, for 15 days, no significant adverse reactions were detected in both patients with normal body weight and obese patients. When using orlistat 240 mg 3 times / day for 6 months, there was no increase in the frequency of adverse reactions.

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

Treatment: in case of overdose, a doctor's consultation is necessary. With a significant overdose of orlistat, observation of the patient for 24 hours is recommended. Based on data from studies in humans and animals, all systemic effects of orlistat due to lipase inhibition are usually rapidly reversible.

Interaction

With the simultaneous use of cyclosporine and orlistat, a decrease in the concentration of cyclosporine in the blood plasma is observed, which may be accompanied by a decrease in its immunosuppressive activity. Simultaneous use of the drug Orsoten Slim and cyclosporine is contraindicated.

With the simultaneous use of warfarin or other oral anticoagulants and orlistat, a change in the MHO value may occur.

The use of orlistat may lead to malabsorption of fat-soluble vitamins (A, D, E and K).

Due to the lack of data on pharmacokinetic interactions, it is not recommended to use orlistat simultaneously with acarbose.

With simultaneous use with orlistat, a decrease in the concentration of amiodarone in the blood plasma was noted after a single application. The clinical significance of this effect in patients taking amiodarone is unclear. Simultaneous use of orlistat and amiodarone is possible only on the recommendation of a doctor.

Orlistat does not interact with amitriptyline, phenytoin, fluoxetine, sibutramine, phentermine; atorvastatin, pravastatin, fibrates; biguanides; digoxin, nifedipine, losartan; oral contraceptives and ethanol.

Side effects

Classification of the incidence of side effects (WHO): very often (≥1 / 10); often (from ≥1/100 to<1/10); нечасто (от ≥1/1000 до <1/100); редко (от ≥1/10 000 до <1/1000); очень редко (от <1/10 000), включая отдельные сообщения.

When using orlistat, reactions from the gastrointestinal tract are usually observed and are associated with the pharmacological action of the drug.

From the digestive system: very often - oily discharge from the rectum, gas with some discharge, imperative urge to defecate, steatorrhea; often - abdominal pain, fecal incontinence, loose stools, increased bowel movements.

During the post-marketing use of orlistat, the following adverse reactions were noted (frequency unknown).

On the part of the hematopoietic system: a decrease in the concentration of prothrombin; an increase in INR in patients taking orlistat simultaneously with anticoagulants.

From the digestive system: slight rectal bleeding, diverticulitis, hepatitis, cholelithiasis, increased activity of hepatic transaminases and alkaline phosphatase.

On the part of the skin: bullous rash.

Allergic reactions: itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis.

Indications

• to reduce body weight in patients over 18 years of age with overweight (BMI ≥28 kg / m 2) in combination with a moderate hypocaloric diet with low fat food.

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

Application for violations of liver function

Application for violations of kidney function

The effects of orlistat in individuals with impaired renal function have not been studied, however, given that the absorption of orlistat is minimal, dose adjustment in patients with impaired renal function is not required.

Use in children

Contraindicated in children and adolescents under 18 years of age.

special instructions

Patients should be advised 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 content of fat.

Treatment with Orsoten Slim may lead to malabsorption of fat-soluble vitamins (A, D, E and K). For this reason, multivitamins should be taken at bedtime.

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

Weight loss may be accompanied by an improvement in blood pressure and a decrease in cholesterol concentration. Patients taking medications for arterial hypertension or hypercholesterolemia, when using the drug Orsoten ® slim, should consult a doctor and, if necessary, adjust the dose of these drugs.

Patients taking amiodarone should consult a physician before starting therapy with Orsoten Slim.

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

Influence on the ability to drive vehicles and control mechanisms

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