Figurin

General characteristics. Structure:

Active ingredient: 60 mg or 120 mg of an orlestat.

Excipients: gidroksipropilmetiltsellyuloza, sodium lauryl sulfate, starch sodium glycollate.

Structure of a cover of the capsule: titanium dioxide (E171), crimson 4R (E124), quinolinic yellow (E104), orange yellow (E110), patent blue V (E131), water cleared, gelatin.

Medicine for treatment of obesity, including reduction and maintenance of body weight, in combination with a hypocaloric diet.

Indications to use:

Therapy in combination with moderately low-calorie diet of patients with obesity (the body weight index (BWI)> of 30 kg/sq.m) or patients with the excess body weight (IMT> of 28 kg/m), having the risk factors associated with obesity.

Treatment orlistaty should be stopped in 12 weeks in case of lack of decrease in body weight at least for 5% in comparison with initial body weight.

Route of administration and doses:

Figurin accept three times a day, washing down with water, just before each main meal, during food or no later than in an hour after food. If meal is missed or food does not contain fat, then reception of an orlistat can be missed. The recommended single dose of an orlistat — 120 mg. Doses of an orlistat over 360 mg a day do not strengthen its therapeutic effect.

Features of use:

In clinical tests of decrease in body weight at treatment orlistaty patients had less with a diabetes mellitus of the II type in comparison with patients without diabetes mellitus. Reception of an orlistat during treatment by antidiabetic drugs demands careful monitoring of level of glucose.

The patient has to adhere to sbaoansirovanny moderately low-calorie diet which contains about 30% of calories at the expense of fats. Possibility of gastrointestinal by-effects can increase when орлистат is accepted against the background of a diet with the high content of fat (for example, with the caloric content of 2000 kcal a day, from them more than 30% a type of fats that more than 67 g of fat are equivalent). The diet rich with fruit and vegetables is recommended. Daily consumption of fats, carbohydrates and proteins has to be distributed on three main meals.

During reception of an orlistan cases of a proctorrhagia were registered. In case of existence of heavy and/or long symptoms it is necessary to conduct careful examination.

Use of additional methods of contraception for prevention of lack of effect of use of oral contraceptives is recommended that is possible in case of development of heavy diarrhea.

At the patients receiving the accompanying therapy by oral anticoagulants parameters of coagulant system of blood have to be controlled.

Reception of an orlistat can lead to development of a hyperoxaluria and oxalic nephropathy in patients with chronic diseases of kidneys and/or with dehydration symptoms.

During reception of an orlistat the hypothyroidism and/or decrease in control of a condition of a hypothyroidism can develop. The possible mechanism can be connected with decrease in absorption of salts of iodine and/or left thyroxine.

At the patients receiving antiepileptic drugs орлистат can reduce absorption of antiepileptic means that can lead to development of spasms.

Orlistat does not exert impact on ability to drive the car or other means of transport and to use mechanisms.

Side effects:

Side reactions on drug arose, mainly, from a GIT and were caused by pharmacological effect of the drug interfering absorption of fats of food. Such phenomena as oily allocations from a rectum, release of gases with a quantity separated, imperative desires on defecation, defecation increase, an involuntary chair were very often noted. Patients should be informed on possibility of the specified reactions and to train how to eliminate them by the best observance of a diet, especially concerning a kolchestvo of the fat which is contained in it. Possibility of gastrointestinal side reactions can increase when орлистат is accepted against the background of a diet with high content of fat (for example, with the caloric content of 2000 kcal a day, from them more than 30% in the form of fats) that more than 67 g of fat are equivalent). As a rule, the specified reactions are slight and tranzitorny.

Also at treatment orlistaty often there are following undesirable phenomena from a GIT: pains or discomfort in an abdominal cavity, abdominal distention, a soft chair, a liquid chair, pains or discomfort at an urination; damage of teeth, damage of gums.

Development of disturbances of a menstrual cycle, increase in activity of hepatic transaminases and alkaline phosphatase, development of a cholestasia and cholelithiasis is possible.

Side reactions from skin are possible and hypodermic cellulose (a violent dermatosis), hypersensitivity reaction (an itch, rash, urticaria, a Quincke's edema, a bronchospasm, anaphylactic reactions), an infection of upper and lower respiratory tracts, a diverticulitis, pancreatitis, a hypoglycemia, an oxalic nephropathy and a proctorrhagia.

At the patients receiving anticoagulants in combination with orlist decrease in a prothrombin, increase in MNO as a result of changes of haemo static parameters is possible.

Cases of such undesirable phenomena as are also registered: flu, headaches, alarm, fatigue, infections of urinary tract. During post-registration monitoring isolated cases of a heavy liver failure with a hepatocellular necrosis or an acute liver failure were revealed. Now relationship of cause and effect between use of an orlistat and damage of a liver is not established. The specific undesirable phenomena patients with a diabetes mellitus of the II type had hypoglycemic states (very often) and abdominal distention (frequent). At patients with a diabetes mellitus of the II type the body degrowth at treatment orlistaty is followed by improvement of regulation of carbohydrate metabolism that is able to afford or will cause the necessity to lower a dosage of glucose-lowering drugs.

Interaction with other medicines:

Left thyroxine. At a concomitant use with orlistaty emergence and/or strengthening of manifestation of a hypothyroidism is possible. It can be connected with decrease in absorption of salts of iodine and/or left thyroxine.

Antiepileptic medicines. Orlistat can reduce absorption of antiepileptic medicines that leads to emergence of convulsions.

Cyclosporine. Simultaneous use with orlistaty is the reason of decrease in concentration of a kiklosporin in plasma that reduces immunodepressive efficiency of the last. The combination of an orlistat with cyclosporine is not recommended. However if reception of these drugs is inevitable, it is necessary to carry out frequent control of level of cyclosporine to blood of patients after the beginning of reception and after the termination of reception of an orlistat. Cyclosporine level in blood should be controlled before stabilization.

Peroral anticoagulants. At a concomitant use of an orlistat and peroral anticoagulants prothrombin level can decrease. Control of the MNO level is necessary.

Fat-soluble drugs. Reception of an orlistat can significantly worsen absorption of fat-soluble vitamins (And, D, E, K).

Acarbose. Due to the lack of data on pharmacokinetic vozdeytviya joint reception with orlistaty is not recommended.

Amiodaronum. At a concomitant use with orlistaty reduction of level of Amiodaronum in plasma after a single dose is noted. Simultaneous use of Amiodaronum and orlistat is possible only according to the recommendation of the doctor.

Lack of interaction. Interaction with amitriptyline, atorvastatiny, guanyl guanidines, digoxin, fibrata, fluoxetine, lozartany, Phenytoinum, pravastatiny, GITS nifedipine (gastrointerstinalny therapeutic system) and nifedipine with slow release, sibutraminy or alcohol is not revealed.

Lack of interaction between oral contraceptives and orlistany was shown in researches. However, орлистат can indirectly reduce absorption of oral contraceptives that in certain cases can lead to undesirable pregnancy. In case of development of heavy diarrhea use of additional methods of contraception is recommended.

Contraindications:

- syndrome of chronic malabsorption;
- cholestasia;
- hypersensitivity to active agent or any of ingredients;
- pregnancy and period of a lactation;
- age of patients up to 18 years.

Overdose:

In clinical trials at persons with normal body weight and the examinees having obesity reception of single doses of an orlistat to 800 mg or multiple dose of drug on 400 mg 3 times a day within 15 days was not followed by manifestation of the essential undesirable phenomena. Besides, patients with obesity conducted administration of drug on 240 mg 3 times a day within 6 months that was not followed by significant increase in frequency of undesirable reactions. In case of the expressed overdose drug recommends to observe the patient within the 24th hour.

Storage conditions:

To store in the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 1 year.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in blister strip packagings from a film of polyvinyl chloride and aluminum foil. On 3 or 6 blister strip packagings in a cardboard pack together with the application instruction.