Name:
Figurin caps. 60 mg in a box. unitary enterprise No. 10х6
Description:
Hard gelatin capsules No. 1 of a cylindrical form with the hemispherical ends of white color. The main active ingredient Orlistat Release form Capsules Dosage 60 mg Indications for use Therapy in combination with a moderately low-calorie diet in obese patients (body mass index (BMI) ≥ 30 kg/m2) or overweight patients (BMI ≤ 28 kg/m2) associated with obesity risk factors. Treatment with orlistat should be discontinued after 12 weeks in the absence of a decrease in body weight of at least 5% compared with the initial body weight. Dosage and administration Figurin is taken three times a day with water, immediately before each main meal, during meals or no later than one hour after meals. If a meal is skipped or the food does not contain fat, then the intake of orlistat can be skipped. The recommended single dose of orlistat is 120 mg. Doses of orlistat above 360 mg per day do not enhance its therapeutic effect. Influence on the ability to drive vehicles or potentially dangerous mechanisms Orlistat does not affect the ability to drive a car or other modes of transport and use mechanisms. Precautions In clinical trials, weight loss with orlistat treatment was less in patients with type II diabetes compared with patients without diabetes. The use of orlistat during treatment with antidiabetic drugs requires careful monitoring of glucose levels. The patient should follow a balanced, moderately low-calorie diet that contains about 30% of calories from fat. The possibility of gastrointestinal adverse reactions may be increased when orlistat is taken on a high-fat diet (e.g., 2000 calories per day, of which more than 30% are in the form of fat, equivalent to more than 67 g of fat). A diet rich in fruits and vegetables is recommended. Daily intake of fats, carbohydrates and proteins should be divided into three main meals. Rectal bleeding has been reported while taking orlistat. In case of severe and/or prolonged symptoms, a thorough examination should be carried out. It is recommended to use additional methods of contraception to prevent the lack of effect from the use of oral contraceptives, which is possible in case of severe diarrhea (see section “Side effects”). In patients receiving concomitant therapy with oral anticoagulants, the parameters of the blood coagulation system should be monitored. Orlistat may lead to the development of hyperoxaluria and oxalate nephropathy in patients with chronic kidney disease and/or symptoms of dehydration. While taking orlistat, hypothyroidism and / or decreased control of the state of hypothyroidism may develop. A possible mechanism may be associated with a decrease in the absorption of iodine salts and / or levothyroxine. In patients receiving antiepileptic drugs, orlistat may reduce the absorption of antiepileptic drugs, which can lead to the development of seizures. Interaction with other drugs Levothyroxine. With the simultaneous administration of orlistat and levothyroxine, the occurrence and / or increase in the manifestation of hypothyroidism is possible. This may be due to a decrease in the absorption of iodine salts and / or levothyroxine. Antiepileptic drugs. Orlistat may reduce the absorption of antiepileptic drugs, leading to convulsions. Cyclosporine. The simultaneous use of orlistat and cyclosporine is the cause of a decrease in the concentration of cyclosporine in plasma, which reduces the immunosuppressive effectiveness of the latter. The combination of cyclosporine and orlistat is not recommended. However, if the intake of these drugs is unavoidable, it is necessary to frequently monitor the level of cyclosporine in the blood of patients after the start of administration and after discontinuation of orlistat. The level of cyclosporine in the blood should be monitored until stabilization. Oral anticoagulants. With the simultaneous administration of orlistat and oral anticoagulants, the level of prothrombin may decrease. It is necessary to control the level of INR. fat soluble drugs. Taking orlistat can potentially impair the absorption of fat-soluble vitamins (A, D, E, K). Acarbose. Due to the lack of data on pharmacokinetic interactions, it is not recommended to co-administer orlistat with acarbose. Amiodarone. When taken simultaneously with orlistat, a decrease in the plasma level of amiodarone was noted after a single dose. Simultaneous use of amiodarone and orlistat is possible only on the recommendation of a doctor. Lack of interaction. Interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, pravastatin, nifedipine GITS (gastrointestinal therapeutic system) and slow-release nifedipine, sibutramine or alcohol have not been identified. No interaction between oral contraceptives and orlistat has been demonstrated in studies. However, orlistat may indirectly reduce the absorption of oral contraceptives, which in some cases may lead to unwanted pregnancies. In the event of severe diarrhea, the use of additional methods of contraception is recommended. Contraindications chronic malabsorption syndrome; cholestasis; hypersensitivity to the active substance or any of the ingredients; pregnancy and lactation; patients under 18 years of age. Composition Each capsule contains: Active substance: orlistat (in the form of pellets 50%) – 60 mg. Excipients: hypromellose, starch, sodium lauryl sulfate, sodium starch glycolate, povidone, talc. The composition of the hard gelatin capsule for a dosage of 60 mg: titanium dioxide E-171, gelatin. Overdose In clinical studies in subjects with normal body weight and subjects suffering from obesity, taking single doses of orlistat up to 800 mg or multiple doses of the drug 400 mg 3 times a day for 15 days was not accompanied by the appearance of significant adverse events. In addition, obese patients received the drug at 240 mg 3 times a day for 6 months, which was not accompanied by a significant increase in the frequency of adverse reactions. In case of a severe overdose of the drug, it is recommended to observe the patient for 24 hours. Side effectsThe frequency of development of adverse reactions is set out in accordance with the following gradation: very often (more than or equal to 10%), often (from 1 to less than 10%), infrequently (from 0.1 to less than 1%), rarely (from 0.01 to less than 0.1%), very rarely (less than 0.01%). Adverse reactions to the drug occurred mainly in the gastrointestinal tract and were due to the pharmacological action of the drug, which prevents the absorption of dietary fats. Very often, such phenomena as oily discharge from the rectum, gas with a certain amount of discharge, imperative urge to defecate, increased defecation, and involuntary stools were noted. Patients should be informed of the possibility of these reactions and taught how to manage them through better dietary compliance, especially with regard to the amount of fat it contains. The possibility of gastrointestinal adverse reactions may be increased when orlistat is taken on a high-fat diet (e.g., 2000 calories per day, of which more than 30% are in the form of fat, equivalent to more than 67 g of fat). As a rule, these reactions are mild and transient. Also, during treatment with orlistat, the following adverse events from the gastrointestinal tract often occur: pain or discomfort in the abdominal cavity, bloating, loose stools, soft stools, pain or discomfort when urinating; tooth decay, gum disease. Perhaps the development of menstrual disorders, increased activity of hepatic transaminases and alkaline phosphatase, the development of cholestasis and cholelithiasis. Possible adverse reactions from the skin and subcutaneous tissue (bullous dermatosis), hypersensitivity reactions (itching, rash, urticaria, angioedema, bronchospasm, anaphylactic reactions), infections of the upper and lower respiratory tract, diverticulitis, pancreatitis, hypoglycemia, oxalate nephropathy and bleeding from rectum (see Precautions section). In patients receiving anticoagulants in combination with orlistat, a decrease in prothrombin, an increase in INR as a result of changes in hemostatic parameters is possible. Cases of such adverse events as flu, headaches, anxiety, fatigue, urinary tract infections have also been reported. During post-registration monitoring, isolated cases of severe liver failure with hepatocellular necrosis or acute liver failure were identified. At present, a causal relationship between the use of orlistat and liver damage has not been established. Specific adverse events in patients with type II diabetes mellitus were hypoglycemic conditions (very common) and bloating (common). In patients with type II diabetes mellitus, weight loss during orlistat treatment is accompanied by improved regulation of carbohydrate metabolism, which may or will necessitate a reduction in the dosage of hypoglycemic drugs. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Figurin capsules 60mg No. 10×6 Price for Figurin capsules 60mg No. 10×6
INN | ORLISTAT |
---|---|
The code | 68 666 |
Barcode | 4 812 608 003 484 |
Dosage | 60mg |
Active substance | Orlistat |
Manufacturer | Lekpharm SOOO, Belarus |
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