Cursor 250 mg (30 capsules)

The instruction for medical use



of Ursorom Torgovoye medicine a name
Ursor

the International unlicensed
name Ursodezoksikholevaya acid
the Dosage form
of the Capsule, 250 mg

Structure
One capsule contains
active agent - ursodezoksikholevy acid of 250 mg,
excipients: starch corn, K30 povidone, silicon dioxide colloidal anhydrous, magnesium stearate vegetable, gelatin, titan dioxide (E171), blue patent V (E131).

Description
gelatinous solid capsules, blue color, number 0. Contents of capsules – granules of white or almost white color.

Pharmacotherapeutic group
Digestive tract and metabolism. Drugs for treatment of diseases of a liver and biliary tract. The drugs containing biliary acids.
The code of automatic telephone exchange A05AA02

the Pharmacological

Pharmacokinetics At properties intake is well soaked up in a small intestine due to passive diffusion, and in an ileal gut – by means of active transport. The maximum concentration in blood plasma is reached in 1-3 h. The maximum concentration in bile is noted at a daily dose 10-14 mg/kg of weight. At further increase in a dose the concentration of ursodezoksikholevy acid in bile does not increase. Gets through a placental barrier. About 50-70% of a dose are removed with bile.
Pharmacodynamics
Hepatoprotective means. Renders the bile-expelling, cholelitholytic, hypolipidemic, gipokholesterinemichesky and immunomodelling action. Reduces bile saturation by cholesterol by reduction of synthesis and secretion of cholesterol in a liver and inhibition of its absorption in intestines. Increases solubility of cholesterol in a bile-excreting system, stimulates education and biliation. Reduces a bile lipogennost, increases in it concentration of bile acids, causes strengthening of gastric and pancreatic secretion, enhances activity of a lipase, has hypoglycemic effect. Causes partial or full dissolution of cholesteric gallstones, reduces bile saturation cholesterol that promotes its mobilization from gallstones. Has the immunomodelling activity, influences immunological reactions in a liver.

Indications
- an uncomplicated cholelithiasis (dissolution of cholesteric gallstones in a gall bladder at impossibility of their removal surgical or endoscopic methods)
- primary biliary cirrhosis
- primary sclerosing cholangitis
- acute and chronic hepatitis of various etiology (virus, alcoholic, medicinal, toxic, etc.)
- an atresia of intra hepatic ways
- a cholestasia at parenteral nutrition
- a reflux esophagitis
- a reflux gastritis
- dyskinesia of biliary tract
- a fat hepatosis
- liver pathology against the background of a mucoviscidosis
- a congenital atresia of a bile duct
- a biliary dispepsichesky syndrome (in a cholecystopathy and dyskinesia of biliary tract)
- prevention of damages of a liver when using hormonal contraceptives and tsitostatik
- prevention of formation of bilious concrements at patients with obesity during fast loss of body weight.

The route of administration and doses
For treatment of acute and chronic diseases of a liver, dissolution of gallstones accept 10 mg/kg/days in a dose. The daily dose of drug should be accepted before going to bed, without chewing, with a small amount of liquid.
At treatment of chronic diseases of a liver duration of treatment is from several months to 2 years. Duration of process of dissolution of gallstones at use of drug is from 6 months to 2 years. If in 6 months from the beginning of use the reduction of gallstones is not observed, then it is inexpedient to continue treatment.
For treatment biliary the reflux gastritis and a reflux esophagitis are appointed on 250 mg before going to bed within 10-14 days.

Side effects
- a dorsodynia
- pain in epigastric area
- diarrhea, constipations, vomiting
- increase in activity of transaminases
- an alopecia
- exacerbation of earlier being available psoriasis
- allergic reactions
- is very rare – calcination of gallstones
of the Contraindication
- hypersensitivity to drug components
- rentgenpolozhitelny gallstones
- a nonfunctioning gall bladder
- zhelche-gastrointestinal fistula
- inflammatory diseases of a small and large intestine
- acute cholecystitis
- an acute cholangitis
- cirrhosis in a decompensation stage
- a liver and/or renal failure
- pancreatitis
- an obturation of biliary tract
- acute infectious diseases of a gall bladder and bile ducts
- an empyema of a gall bladder
- pregnancy and the period of a lactation

Medicinal interactions
Colestyraminum and antacids containing aluminum connect ursodezoksikholevy acid in intestines, thereby reducing its absorption. Hypolipidemic drugs, especially Clofibratum, estrogen, Neomycinum or progestins increase bile saturation by cholesterol and can reduce ability to dissolve cholesteric bilious concrements.
Increases effect of oral hypoglycemic drugs.

Special instructions
it is necessary For successful dissolution of gallstones that stones were purely cholesteric, no more than 15-20 mm in size, the gall bladder is filled with stones no more than on a half and biliary tract completely kept the function. For control of efficiency of treatment it is recommended to conduct each 6 months ultrasonic and X-ray research of biliary tract. If in 6 months after the beginning of use of drug the reduction of gallstones is not observed, it is inexpedient to continue treatment.
To women of childbearing age, during treatment it is recommended to apply non-hormonal contraceptives or oral hormonal contraceptives with the low content of estrogen.
At long (more than 1 month) administration of drug it is necessary to carry out periodically biochemical analysis of blood for determination of activity of hepatic transaminases, alkaline phosphatase, gamma glutamiltranspeptidazy, bilirubin, especially to the first 3 months of treatment. At disturbances of a biochemical picture of blood it is recommended to reduce a drug dose. If indicators are not normalized for 1 month, administration of drug needs to be stopped.
Use in pediatrics
This dosage form is not appointed to children up to 6 years.
Influence on ability to drive the car and to work with mechanisms
does not influence.

The overdose
Is not present the probability of emergence of heavy side effects at overdose, but observation of function of a liver is recommended. In case of need it is possible to enter ion-exchange resin for binding of biliary acids in intestines.

A form of release and packing
On 15 capsules in the blister, on 2 blisters together with the instruction for use in a cardboard box.

To Store storage conditions at a temperature from +15 to + 250C, in the dry, protected from light place.
To store out of children's reach!
A period of storage
4 years
do not use drug after the expiry date specified on packing.
Prescription status
According to the prescription



of Proizvoditel Rompharm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38



































APPROVED
by the Order of the Chairman of the Committee
of pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan
from ___ ______________ 200_g.
No. _________


IInstruktsiya on medical use




of Ursorom Torgovoye medicine a name
by Ursor

the International unlicensed
name Ursodezoksikholevaya acid
the Dosage form
of the Capsule, 250 mg

Structure
One capsule contains
active agent - ursodezoksikholevy acid of 250 mg,
excipients: starch corn, K30 povidone, silicon dioxide colloidal anhydrous, magnesium stearate vegetable, gelatin, titan dioxide (E171), blue patent V (E131).

Description
gelatinous solid capsules, blue color, number 0. Contents of capsules – granules of white or almost white color.

Pharmacotherapeutic group
Digestive tract and metabolism. Drugs for treatment of diseases of a liver and biliary tract. The drugs containing biliary acids.
The code of automatic telephone exchange A05AA02

the Pharmacological

Pharmacokinetics At properties intake is well soaked up in a small intestine due to passive diffusion, and in an ileal gut – by means of active transport. The maximum concentration in blood plasma is reached in 1-3 h. The maximum concentration in bile is noted at a daily dose 10-14 mg/kg of weight. At further increase in a dose the concentration of ursodezoksikholevy acid in bile does not increase. Gets through a placental barrier. About 50-70% of a dose are removed with bile.
Pharmacodynamics
Hepatoprotective means. Renders the bile-expelling, cholelitholytic, hypolipidemic, gipokholesterinemichesky and immunomodelling action. Reduces bile saturation by cholesterol by reduction of synthesis and secretion of cholesterol in a liver and inhibition of its absorption in intestines. Increases solubility of cholesterol in a bile-excreting system, stimulates education and biliation. Reduces a bile lipogennost, increases in it concentration of bile acids, causes strengthening of gastric and pancreatic secretion, enhances activity of a lipase, has hypoglycemic effect. Causes partial or full dissolution of cholesteric gallstones, reduces bile saturation cholesterol that promotes its mobilization from gallstones. Has the immunomodelling activity, influences immunological reactions in a liver.

Indications
- an uncomplicated cholelithiasis (dissolution of cholesteric gallstones in a gall bladder at impossibility of their removal surgical or endoscopic methods)
- primary biliary cirrhosis
- primary sclerosing cholangitis
- acute and chronic hepatitis of various etiology (virus, alcoholic, medicinal, toxic, etc.)
- an atresia of intra hepatic ways
- a cholestasia at parenteral nutrition
- a reflux esophagitis
- a reflux gastritis
- dyskinesia of biliary tract
- a fat hepatosis
- liver pathology against the background of a mucoviscidosis
- a congenital atresia of a bile duct
- a biliary dispepsichesky syndrome (in a cholecystopathy and dyskinesia of biliary tract)
- prevention of damages of a liver when using hormonal contraceptives and tsitostatik
- prevention of formation of bilious concrements at patients with obesity during fast loss of body weight.

The route of administration and doses
For treatment of acute and chronic diseases of a liver, dissolution of gallstones accept 10 mg/kg/days in a dose. The daily dose of drug should be accepted before going to bed, without chewing, with a small amount of liquid.
At treatment of chronic diseases of a liver duration of treatment is from several months to 2 years. Duration of process of dissolution of gallstones at use of drug is from 6 months to 2 years. If in 6 months from the beginning of use the reduction of gallstones is not observed, then it is inexpedient to continue treatment.
For treatment biliary the reflux gastritis and a reflux esophagitis are appointed on 250 mg before going to bed within 10-14 days.

Side effects
- a dorsodynia
- pain in epigastric area
- diarrhea, constipations, vomiting
- increase in activity of transaminases
- an alopecia
- exacerbation of earlier being available psoriasis
- allergic reactions
- is very rare – calcination of gallstones
of the Contraindication
- hypersensitivity to drug components
- rentgenpolozhitelny gallstones
- a nonfunctioning gall bladder
- zhelche-gastrointestinal fistula
- inflammatory diseases of a small and large intestine
- acute cholecystitis
- an acute cholangitis
- cirrhosis in a decompensation stage
- a liver and/or renal failure
- pancreatitis
- an obturation of biliary tract
- acute infectious diseases of a gall bladder and bile ducts
- an empyema of a gall bladder
- pregnancy and the period of a lactation

Medicinal interactions
Colestyraminum and antacids containing aluminum connect ursodezoksikholevy acid in intestines, thereby reducing its absorption. Hypolipidemic drugs, especially Clofibratum, estrogen, Neomycinum or progestins increase bile saturation by cholesterol and can reduce ability to dissolve cholesteric bilious concrements.
Increases effect of oral hypoglycemic drugs.

Special instructions
it is necessary For successful dissolution of gallstones that stones were purely cholesteric, no more than 15-20 mm in size, the gall bladder is filled with stones no more than on a half and biliary tract completely kept the function. For control of efficiency of treatment it is recommended to conduct each 6 months ultrasonic and X-ray research of biliary tract. If in 6 months after the beginning of use of drug the reduction of gallstones is not observed, it is inexpedient to continue treatment.
To women of childbearing age, during treatment it is recommended to apply non-hormonal contraceptives or oral hormonal contraceptives with the low content of estrogen.
At long (more than 1 month) administration of drug it is necessary to carry out periodically biochemical analysis of blood for determination of activity of hepatic transaminases, alkaline phosphatase, gamma glutamiltranspeptidazy, bilirubin, especially to the first 3 months of treatment. At disturbances of a biochemical picture of blood it is recommended to reduce a drug dose. If indicators are not normalized for 1 month, administration of drug needs to be stopped.
Use in pediatrics
This dosage form is not appointed to children up to 6 years.
Influence on ability to drive the car and to work with mechanisms
does not influence.

The overdose
Is not present the probability of emergence of heavy side effects at overdose, but observation of function of a liver is recommended. In case of need it is possible to enter ion-exchange resin for binding of biliary acids in intestines.

A form of release and packing
On 15 capsules in the blister, on 2 blisters together with the instruction for use in a cardboard box.

To Store storage conditions at a temperature from +15 to + 250C, in the dry, protected from light place.
To store out of children's reach!
A period of storage
4 years
do not use drug after the expiry date specified on packing.
Prescription status
According to the prescription



of Proizvoditel Rompharm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38


To develop