Ursofalk - official * instructions for use

In this article, you can read the instructions for using the drug Ursofalk. Provides feedback from visitors to the site - consumers of this medicine, as well as the opinions of medical specialists on the use of Ursofalk in their practice. A big request is to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, possibly not announced by the manufacturer in the annotation. Ursofalk analogs in the presence of available structural analogues. Use for the treatment of cirrhosis of the liver and jaundice in adults, children (including infants and newborns), as well as during pregnancy and lactation. The composition of the drug.

Ursofalk - hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it. It causes an increase in gastric and pancreatic secretion, enhances lipase activity. It has a hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which helps mobilize cholesterol from gallstones.

It has an immunomodulatory effect, affects the immunological reactions in the liver: reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, reduces the number of eosinophils.

Composition

Ursodeoxycholic acid + excipients.

Indications

  • dissolution of gallbladder cholesterol stones,
  • biliary reflux gastritis,
  • primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).

Release Forms

Capsules 250 mg (sometimes erroneously called tablets).

Suspension for oral administration (sometimes mistakenly called syrup).

Instructions for use and dosage

Children and adults with body weight less than 34 kg are recommended to use Ursofalk in the form of a suspension.

To dissolve cholesterol gallstones, a dose of 10 mg / kg of body weight is prescribed once a day.

The following dosage regimen is recommended:

  • body weight up to 60 kg - 2 capsules per day,
  • body weight 61-80 kg - 3 capsules per day,
  • body weight 81-100 kg - 4 capsules per day,
  • body weight over 100 kg - 5 capsules per day.

Suspension for oral administration

  • body weight 5-7 kg - the number of measuring spoons 0.25 per day,
  • body weight 8-12 kg - the number of measuring spoons 0.50 per day,
  • body weight 13-18 kg - the number of measured spoons 0.75 per day,
  • body weight 19-25 kg - the number of measuring spoons 1 per day,
  • body weight 26-35 kg - the number of measuring spoons 1.5 per day,
  • body weight 36-50 kg - the number of measuring spoons 2 per day,
  • body weight 51-65 kg - the number of measuring spoons 2.5 per day,
  • body weight 66-80 kg - the number of measuring spoons 3 per day,
  • body weight 81-100 kg - the number of measured spoons 4 per day,
  • body weight over 100 kg - the number of measuring spoons 5 per day.

The drug must be taken daily in the evening, before bedtime (capsules do not chew), washed down with a small amount of liquid.

The duration of treatment is 6-12 months. For the prevention of re-cholelithiasis, the drug is recommended for several months after the dissolution of the stones.

For the treatment of biliary reflux gastritis, 1 capsule (1 mers.spoon) Ursofalk daily in the evening before going to bed with a little water. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

For the symptomatic treatment of primary biliary cirrhosis, the daily dose depends on body weight and ranges from 2 to 6 capsules (measured spoons) (approximately 10-15 mg / kg body weight).

The following dosage regimen is recommended:

  • body weight 34-50 kg - 2 capsules per day,
  • body weight 51-65 kg - 3 capsules per day,
  • body weight 66-85 kg - 4 capsules per day,
  • body weight 86-110 kg - 5 capsules per day,
  • body weight over 110 kg - 6 capsules per day.

Suspension for oral administration

  • body weight 5-7 kg - the number of measuring spoons 0.25 per day,
  • body weight 8-12 kg - the number of measuring spoons 0.5 per day,
  • body weight 13-18 kg - the number of measured spoons 0.75 per day,
  • body weight 19-25 kg - the number of measuring spoons 1 per day,
  • body weight 26-35 kg - the number of measuring spoons 1.5 per day,
  • body weight 36-50 kg - the number of measuring spoons 2 per day,
  • body weight 51-65 kg - the number of measuring spoons 3 per day,
  • body weight 66-80 kg - the number of measured spoons 4 per day,
  • body weight 81-100 kg - the number of measuring spoons 5 per day,
  • body weight over 100 kg - the number of measuring spoons 6 per day.

Side effect

  • diarrhea,
  • nausea,
  • pain in the epigastric region and right hypochondrium,
  • calcification of gallstones,
  • allergic reactions.

Contraindications

  • X-ray positive (high calcium) gallstones,
  • non-functioning gall bladder,
  • acute inflammatory diseases of the gallbladder, bile ducts and intestines,
  • decompensated liver cirrhosis,
  • severe renal dysfunction,
  • severe liver dysfunction,
  • severe pancreatic dysfunction,
  • pregnancy,
  • lactation (breastfeeding),
  • hypersensitivity to the components of the drug.

Pregnancy and lactation

The drug is contraindicated during pregnancy and during lactation (breastfeeding).

Use in children

Perhaps according to the dosage regimen.

special instructions

In cholelithiasis, treatment effectiveness is monitored every 6 months by X-ray and ultrasound examination of the biliary tract in order to prevent relapse of cholelithiasis.

In cholestatic liver diseases, serum transaminases, alkaline phosphatases and gamma-glutamyl transpeptidases should be periodically determined.

In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

During treatment, women of childbearing age should use reliable methods of contraception.

Drug interaction

Colestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is nevertheless necessary, they must be taken at least 2 hours before taking Ursofalk.

Ursodeoxycholic acid can enhance the absorption of cyclosporin from the intestine. Therefore, in patients taking cyclosporine, the doctor should check the concentration of cyclosporin in the blood and adjust the dose of cyclosporine if necessary.

In some cases, Ursofalk may decrease the absorption of ciprofloxacin.

Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase bile saturation with cholesterol and may reduce the ability to dissolve cholesterol bile calculi.

Analogs of the drug Ursofalk

Structural analogues of the active substance:

  • Livodex,
  • Urdox,
  • Urso 100,
  • Ursodez
  • Ursodeoxycholic acid,
  • Ursodex,
  • Ursoliv
  • Ursorom Rompharm
  • Ursor C,
  • Ursosan
  • Holudexan
  • Exhol.

Dosage and administration

250 mg capsules

Body massCapsules
Up to 60 kg2
61-80 kg3
81-100 kg4
Over 100 kg5

Suspension for oral administration

Body massMeasuring spoonsCompliant (ml)
5-7kg¼1,25
8 - 12 kg1/22,50
13-18 kg¾(=¼+½)3,75
19-25 kg15,00
26-35 kg7,50
36 - 50 kg210,00
51 -65 kg12,50
66 - 80 kg315,00
81-100 kg420,00
Over 100 kg525,00

The drug must be taken daily in the evening, before bedtime (capsules do not chew), washed down with a small amount of liquid. The duration of treatment is 6-12 months. For the prevention of re-cholelithiasis, the drug is recommended for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis

1 capsule (1 scoop) Ursofalk daily in the evening before bedtime with a little water. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 2 to 6 capsules (scoops) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).

The following application regimen is recommended:

250 mg capsules

Body massDaily doseIn the morningIn the afternoonIn the evening
34-50 kg21-1
51-65 kg3111
66-85 kg4112
86-110 kg5122
Over 110 kg6222

Suspension for oral administration

Body massDaily doseIn the morningIn the afternoonIn the evening
Dimensional
spoon
Acc.
(ml)
(dimensional
spoon)
(dimensional
spoon)
(dimensional
spoon)
5-7 kg¼1,25--¼
8 - 12 kg½2,50-¼¼
13-18 kg¾3,75¼¼¼
19 - 25 kg15,00½1½
26 - 35 kg7,50½½½
36 - 50 kg210,001-1
51-65 kg315,00111
66 - 80 kg420,00112
81-100 kg525,00122
Over 100 kg630,00222

SIDE EFFECTS
Diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of “liver” transaminases, allergic reactions.

In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

OVERDOSE
No cases of overdose have been identified. In case of an overdose, symptomatic treatment is performed.

INTERACTION WITH OTHER MEDICINES
Colestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is nevertheless necessary, they must be taken at least 2 hours before taking Ursofalk.

Ursodeoxycholic acid can enhance the absorption of cyclosporin from the intestine. Therefore, in patients taking cyclosporine, the doctor should check the concentration of cyclosporin in the blood and adjust the dose of cyclosporine if necessary.

In some cases, Ursofalk may decrease the absorption of ciprofloxacin. Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol bile calculi.

SPECIAL INSTRUCTIONS
In cholelithiasis, treatment effectiveness is monitored every 6 months by X-ray and ultrasound examination of the biliary tract in order to prevent relapse of cholelithiasis. In cholestatic liver diseases, serum transaminases, alkaline phosphatases and gamma-glutamyl transpeptidases should be periodically determined.

ISSUE FORM
Capsules 250 mg, 10 capsules in aluminum / PVC blister, 1 blister together with instructions for use in a cardboard box.
Capsules 250 mg, 25 capsules per aluminum / PVC blister, 2 and 4 blisters together with instructions for use in a cardboard box.
Suspension for oral administration 250 mg / 5 ml, 250 ml per bottle of dark glass with a screw cap with the control of the first opening, 1 bottle together with a measuring spoon and instructions for use in a cardboard pack.

STORAGE CONDITIONS
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

SHELF LIFE
Capsules - 5 years.
Suspension - 4 years. After opening, 4 months.
Do not use after the expiration date indicated on the package.

PHARMACY HOLIDAY CONDITIONS
By prescription.

OWNER OF REGISTRATION CERTIFICATE (RELEASING QUALITY CONTROL)
Dr. Falk Pharma GmbH
Lainenweberstr. 5, 79108 Freiburg, Germany

Claims and proposals should be sent to: 6870, Butyrsky Val, Moscow, 127055, Russia

Analogs what is better and what is the difference

Before proceeding to the consideration of analogues, it is worth clarifying what is better - tablets or capsules Ursofalk. The dosage forms of this drug do not affect the effectiveness of treatment. They are equally good. Tablets or capsules are selected depending on the swallowing capabilities of the patient and his weight category.

Release form

The medicine is in the form of capsules and suspensions.

  • Capsules gelatinous, hard, white, opaque. Inside the capsules is white powder or granules. There are 10 capsules in a blister; blisters fit in cardboard packs.
  • Suspension homogeneous consistency, has a white color, it may contain small bubbles. It has a lemon smell. Contained in 250 ml dark glass bottles, a 5 ml measuring cup is also put in a cardboard box.

Pharmachologic effect

This drug is hepatoprotector, that is, a medicine that helps dissolve bile cholesterol stones, significantly lowering blood cholesterol. It has a wide range of effects, in particular, it acts as a hepatoprotective, cholelitolytic, immunomodulating agent. A hypoglycemic effect is also noted.

Ursodeoxycholic acid - the active substance that is contained in the medicine Ursofalk is also present in certain amounts in bile. But if certain liver functions are impaired, the synthesis of this substance and its content in the composition of bile decreases. Positive effect on immunological reactions in the liver.

The following effects of ursodeoxycholic acid are highlighted:

  • is having choleretic effectby reducing the amount of bile acids in bile and increasing their excretion into the intestinal lumen, also reducing the absorption of toxic bile hydrophobic acids,
  • manifests itself cytoprotective effect, which consists in the ability of this substance to incorporate into the lipid layer of the cell membrane, which leads to stabilization of the cell membrane and enhance its protective properties,
  • celebrated andimmunomodulatory effect and a decrease in the synthesis of pro-inflammatory cytokines,
  • produces hypercholesterolemic effect due to reduced absorption cholesterolin the ileum, reducing the synthesis of cholesterol in the liver, as well as activating the process of its excretion with bile.

Also under the influence of ursodeoxycholic acid lithogenicity decreases bile. As a result, the conversion of cholesterol compounds leads to a decrease in the formation of cholesterol and to the dissolution of cholesterol stones.

Under the influence of the drug Ursofalk, gastric and pancreatic secretions increase.

Pharmacokinetics and pharmacodynamics

After taking the medicine in the form of a suspension or capsules, the process of absorption of ursodeoxycholic acid in the small intestine occurs. In the total blood flow, approximately 60-80% of the dose that has been taken is determined. The metabolism of the active component occurs in the liver. The partially active ingredient breaks down in the intestine, resulting in the formation of toxic 7-keto-lithocholic acid. This substance is slightly absorbed into the general bloodstream, its detoxification occurs in the liver.

Characteristic of this drug is the effect of feather passage through the liver. The elimination half-life is 3-5 days. Excretion occurs with feces mainly in the form of metabolites, and a small part is excreted unchanged.

Indications for use

Those indications for the use of Ursofalk medication, which are indicated in the instructions, are associated with the use in diseases of the liver and gall bladder, in which cholestasis is noted, an increase in blood cholesterol, as well as a decrease in a number of liver functions. The medicine is prescribed for such diseases:

  • cirrhosis of the liver primary biliary,
  • primary sclerosing cholangitis,
  • hepatitis of different origin (acute and chronic), accompanied by cholestasis,
  • reflux esophagitis and biliary reflux gastritis,
  • the presence of cholesterol stones in the gallbladder (provided that the stones are X-ray negative, their diameter is not more than 15 mm, a person has no impairment of the gallbladder),
  • cystic fibrosis,
  • toxic liver damage (including alcohol poisoning),
  • atresia of the intrahepatic bile ducts.

Also, tablets and suspension are prescribed in order to eliminate stagnation of bile in people who are on parenteral nutrition. It is advisable to prescribe them to patients who underwent liver transplant surgery in order to prevent liver damage in the case of treatment with drugs with a cholestatic effect and taking hormonal contraceptives. Ursofalk is also prescribed for the prevention of colon cancer in those people who are at risk.

Contraindications

The instructions indicate such contraindications to the use of tablets and suspensions:

  • X-ray gallstones (i.e. stones with a high calcium content),
  • acute inflammatory diseases of the bile ducts, intestines, gall bladder,
  • decompensated liver cirrhosis,
  • gall bladder non-functioning
  • severe violations in the functions of the liver, pancreas, kidneys,
  • pregnancy and lactation
  • pronounced sensitivity to the components of drugs.

Side effects

During the treatment period, the following side effects may occur:

  • digestive system: diarrhea, the manifestation of acute pain in the upper abdomen on the right during primary therapy biliary cirrhosis,
  • liver and biliary tract: in rare cases - calcification of stones, decompensation cirrhosis those who are undergoing primary treatment biliary cirrhosis,
  • skin, subcutaneous tissue: in rare cases - hives.

If the side effects mentioned above are aggravated or if any other negative symptoms appear during treatment, the patient must inform the specialist about this.

Capsule instructions

The drug for dissolving gallstone cholesterol stones must be used at a dose of 10 mg per 1 kg of patient weight 1 time per day.

With a patient weighing up to 60 kg, 2 capsules per day are indicated, with a weight of 61 to 80 kg - 3 caps., With a weight of 81 to 100 kg - 4 caps., With a weight of more than 100 kg - 5 caps. You need to take pills in the evening, before going to bed. Chewing capsules is not recommended.

The duration of taking the drug is from 6 to 12 months. To provide quality prevention repeated cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.

In the treatmentbiliary reflux gastritis 1 capsule of Ursofalk should be used every day in the evening for 10 days to 6 months, sometimes up to 2 years.

In case of symptomatic therapy primary biliary cirrhosis The dose of the drug depends on the weight of the person. It can be from 2 to 7 tablets. The first three months of therapy during the day, the capsules need to be taken several times, then, when the liver indicators improve, it is enough to drink 1 capsule. Ursofalk in the evening. Treatment for primary biliary cirrhosis can continue for an unlimited period of time. It should be noted that in people with such a disease in rare cases, worsening of symptoms at the beginning of taking the drug may be noted. In this situation, you need to reduce the dose to 1 capsule per day, and after improvement, you need to gradually increase the dosage.

With symptomatic treatment chronic hepatitis of different originthe dose of the drug per day is 10-15 mg per 1 kg of weight, you need to take it in 2-3 doses. Reception lasts from 6 to 12 months.

In patients with primary sclerosing cholangitis, cystic fibrosisthe dose is 12-15 mg of the drug per 1 kg of weight. If necessary, the dosage is increased to 20-30 mg per 1 kg of weight.Treatment lasts from 6 months to several years.

In people with non-alcoholic steatohepatitisas well as alcoholic liver diseaseapply a dose of 10-15 mg per 1 kg of weight. The treatment lasts 6-12 months and longer.

Sick with biliary dyskinesiaprescribe 10 mg per day per 1 kg of weight per day, you need to take the medicine from 2 weeks. up to 2 months Treatment can be repeated if necessary.

Ursofalk suspension, instructions for use

For newborns, children and adults, whose weight does not exceed 47 kg, the drug is prescribed in the form of a suspension. To dissolve cholesterol stones, you need to take a suspension at a dose of 10 mg per 1 kg of weight once a day. Children weighing 5-7 kg receive 0.25 measured spoons, 8-12 kg - half a measured spoon, 13-18 kg - 0.75 tablespoons, 19-25 kg - 1 spoon, 26-35 kg - 1.5 tablespoons, 36-50 kg - 2 tablespoons, 51-65 kg - 2.5 tablespoons, 66-80 kg - 3 tablespoons, 81-100 kg - 4 tablespoons, more than 100 kg - 4 tablespoons.

In the treatment of other diseases, it should be borne in mind that the content of 1 scoop corresponds to the content of the active substance in one capsule. How to take - before meals or after - does not matter.

Interaction

The absorption of ursodeoxycholic acid in the intestine and, accordingly, the effectiveness of the drug is reduced while taking colestipol, colestyramine, as well as antacids, which contain aluminum hydroxide or aluminum oxide. If you need to use these drugs, you need to drink them at least two hours before taking Ursofalk.

Under the influence of ursodeoxycholic acid, absorption is enhanced cyclosporinfrom the intestines. That is, if you need to take cyclosporine, you need to control the concentration of cyclosporin in the blood and adjust the dose of the drug.

There is a possibility that absorption may decrease when taking Ursofalk Ciprofloxacin.

It should be borne in mind that when taking lipid-lowering drugs (especially clofibrate), neomycin, estrogens, progestins, the saturation of bile with cholesterol increases, so the ability of the active substance to dissolve cholesterol gallstones may decrease.

Ursosan

Ursosan, which is a structural analogue of Ursofalk, is produced in the Czech Republic. The German drug is the original, so many in the dilemma, which is better - Ursosan or Ursofalk, tend to the latter. Although, in fact, it is difficult to say which is more effective - Ursofalk or Ursosan. Both drugs have the same active active ingredient.

Ursosan is a high-quality Czech generic, but it is believed that the original drugs are more reliable, because they have undergone numerous stages of research, which can not always be said about copy medicines. For those who still want to figure out what is the difference between Ursofalk and Ursosan, only some distinctive auxiliary components in the composition of these drugs and the price category can be noted.

Description of the dosage form

Solid, opaque gelatin No. 0, a cover and the case of white color. The contents of the capsule are white powder or granules.

Suspension for oral administration

Homogeneous, white in color, containing small air bubbles, with the aroma of a lemon.

Film-coated tablets

Biconvex, oblong in shape, covered with a film membrane of white color, with a risk on both sides.

Ursodez

Ursofalk's analogs also include Ursodez. This is a Russian copy of a German drug. Any patient wants to save, but if he is interested in what is better - Ursodez or Ursofalk, then the latter is preferable. Although, at first glance, they are equally effective, the Russian hepatoprotector often causes adverse reactions.

Description and composition

Ursofalk is a drug based on ursodeoxycholic acid. According to the instructions, this substance has a pronounced choleretic and hypoglycemic effect, destroys cholesterol stones, improves the liver and gall bladder.Taking the drug protects cell membranes from toxic effects, prevents the growth of connective tissue in case of damage to hepatocytes.

Urodesoxycholic acid as part of the drug interacts with lipophilic structures of liver cells, which has a cytoprotective (protective) effect. It reduces the amount of cholesterol in the bile ducts due to its reverse absorption by the intestines.

Due to this property, the amount of bile acids in bile increases, which causes the dissolution of stones, the exclusion of new foci. Taking the drug enhances the secretion of the stomach and pancreas, has a moderate immunological effect. It has a pronounced anti-inflammatory, antioxidant effect.

According to clinical trials, Ursofalk is one of the few drugs that can slow the development of primary biliary cirrhosis (PBC). It was found that 80% of patients significantly improved their well-being, symptomatology decreased. In addition, the drug is effective in the treatment of patients with alcoholic liver damage. Some unofficial sources claim that including Ursofalk in colon cancer therapy can slow the growth of malignant cells.

Pharmacodynamics

Hepatoprotective agent, has a choleretic effect. It reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. It reduces the lithogenicity of bile, increases the content of bile acids in it, causes an increase in gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. Causes partial or complete dissolution of Xc stones during enteral use, reduces the saturation of bile Xc, which contributes to the mobilization of Xc from gallstones. It has an immunomodulatory effect, affects the immunological reactions in the liver: reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of IL-2, reduces the number of eosinophils.

Cystic fibrosis (cystic fibrosis). According to clinical reports, there is many years of experience (up to 10 years or more) in the treatment of UDCA in pediatric patients suffering from hepatobiliary disease associated with cystic fibrosis (CFAHD) There is evidence that UDCA therapy can reduce the proliferation of bile ducts, slow down the development of lesions detected by histological examination, and even contribute to the reverse development of changes in the hepatobiliary system if therapy begins in the early stages CFAHD. In order to optimize the effectiveness of treatment, UDCA therapy should be started as soon as possible after diagnosis CFAHD.

Urdox

Ursofalk is another structural analogue of Ursofalk. It is also a product of Russian pharmacology. Doubting that it is better - Urdoksa or Ursofalk, the patient should remember that the latter is the original German drug, the first - only the domestic generic. But giving preference to the Russian hepatoprotector, the patient will be able to significantly save the family budget.

Heptral

The Italian drug Heptral has a similar pharmacological effect on the body, but contains another active substance. Its active ingredient is ademethionine. Formal comparisons of which is better - Heptral or Ursofalk, were carried out only regarding intrahepatic cholestasis in pregnant women. Ursodeoxycholic acid made it easier to deal with the symptoms of itching.

Ursosan is used in pediatrics, and Heptral is only 18 years old.

Description and release forms

Currently, the drug Ursofalk is available in three dosage forms - capsules, tablets and suspension. All three dosage forms of the drug (tablets, capsules and suspension) are for oral administration.

Ursofalk Capsules consist of solid opaque gelatin caps and white painted bodies.The capsule contains white powder or granules. Capsules are packed in blisters (konvalyutki) of 10 pieces, and blisters, in turn, are packed in a cardboard box along with a leaflet with instructions for use. Currently, Ursofalk capsules in Russia are sold in packs of 10, 50 and 100 pieces.

Ursofalk tablets covered with a white film sheath, have an oblong biconvex shape and are at risk on both sides. Tablets are packed in blisters (konvalyutki) of 25 pieces, which, in turn, are placed in cardboard boxes with a leaflet with instructions for use. Tablets are sold in packs of 25, 50 and 100 pieces.

Ursofalk Suspension It is a homogeneous white liquid containing small air bubbles and having a distinct lemon aroma. The suspension is available in 250 ml dark glass bottles. Bottles are packed in cardboard bundles complete with a measuring cup and a leaflet with instructions for use.

The shelf life of Ursofalk tablets and suspension is 4 years, and capsules - 5 years from the date of manufacture indicated on the package. It is necessary to store the medicine in any form in a dry, dark place at an air temperature of no higher than 25 o C. Violation of storage conditions entails a decrease in the therapeutic effectiveness of the drug.

After opening, the suspension can be stored in the refrigerator for 4 months after opening. If after this period the suspension has not been used, then it should be discarded and not used.

Composition and dosage

All dosage forms of the drug Ursofalk as an active, active substance contain ursodeoxycholic acid. In the accompanying instructions, this active substance is usually indicated under the abbreviation INN (international non-proprietary name). Ursofalk capsules contain the active substance in a dosage of 250 mg, and tablets - 500 mg. The suspension contains ursodeoxycholic acid at a concentration of 250 mg / 5 ml (2.5%).

The auxiliary components of capsules, tablets and suspensions of Ursofalk are different, so we give them below in the table.

Auxiliary components of Ursofalk tabletsAuxiliary components of Ursofalk capsulesAuxiliary components of the suspension Ursofalk
Povidone K-25Corn starchBenzoic acid
Crospovidone Type AMagnesium stearateXylitol
TalcTitanium dioxideGlycerol
Microcrystalline celluloseSilicon Colloidal DioxideMicrocrystalline cellulose
Magnesium stearateGelatinPropylene glycol
Polysorbate 80Sodium Lauryl SulfateSodium Citrate
Silicon Colloidal DioxidePurified waterSodium Cyclamate
HypromelloseLemon acid
Macrogol 6000Lemon Flavor
Purified water

Special instructions

Take Ursofalk under the supervision of a specialist.

In the first 3 months of admission, it is very important to monitor liver function indices, first every 4 weeks, then once every three months. It is important to identify impaired liver function in the earliest stages. It is also important to determine as soon as possible whether there is a reaction to treatment in people with primary biliary cirrhosis.

To determine whether there has been some progress in the treatment of calcification of stones, oral cholecystography should be performed with examination in a standing position, as well as in a supine position 6-10 months after the start of therapy.

Ursofalk should not be prescribed if it is not possible to visualize the gallbladder during the x-ray, if calcification of stones, bouts of colic are noted.

In very rare cases, cases of decompensation of cirrhosis of the liver have been recorded.

People suffering diarrhea, you need to reduce the dose of drugs. Patients with persistent diarrhea need to suspend therapy.

Hofitol

The French drug Hofitol can not be called a direct analogue of Ursofalk. These two drugs affect the body in different ways. Hofitol is an artichoke-based herbal preparation. It is often used to prevent gallbladder disease.Compare with each other and say that it is better - Ursofalk or Hofitol, is inappropriate, since the drugs have differences in indications and contraindications.

Indications of the drug Ursofalk

dissolution of cholesterol gallstones in the gallbladder,

primary biliary cirrhosis of the liver in the absence of signs of decompensation (symptomatic treatment),

chronic hepatitis of various origins,

primary sclerosing cholangitis,

cystic fibrosis (cystic fibrosis) - as part of complex therapy,

alcoholic liver disease,

biliary dyskinesia.

Ursofalk - instructions for use

Ursofalk and its substitute Ursosan are dispensed strictly by prescription and are prescribed by a specialist, and the dosage is calculated. With a small daily dosage, capsules can be used. However, if you need to drink 8 or more capsules per day, it is advisable to replace with tablets and recount the amount of medicine.

Ursofalk tablets are better than capsules if you need to take a large dosage. They contain 500 mg of the active substance, capsules are half as much - 250 mg. If necessary, the tablet can be broken at risk.

The disadvantage of the drug is its high cost. The price of 100 tablets can reach 4,500 rubles, the cost of capsules is the same.

Ursofalk 100 and 250

In practice, usually a number is added to the name of the drug, which means the dosage of the active substance in a tablet, capsule, ampoule, etc. This allows doctors, pharmacists and patients to quickly navigate what kind of medicine is needed and in what dosage. Accordingly, the designation "Ursofalk 250" means that capsules with a dosage of 250 mg of ursodeoxycholic acid are meant. But the designation "Ursofalk 100", contrary to the described, usual and standard scheme, does not mean a dosage of 100 mg, since there is simply no such dose, but the number of tablets or capsules in the package.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Data on the use of UDCA in pregnant women is limited or not available. Animal studies have shown reproductive toxicity in early pregnancy. During pregnancy, Ursofalk should not be used, unless it is clearly necessary.

According to animal studies, UDCA has no effect on fertility. There are no data on the effect of UDCA treatment on human fertility.

The use of the drug in women with childbearing potential is possible only if they use reliable methods of contraception. Non-hormonal contraceptives or low estrogen oral contraceptives are recommended. However, patients taking Ursofalk to dissolve gallstones should use effective non-hormonal contraceptives, as hormonal oral contraceptives can increase the formation of gallstones. The presence of pregnancy should be ruled out before starting treatment.

According to several documented cases, the level of UDCA in breast milk in women is very low, and therefore the occurrence of adverse reactions in children with breastfeeding is not expected.

Therapeutic effects and effects

Ursofalk has hepatoprotective, choleretic, anticholestatic, cholelitholytic, antilithogenic, hypocholesterolemic, antifibrotic and immunomodulatory effects.

Hepatoprotective effect The drug consists in the fact that under its action the liver cells become more resistant to negative influences, they are destroyed in a smaller amount, which minimizes the activity of the pathological process in the organ. Due to this, the progression of chronic liver diseases is slower, the body has time to recover, thereby reducing the risk of complications and the development of cirrhosis or cancer.Also, thanks to Ursofalk, exacerbations of chronic liver diseases are prevented, as a result of which a person does not suffer from the periodic appearance of clinical symptoms of hepatic pathologies. Such a hepatoprotective effect of Ursofalk is ensured by the fact that its component ursodeoxycholic acid binds the excess of bile acids in the liver and, thus, does not allow them to destroy liver cells due to their chemical aggressiveness and toxicity. In addition, Ursofalk increases the strength of the membranes of the liver cells, so that they are resistant to damage by free radicals and other toxic substances.

Cholagogue and anticholestatic (eliminating stagnation of bile) action Ursofalk is to increase the fluidity of bile, due to which it does not stagnate, but flows freely from the hepatic ducts and gall bladder without causing damage to these organs due to cholestasis. The choleretic effect of Ursofalk is ensured by the fact that the drug blocks the absorption of fatty acids in the intestine, from where they enter the liver, as a result of which the liver cells must synthesize them again, and this is what stimulates active bile secretion. Also, the increased formation and excretion of bile leads to the elimination of its stagnation in the hepatic ducts.

In addition, Ursofalk reduces cholesterol synthesis by liver cells (hypocholesterolemic effect) and its absorption in the intestine, and also increases the solubility of cholesterol in the gallbladder and ducts, which improves the flow of bile and eliminates its stagnation. By increasing the concentration of fatty acids and lowering cholesterol in bile, Ursofalk promotes the dissolution of gallstones (cholelitolytic effect) In addition, by providing better fluidity and lower viscosity of bile, Ursofalk prevents the formation of new gallstones (antilithogenic effect).

Ursofalk also enhances the production of enzymes by the pancreas, hydrochloric acid and enzymes by the stomach, which allows the drug to eliminate digestive disorders and reduce blood sugar.

Antifibrotic the action of Ursofalk is that the drug reduces the rate of degeneration of liver cells into connective tissue and the formation of cirrhosis beams.

Separately, it should be said that Ursofalk has immunomodulatory effect, which is ensured by the fact that ursodeoxycholic acid normalizes the number of immune cells and their production of biologically active substances.

With cystic fibrosis, Ursofalk reduces the rate of cirrhosis and even contributes to the reverse process - the gradual resorption of connective tissue and its replacement by liver cells. However, the reverse process is possible only with the use of Ursofalk in the initial stages of cystic fibrosis. That is why it is currently recommended that, when diagnosing cystic fibrosis, the use of ursodeoxycholic acid preparations be started as early as possible.

Side effects

The assessment of adverse events is based on the following classification: very often (≥1 / 10), often (≥1 / 100– GIT: often - unformed stools or diarrhea, in the treatment of primary biliary cirrhosis very rarely - acute pain in the upper right abdomen.

On the part of the liver and biliary tract: very rarely - calcification of gallstones. In the treatment of severe stages of primary biliary cirrhosis, it is very rare - decompensation of cirrhosis, which disappears after discontinuation of the drug.

On the part of the skin and subcutaneous tissue: very rarely - urticaria.

If any of the side effects specified in this description is aggravated or the patient has noticed other side effects not listed in the description, you should inform your doctor.

Ursofalk's analogs

Replacing the drug with Ursosan and other medicines is advisable in the following cases:

  • high cost
  • individual intolerance of the active substance and auxiliary components,
  • absence or defect in pharmacy organizations,
  • dissatisfaction with the quality or the effect,
  • difficulty swallowing a large number of capsules or tablets,
  • the occurrence of side effects,
  • the presence of contraindications and restrictions.

The replacement of the drug with any factor, especially for young children and newborns, should be agreed with the doctor. Analogs are presented by the active substance (for example, Ursosan, Urdox) or group.

Only a doctor can replace a child's Ursofalk suspension with another analogue. Analogs for the active substance in liquid form are not made.

Listanalogues showing the form of release, country of manufacture and approximate cost in Moscow

AnalogueRelease formPrice, in rublesThe country of manufacture
Ursofalk250 mg capsules190-2300Germany
500 mg tablets1800-2300
suspension1100-1350
Ursosancapsules170-1750Czech Republic
tablets1500-3300
Heptralinjections1600-1900France, Italy, Germany
tablets1600-2300
Ursodezcapsules600-1300Russia
Urdoxpills capsules1300-1550
Hofitolsolution tablets400-1000France
Essentialecapsules500-1700Germany
Greenterolcapsules600-1500Latvia
Phosphoglivcapsules450-1100Russia
Odestontablets300-950Poland
Allocholtablets15-90Russia

Other generics of Ursofalk and Ursosan:

  • Livodex (tablets 150 and 300 mg, India),
  • Exhol (capsules 250 mg, tablets 500 mg, Russia),
  • Urbichol (capsules 250 mg, RF),
  • Choludexan (300 mg capsules, Egypt), etc.

Instructions for use (tablets, capsules)

Tablets and capsules are intended for use by adults and children older than 3 years. However, it is advisable for children, as well as adults with body weight less than 47 kg or having difficulty swallowing, to take Ursofalk in the form of a suspension.

Tablets and capsules should be swallowed whole without biting, chewing or crushing in any other way, but with a small amount of water (half a glass is enough).

The entire daily dose of Ursofalk tablets and capsules is taken once a day, in the evening, before going to bed. The dosage and duration of treatment with Ursofalk are determined individually, depending on the nature of the disease and the effectiveness of the therapy.

To dissolve gallstones, Ursofalk in tablets and capsules is recommended to be taken in a dosage calculated at a ratio of 10 mg / kg. For example, a person’s body weight is 70 kg - which means that he needs to take 10 mg * 70 = 700 mg per day. And 700 mg is either 1.5 tablets of 500 mg, or 3 capsules of 250 mg. In order not to calculate the necessary dose of tablets and capsules for dissolving gallstones each time, in the table below we present ready-made dosages of Ursofalk depending on the weight of the person.

Human body massDosage in the number of tablets UrsofalkDosage in the number of capsules Ursofalk
Less than 60 kg1 tablet2 capsules
61 - 80 kg1.5 tablets3 capsules
81 - 100 kg2 tablets4 capsules
More than 100 kg2.5 tablets5 capsules

The number of tablets or capsules determined depending on body weight is taken at a time, in the evening, before going to bed. Tablets and capsules are washed down with a small amount of water, and swallowed, without biting or chewing.

The duration of the course of therapy is from 6 to 24 months, depending on how fast the stones dissolve in the gallbladder or common bile duct. During treatment, an ultrasound scan or X-ray should be taken every 6 months to assess how much the size of the stones has decreased and whether their calcification has occurred. If the stones have calcified, or if after 12 months of treatment they have not decreased in size, then Ursofalk is discontinued due to inefficiency. If the stones have successfully dissolved under the action of Ursofalk, then to prevent their re-formation, it is advisable to continue taking the drug for another 2 to 4 months after the stones are completely dissolved.

For the treatment of biliary reflux gastritis or reflux esophagitis, Ursofalk is recommended to take 1/2 tablet or 1 capsule every day in the evening, before going to bed. The capsule and half-tablet are swallowed with a little water.The duration of therapy depends on the rate of normalization and the disappearance of symptoms, and ranges from 10 days to 6 months. In severe cases, treatment is continued for up to two years without interruption.

For the treatment of biliary cirrhosis, Ursofalk is taken for an unlimited period of time - while this is necessary and while the drug is effective. The dosage is calculated individually, depending on body weight, and it can be 3 to 7 capsules or 1.5 to 3.5 tablets per day. In the table below we give the recommended dosages for the treatment of biliary cirrhosis of the liver for capsules and tablets of Ursofalk, depending on the person’s body weight.

Patient body weightDosage in the number of capsules and tablets Ursofalk
Dosage in the first three monthsDosage three months after the start of treatment
MorningDayEveningEvening
47 - 62 kg0.5 tablets or 1 capsule0.5 tablets or 1 capsule0.5 tablets or 1 capsule1.5 tablets or 3 capsules
63 - 78 kg0.5 tablets or 1 capsule0.5 tablets or 1 capsule1 tablet or 2 capsules2 tablets or 4 capsules
79 - 93 kg0.5 tablets or 1 capsule1 tablet or 2 capsules1 tablet or 2 capsules2.5 tablets or 5 capsules
94 - 109 kg1 tablet or 2 capsules1 tablet or 2 capsules1 tablet or 2 capsules3 tablets or 6 capsules
More than 110 kg1 tablet or 2 capsules1 tablet or 2 capsules1.5 tablets or 3 capsules3.5 tablets or 7 capsules

As can be seen from the table, in the first three months of treatment, the daily dosage of Ursofalk should be divided into three doses, and drink tablets or capsules three times a day - in the morning, at lunch, and in the evening. Take the drug optimally with meals or immediately after. In this case, you need to swallow capsules and tablets with a small amount of water and without chewing in your mouth. At the beginning of treatment, clinical symptoms may worsen, for example, itching may intensify. In this case, Ursofalk is taken only once a day - in the evening (before bedtime) in a dosage that is given in the evening for the first three months of treatment. For example, a patient weighing 47 - 62 kg began taking Ursofalk 0.5 tablets three times a day, and itching intensified. In this case, you need to switch to taking 0.5 tablets only once a day (in the evening), and continue in this mode for a week. Then, every week, increase the dosage by 0.5 tablets (1 capsule), gradually bringing it to the recommended one.

After three months, when blood tests and well-being improve, they switch to taking the entire dose of Ursofalk once a day - in the evening before bedtime. Further, the drug is taken for as long as necessary (months, years).

For the treatment of chronic hepatitis of any origin, non-alcoholic steatohepatitis, congenital atresia of the bile duct and alcoholic liver disease, the dosage of Ursofalk is calculated according to body weight, based on a ratio of 10-15 mg per kg of weight. For example, a person has a body weight of 80 kg, which means that the dosage of Ursofalk for him is 10 * 80 = 800 mg or 15 * 80 = 1200 mg. That is, a patient with a body weight of 80 kg for the treatment of chronic hepatitis or alcoholic liver disease should take Ursofalk in a dosage of 800 - 1200 mg. This calculated dosage is daily, and for hepatitis, the drug is recommended to be taken 2-3 times a day. So, then the calculated daily dosage should be divided into 2 or 3. We will divide by 2 and get - 400 - 600 mg. Thus, a person with a body weight of 80 kg and chronic hepatitis or alcoholic liver disease should take Ursofalk 400 to 600 mg 2 times a day.

Finally, we recount how many tablets or capsules the calculated dosage corresponds to. For this, the calculated dosage is divided by the content of the active substance in the tablet or capsule. So, a tablet contains 500 mg of the active substance, which means that to find out how many tablets a patient weighing 80 kg should drink, you need to divide 400 into 500 and 600 divide by 500, we get 0.8 and 1.2, respectively.It is impossible to divide the tablets in such a way as to obtain 0.8 and 1.2, so we round these values ​​to the possible. And it is possible to divide the tablets into 4 parts, each of which is 0.25 tablets. So, 0.8 is rounded to 0.75, and 1.2 to 1.25. As a result, we get that a patient with a body weight of 80 kg should take Ursofalk 3/4 (0.75) - 1 + 1/4 (1.25) tablets twice a day for chronic hepatitis. You can choose the average from the calculated dose range and take 1 tablet twice a day.

The calculation of dosages for capsules is exactly the same, only to calculate the number of capsules will need to be divided by 250, since exactly so many mg of ursodeoxycholic acid are contained in one capsule. Also, capsules need to be rounded to the nearest integer in the direction of a larger number, since they cannot be divided. Consider the calculation of capsules in our example. So, we calculated that a patient with a body weight of 80 kg should take 400 - 600 mg of Ursofalk twice a day. Divide 400 by 250 and 600 by 250, we get 1.6 and 2.4, respectively. This means that the patient should take 1.6 - 2.4 capsules twice a day. Next, we take some integer average value from the range calculated by us - in the example it will be 2. That is, you need to take 2 capsules of Ursofalk twice a day.

Capsules and tablets are swallowed without chewing or biting into the mouth, but with a little water. The duration of treatment for chronic hepatitis of any origin, alcoholic liver disease and non-alcoholic steatohepatitis is 6 to 12 months. The duration of therapy for congenital atresia of the bile duct is determined by how quickly the operation will be performed.

For the treatment of primary sclerosing cholangitis, Ursofalk is taken in dosages calculated individually by body weight, based on a ratio of 12-15 mg per kg of body weight. The calculated daily dosage is divided into 2 to 3 doses, and capsules or tablets are taken 2 to 3 times a day. In cases of inefficiency, the dosage is increased to 20-30 mg per kg of body weight. The increased daily dosage is also divided into 2 to 3 doses and is drunk 2 to 3 times a day. A detailed example of the calculation of dosages is given in the description of the rules for taking Ursofalk in chronic hepatitis.

The duration of treatment for primary sclerosing cholangitis with Ursofalk is from six months to several years.

For the treatment of biliary dyskinesia, digestive disorders due to gall bladder diseases, as well as for the prevention of liver damage when taking toxic drugs (oral contraceptives, cytostatics, antibiotics, etc.) Ursofalk is taken in an individual dosage calculated at a ratio of 10 mg per 1 kg of body weight body. The calculated daily dosage is divided into two doses and the drug is drunk 2 times a day. Detailed examples of calculating the daily dose, dividing it into two doses and calculating the number of tablets or capsules that you need to drink are given above in the description of Ursofalk treatment of chronic hepatitis, alcoholic liver disease.

It must be remembered that Ursofalk is taken with food or immediately after, swallowing capsules and tablets, not chewing and not biting, but washed down with a small amount of water. The duration of therapy for biliary dyskinesia and digestive disorders due to diseases of the gallbladder is from two weeks to two months. If necessary, the courses of therapy are repeated, keeping the intervals between them at least two weeks.

Ursofalk should be taken to prevent liver damage due to the use of toxic medications until the course of treatment with dangerous drugs ends.

With cystic fibrosis, Ursofalk is used only in tablets or suspensions. Moreover, tablets are used only if the patient's body weight is 20 kg or more. At lower weights, only suspension is used. The dose of the drug is calculated individually according to body weight based on a ratio of 12-30 mg per 1 kg of weight.The calculated daily dosage is divided into 2 to 3 doses, and tablets are taken 2 to 3 times a day during or immediately after a meal. The tablets are swallowed with water. The duration of treatment with Ursofalk in cystic fibrosis ranges from six months to several years.

For convenience, we present the dosages of Ursofalk in the table below for the treatment of cystic fibrosis for people with different body weights that have already been calculated and recognized by doctors as effective.

Human body massDosage of Ursofalk in mg (daily dose)Dosage of Ursofalk in the number of tablets
In the morningIn the afternoonIn the evening
20 - 29 kg17 - 25 mg0.5 tablets00.5 tablets
30 - 39 kg19 - 25 mg0.5 tablets0.5 tablets0.5 tablets
40 - 49 kg20 - 25 mg0.5 tablets0.5 tablets1 tablet
50 - 59 kg21 - 25 mg0.5 tablets1 tablet1 tablet
60 - 69 kg22 - 25 mg1 tablet1 tablet1 tablet
70 - 79 kg22 - 25 mg1 tablet1 tablet1.5 tablets
80 - 89 kg22 - 25 mg1 tablet1.5 tablets1.5 tablets
90 - 99 kg23 - 25 mg1.5 tablets1.5 tablets1.5 tablets
100 - 109 kg23 - 25 mg1.5 tablets1.5 tablets2 tablets
More than 110 kg23 - 25 mg1.5 tablets2 tablets2 tablets

Overdose

Symptoms diarrhea. As a rule, other symptoms of an overdose are unlikely, because with an increase in dose, UDCA absorption decreases and, accordingly, a larger amount is excreted in the feces.

Treatment: symptomatic, aimed at replenishing the volume of fluid and restoring electrolyte balance. There is no need to apply specific measures in case of an overdose.

Instructions for use Ursofalk in suspension

Ursofalk suspension is intended primarily for use by children, but it is also used to treat adults weighing less than 47 kg or having difficulty swallowing, as a result of which they cannot swallow tablets and capsules. The suspension is taken orally, washed down with a small amount of water, or diluted in water. The drug, depending on the dosage, is taken either once in the evening, or 2 to 3 times a day. Ursofalk is taken once a day in the evening before bedtime. If the drug needs to be taken 2 to 3 times a day, then this is done during or immediately after a meal.

The required amount of suspension is poured into a measuring cup, which is attached to the bottle with the medicine. After each use, rinse the measuring cup with warm water and rinse with soap every few days.

In cases where Ursofalk should be given to young children with a body weight of less than 10 kg, the required amount of suspension is measured with a 0.1 ml syringe, since a measuring cup has risks of only 1.25 ml.

To measure the required dose with a syringe, before opening, shake the vial with the suspension, open it and pour a small amount of liquid into a measuring cup. Next, lowering the tip of the cannula of the syringe into a measuring cup, collect the suspension in a volume slightly larger than necessary. After this, the syringe is lifted by the cannula up and a finger is tapped on its wall in the direction from the piston to the needle to remove air bubbles. Then the syringe is turned by the cannula down and make sure that the right amount of suspension is collected. If the suspension is less than necessary, then get out of a measuring cup. If there are more suspensions than necessary, then the excess is poured back into the measuring cup. Then, directly from the syringe, the drug is poured into the child's mouth.

It should be remembered that each time it is advisable to use a new disposable syringe to set up the suspension. It is not recommended to wash and reuse syringes because of the risk of suspension contamination. It is optimal to take 2 ml syringes. It is also unacceptable for a set of suspension to insert a syringe into the vial, as this will lead several times to severe contamination of the drug and its unsuitability for use.

Dosages and duration of therapy with Ursofalk suspension depend on the disease and human body weight, therefore, are determined individually.

So, to dissolve cholesterol stones, Ursofalk take 10 mg per 1 kg of weight. Moreover, the entire daily dose is taken at a time, in the evening, before bedtime. For convenience and to avoid confusion, the table below shows the dosage of Ursofalk in milliliters of suspension for children and adults with different body weights.

Body weight kgDosage by the number of measured cups of suspensionDosage by volume of suspension, ml
5 - 7 kg1/4 (0.25) cup1.25 ml
8 - 12 kg1/2 (0.5) cup2.5 ml
13 - 18 kg3/4 (0.75) cup3.75 ml
19 - 25 kg1 cup5 ml
26 - 35 kg1.5 cups7.5 ml
36 - 50 kg2 cups10 ml
51 - 65 kg2.5 cups12.5 ml
66 - 80 kg3 cups15 ml
81 - 100 kg4 cups20 ml
More than 100 kg5 cups25 ml

In order to dissolve the stones in the gallbladder and common bile duct, the suspension is taken for 6 to 24 months, and an ultrasound scan or X-ray is taken every six months to monitor the effectiveness of the therapy. If the stones have calcified or within 12 months have not decreased in size, then Ursofalk is discontinued due to treatment inefficiency.

In cases where the stones successfully dissolve, it is recommended to continue taking Ursofalk for a few more months after the stones disappear to prevent their re-formation.

It should be remembered that you can start taking Ursofalk to dissolve the stones when their diameter is not more than 1.5 - 2 cm. If the stones are larger, then they are crushed first, and only then when the fragments are not in diameter more than 2 cm, start taking Ursofalk for their final dissolution.

For the treatment of biliary reflux gastritis and reflux esophagitis, Ursofalk is taken in one measuring cup once a day, in the evening, at bedtime, with a little water. The duration of therapy is from 10 days to six months, depending on the speed of treatment. In severe cases, the course of therapy is extended to two years.

For the treatment of biliary cirrhosis, Ursofalk is taken, depending on body weight, 1/2 to 7 measuring cups per day. Moreover, in the first three months of therapy, the daily dose is divided into three doses and drunk in the morning, at lunch and in the evening during or immediately after a meal, washed down with a small amount of water. After three months, the entire daily dose is taken at a time, in the evening, before bedtime, also with a small amount of water.

At the beginning of treatment with Ursofalk, the clinical symptoms of cirrhosis may worsen, for example, itching intensifies. In this case, you should reduce the daily dosage by three times, and take the drug only once a day in a single dosage. Thus, if a person began to take 1/4 cup in the morning, at lunch and in the evening, then after exacerbation of symptoms of liver damage, you should drink Ursofalk in 1/4 of a cup only in the evening, before going to bed, and cancel the morning and lunch receptions. After a week, you should enter the reception of another, lunch dosage, and after another week start taking the suspension three times a day.

The duration of therapy for liver cirrhosis is unlimited, that is, the drug can be taken as long as desired until it gives clinical results.

Dosages of Ursofalk suspension for administration in cirrhosis of the liver for people with different body weights are shown in the table below.

Patient body weightDosage in the amount of suspension Ursofalk
Dosage in the first three monthsDosage three months after the start of treatment
MorningDayEveningEvening
8 - 11 kg01/4 cup (1.25 ml)1/4 cup (1.25 ml)1/2 cup (2.5 ml)
12 - 15 kg1/4 cup (1.25 ml)1/4 cup (1.25 ml)1/4 cup (1.25 ml)3/4 cup (3.75 ml)
16 - 19 kg1/2 cup (2.5 ml)01/2 cup (2.5 ml)1 cup (5 ml)
24 - 27 kg1/2 cup (2.5 ml)1/2 cup (2.5 ml)1/2 cup (2.5 ml)1.5 cups (7.5 ml)
28 - 31 kg1/4 cup (1.25 ml)1/2 cup (2.5 ml)1 cup (5 ml)1.75 (1 + 3/4) cups (8.75 ml)
32 - 39 kg1/2 cup (2.5 ml)1/2 cup (2.5 ml)1 cup (5 ml)2 cups (10 ml)
40 - 47 kg1/2 cup (2.5 ml)1 cup (5 ml)1 cup (5 ml)2.5 cups (12.5 ml)
48 - 62 kg1 cup (5 ml)1 cup (5 ml)1 cup (5 ml)3 cups (15 ml)
63 - 80 kg1 cup (5 ml)1 cup (5 ml)2 cups (10 ml)4 cups (20 ml)
81 - 95 kg1 cup (5 ml)2 cups (10 ml)2 cups (10 ml)5 cups (25 ml)
96 - 115 kg2 cups (10 ml)2 cups (10 ml)2 cups (10 ml)6 cups (30 ml)
More than 116 kg2 cups (10 ml)2 cups (10 ml)3 cups (10 ml)7 cups (35 ml)

For the treatment of chronic hepatitis of any origin, congenital atresia of the bile duct, non-alcoholic steatohepatitis and alcoholic liver disease, Ursofalk is taken for 6 to 12 months in individual dosages calculated on the basis of body weight based on a ratio of 10-15 mg per 1 kg of weight. Consider the dosage calculation in more detail.

For example, a patient’s body weight is 50 kg. So, the daily dosage of Ursofalk for him ranges from 10 * 50 to 15 * 50, and is, respectively, 500 - 750 mg per day. Now these milligrams need to be converted to milliliters of suspension according to the formula:

calculated daily dosage in mg * 5/250. That is, in our example, 500 mg is 500 * 5/250 = 10 ml of suspension, and 750 mg is 750 * 5/250 = 15 ml of suspension. This means that the daily dosage for a person weighing 50 kg is 10-15 ml of Ursofalk suspension.

Next, we calculate how many measuring cups correspond to the milliliters of suspension found. For this, we divide the milliliters of the suspension by 5 (the cup holds so much). In our example, 10/5 and 15/5 will be 2 and 3 measuring cups, respectively.

So, a patient with a body weight of 50 kg should take 2 - 3 cups of Ursofalk per day. This calculated amount is divided into two or three doses to drink 2-3 times a day. Moreover, the division is carried out for convenience. Regarding our example, it is obvious that if a person takes 2 cups of suspension per day, then it is convenient to divide them into 2 doses, and drink 1 cup in the morning and evening. If the patient decides to take 3 cups per day, then it is more convenient to divide them into three doses, and drink 1 cup in the morning, afternoon and evening. If you cannot divide the cups evenly into 2 - 3 doses, then you should do one more meal than others (for example, 1 glass in the morning, and 1.5 glasses in the evening, etc.). Moreover, in such cases, the largest amount of suspension should be taken in the evening.

Take Ursofalk 2 to 3 times a day should be done during or immediately after a meal, drinking a suspension with a small amount of water.

For the treatment of biliary dyskinesia, digestive disorders due to cholecystitis, as well as for the prevention of liver damage when taking toxic drugs (antibiotics, cytostatics, oral contraceptives, etc.) Ursofalk should be taken in an individual dosage calculated at a ratio of 10 mg per 1 kg of weight. A detailed example of dose calculation is given above in the section on the treatment of chronic hepatitis.

The duration of treatment for biliary dyskinesia and digestive disorders against the background of pathology of the biliary system is from 2 weeks to 2 months, and depends on the rate of disappearance of clinical symptoms. If necessary, courses of therapy can be repeated.

Against the background of the use of liver-toxic drugs, Ursofalk for prophylaxis is taken until the drugs are canceled, because of which hepatoprotector was needed.

For the treatment of primary sclerosing cholangitis, Ursofalk is taken at a dosage calculated by the ratio of 12-15 mg per 1 kg of weight. After 1 - 3 weeks, this dosage is increased to 20 - 30 mg per 1 kg of body weight, and already in this amount they drink the drug from six months to two years. The calculated daily dosage of Ursofalk is divided into 2 to 3 doses and drunk in the morning, at lunch and in the evening during or immediately after a meal. A detailed example of dosage calculation is given above in the section on the use of Ursofalk in chronic hepatitis.

For the treatment of cystic fibrosis, Ursofalk is taken for a long period of time - from six months to several years. In this case, the dosage is calculated individually according to the ratio of 20-30 mg per 1 kg of body weight.The calculated daily dosage is divided into two doses, and the drug is drunk in the morning and in the evening during or immediately after a meal, washed down with a small amount of water. For young children, a suspension from a syringe is poured directly into the mouth.

In the table below, to avoid confusion and for convenience, we present the already calculated dosages of Ursofalk suspension for the treatment of cystic fibrosis for patients with different body weights.

Body weight kgDaily dosage Ursofalk, mg per 1 kgA single dosage of the suspension in the number of measuring cups and milliliters
MorningEvening
4 kg20 mg / kg0.8 ml (in a syringe)0.8 ml (in a syringe)
4,5 kg20 mg / kg0.9 ml (in a syringe)0.9 ml (in a syringe)
5 kg20 mg / kg1.0 ml (in a syringe)1.0 ml (in a syringe)
5.5 kg20 mg / kg1.1 ml (in a syringe)1.1 ml (in a syringe)
6 kg20 mg / kg1.2 ml (in a syringe)1.2 ml (in a syringe)
6.5 kg20 mg / kg1.3 ml (in a syringe)1.3 ml (in a syringe)
7 kg20 mg / kg1.4 ml (in a syringe)1.4 ml (in a syringe)
7.5 kg20 mg / kg1.5 ml (in a syringe)1.5 ml (in a syringe)
8 kg20 mg / kg1.6 ml (in a syringe)1.6 ml (in a syringe)
8.5 kg20 mg / kg1.7 ml (in a syringe)1.7 ml (in a syringe)
9 kg20 mg / kg1.8 ml (in a syringe)1.8 ml (in a syringe)
9.5 kg20 mg / kg1.9 ml (in a syringe)1.9 ml (in a syringe)
10 kg20 mg / kg2.0 ml (in a syringe)2.0 ml (in a syringe)
11 - 12 kg21 - 23 mg / kg1/2 cup1/2 cup
13 - 15 kg21 - 24 mg / kg1/2 cup3/4 cup
16 - 18 kg21 - 23 mg / kg3/4 cup3/4 cup
19 - 21 kg21 - 23 mg / kg3/4 cup1 cup
22 - 23 kg22 - 23 mg / kg1 cup1 cup
24 - 26 kg22 - 23 mg / kg1 cup1.25 cups
27 - 29 kg22 - 23 mg / kg1.25 cups1.25 cups
30 - 32 kg21 - 23 mg / kg1.25 cups1.5 cups
33 - 35 kg21 - 23 mg / kg1.5 cups1.5 cups
36 - 38 kg21 - 23 mg / kg1.5 cups1.75 cups
39 - 41 kg21 - 22 mg / kg1.75 cups1.75 cups
42 - 47 kg20 - 22 mg / kg1.75 cups2 cups
48 - 56 kg20 - 23 mg / kg2.25 cups2.25 cups
57 - 68 kg20 - 24 mg / kg2.75 cups2.75 cups
69 - 81 kg20 - 24 mg / kg3.25 cups3.25 cups
82 - 100 kg20 - 24 mg / kg4 cups4 cups
More than 101 kg20 - 24 mg / kg4,5 cups4,5 cups

Ursofalk for newborns (from jaundice)

In newborns, Ursofalk is used, as a rule, to treat jaundice. The so-called jaundice of newborns, in which the skin and sclera of the child’s eyes are yellow, is due to the high level of bilirubin in the blood of the baby, which does not have time to be excreted and adversely affects the central nervous system. The causes of jaundice are various (for example, Rhesus conflict during pregnancy).

In order to prevent damage to the central nervous system with prolonged jaundice of newborns, when it does not pass on its own within two to three weeks after discharge from the maternity hospital, pediatricians recommend taking medications that have hepatoprotective and choleretic action and help to remove bilirubin from the blood. Under the influence of such drugs, the neutralization of bilirubin in the liver is activated, it is more rapidly excreted from the body, the jaundice passes, and the baby acquires normal skin color and sclera of the eyes.

One of the effective hepatoprotectors with choleretic action, which are used to treat newborn jaundice, is Ursofalk. The drug should be given to babies exclusively in the form of a suspension of 1 - 2 ml once a day, before bedtime. It is better to measure the required amount of the drug with a syringe, and not with a measuring cup, since the latter does not have divisions by 1 and 2 ml. The duration of administration of Ursofalk depends on the rate of disappearance of the jaundice.

Many mothers and pediatricians note that against the background of the use of Ursofalk in children, digestion is upset and colic appears. Therefore, against the background of taking Ursofalk for the prevention of colic and digestive disorders, it is also recommended to give Enterosgel to infants.

Manufacturer

The owner of the registration certificate / issuing quality control: dr. Falk Pharma GmbH, Lainenweberstr. 5, 79108, Freiburg, Germany.

Tel: 49076115140, Fax: 4907611514356.

Organization authorized by the owner of the registration certificate for accepting claims from consumers: representative office of the company Dr. Falk Pharma GmbH. 127055, Moscow, st.Butyrsky Val, 68/70, p. 4, 5.

Tel./fax: (495) 933-99-04.

Use during pregnancy and breastfeeding

Ursofalk in any form (tablets, capsules and suspension) is undesirable for use during pregnancy and during breastfeeding.

In animal experiments, the negative effect of Ursofalk in early pregnancy was revealed. But when taking Ursofalk by non-pregnant women, it does not adversely affect their fertility (that is, the ability to conceive in the future). Thus, the drug is undesirable for pregnant women, but in other periods of life it can be taken without concern for child-bearing function using reliable contraception (so that pregnancy does not occur during the course of therapy).

Of course, if necessary, Ursofalk can be used by pregnant women, but it should be taken solely according to indications.

Contraindication to the use of Ursofalk during breastfeeding is due to the fact that ursodeoxycholic acid penetrates into milk, and with it can enter the body of the child. Although the concentration of the active substance in milk is low, and the occurrence of side effects in a child due to feeding with such milk is unlikely, Ursofalk should not be taken during breastfeeding.

Impact on the ability to control mechanisms

Ursofalk does not affect the mental processes and the central nervous system, therefore, does not violate the ability to control mechanisms, as a result of which, against the background of its use, you can engage in any kind of activity, including those requiring a high reaction rate and concentration (for example, driving a car).

Combination with other means

Ursofalk suspension for newborns is not prescribed simultaneously with cholestyramine, antacids and colestipol. These drugs bile bile acid in the intestines and reduce the effect of the application. If one of the prescribed drugs contains a similar substance, then the drugs are taken with an interval of 2 hours.

The suspension may have an effect on the absorption of cyclosporin from the intestine. As a result of this feature, after taking cyclosporine, it is necessary to check its amount in the blood plasma and if you need to adjust the dosage. In some cases, the suspension can reduce the absorption of ciprofloxacin.

Some studies have shown that bile acid, which is part of Ursofalk, reduces the peak plasma concentration level in healthy volunteers, therefore, the results of the simultaneous use of a suspension with nifedipine should be observed. You may need to increase the dosage of nifedipine.

Estrogen hormones and drugs, whose action is aimed at lowering cholesterol levels in the blood, can significantly increase the secretion of cholesterol by the liver. As a result of this reaction, favorable conditions are created for the formation of stones in the gallbladder, which is ultimately considered the opposite effect of taking ursodeoxycholic acid, taken to dissolve them.

Review of reviews of sick people

The popular drug Ursofalk has many positive reviews from patients. But it should be borne in mind that the drug should be prescribed only by an experienced gastroenterologist and hepatologist after a full examination. In reviews of Ursofalk treatment, experts note that only cholesterol stones (X-ray negative) can be dissolved with this drug. And when you try to dissolve calcifications with it, the condition may worsen.

Patients in their reviews of Ursofalk note that treatment is usually long and costly from a financial point of view. But for many, this drug helped to do without surgical intervention, which they are immensely happy with. During the therapeutic course, side effects are not excluded, but most often Ursofalk is well tolerated by patients.

The use of the drug Ursofalk

Capsules The daily dose is determined depending on the indications. For the lysis of cholesterol stones in the gallbladder
A dose approximately corresponding to 10 mg / kg is at body weight:

  • up to 60 kg - 2 capsules,
  • up to 80 kg - 3 capsules,
  • up to 100 kg - 4 capsules,
  • more than 100 kg - 5 capsules.

Capsules should be taken without chewing, in the evening, before bedtime, with a small amount of liquid. The drug should be taken regularly. The necessary duration of use may be 6-24 months. If, after 12 months of use of the drug, a decrease in the size of stones was not noted, further treatment is impractical. The effectiveness of therapy is monitored by ultrasound or radiography every 6 months. With the development of calcification of calculi, treatment is stopped. For the treatment of reflux gastritis
Assign, as a rule, within 10-14 days. The decision on the duration of the drug is taken individually. For the symptomatic treatment of primary biliary cirrhosis
The daily dose depends on body weight and ranges from 2 to 6 capsules (approximately 10-15 mg of ursodeoxycholic acid per 1 kg of body weight). This dosage regimen is recommended:

What is better than Ursofalk?

In medical practice, there is no concept of a better drug; instead, the term "optimal" is used. The optimal drug is the one that best provides the therapeutic effect in a given patient at the current time. This means that for the same person with a chronic disease at different periods of his life, completely different drugs may be optimal. Therefore, it cannot be said that Ursofalk is better. Indeed, for one person, as a choleretic and hepatoprotector, Ursofalk will be an ideal remedy, and for another - a completely different drug.

Admission course

Therapy for taking Ursofalk is from 10 days to 12 months. In some cases with severe illnesses, the treatment course lasts 2 years.

During treatment with this drug, it is recommended to periodically visit a doctor, undergo diagnostic tests that will help monitor the dynamics of the disease.

Analogues of the drug

Currently, there are two categories of analogue drugs on the pharmaceutical market - these are synonyms and, in fact, analogues. Synonyms are medicines that contain the same active substance. Analogs are drugs with different active substances, but having a similar therapeutic effect.

Accordingly, as applied to Ursofalk, we can say that its synonyms are drugs that also contain ursodeoxycholic acid as an active substance. And other hepatoprotectors with choleretic action will be analogues of Ursofalk.

So, the following drugs belong to the synonyms of Ursofalk:

  • Livodex,
  • Urdox,
  • Ursodeoxycholic acid,
  • Ursodex,
  • Ursoliv
  • Ursor
  • Ursor C,
  • Ursosan
  • Urso 100,
  • Ursodez
  • Holudexan
  • Exhol.

The following hepatoprotectors with choleretic effect are referred to Ursofalk's analogues:
  • Ademethionine Vial,
  • Allohol
  • Altan
  • Astaxanthin
  • Betulin GEPATO,
  • Bongjigar
  • VG-5,
  • Gepabel
  • Gepabene
  • Hepatitis
  • Hepanorm,
  • Heparetta
  • Hepatofalk plant
  • Heptral
  • Dipana
  • Zixorin,
  • Cavehol,
  • Curcumin
  • Liv-52,
  • Lohein
  • Maksar
  • Foam
  • Transhepar
  • Tykveol
  • Febichol
  • Flaming
  • Holiver
  • Cholenzyme
  • Hofitol
  • Tsinarin,
  • Entofit Hepato.

Recommendations of doctors when taking the drug

When taking the medicine every 6 months, it is recommended to undergo an ultrasound examination. Its results will help determine how much the stones have decreased. If there is no change after 6 months of regular medication, it is stopped taking due to inefficiency. If the formations have successfully dissolved after the course, then for the purpose of prevention, the drug is prescribed again after 4 months.

After discontinuation of the medicine and its long-term administration, a temporary deterioration in well-being may be noted.

The medicine Ursofalk belongs to the drugs of the Rx group, therefore, in pharmacies it is dispensed by prescription. It is forbidden to take this medicine without medical prescription, as this can lead to a deterioration in well-being, the development of various complications.

Reviews

Most reviews of Ursofalk are positive (up to 90%), which is due to the high effectiveness of the drug in the treatment of liver and biliary tract diseases. The reviews indicate that Ursofalk helps to get rid of stones and sand in the gallbladder, cure biliary dyskinesia, relieve hepatosis of the liver, stagnation of bile, etc. In addition, the reviews noted that against the background of chronic liver diseases, Ursofalk improves the functioning and condition of the organ, which leads to the disappearance of exhausting clinical symptoms. Separately, it should be noted that due to the normalization of digestion, Ursofalk helps to improve the condition of the skin, hair, nails, and eliminates dandruff and acne.

A few negative reviews are due to the lack of the expected therapeutic effect and its high cost.

Ursofalk during pregnancy and lactation

During pregnancy and lactation, taking Ursofalk is not recommended. The drug does not have a toxic effect on the development of the fetus or the condition of the expectant mother, but due to the fact that the necessary studies have not been conducted and the effect of the drug during the period of gestation has not been studied, it is better to refuse to take it.

Ursofalk for newborns from jaundice

In newborn children, physiological jaundice is often found, which is the norm and passes within a few days. However, with increased bilirubin in the blood, the jaundice acquires a pathological condition. The skin of the baby, the whites of the eyes turn yellow 2 to 3 days after birth. This condition is not the norm, requires proper treatment.

To eliminate jaundice and normalize bilirubin in the blood, the doctor may prescribe a suspension of Ursofalk. Taking the drug allows the liver cells to work more actively, to produce the necessary amount of enzymes to remove bilirubin from the body. Also, the medicine copes with stagnation of bile in the liver, improves its outflow.

Newborns are prescribed medicine at a dose of 40 mg per 1 kg of body weight per day. The duration of the drug is determined by the doctor individually, but generally does not exceed 5 - 10 days.

Livodex

Livodex is a cheap analogue, the price of which does not exceed 90 rubles per package. Available in tablets of 150 and 300 mg. Contains urodesoxycholic acid. Designed to normalize the liver, also improves the digestive system, cleanses the body of toxins. Preschool children are not prescribed any medicine.

Oatsol

Ovesol is not a structural analogue of Ursofalk, but has a similar therapeutic effect. This remedy relates to herbal medicines. It contains various herbs to improve the liver and gall bladder. It has a detoxifying and hepatoprotective effect, the process of eliminating bile is normalized, and is often used in combination with other drugs.

Which is better - Ursofalk or Essentiale forte

Essentiale forte is a German analogue from the group of hepatoprotectors based on phospholipids. It is used for various liver lesions, intoxication by adults, including pregnant women. Often prescribed for toxicosis, hepatitis, cirrhosis, fatty degeneration. Serves as a preventive measure against the formation of gallstones. It is released without a doctor’s prescription.

Which is better - Ursofalk or an analog of Essentiale forte depends on the testimony, the degree of organ damage. Often, experts in severe cases prescribe both drugs at once.

Greenterol or Ursofalk

Grinterol is the Latvian analogue of Ursofalk, but cheaper. It is produced in one form - 250 mg capsules. It is used from 3-4 years, depending on the indications. The price of Greenterol is 25% lower than Ursofalk.

Both drugs are identical, manufactured by imported pharmaceutical companies. They have the same indications and limitations. The analogue is not available in tablets with a higher dosage and does not replace Ursofalk syrup for the treatment of jaundice in newborns.

Ursofalk or Phosphogliv - which is better

Phosphogliv is a Russian substitute for Ursofalk based on phospholipids. The capsule form is dispensed without a prescription, reinforced is prescribed by a doctor. The price of Phosphogliv is lower both for packaging and for the course, starts from 450 rubles for 50 capsules.

This Ursofalk analogue is used as a hepatoprotective agent for hepatosis, cirrhosis, viral hepatitis and other liver lesions. Reduces intoxication, restores organ cells. Used in childhood practice from 12 years old.

Ursofalk, Ursosan and Phosphogliv are based on different mechanisms of action, have a different pricing policy, indications and restrictions. Which is better depends on each case of the disease.

Odeston or Ursofalk - which is better

Odeston is a Polish analogue that has a choleretic and antispasmodic effect. It relaxes the bile ducts and prevents stagnation of bile. It is used for biliary dyskinesia, cholecystitis, with reduced secretion of bile and associated symptoms - constipation, lack of appetite, nausea and vomiting. Odeston is an over-the-counter drug, it is allowed from 7 years.

Ursofalk and Odeston are excellent, safe drugs. However, without a doctor should not be taken, it is not recommended to replace it yourself.

Allohol or Ursofalk

Allohol is a cheap analogue in tablets based on dry bile, nettle extract, garlic, activated carbon. It is used as a choleretic agent in courses of 1-2 months. You can not drink with acute pancreatitis and hepatitis. It is sold freely, without a prescription.

The advantage of Allohol is the low price.

According to the purpose, the medicines are different. Allohol is used to improve the secretion and outflow of bile. Ursofalk additionally restores damaged liver cells.

Ursofalk is a prescription drug that is better not to replace a newborn without agreement with the pediatrician. The original tool, clinically tested in patient categories. There are no analogues of Ursofalk suspension for the active substance. If replacement is necessary, for example, at high cost, drugs of the same group can be chosen based on ursodeoxycholic acid.