• Compound
  • Indications for use
  • Contraindications
  • Dosage and administration
  • Side effect
  • Overdose
  • Application features
  • Precautionary measures
  • Release form
  • Storage conditions
  • Shelf life

Compound

The active substance of the drug is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.

Excipients - corn starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, purified water, sodium lauryl sulfate.

Indications for use

Ursodeoxycholic acid - active substance capsules Ursofalk 250 mg. It is a naturally occurring bile acid found in small amounts in human bile.

Capsules Ursofalk at a dosage of 250 mg are used:

- to dissolve cholesterol stones. These stones must be radiolucent (not visible on plain radiographs) and not exceed 15 mm in diameter. Despite the presence of stones, gallbladder function must be preserved;


- for treatment inflammatory process in the stomach caused by reverse current bile acids(bile reflux gastritis);

- for the symptomatic treatment of primary biliary cirrhosis of the liver (PBC) in the absence of signs of decompensation (diffuse chronic liver disease in the stage when reduced liver function is not able to be compensated).

Contraindications

- you have acute inflammatory diseases gallbladder or bile ducts;

- you have an obstruction of the bile ducts (blockage of the common bile ducts or cystic ducts);

- You are pregnant;

- gallstones of non-cholesterol origin;

- you have calcification of gallstones;

- you have impaired contractile function of the gallbladder;

Do you suffer from frequent cramping pains in upper section abdominal cavity.

Please tell your healthcare provider about any of the above conditions. You should also tell your doctor if you have previously experienced any of these conditions.

Pregnancy and lactation

Data on the use of Ursofalk during pregnancy is limited. Animal studies have shown signs of teratogenic effects when taking the drug in the first trimester (early stage) of pregnancy. You should not use Ursofalk during pregnancy unless your doctor, after weighing the benefits/risks, decides that it is absolutely necessary.


Pregnancy should be excluded before taking Ursofalk. Women of childbearing age can use the drug Ursofalk only when using reliable contraceptives.

breastfeeding period

You should not take Ursofalk during breastfeeding, since it is not known whether ursodeoxycholic acid passes into breast milk. If treatment with this drug is necessary, breastfeeding should be discontinued.

Dosage and administration

For the treatment of biliary reflux gastritis:

Take 1 capsule 1 time per day, in the evening, at bedtime, without chewing and with a small amount of water or other liquid.

The duration of treatment is usually 10-14 days. Depending on the course of the disease, your doctor will determine how long you should take the drug.

For symptomatic treatment of primary biliary cirrhosis:

Dosage

The daily dose depends on body weight and varies from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid/kg body weight).

In the first 3 months of treatment with Ursofalk, 250 mg capsules, the daily dose should be divided into several doses. After improving the results of laboratory parameters, the daily dose of the drug can be taken once, in the evening.


The use of Ursofalk 250 mg capsules in primary biliary cirrhosis can be unlimited in duration.

Note:

Patients with primary biliary cirrhosis may worsen at the start of treatment. clinical symptoms for example, itching may increase. In this case, treatment should be continued by taking one capsule of Ursofalk daily, then the dose should be gradually increased (increasing the daily dose by one capsule weekly) until the recommended dosage regimen is reached again.

If you feel that the effect of Ursofalk 250 mg capsules is too strong or too weak, please tell your doctor.

Side effect

Like the rest medicines, Ursofalk can call side effects and may not be suitable for all patients.

Common side effects (may affect less than 1 in 10 people and more often than 1 in 100 people):

- soft, frequent loose stools or diarrhea.

Very rare side effects (occur less than 1 in 10,000 patients):

- during the treatment of primary biliary cirrhosis: severe pain in the abdomen, with right side, decompensation of cirrhosis of the liver, which partially decreases after discontinuation of the drug;

- calcification of stones;

allergic reaction(hives).

If any of the side effects get worse or if you notice any side effects not listed in this package leaflet, please tell your doctor.

Overdose

An overdose may result in diarrhea. Please tell your doctor immediately if diarrhea persists, as a dose reduction may be necessary. If you suffer from diarrhea, take enough fluids to restore the water-salt balance.

Interaction with other drugs

Please tell your doctor if you are taking or have recently taken any medicines containing the substances listed below. When interacting with Ursofalk, the effectiveness of these drugs may change.

Possible reduction in the effect of the following drugs while taking them with Ursofalk, 250 mg capsules:

- cholestyramine, cholestipol, (affecting blood lipids); aluminum hydroxide and / or smectite (aluminum oxide) containing antacids (agents that reduce the acidity of gastric juice). If you are taking a preparation containing any of these active substances, you should take it 2 hours before or after taking Ursofalk capsules.

- ciprofloxacin, diaphenylsulfone (antibiotics), nitrendipine (to reduce blood pressure) and other drugs that are metabolized in a similar way. Your doctor may change the doses of these drugs.

It is possible to enhance the effect of the following drugs when used simultaneously with Ursofalk, 250 mg capsules:


- cyclosporine (reduces the activity immune system). If you are taking ciclosporin, your dose may need to be adjusted.

Please tell your doctor or pharmacist about all medicines you are taking, even if they are available without a prescription. Your doctor will determine which drugs and at what dosage are your priorities at the moment.

Pregnancy and lactation.

Before using any medicine, you should consult your doctor.

Application features

Application in children.

The use of Ursofalk capsules 250 mg in children under 6 years of age is not recommended, since according to generally accepted rules, drugs in the pharmaceutical form of "capsules" are not recommended for use in children under 6 years of age. The dosage of the drug is based on the patient's body weight and medical indications.

Management ability vehicles or mechanisms.

No effect on the ability to drive vehicles or mechanisms was observed.

Precautionary measures

Ursofalk capsules at a dosage of 250 mg should be used under medical supervision.

Your healthcare provider should monitor liver function every 4 weeks for the first three months of treatment. After that, the control should be carried out every 3 months.

Release form

Ursofalk 250 mg capsules are white, opaque, hard gelatin capsules containing a white compressed powder or granules.

Ursofalk capsules at a dosage of 250 mg are available in packs of 50 capsules (2 blisters x 25 capsules) or 100 capsules (4 blisters x 25 capsules) in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep all medicines out of the reach of children.

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Indications for the use of Ursofalk are quite extensive:

  • Cirrhosis of the liver, primary biliary;
  • Cholangitis sclerosing;
  • cholelithiasis (cholesterol stones, no more than 15 mm in diameter);
  • Hepatitis of any origin;
  • alcoholic liver disease;
  • Acute alcohol poisoning;
  • Steatohepatitis of non-alcoholic origin;
  • Dyskinesia of the bile ducts and gallbladder;
  • Liver damage in cystic fibrosis;
  • Consequences of a liver transplant operation;
  • Long-term use of hepatotoxic and cholestatic drugs (hormones, including contraceptives, some antibiotics, etc.);
  • Atresia of the bile ducts within the liver.

Contraindications

Patient conditions in which the use of Ursofalk is contraindicated:

  • Allergy to the drug and its components;
  • Acute cholecystitis;
  • Acute cholangitis;
  • cholelithiasis with a stone size of more than 15 mm;
  • Obturation of the biliary tract (overlapping with a stone);
  • Hypomotor disorders in the gallbladder (decrease in motor activity);
  • biliary colic;
  • lactation period;
  • Children under 3 years (for the drug in the form of capsules);
  • Cirrhosis of the liver, decompensation;
  • kidney failure;
  • Liver failure.

Operating principle

Once in the systemic circulation, Ursofalk has a hepatoprotective, choleretic and immunomodulatory effect. The active substance of the drug reduces bile acids in the bile and removes them through the intestines, which reduces the stagnation of bile in the liver and gallbladder. Also, the drug restores the membrane of hepatocytes, improves its ability to protect itself from toxins and other harmful substances. Ursofalk reduces inflammation in the liver, gallbladder and bile ducts. In addition, Ursofalk helps dissolve soft cholesterol stones.

Mode of application

Ursofalk in the form of capsules

Ursofalk capsules should be taken orally, without chewing, with a sufficient amount of liquid. The dosage is usually selected individually, depending on the weight of the patient, his pathology and its severity. Average dosage calculations:

  • Dissolution of stones - with a patient weighing up to 60 kg - 2 capsules in the evening; 60-80 kg - 3 capsules; 80-100 kg - 4 capsules; from 100 kg - 5 capsules. The course of treatment - from 6 months to 1 year

  • Biliary cirrhosis: with a weight of 45-60 kg - 1 capsule three times a day; 60-80 kg - 4 capsules per day, divided into 3 doses; 80-95 kg - 5 capsules per day, divided into 3 doses; 95-110 kg - 2 capsules three times a day; more than 110 kg - 7 capsules per day, divided into 3 doses. The course of treatment is long, possibly lifelong
  • Hepatitis of any origin - 10-15 mg for each kg of the patient's weight, divided into 2-3 doses. The course of treatment is about 1 year. Can be extended if necessary

Ursofalk in the form of a suspension

Ursofalk in the form of a suspension is recommended for children under 3-6 years of age and for patients who have impaired swallowing processes. Average dosage calculations for specific pathologies, given that 5 ml contains 250 mg of the drug, and 1 ml contains 50 mg, respectively:

  • Dissolution of stones: weight 5-7 kg - 1.25 ml; 8-12 kg - 2.5 ml; 13-18 kg - 3.75 ml; 19-25 kg - 5 ml; 26-35 kg - 7.5 ml; 36-50 kg - 10 ml; 51-65 kg - 12.5 ml; 66-80 kg - 15 ml; 81-100 kg - 20 ml; from 100 kg - 25 ml. The course of treatment is from 6 months to 1 year

  • Biliary cirrhosis: with a weight of 5-7 kg - 1.25 ml 1 time per day, in the evening; 8-12 kg - 1.25 ml each day and evening; 13-18 kg - 1.25 ml three times a day; 19-25 kg - 2.5 ml in the morning and evening; 26-35 kg - 2.5 ml three times a day; 36-50 kg - 5 ml in the morning and evening; 51-65 kg - 5 ml three times a day; 66-80 kg - 5 ml in the morning and afternoon and 10 ml in the evening; 81-100 kg - 5 ml in the morning and 10 ml in the afternoon and evening; from 100 kg - 10 ml three times a day. The course of treatment is long, possibly lifelong
  • Hepatitis - 10-15 mg for each kg of the patient's weight, divided into 2-3 doses. The course of treatment is about 1 year. Can be extended if necessary
  • Cholangitis and liver damage in cystic fibrosis - from 12 to 30 mg per kg of the patient's weight, dividing the dose by 2-3 times. The course of treatment is on average about 6 months, but can be extended up to 2-3 years
  • Steatohepatitis and alcoholic liver disease - 10-15 mg per kg of the patient's weight, divided into 2-3 doses. The course of treatment is 6-18 months
  • Dyskinesia of the biliary tract - 10 mg per kg of weight, divided into 2 doses. The course of treatment - from 2 weeks to 2 months

Side effects of Ursofalk

Side effects Ursofalk causes extremely rarely, and they all disappear after reducing the dosage of the drug or after its cancellation:

  • Pain in the abdomen;
  • Liquid stool;
  • Itchy rash on the skin;
  • Nausea.

No cases of overdose with this drug have been reported.

special instructions

During pregnancy, the drug can be used, it does not affect the development of the fetus and the formation of organs. During lactation for the entire period of treatment, it is recommended to stop breastfeeding, because there is no reliable data on the effect of the drug on the body of a healthy infant.

Alcohol does not affect the properties of the drug, but aggravates the condition of the liver.

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Manufacturer

"Dr. Falk Pharma GmbH", Germany

Active ingredient matches for Ursofalk

ursodeoxycholic acid;, ursodeoxycholic acid

Release form Ursofalk

Capsules 250 mg No. 10 (10x1), No. 50 (25x2), No. 100 (25x4)
Suspension for oral administration, 250 mg/5 ml, 250 ml each in bottles No. 1, No. 2

Who is shown Ursofalk

For the dissolution of radiopaque cholesterol gallstones not more than 15 mm in diameter in patients with a functioning gallbladder, regardless of the presence of gallstone(s) in it(s). For the treatment of gastritis with bile reflux. For the symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis

How to use Ursofalk

The following daily doses are recommended for various indications. To dissolve cholesterol gallstones:
Approximately 10 mg per 1 kg of body weight daily, which corresponds to:
Body weight Daily dose
up to 60 kg 2 capsules
61 - 80 kg 3 capsules
81 - 100 kg 4 capsules
over 100 kg 5 capsules
Capsules should be swallowed whole, without chewing, 1 time per day with a small amount of liquid, in the evening before bedtime. The time it takes for gallstones to dissolve is usually 6 to 24 months. If a decrease in the size of gallstones is not observed after 12 months of treatment, drug therapy should be discontinued. Treatment should be monitored with ultrasound or cholecystography every 6 months. It is necessary to carry out additional research to identify possible calcification of stones, which should be the basis for stopping treatment.

To treat gastritis with bile reflux:
Take one capsule daily with a small amount of liquid in the evening before bedtime. Ursofalk capsules usually need to be taken within 10 to 14 days. As a rule, the duration of admission depends on the course of the disease. The decision on the duration of treatment is made by the doctor on an individual basis.
For symptomatic treatment of primary biliary cirrhosis (PBC):
The daily dose depends on body weight and is approximately 2 to 6 capsules (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight). The following dosage regimen is recommended:
Body weight Daily dose Morning Afternoon Evening
From 34 to 50 kg - 2 capsules 1 - 1
From 51 to 65 kg - 3 capsules 1 1 1
From 66 to 85 kg - 4 capsules 1 1 2
From 86 to 110 kg - 5 capsules 1 2 2
Over 110kg 6 capsules 2 2 2
It is necessary to pay attention to the regularity of taking capsules. The use of Ursofalk capsules in primary biliary cirrhosis can continue indefinitely.
For patients weighing less than 34 kg, as well as with difficulty swallowing, it is recommended to prescribe Ursofalk in the form of a suspension for oral administration.
In some cases, in patients with primary biliary cirrhosis, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. If this happens, therapy should be continued using 1 Ursofalk capsule per day, and then gradually increase the dose (by 1 capsule weekly) until the recommended dose is reached.

Application features

Ursofalk capsules should be used under medical supervision. During the first three months of treatment, it is necessary to check liver function parameters (AST (SGOT), ALT (SGPT) and g-gt) every 4 weeks, and then every 3 months.
Depending on the size of the stone, a study should be performed to evaluate the progress of treatment and detect early calcification of gallstones. general condition gallbladder (cholecystography) and possible obstruction in the standing position and lying on the back (ultrasound control) after 6-10 months from the start of treatment.
No effect on the ability to drive vehicles and use tools was observed.

Side effects of Ursofalk

The assessment of adverse events is based on data on their frequency:
Side effects from gastrointestinal tract:

  • in clinical trials, there have been reports of fluid stools or diarrhea during ursodeoxycholic acid therapy (often). In the treatment of primary biliary cirrhosis, there was severe pain in the right upper part of the abdominal cavity (very rarely);
  • violation of the liver and gallbladder (very rare);
  • calcification of gallstones may occur during treatment with ursodeoxycholic acid. In the treatment of advanced stages of primary biliary cirrhosis, decompensation of hepatic cirrhosis was observed, which partially regressed after discontinuation of treatment.

Hypersensitivity reactions (very rare): Rash may occur.

Who is contraindicated Ursofalk

With acute inflammation of the gallbladder or biliary tract; with obstruction of the bile ducts (common bile duct or bladder duct).
Ursofalk capsules are not prescribed to patients with a gallbladder that is not visualized by radiological methods, with calcified stones, impaired contractility of the gallbladder and those patients who often have biliary colic.

Pregnancy and lactation
Experience with the use of the drug during the first trimester of pregnancy in humans is insufficient. Women of childbearing age can take the drug only under the conditions of the use of reliable contraceptives. Pregnancy must be ruled out before starting treatment. Since there is insufficient data on the penetration of ursodeoxycholic acid into breast milk, it should not be taken during lactation.

Ursofalk interaction

Ursofalk capsules should not be used concomitantly with cholestyramine, colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), since these drugs bind ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs that contain one of these substances is still necessary, they should be taken at least 2 hours before or after taking Ursofalk.
Ursofalk capsules may enhance the absorption of cyclosporine from the intestine. Therefore, in patients receiving ciclosporin, it is necessary to check the concentration of ciclosporin in the blood and adjust the dose of ciclosporin if necessary. In some cases, Ursofalk capsules may reduce the absorption of ciprofloxacin. Ursodeoxycholic acid reduces the maximum plasma concentration (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine.
Based on this, as well as the only reported interaction with the substance dapsone (reduced therapeutic effect) and from in vitro studies, it can be assumed that ursodeoxycholic acid induces the activity of the metabolizing drug cytochrome P450 3A4. Therefore, with the simultaneous use of drugs that are metabolized with the participation of this enzyme, care must be taken and it should be borne in mind that there may be a need for dose adjustment.

Overdose of Ursofalk

Overdose may cause diarrhea. In general, overdose is unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and it is mostly excreted in the feces. If diarrhea occurs, the dose should be reduced, and if diarrhea persists, Ursofalk should be discontinued.
No specific countermeasures are required; the effects of diarrhea should be treated symptomatically while maintaining fluid and electrolyte balance.

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Pharmacological action of Ursofalk

Ursofalk, according to the instructions, has a choleretic, destroying cholesterol stones, cholesterol-lowering effect.

The drug protects the cell membranes of the liver and biliary tract from damage by toxic bile acids, and also prevents the growth of connective tissue in the liver in case of damage to hepatocytes.

Ursofalk contains urodeoxycholic acid in its composition. It, as it were, delimits the smallest structures of bile acids with a structural shell - it forms the so-called mixed micelles. Urodeoxycholic acid also interacts with the lipophilic structures of membranes, making them resistant to damage. Thus, it implements a cytoprotective (protective) effect.

Like its analogues, Ursofalk enhances the secretion of the stomach and pancreas.

The drug has an immunological effect - it affects the content of different classes of immune cells in the body, and at the level of the liver - slows down the development of fibrosis in patients with cystic fibrosis, primary biliary cirrhosis, alcoholic liver disease, reduces the likelihood of esophageal varicose veins. There are positive reviews about Ursofalk when included in the treatment program malignant diseases colon (cancer), it is able to inhibit the growth of tumor cells.

Release form

Ursofalk is produced in capsules of 250 mg and in suspension (250 ml vials, the content of urodeoxycholic acid is 250 mg/5 ml).

Indications for use Ursofalk

The drug is prescribed for the treatment of primary biliary cirrhosis under the condition of a compensated state, biliary reflux gastritis, for the dissolution of cholesterol stones in the gallbladder and in the case of cholestasis with parenteral nutrition, in complex treatment cystic fibrosis, biliary dyskinesia. It is also recommended to prevent the development of colon cancer in high-risk groups for this disease.

There are no age restrictions. Thus, the use of Ursofalk as a means of reducing the level of indirect bilirubin in the blood is possible in newborns with conjugated hyperbilirubinemia (jaundice).

Ursodeoxycholic acid is the active ingredient in Ursofalk® 250 mg capsules. It is a naturally occurring bile acid found in small amounts in human bile.
Ursofalk® capsules at a dosage of 250 mg are used:
- to dissolve cholesterol stones. These stones must be radiolucent (not visible on plain radiographs) and not exceed 15 mm in diameter. Despite the presence of stones, gallbladder function must be preserved;
- for the treatment of an inflammatory process in the stomach caused by a reverse flow of bile acids (bile reflux gastritis);
- for the treatment of primary biliary cirrhosis (PBC) in patients without decompensated liver cirrhosis (diffuse chronic liver disease in the stage when reduced liver function is not able to be compensated);
- for the treatment of hepatobiliary disease associated with fibrocystic degeneration (cystic fibrosis) in children aged 6 to 18 years.

What you need to pay attention to before taking

Do not take if:
- you are hypersensitive to the active substance or other ingredients of this medicinal product;
- you have acute inflammatory diseases of the gallbladder or bile ducts;
- you have an obstruction of the bile ducts (blockage of the common bile duct or cystic duct);
- you have calcification of gallstones;
- you have impaired contractility of the gallbladder;
- you suffer from frequent cramping pains in the upper abdomen;
- Your child has bile duct obstruction and reduced bile secretion (biliary atresia), even after surgery.
Please tell your healthcare provider about any of the above conditions. You should also tell your doctor if you have previously experienced any of these conditions.
Additional Precautions
Ursofalk® capsules at a dosage of 250 mg should be used under medical supervision.
Your healthcare provider should monitor liver function every 4 weeks for the first three months of treatment. After that, the control should be carried out every 3 months.
When used to dissolve cholesterol gallstones, your doctor should schedule you for a gallbladder scan after 6 to 10 months of treatment.
Women taking Ursofalk® to dissolve stones should use non-hormonal methods of contraception, as hormonal contraceptives may contribute to the formation of gallstones.
In the treatment of primary biliary cirrhosis, in rare cases, symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, you should contact your doctor to reduce the initial dose.
Tell your doctor if you have diarrhea. In this case, it may be necessary to reduce the dose of the drug or stop taking Ursofalk®, 250 mg capsules.

Co-administration with other drugs

Please tell your doctor if you are taking or have recently taken any medicines containing the substances listed below. When interacting with Ursofalk®, the effectiveness of these drugs may change.
It is possible to reduce the effect of the following drugs while taking them with Ursofalk®, 250 mg capsules:
- cholestyramine, cholestipol (affecting blood lipids); aluminum hydroxide and / or smectite (aluminum oxide) containing antacids (agents that reduce the acidity of gastric juice). If you are taking a preparation containing any of these active substances, you should take it 2 hours before or after taking Ursofalk® capsules.
- ciprofloxacin, dapsone (antibiotics), nitrendipine (to lower blood pressure) and other drugs that are metabolized in a similar way. Your doctor may change the doses of these drugs.
It is possible to change the effect of the action of the following drugs when used simultaneously with Ursofalk®, capsules 250 mg:
- cyclosporine (reduces the activity of the immune system). If you are taking ciclosporin, your doctor will monitor your blood levels and your dose may need to be adjusted.
- rosuvastatin (lowers blood cholesterol levels).
If you are taking Ursofalk®, 250 mg capsules to dissolve cholesterol stones, please tell your doctor if you are also taking medicines containing estrogen or cholesterol-lowering medicines, such as those containing clofibrate. These drugs may promote the formation of gallstones, which is the opposite effect of ursodeoxycholic acid, which is used to dissolve gallstones.
Please tell your doctor or pharmacist about all medicines you are taking, even if they are available without a prescription. Your doctor will determine which drugs and at what dosage are your priorities at the moment.

Fertility, pregnancy and breastfeeding

Before using any medicine, you should consult your doctor.
Fertility
Animal studies have not shown the effect of ursodeoxycholic acid on fertility. Data on the effect of ursodeoxycholic acid on human fertility after treatment with ursodeoxycholic acid are not available.
Pregnancy period
There are no data on the use of ursodeoxycholic acid in pregnant women. Animal studies have provided evidence of reproductive toxicity in early pregnancy. Ursofalk capsules should not be used during pregnancy unless absolutely necessary.
Women of childbearing age
Women of childbearing age should only take this medicine if they are using reliable contraception. It is recommended to use non-hormonal contraceptives or low estrogen oral contraceptives. Patients taking Ursofalk to dissolve gallstones should use effective non-hormonal agents contraception, since hormonal oral contraceptives can increase gallstone formation.
Before starting treatment, the possibility of pregnancy should be excluded.
breastfeeding period
According to the few reported cases of the use of the drug in women who are breastfeeding, the concentrations of ursodeoxycholic acid in breast milk are very low, and adverse reactions are probably not expected in breastfeeding infants.

Use in children

There are no age restrictions on the use of Ursofalk®, 250 mg capsules. The dose of the drug is based on the patient's body weight and medical indications. For children who cannot swallow capsules or who weigh less than 47 kg, Ursofalk® is not prescribed.

Influence on the ability to drive vehicles or mechanisms

Ursodeoxycholic acid does not affect the ability to drive vehicles or mechanisms, or this effect is extremely insignificant.

How to use

Always take Ursofalk® capsules as directed by your doctor. If you have any doubts or questions, please consult your doctor again.
To dissolve cholesterol stones:
Dosage
Approximately 10 mg of ursodeoxycholic acid per 1 kg of body weight daily as follows:
up to 60 kg 2 capsules
61-80 kg 3 capsules
81-100 kg 4 capsules
over 100 kg 5 capsules
Take the capsules without chewing with a small amount of water or other liquid once a day, at bedtime. The capsules should be taken regularly.
Duration of treatment
As a rule, the duration of treatment for the dissolution of stones is 6-24 months. If the size of the stones does not decrease after 12 months of treatment, the drug should not be continued. Every 6 months, the doctor must monitor the success of the treatment. At subsequent examinations, whether calcification of stones has occurred in the interim. If this happens, the use of Ursofalk® should be discontinued.
For the treatment of biliary reflux gastritis
Take 1 capsule 1 time per day, in the evening, at bedtime, without chewing and with a small amount of water or other liquid.
The duration of treatment is usually 10-14 days. Depending on the course of the disease, your doctor will determine how long you should take the drug.
For the symptomatic treatment of primary biliary cirrhosis
Dosage
The daily dose depends on body weight and varies from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid/kg body weight).
In the first 3 months of treatment with Ursofalk®, 250 mg capsules, the daily dose should be divided into several doses. You must take Ursofalk® 250 mg capsules in the morning, afternoon and evening. After improving the results of laboratory parameters (liver tests), the daily dose of the drug can be taken once, in the evening.

Body weight (kg)

Daily dose (mg/kg body weight)

Ursofalk ® , capsules 250 mg

First 3 months

Further

(1 per day)


Capsules should be taken without chewing with a small amount of water or other liquid. The capsules must be taken regularly.
The use of Ursofalk 250 mg capsules in primary biliary cirrhosis can be unlimited in duration.
Note:
In patients with primary biliary cirrhosis, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, treatment should be continued by taking one capsule of Ursofalk® daily, then the dose should be gradually increased (increasing the daily dose by one capsule weekly) until the recommended dosage regimen is reached again.
For the treatment of hepatobiliary disease associated with fibrocystic degeneration in children 6 to 18 years of age:
Dosage:
Recommended daily dose is 20 mg per 1 kg of body weight, divided into 2-3 doses. If necessary, the doctor may increase the dose to 30 mg per 1 kg of body weight.

Body weight [kg]

Daily dose

(mg/kg body weight)

Ursofalk ® , capsules 250 mg

20 – 29

30 – 39

40 – 49

50 – 59

60 – 69

70 – 79

80 – 89

90 – 99

100 – 109


If you feel that the effect of Ursofalk® 250 mg capsules is too strong or too weak, please tell your doctor.
If you have taken more Ursofalk® capsules than your doctor has prescribed
An overdose may result in diarrhea. Please tell your doctor immediately if diarrhea persists, as a dose reduction may be necessary. If you suffer from diarrhea, drink enough fluids to restore the water-salt balance.
If you forget to take Ursofalk® 250 mg capsules
Do not increase the number of capsules in the next dose, just continue the prescribed dosing regimen.
EUwhether you stop taking Ursofalk® 250 mg capsules
Always consult your doctor if you decide to stop treatment with Ursofalk®, 250 mg capsules or stop treatment prematurely.
If you have any further questions on the use of this medicine, ask your doctor.

Hepatoprotective agent, has choleretic action. Ursofalk's main active ingredient is ursodeoxycholic acid.

It reduces the synthesis of cholesterol in the liver, its absorption in the intestines and its concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile.

The choleretic effect is to reduce the amount of hydrophobic bile acids in the bile and increase their excretion into the intestinal lumen, in addition, the drug, due to its association with receptors located in the ileum, reduces the absorption of toxic hydrophobic bile acids.

During cholestasis, there is a violation of the excretion of bile and its stagnation in the intrahepatic bile ducts - this leads to the absorption of toxic bile acids into the blood. As indicated by reviews on the use of Ursofalk by doctors, the drug contributes to the complete or partial dissolution of cholesterol stones and stimulates the mobilization of cholesterol from gallstones. In addition, the drug has a local immunomodulatory effect on the liver.

The period of complete elimination of Ursofalk from the body is 8-12 days. Excreted with bile and feces.

Indications for use Ursofalk

According to the instructions for use, Ursofalk is prescribed for various diseases caused by both alcohol abuse, an unhealthy lifestyle, and the consequences of various infections, uncontrolled self-administration of complex medications, which resulted in cell damage and impaired liver function.

What helps Ursofalk:

  1. Dyskinesia of the biliary tract;
  2. Primary biliary cirrhosis of the liver (in the absence of symptoms of decompensation);
  3. Chronic hepatitis (regardless of the cause);
  4. Cystic fibrosis or sclerosing cholangitis of the primary form;
  5. Steatohepatitis of non-alcoholic origin;
  6. Any disturbances in the functioning of the liver after prolonged alcohol abuse;
  7. Biliary reflux gastritis.

Instructions for use Ursofalk, dosage

The form and dosage of the drug depends on the pathology and weight / age of the patient. Adults and children weighing less than 34 kg are recommended to take the suspension.
When should I take Ursofalk? It is recommended before going to bed with a sufficient amount of clean water.

How to take Ursofalk? The dose of the drug is calculated from body weight - at the rate of 10 mg per 1 kg of weight. See dosage table.

Capsules Ursofalk:

Suspension for oral administration:

Quantity ml.

Dissolution of cholesterol gallstones- capsules and suspension are prescribed 1 time per day.

The duration of the course of treatment is from six months to a year. For preventive purposes, doctors recommend taking Ursofalk for some time after the disappearance of gallstones.

Treatment of biliary reflux gastritis

1 measuring cup of Ursofalk daily in the evening, before going to bed (capsules are not chewed), washed down with a small amount of water.

The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.

With cystic fibrosis- daily at a dose of 20-30 mg per 1 kg of body weight for six months to 2 years.

Primary therapy biliary cirrhosis- the daily dose depends on body weight and ranges from 3 to 7 capsules or 2-7 measuring cups (from about 14±2 mg/kg of ursodeoxycholic acid).

It is recommended that during the first 3 months of treatment with the drug, Ursofalk 250 capsules should be divided into several doses throughout the day. After some normalization of liver parameters, the daily dose of the drug can be taken 1 time in the evening (standard use).

The use of Ursofalk 250 mg capsules in primary biliary cirrhosis may be time-limited.

It is possible to use ursofalk from jaundice for newborns, according to doctors, as part of the complex therapy of persistent jaundice, the drug accelerates the recovery time. Use for indications only in a hospital under the supervision of a physician, after assessing the side effects for the newborn and potential benefits.

Contraindications Ursofalk

  • Hypersensitivity to active ingredient or any component of the drug;
  • Acute inflammation of the gallbladder or biliary tract;
  • Obstruction of the bile ducts.

Ursofalk suspension should not be prescribed to patients with a gallbladder that is not visualized by radiological methods, as well as with calcified stones, impaired contractility of the gallbladder or frequent biliary colic.

The drug is contraindicated during pregnancy and lactation. The drug can be used during pregnancy only in cases where the potential benefit of its use for the mother outweighs the possible risk to the fetus.

Side effect

Patients in most cases tolerate the medication well. In some cases, the following side effects of Ursofalk may be observed:

  • mushy stool;
  • diarrhea;
  • possible calcification of stones.

Overdose

In case of an overdose of Ursofalk, it is possible to increase the side effects of the drug, diarrhea. In the case of persistent diarrhea, it is recommended to stop treatment, use symptomatic therapy for dehydration.

Ursofalk's analogues, list of drugs

There are no analogues of the drug in the form of suspensions containing ursodeoxycholic acid as an active ingredient in the pharmacy network. Drugs of similar action (list):

  • Oveson,
  • Heptral,
  • Peponen.

Be careful - these are not complete analogues of Ursofalk, but drugs of a similar effect. Self-replacement during treatment is not allowed! It is important to understand that the instructions for use of Ursofalk, the price and reviews do not apply to analogues and cannot be used to prescribe replacements, dosages, etc.

Other analogues are cheaper than Ursofalk (depending on the network of pharmacies):

  • Ursosan
  • Urdox
  • Ursodez

Content

Liver problems can overtake any patient. The causes of diseases are unbalanced food, negative environmental conditions, long-term treatment with antibiotics or other drugs. To protect the liver, you need to take gastroprotectors - special drugs. One of the popular means of this group is Ursofalk. Check out its instructions for use.

Composition and form of release

Ursofalk is a remedy that is designed to dissolve stones in the liver and improve liver function. It is available in two formats:

Capsules (erroneously called tablets)

Suspension

Description

Opaque white capsules with white powder or granules inside

Homogeneous white suspension with lemon flavor

Ursodeoxycholic acid concentration, mg

250 per 5 ml (one measuring cup)

Auxiliary components

Water, corn starch, sodium lauryl sulfate, colloidal silicon dioxide, gelatin, magnesium stearate, titanium dioxide

Water, Benzoic Acid, Lemon Flavor, Xylitol, Sodium Chloride, Glycerol, Anhydrous lemon acid, microcrystalline cellulose, sodium cyclamate, sodium citrate, propylene glycol

Package

Blisters of 10 or 25 pcs., packs of 1, 2 or 4 blisters with instructions for use

Glass bottles 250 ml, with a measuring cup and instructions for use included

Pharmacodynamics and pharmacokinetics

Instructions for use Ursofalk contains information about its pharmacodynamic and pharmacokinetic properties. This medicine belongs to hepatoprotectors, has a choleretic effect by reducing the synthesis of cholesterol, its absorption in the intestine. The drug-hepatoprotector stimulates the synthesis and excretion of bile, has a hypoglycemic effect. Ursofalk reduces the lithogenicity of bile, increases the concentration of bile acids.

Also, the drug mobilizes cholesterol and 7-keto-lithocholic acid from gallstones, enhances the secretion of gastric and pancreatic juices, and lipase activity. Additionally, the agent serves as an immunomodulator, affects the immunological type reactions in the liver: it reduces the number of eosinophils. There is no data on the pharmacokinetics of the drug, it is not absorbed into the bloodstream, it is excreted through the rectum.

Indications for use

According to the instructions for use, Ursofalk hepatoprotector has a wide range of intended uses. The indications are:

  • dissolution of cholesterol stones in the gallbladder that have not undergone calcification;
  • primary biliary cirrhosis of the liver (not decompensated);
  • primary sclerosing cholangitis;
  • chronic hepatitis;
  • atresia;
  • cystic fibrosis (cystic fibrosis);
  • biliary reflux gastritis;
  • non-alcoholic steatohepatitis;
  • biliary dyskinesia.

How to take Ursofalk

Instructions for use of Ursofalk tablets and suspensions include a section with the rules for the use of funds. They are slightly different, but both release formats are taken orally (by mouth). The dosage of drugs depends on the age of the patient, the type of disease and the severity of its course. Each drug has its own contraindications and side effects.

Tablets Ursofalk

Adults and children weighing up to 47 kg tablets are contraindicated. For everyone else, the average daily dosage of intake is 10 mg / kg of body weight. The course of therapy lasts 0.5-1 year. To prevent the recurrence of the formation of hydrophobic cholesterol stones, the drug is taken an additional couple of months from the moment they dissolve.

In the treatment of reflux gastritis, a capsule is shown every evening for a course of 0.5–6 months, if necessary, up to two years. Treatment of liver cirrhosis involves taking 2-7 capsules every day (12-16 mg/kg body weight). Initially, for three months, the capsules are divided into several applications, after achieving normalization of liver function, the instruction suggests a transition to a single dose.

If symptoms worsen in patients with biliary cirrhosis (itching becomes more frequent), treatment consists of taking one capsule daily with a gradual increase in dose to the required. Chronic hepatitis is treated by taking 10–15 mg/kg body/day in 2–3 doses for a course of 6–12 months. For primary sclerosing cholangitis, cystic fibrosis it is supposed to take 12-15 mg / kg of body weight or 20-30 mg / kg of body weight in 2-3 doses for a course of up to several years.

With non-alcoholic steatohepatitis or alcoholic liver disease, 10-15 mg / kg of body weight is taken per day in 2-3 doses for a course of 6-12 months. If the patient has biliary dyskinesia, he is prescribed a dose of 10 mg / kg of body weight in two doses for a course of 0.5-2 months, if necessary, the therapy is repeated. The drug is taken at night, the capsules should not be chewed, they should be washed down with water.

Ursofalk suspension

For children and adults weighing up to 47 kg, Ursofalk suspension is prescribed. According to the instructions, its dosage is 10 mg / kg of body weight once / day. The approximate amount of suspension with a weight of 5-7 kg will be 1.25 ml (0.25 scoops), with 26-35 kg - 2 scoops (10 ml). Suspension is taken at night, washed down with half a glass of water. The duration of therapy is 6-12 months.

To exclude the formation of new stones, it is recommended to take the remedy for a couple of months after their complete disappearance on ultrasound. In the treatment of reflux gastritis, one scoop of Ursofalk is prescribed every evening for a course of 0.5–2 months, sometimes treatment can last up to two years. In the treatment of cirrhosis, 2-6 scoops of the drug are prescribed per day additionally with parenteral administration of other drugs.

special instructions

The use of Ursofalk tablets and suspensions, according to the instructions, is carried out under the supervision of a physician. For 90 days of therapy, liver function is monitored: blood is taken every month to determine the activity of transaminases, then every three months. This monitoring will help determine the response to treatment of patients with cirrhosis and identify organ dysfunction at early stages. Every 6-10 months, cholecystography is performed to determine the progress of the disease. Ultrasound is performed to detect calcification of gallstones.

If a gallbladder is not visualized on x-rays, the stones are calcified, the gallbladder has a weak contractility, the patient is worried about colic, the drug is not used. In the treatment of liver cirrhosis, cases of its decompensation were very rare, but after the cessation of therapy, these phenomena were partially eliminated. If the patient develops diarrhea, the dose of the drug is reduced, with the appearance of persistent diarrhea, treatment is stopped.

Ursofalk during pregnancy

According to the instructions, during pregnancy and breastfeeding (lactation), the use of Ursofalk is not recommended, only for health reasons and under medical supervision. It has been proven that the active substance of the drug does not exhibit mutagenic, hormonal, embryotoxic teratogenic effects, does not detoxify, but it is not known whether it penetrates the barriers of the placenta and the meninges.

Ursofalk for children

Children and adolescents under 18 years of age are only allowed to take the suspension according to the scheme described above. Instructions for use allow the use of the drug in newborns according to the indication of physiological jaundice, which manifests itself a week after birth. Therapy is carried out strictly under the supervision of a doctor and stops when the health of the newborn deviates.

drug interaction

The use of Ursofalk with other drugs can lead to side effects. Possible combinations and effects are indicated in the instructions:

  1. Colestyramine, antacids based on aluminum hydroxide or oxide, smectite, Colestipol reduce the level of absorption of ursodeoxycholic acid in the intestine, which leads to a decrease in its effectiveness when participating in cholestasis and increased excretion. The difference between the receptions of such groups should be two hours.
  2. The active component of the composition can enhance the absorption of Cyclosporine (in patients after organ transplantation) from the intestine, so the dose of the latter is adjusted.
  3. Sometimes Ursofalk is able to reduce the absorption of Ciprofloxacin (antibiotic), which enhances the toxic effect.
  4. Clofibrate, lipid-lowering drugs, Neomycin, estrogens or progestins can increase the degree of saturation of bile with cholesterol, reduce the effectiveness of the drug to dissolve stones.

Side effects

The use of Ursofalk may be accompanied by a number of side effects. The instruction assumes the following effects:

  • diarrhea, nausea, pain in the abdomen, right hypochondrium, calcification of stones (cholelithiasis), increased activity of liver enzymes, unformed stools, diarrhea;
  • decompensation of liver cirrhosis leaving after discontinuation of treatment;
  • allergic reactions, urticaria, pruritus.

Overdose

To date, no cases of Ursofalk overdose have been identified, because active ingredient composition of the drug is practically safe and well tolerated by patients. Possible signs of overdose of tablets or suspension poisoning will be increased side effects. According to the instructions, when they appear, symptomatic treatment and medical supervision are required.

Contraindications

Instructions for use highlights a number of contraindications in which the use of the drug is prohibited. These include:

  • X-ray-positive (containing a large amount of calcium) gallstones;
  • gallbladder dysfunction;
  • acute inflammation in the gallbladder, its ducts, intestines;
  • decompensated cirrhosis of the liver;
  • severe disorders of the kidneys, pancreas, liver, iliac tissues;
  • pregnancy, lactation;
  • hypersensitivity to ingredients, allergy to them or individual intolerance.

Terms of sale and storage

You can buy Ursofalk only with a prescription. It is stored at temperatures up to 25 degrees. The shelf life of capsules is 5 years, suspensions - 4 years. The opened bottle of suspension is stored no longer than 4 months.

Analogues

Based on ursodeoxycholic acid and its analogues, substitute drugs for Ursofalk are produced. These include:

  • Ursolit - hepatoprotective capsules with choleretic and cholelitholytic effects;
  • Ursobil is a direct substitute for a remedy with the same active ingredient;
  • Ursolvan - capsules based on ursodeoxycholeic acid;
  • Cholacid is a hepatoprotective agent;
  • Ursohol - capsules with choleretic, cholelitholytic, hepatoprotective effects;
  • Ursosan - hepatoprotective capsules;
  • Delursan - tablets for dissolving gallstones.

Price Ursofalk

You can buy Ursofalk in pharmacies or on the Internet at a cost that is influenced by the form of release of the product, the volume of the pack. Approximate prices in Moscow will be.

What is Ursofalk medicine? This European-made hepaprotector is designed to protect the liver, preserve the integrity of the tissue and functionality of the biliary tract, and prevent various pathologies, including:

  • membrane destruction;
  • problems with hepatitis;
  • the formation of stones;
  • stagnation of bile;
  • proliferation and specific increase in liver tissue;
  • accumulation of cholesterol.

The ATC drug code is A05AA02, the name accepted in the world is Ursofalk. The official website of the drug //www.drfalkpharma.ru.

In addition to diseases directly related to the liver, Ursofalk is actively used in the treatment of diseases of the esophagus and large intestine, this drug also prevents the expansion of veins in organs and slows down the growth of malignant tumors.

How is it produced?

Ursofalk is produced in only two versions:

  • capsules - 10 pieces in a blister, in a carton of 5 or 10 blisters;
  • suspension - in darkened glass bottles of 250 ml, in a cardboard box, in addition to the suspension, there is a measuring plastic cap.

In each package of Ursofalk there is an instruction for use containing detailed description medication.

Compound

The composition of the drug is ursodeoxycholic acid, as the main active substance and auxiliary, supplementing the action of the main component.

In suspension it is:

  • acids (benzoic and citric);
  • xylitol;
  • glycerol;
  • propylene glycol;
  • sodium (chlorides, cyclamates and citrates);
  • flavor "Lemon";
  • water.

For capsules it is:

  • hard starch;
  • magnesium (stearates);
  • silicon (colloids and dioxides);
  • sodium (lauryl sulfates);
  • gelatin;
  • titanium (dioxides).

More details of the composition of Ursofalk can be seen in the table:

Pharmacological influence

The hepatoprotector is characterized by a hypoglycemic effect and its use has a number of actions, including:

  • choleretic - a decrease in toxic "burning" components in bile, a decrease in the stagnation of hydrophobic acid components of bile and their effect on the tissues of the liver and ducts;
  • cytoprotective - strengthening lipids in cell membranes, which increases the protective capabilities of cell membranes and stabilizes them, normalizing functionality;
  • immunomodulatory - normalization of the work and general condition of the tissues of the organ and a decrease in the synthesis of cytokines;
  • hypercholesterolemic - a decrease in the absorption of cholesterol in the ileal "sinuses" of the intestine, the activation of its natural excretion from the body with bile.

Ursofalk's intake significantly lowers the level of bile lithogenicity, which leads to the cessation of formation and dissolution of existing ones:

  • cholesterol sand,
  • stones.

The drug affects the gastric and pancreatic processes of secretion, enhancing them.

Much of what and for what they take pills, Ursofalk cures much more effectively, due to a combination of effects on:

  • internal processes of the body
  • strengthening of organ cells.

Dynamics and kinetics in pharmacology

The drug is absorbed in the small intestine. Absorption occurs slowly, and from the amount taken in the bloodstream is from 60 to 80%.

The metabolism of the active drug component occurs:

  • in the liver - the main amount that entered the bloodstream;
  • in the intestine - with the release of keto-lithocholic acids in an insignificant amount.

The half-life varies from 3 to 5 days, excreted in the feces. To completely remove the components of Ursofalk, you need to stop taking it, hepatoprotectors have a cumulative effect.

Indications for use

Ursofalk should be prescribed for such diseases:

  • biliary or primary form of cirrhosis;
  • all types and forms of hepatitis;
  • reflux esophagitis and gastritis of the biliary form;
  • cystic fibrosis;
  • X-ray negative types of stones in the ducts of the liver or in the gallbladder;
  • atresia pathology of the bile ducts in the liver;
  • toxic poisoning of liver cells, including those caused by alcohol.

In addition, the doctor observing the patient may recommend using Ursofalk:

  • to eliminate and prevent stagnation of bile;
  • after surgical interventions directly on the liver for its speedy recovery;
  • to prevent liver health with drugs in long-term therapy with cholestatic drugs, antibiotics, or when used hormonal ways contraception.

Although the indications do not include therapy for oncology and a number of other complex diseases in the intestines and esophagus, the benefits of using Ursofalk for such ailments have been clinically proven, in practice, which is why many oncologists prescribe it for their patients.

Overdose and side effects

The drug has a well-perceived, liver-like composition, so the symptoms of an overdose of Ursofalk and side effects are the same, they are caused by a reception that does not take into account contraindications, recommended dosages or individual susceptibility.

Side effects are:

  • sudden paroxysmal diarrhea with a characteristic odor and color of stools;
  • cutting pains over the stomach, in the upper right part of the abdomen;
  • urticaria - both throughout the body and in local form.

If you drink alcohol during treatment, then side effects are inevitable.

Contraindications

Like any medicine, Ursofalk has benefits and harms. The use of this remedy will inevitably cause harm to health if taken ignoring contraindications:

  • stones, with a high percentage of calcium, giving an X-ray positive result;
  • an acute condition of inflammation and bleeding in the bile ducts, bladder or intestines;
  • decompensation stage of the course of cirrhosis;
  • anatomical or other defects in the gallbladder that led to its dysfunction or its prerequisites;
  • inflammation, bleeding, pathological dysfunctions;
  • during pregnancy and lactation;
  • personal intolerance.

How to drink Ursofalk capsules and for how long?

How to drink Ursofalk capsules and how long to do it depends on the specific ailment and the weight of the patient:

  • 60 kg - 2 capsules;
  • from 60 to 85 kg - 3 each;
  • from 85 to 105 kg - 4 each;
  • over 105 kg - from 5 capsules and more.

You need to take the medicine every evening, before going to bed, at a time.

Duration necessary treatment is also individual and can last a month. On average, with the right course of treatment and good susceptibility of the body, the terms are:

  • from six months to a year - to dissolve sand and stones;
  • from six months to one and a half years - for the treatment of hepatitis, sometimes supportive additional therapy is used, which consists in the prophylactic administration of 10-20 mg of the drug;
  • from a week to 2 years - to restore the liver after intoxication and treat cirrhosis;
  • from six months to several years - with sclerosing cholangitis and cystic fibrosis;
  • from a couple of weeks to a couple of months - in the treatment of biliary dyskinesia.

Treatment with Ursofalk is always individual. The duration, dosage and regimen are set by doctors, regardless of whether the remedy is taken in:

  • capsules
  • in the form of a suspension.

How to use the suspension?

Suspension Ursofalk is intended primarily for children and those patients whose weight is not more than 45-50 kg. Liquid Ursofalk, like capsules, should be taken based on weight:

  • 3−5 - 0.1 measuring cup;
  • 5−8 - 0.25 measuring cup;
  • 8−12 - half a measure;
  • 12−18 - 0.75 measuring cup;
  • 18-25 - 1 whole scoop;
  • 26-35 - 1.5 measuring spoons;
  • 35-50 - 2 full measuring cups;
  • 50-65 - 2.5-3 measuring cups.

In some situations, with certain intestinal diseases or if there has been an incorrect intake of any tablets, capsule therapy may not be possible. In such cases, a suspension is used, based on:

  • 66-80 kg - 3 full measuring cups;
  • 80-100 kg - 4 full measuring cups;
  • over 100 kg - from 4.5 measuring spoons.

The volume of a full measuring container contains the same amount of the drug as one capsule.

When and how to take Ursofalk: before or after meals?

The instruction to the drug informs that in the question - when and how to take Ursofalk, before or after meals - only time matters.

The medicine must be taken in the late evening, before going to bed. The liver is a “night” organ, most of the processes in it occur while a person is sleeping. In addition, in a dream, a horizontal calm position is maintained, during which the bile organ:

  • relaxes
  • the tension of muscle tissues decreases, preventing contractions that provide the bile duct.

In addition, the night state of the organs contributes to the likelihood of movement of stones, and this state of them is most favorable for the dissolution of these deposits.

Why do they drink Ursofalk at night?

That is why Ursofalk is drunk at night, while there is food in the stomach or not - it does not matter. But a heavy "cholesterol" diet, repeated from day to day, is inevitable:

  • slow down the duration of therapy
  • reduce the effectiveness of the drug.

According to the reviews of practicing doctors and the clinical evaluation of the drug by pharmacologists, Ursofalk is less dependent on the lifestyle and diet of patients than other hepaprotectors. But this does not mean that it is permissible to ignore:

  • dietary advice,
  • mode.

Drug interactions of Ursofalk with other drugs

Properties Ursofalk reduces by half simultaneous reception with:

  • colestipol;
  • cholestyramine;
  • all drugs from the antacid group;
  • all means containing aluminum oxides and hydroxides.

Ursofalk enhances the effect of Cyclosporine and reduces the effect of Ciprofloxacin.

Simultaneous administration with lipid-lowering drugs leads to the opposite result, that is, to:

  • an increase in the level of cholesterol in the composition of bile,
  • increased rate of stone formation.

Compatibility with other drugs is quite acceptable.

Terms, vacation and storage conditions

You can buy Ursofalk at any pharmacy, but only with a prescription from a doctor. We advise you to use the services of only trusted pharmacy chains:

The shelf life of the drug is:

  • 5 years - capsules;
  • 4 years - unopened vials with a suspension;
  • 4 months - for the bottle started to be used.

Place the drug in a dry place, safe from curious children, at a temperature not exceeding 20-25 degrees.

The price of Ursofalk directly depends on the number of capsules and varies from 219 to 718 rubles on average, in major cities- more expensive, in Moscow the cost of the drug reaches 1017 rubles.

Ursofalk and his analogues

Almost every medication has an analogue and not one. Ursofalk is no exception, his analogues are:

  • Ursolite;
  • Hepatrin;
  • Heptral;
  • Henofalk;
  • Ursobil;
  • Holodexan;
  • Ursolvan;
  • Liv-52;
  • Livodex;
  • Ursodex;
  • Essliver Forte;
  • Urdox;
  • Ovesol;
  • Holacid;
  • Flamin;
  • Rezalut Pro;
  • Gepabene;
  • Ursohol;
  • Heptor;
  • Hofitol;
  • Ursosan;
  • Karsil.

For some time, a drug called Ursofalk was sold on the Internet. He has nothing to do with a real European medicine, buying a medicine, you need to pay attention to how much Ursofalk costs. The price and cost of a small wholesale of a European drug cannot be too low.

mirpecheni.ru

And, nevertheless, we are HepSnickers, without stones, but with gallbladder dyskinesia, mild cholecystitis, poor bile outflow, well, as a hepatoprotection, how is it better / more correct / more effective to take Ursofalk?
3-4 times a day 1 capsule (with meals) or 3-4 capsules at bedtime with a large glass of water?

From experience I can not clearly understand which is better. It seems to be fractional, during the day, lowered trances more efficiently and more stable.
How are you? How do you accept, according to what scheme? How much do you take (by time)? Do you take breaks? Do you feel the effect is objective/subjective?

upd: stopping drinking (taking a break, for financial reasons or just tired) I begin to clearly feel the very heaviness and “tugginess” in my right side. Perhaps, of course, psychosomatics, but starting to take Ursofalk, after 3-5 days the pain and tightness disappear. This, of course, can also be psychosomatics, de brain fixed the pattern “ate Ursofalk - the pain has passed”, but this way you can come to psychosomatics in everything, even in HTP issues
___

upd2: in order not to produce topics and not litter, I'll ask right there. Here, in Honduras, we are passionate about taking NAC-long (ACC in Russian) acetylcysteine), they take it literally from everything - as an antioxidant, as a detoxifier, “for cancer”, etc., etc. I confess, I fell for the social experience, I take the 3rd week, I dissolve 1 tablet (600 mg) at night. Again - subjectively, in the morning I feel more sleepy, lighter or something.
What do you think about ACECE?

hcv.ru

Composition and form of release

To date, the drug Ursosan is produced exclusively in the form of capsules, which are sometimes mistakenly called tablets. The capsule has a gelatinous opaque shell, painted white. Inside each capsule is a powdered content, also colored white or almost white. Among the homogeneous and fine powder, there may be small pieces of white mass. In other cases, the contents of the capsule is a powder, colored white, which is compressed in the form of a column, easily disintegrating with gentle pressure.

Ursosan is produced and sold in packs of 10, 50 or 100 capsules. The manufacturer of the medicinal product is the pharmaceutical corporation PRO.MED.CS Praha, a.s.

The composition of Ursosan capsules as an active, active ingredient includes ursodeoxycholic acid. Each capsule contains 250 mg of this substance. To date, the name "ursodeoxycholic acid" is recommended for use as an international generic name, but in Russia it has historically been a tradition to call this chemical "ursodeoxycholic acid".

Ursosan capsules contain the following substances as auxiliary components:

  • corn starch;
  • magnesium stearate;
  • colloidal silicon dioxide;
  • titanium dioxide;
  • gelatin.

Action and therapeutic effects

The therapeutic effects and action of Ursosan capsules are due to ursodeoxycholic acid. This chemical compound ursodeoxycholic acid has the following pharmacological effects:
1. Hepatoprotective action.
2. Choleretic action (choleretic).
3. Anticholestatic (eliminates stagnation of bile in the liver ducts).
4. Cholelitholytic (destroys cholesterol stones).
5. Antilithogenic (prevents the formation of gallstones).
6. Hypocholesterolemic action (reduces the concentration of cholesterol in the blood).
7. Immunodulatory effect (improves immunity).
8. Antifibrotic (prevents the development of fibrous tissue and the formation of cirrhosis of the liver).

Ursodeoxycholic acid, from a chemical point of view, is a polar substance, that is, it is able to bind various non-polar substances, such as bile acids and cholesterol. Thus, Ursosan binds an excess amount of bile acids, forming micelles, and thus eliminates their toxic effect on liver cells. The drug forms micelles of the following type - inside there is bile acid, surrounded on the outside by a dense layer of several molecules of ursodeoxycholic acid. Such a structure of a complex compound allows you to reliably isolate and chemically neutralize aggressive bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.) so that they do not damage liver cells. This property of Ursosan is used in the treatment of biliary reflux gastritis and reflux esophagitis.

In addition, Ursosan affects the circulation of bile acids, which are secreted into the intestines as part of bile, and then up to 80% is absorbed back into the bloodstream and enters the liver. Ursosan reduces the reabsorption of bile acids in the intestine, thereby stimulating an increase in the synthesis and excretion of bile. Increased formation and excretion of bile increases its passage, and also accelerates the release of toxic bile acids by inhibiting their reabsorption into the blood from the intestine. It is these effects of the drug that eliminate the stagnation of bile in the hepatic ducts.

Ursosan capsules stabilize the membranes of the cells of the liver, biliary tract and epithelium of the gastrointestinal tract, which protects them from the negative effects of environmental factors. Ursodeoxycholic acid is able to enter into chemical interaction with membrane phospholipids, forming complex double molecules. These double molecules, in turn, become structural elements of the cell membrane, which enhance its strength and stabilize it. This property of Ursosan allows you to protect the cells of the liver and biliary tract from the damaging effects of free radicals - that is, the drug acts as an organ-specific antioxidant.

Ursosan capsules have a hypocholesterolemic effect, that is, they reduce the concentration of blood cholesterol by suppressing its synthesis in the liver cells. In addition, the dissolution of cholesterol in bile increases, which significantly reduces its ability to form stones. Due to this effect of the drug, gallstones, formed mainly from cholesterol, are dissolved, and the formation of new ones is also prevented.

Gain immune function under the influence of Ursosan is achieved due to the following reactions:
1. Decrease in the number of tissue compatibility antigens on the cells of the liver and bile ducts.
2. Normalization of the amount of interleukin-2.
3. Normalization of T-lymphocyte activity.
4. Normalization of the number of eosinophils.

In cystic fibrosis, liver cirrhosis or alcoholic hepatitis, Ursosan capsules delay the progression of fibrosis. Also, the drug prevents varicose veins of the esophagus.

In addition, Ursosan capsules slow down the aging process of liver and biliary tract cells, preventing a decrease in the functional activity of the organ. Prophylactic use of the drug significantly reduces the rate of progression of colon cancer. Ursosan capsules increase the production of gastric juice and digestive enzymes of the pancreas, reducing the concentration of blood glucose.

Indications for use

Ursosan capsules are used for a wide range of liver diseases, as well as for the prevention of toxic damage to the organ when working in hazardous industries or taking medicines having a negative impact. Direct indications for the use of Ursosan capsules are the following conditions:

  • Gallstone disease that occurs without complications (capsules are taken to dissolve stones in the gallbladder, as well as to prevent their formation after cholecystectomy).
  • Chronic active hepatitis.
  • Acute hepatitis.
  • Chronic and acute viral hepatitis.
  • Chronic opisthorchiasis.
  • Toxic liver damage, including drug or alcohol.
  • Alcoholic liver disease.
  • Non-alcoholic steatohepatitis.
  • Primary biliary cirrhosis of the liver.
  • Primary cholangitis, occurring with sclerosis of the biliary tract.
  • Cystic fibrosis of the liver.
  • Atresia (defective development in the prenatal period) of the intrahepatic bile ducts.
  • Dyskinesia of the biliary tract.
  • Biliary reflux gastritis and reflux esophagitis.
  • Syndrome of indigestion associated with biliary dyskinesia and gallbladder pathology.
  • Prevention of negative effects on the liver hormonal contraceptives and anticancer drugs.

Capsules Ursosan - instructions for use (how to take)

Ursosan capsules should be taken orally, without chewing, and washed down with a sufficient amount (1/2 - 1 cup) of clean water. The optimal time to take the entire daily dose of Ursosan is in the evening. The dosage and duration of the course of treatment depend on the type and severity of the pathology. On average, the dosage is calculated from the ratio of 10 mg per 1 kg of body weight. For example, a person with a body weight of 75 kg should receive an average effective dosage 75 * 10 \u003d 750 mg, which corresponds to three capsules.

For Therapy cholelithiasis(in order to dissolve stones) Ursosan is taken at a dosage of 2-5 capsules daily, for a long period of time. In this case, the duration of the course of treatment is determined by the rate of dissolution of stones, as well as the development of positive dynamics of the disease. Treatment of gallstone disease with Ursosan capsules can last from several months to several years. It is recommended to take the drug until the stones are completely dissolved, plus for another three months in order to prevent the formation of new ones. The entire daily dosage of the drug should be taken once a day - in the evening, before bedtime.

For Therapy diffuse liver diseases such as acute and chronic hepatitis, cirrhosis and others, the daily dosage of Ursosan is calculated according to the patient's body weight, based on the ratio of 10-15 mg per 1 kg of weight. For example, with a human body weight of 75 kg, the daily dose of Ursosan for him is 75 * (10 - 15) mg = 750 - 1125 mg, which corresponds to 3 - 5 capsules. Then the calculated daily dosage is divided into 2 - 3 doses per day. The resulting single dose of the drug is taken 2-3 times a day with meals. The course of treatment of these liver pathologies is long - from several months to several years. The decision on the duration of treatment is made by the doctor based on the dynamics of the disease and the patient's condition.

For Therapy biliary reflux gastritis and reflux esophagitis it is necessary to take Ursosan 1 capsule in the evening, before going to bed. The duration of therapy is determined by the dynamics of the disease and the rate of development of positive changes. The minimum course of therapy is 10 days, and the maximum is 2 years. During this period, Ursosan can be taken without interruption.

For prevention of stone formation after surgery to remove the gallbladder (cholecystectomy), you must take Ursosan 1 capsule twice a day, for 3-4 months.

For the treatment of liver damage of toxic, medicinal or alcoholic origin, as well as biliary atresia, the individual daily dosage is calculated by body weight, based on the ratio of 10-15 mg per 1 kg of weight. For example, with a human body weight of 75 kg, the daily dose of Ursosan for him is 75 * (10 - 15) mg = 750 - 1125 mg, which corresponds to 3 - 5 capsules. The resulting daily amount of the drug is divided into 2 doses. The single dosage calculated in this way is taken twice a day with meals, for 6 to 12 months.

Therapy primary biliary cirrhosis carried out by Ursosan in dosages calculated by body weight, based on the ratio of 15-20 mg per 1 kg of weight. For example, with a human body weight of 75 kg, the daily dose of Ursosan for him is 75 * (15 - 20) mg = 1125 - 1500 mg, which corresponds to 4 - 6 capsules. The resulting daily amount of the drug is divided into 2-3 doses. The single dosage calculated in this way is taken 2-3 times a day with meals, for six months to several years.

Sclerosing cholangitis requires the use of Ursosan at a dosage of 12-15 mg per 1 kg of body weight per day. The daily dosage, calculated by body weight, is divided by 2 - 3 in order to find out a single dose. Then the calculated single dosage is taken 2-3 times a day for a long period of time (from six months to several years). The average single dosage of Ursosan is 2 capsules three times a day.

Therapy non-alcoholic steatohepatitis requires the use of Ursosan in a dosage, which is calculated by body weight, based on the ratio of 13-15 mg per 1 kg of weight. The resulting daily dosage is divided into 2 - 3 doses per day. Treatment requires daily use of the drug for a long period of time - from six months to several years.

cystic fibrosis requires the use of Ursosan at a dosage of 20-30 mg per 1 kg of body weight. For example, for a person with a body weight of 75 kg, a daily dosage of the drug is 75 * (20 - 30) mg = 1500 - 2250 mg, which corresponds to 6 - 9 capsules. The total daily amount of 6 - 9 capsules is divided into 2 - 3 doses per day with meals. Ursosan is taken daily for a long period of time - from six months to several years.

If necessary dissolve cholesterol stones Ursosan can be taken only if the calculi are X-ray negative, their size is not more than 15 - 20 mm in diameter. It is also necessary that the gallbladder perform its function well, and the total number of stones in it should not exceed half the volume of the organs. In addition, for the successful dissolution of gallstones with the help of Ursosan, good patency of the cystic and common ducts, through which bile is excreted into the duodenum, is required.

The use of Ursosan capsules for more than 1 month requires regular monitoring of the activity of transaminases (AsAT, ALT). At the same time, in the first three months of treatment, the activity of enzymes is determined once every four weeks. And in the future, the activity of transaminases is monitored once every three months. Apart from biochemical analysis blood, while taking Ursosan, a control ultrasound (ultrasound) examination of the biliary tract should be carried out every six months.

After the dissolution of gallstones, it is necessary to prophylactically extend the intake of Ursosan for another 3 months. This measure is necessary to completely dissolve the remains of stones, the size of which does not allow them to be detected by various examination methods, as well as to prevent the formation of new stones in the future.

Overdose

An overdose of Ursosan capsules has not been detected even once during the entire period of use of the drug.

Interaction with other drugs

Simultaneous use with aluminum-containing antacids (for example, Almagel, Gastal, etc.) or Cholestyramine reduces the effectiveness of Ursosan.

The simultaneous use of Ursosan with the following drugs reduces its activity in dissolving gallstones:

  • Clofibrate;
  • estrogens (eg estradiol, estriol, etc.);
  • Neomycin;
  • progestins (eg Desogestrel, Dydrogesterone, Levonorgesterl, Linestrenol, Megestrol, Medroxyprogesterone, etc.).

Ursosan - before meals or after?

Due to the peculiarities of absorption, excretion and distribution of the drug in the human body, Ursosan capsules should be taken with meals or immediately after the meal. However, the best option is to take the drug with food.

Ursosan during pregnancy

The use of Ursosan during pregnancy and lactation is possible in situations where the benefit of the drug will exceed possible risks. This position is based on the fact that large-scale and full-fledged trials of the drug in pregnant women were not conducted for understandable ethical reasons. However, according to experimental data obtained in the course of animal studies, there was no negative effect of Ursosan on the fetus.

German researchers conducted limited clinical trials of Ursosan, during which the drug was taken by pregnant women with severe disorders of the liver and biliary tract. Ursosan was necessary for this group of pregnant women for health reasons. The study did not reveal negative impact on the condition of the child. Due to this circumstance, practical doctors in Germany and France came to the conclusion that Ursosan can be used during pregnancy to treat the following common conditions:
1. Violation of the outflow of bile due to compression of the gallbladder by an enlarging uterus.
2. Chronic pathologies of the gallbladder in the acute stage (for example, colic against the background of the movement of stones).
3. Itching of pregnant women, due to a violation of bile secretion.
4. Chronic liver pathologies, accompanied by a deterioration in well-being and an increase in the activity of AST, ALT, bilirubin and other laboratory tests.

Very often, pregnant women experience excruciating itching, which is due to the fact that the uterus squeezes the gallbladder and disrupts the outflow of bile. Stagnation of bile, in turn, leads to the active excretion of bile acids through the skin, which is accompanied by unbearable itching. This condition can be observed in perfectly healthy pregnant women or in women suffering from various pathologies of the liver and biliary tract. Ursosan in such situations effectively eliminates the itching of pregnant women. Usually you need to take 1 - 2 capsules in the evening, with meals, daily for 1 month. If necessary, the course of taking Ursosan can be extended until childbirth. Pregnant women should remember that itching is a functional reflection of the load on the liver and gallbladder. But itching does not have a negative effect on the child's condition.

Ursosan is also effective for the treatment of gallstone attacks, as well as for maintaining the functional state of the liver in chronic hepatitis in pregnant women. In such situations, Ursosan should be taken 2 capsules twice a day for a month. If the condition has not returned to normal, then the drug can be extended until childbirth.

Ursosan for newborns - instructions for use

A newborn baby may develop jaundice, which is a physiological condition. Physiological is considered jaundice, which lasts no longer than three weeks. If after three weeks the jaundice does not decrease, then we are talking about pathological condition. If jaundice gradually decreases, but by the first month after birth it has not completely disappeared, then this is a variant of the norm. Gradual normalization of color is allowed skin up to 4 months. In these situations, neonatologists recommend not taking any medication.

Jaundice in newborns is caused by the breakdown of a large amount of hemoglobin, which his liver is not able to quickly remove. However, with very severe jaundice, when the bilirubin content is high, damage to the central nervous system. In such situations, it is necessary to reduce the concentration of bilirubin by medication. To eliminate such severe and dangerous jaundice, doctors recommend giving the child Ursosan. The drug is taken 2 - 4 weeks in a row, a quarter capsule daily. Doctors recommend pouring the contents of the capsule on a saucer, dividing it into 4 equal parts and giving it to the child, dissolving it in water or breast milk.

With good, positive dynamics (that is, if jaundice disappears quickly), you can reduce the course of treatment to 10 days. Every week, while taking Ursosan, the concentration of bilirubin in the blood should be monitored. On average, a weekly intake of Ursosan provides a decrease in the concentration of bilirubin by 50 units. After reaching the concentration of bilirubin in the blood equal to 100 mg / ml, the drug can be canceled.

Ursosan for children - application

Ursosan can be used to treat various diseases liver and biliary tract in children from 2 years of age. In this case, the dosage is calculated for each child individually, depending on body weight, based on the ratio of 10-20 mg per 1 kg of weight. In this case, the child should be given the entire daily dosage in the evening, with meals.

If a large enough capsule cannot be swallowed whole, the contents should be poured into water and dissolved. Then let the child drink Ursosan in the form of a solution. In this case, it should be ensured that the child drank the entire solution. In children aged 2-4 years, it may be difficult to swallow capsules, so it is necessary to control the moment of taking the drug.

As a rule, children tolerate this drug well. Ursosan helps in the treatment of acute hepatitis childhood, as well as with various disorders of the outflow of bile (for example, with atresia of the bile ducts). Also, Ursosan will help to cope with various digestive disorders in children that occur when fatty or fried foods are abused.

Ursosan for hepatitis C

Hepatitis C is a serious disease that greatly increases the risk of developing liver cancer. In addition, with a prolonged course of hepatitis C, the liver degenerates, as a result of which normal cellular structures are replaced by fibrous tissue. After some time, fibrosis of the liver leads to a formidable disease - cirrhosis of the liver. Ursosan prevents the development of fibrosis, and also significantly reduces the rate of formation of cirrhosis of the liver. In this case, Ursosan can be considered as a drug that is necessary to prolong the life of a person suffering from hepatitis C.

With hepatitis C, Ursosan is taken for the rest of his life in courses several times a year. Usually a course is prescribed for 1 month, then you need to take a break for 2 - 3 months. Thus, it is necessary to constantly take courses of therapy with the indicated intervals between them. During treatment, the drug is taken 2 capsules twice a day with meals or immediately after a meal with a glass of clean water.

When starting to take Ursosan for hepatitis C, it should be remembered that this drug does not cure liver pathology, but prevents the development of fibrosis and cirrhosis. To date, the treatment of hepatitis C is exclusively antiviral therapy, which is carried out with potent interferon preparations. And Ursosan helps to maintain a good functional state of the liver and effectively cleanse the body of toxic substances.

Side effects

Ursosan capsules are usually well tolerated by patients, but they have few side effects. Most often, Ursosan causes side effects related to the digestive tract, such as:

  • nausea;
  • vomit;
  • diarrhea;
  • constipation;
  • periodic increase in the activity of hepatic transaminases (AlAT, AsAT);
  • calcification of gallstones;
  • stomach ache.

Moreover, the development of diarrhea against the background of Ursosan may depend on the dosage. That is, when taking 3 capsules, a person may develop diarrhea, and when using a smaller dosage - only 1 or 2 capsules, this indigestion will not occur. Therefore, if diarrhea occurs while taking Ursosan, the total daily dosage should be slightly reduced.

Apart from side effects on the digestive tract, Ursosan is able to cause undesirable effects from other organs and systems, such as:

  • back pain;
  • allergic reactions;
  • itching of the skin;
  • baldness.

Contraindications

Ursosan capsules have absolute and relative contraindications. Relative contraindications include the age of the child from 2 to 4 years, since children in this period may have difficulty swallowing a rather large capsule. However, in principle, a child can take Ursosan, since there are no age restrictions this drug does not have.

In the presence of absolute contraindications, Ursosan should not be taken in any case. Absolute contraindications include the following conditions:

  • X-ray positive pattern of gallstones (i.e. high content calcium in stones);
  • low functional activity of the gallbladder;
  • biliary gastrointestinal fistula;
  • acute cholecystitis;
  • acute cholangitis;
  • cirrhosis in the stage of decompensation;
  • liver failure;
  • kidney failure;
  • blockage of the bile ducts;
  • acute diseases of the gallbladder and bile ducts of an infectious nature;
  • empyema of the gallbladder;
  • sensitivity, allergy or intolerance to the components of Ursosan.

Analogues

The drug Ursosan in the domestic pharmaceutical market has analogues and synonyms. Synonyms include drugs that, like Ursosan, contain ursodeoxycholic acid as an active ingredient. Analogues are drugs that have therapeutic effects similar to Ursosan, but contain other substances as active ingredients.

In the Russian pharmaceutical market, Ursosan is synonymous with the following drugs:

  • Livodex - film-coated tablets;
  • Urdoksa - capsules;
  • Ursodeoxycholic acid - capsules;
  • Ursodex - film-coated tablets;
  • Ursoliv - capsules;
  • Ursor Rompharm - capsules;
  • Ursofalk - capsules and suspension;
  • Urso 100 - capsules;
  • Ursodez - capsules;
  • Ursor S - capsules;
  • Choludexan - capsules;
  • Exhol - capsules.

Analogues of Ursosan capsules are the following drugs:

  • Allohol - tablets;
  • Holenzym - tablets.