Ursofalk contraindications. In what cases is use prohibited? Composition and medical indications

• Compound
• Indications for use
• Contraindications
• Directions for use and doses
• Side effect
• Overdose
• Features of application
• Precautionary measures
• Release form
• Storage conditions
• Best before date

Compound

The active ingredient 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 is the active substance of Ursofalk 250 mg capsules. It is a naturally occurring bile acid that is found in small amounts in human bile.

Ursofalk capsules in a dosage of 250 mg are used:

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

- for the treatment of inflammation in the stomach caused by reverse flow bile acids(bile reflux gastritis);

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

Contraindications

- you have acute inflammatory diseases gallbladder or bile ducts;

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

- You are pregnant;

- gallstones of non-cholesterol origin;

- you have calcification gallstones;

— you have impaired contractile function of the gallbladder;

— You suffer from frequent cramping pain in the upper abdominal cavity.

Please tell your healthcare provider if you have 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 are limited. Animal studies have shown evidence of teratogenic effects when taken in the first trimester ( early stage) pregnancy. You should not use Ursofalk during pregnancy until your doctor, after weighing the benefits and risks, decides that it is absolutely necessary.

Before taking Ursofalk, pregnancy should be excluded. Women of childbearing age can use Ursofalk only when using reliable contraception.

Breastfeeding period

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

Directions for use and doses

For the treatment of biliary reflux gastritis:

Take 1 capsule 1 time per day, in the evening, before bed, 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. After laboratory results improve, the daily dose of the drug can be taken once, in the evening.

The use of Ursofalk, capsules 250 mg for 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, 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 achieved again.

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

Side effect

Like other medicines, Ursofalk can cause side effects and may not be suitable for all patients.

Common side effects (occurs in less than 1 in 10 patients and occurs in less than 1 in 100 patients):

- soft, frequent loose stools or diarrhea.

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

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

- calcification of stones;

- allergic reaction (urticaria).

If any of the side effects get worse or you notice more adverse reactions medicinal products not listed in this leaflet, please tell your doctor.

Overdose

An overdose may result in diarrhea. Please tell your doctor immediately if diarrhea continues, as the dose may need to be reduced. If you suffer from diarrhea, take enough fluids to restore your fluid balance.

Interaction with other drugs

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

Possible reduction in the effect of the following drugs when taken simultaneously with Ursofalk, capsules 250 mg:

- 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 drug containing any of these active substances, you should take it 2 hours before or after taking Ursofalk capsules.

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

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

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

Please tell your doctor or pharmacist about all the drugs you take, even those without a prescription. Your doctor will determine which medications and in what dosage are the priority for you at the moment.

Pregnancy and breastfeeding.

Before using any medicine, you should consult your doctor.

Features of application

Use 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.

Ability to operate vehicles or machinery.

There was no effect on the ability to drive vehicles or operate machinery.

Precautionary measures

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

Your healthcare provider should monitor liver function tests every 4 weeks during the first three months of treatment. After this, monitoring should be carried out every 3 months.

Release form

Ursofalk capsules at a dosage of 250 mg are white, opaque, hard gelatin capsules containing 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 medications out of the reach of children.

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Indications for use of Ursofalk are quite extensive:

• Liver cirrhosis, primary biliary;
• Sclerosing cholangitis;
• GSD (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 due to cystic fibrosis;
• Consequences of liver transplant surgery;
• Long-term use of hepatotoxic and cholestatic drugs (hormones, including contraceptives, some antibiotics, etc.);
• Atresia of the bile ducts inside the liver.

Contraindications

Patient conditions in which Ursofalk is contraindicated:

• Allergy to the drug and its components;
• Acute cholecystitis;
• Acute cholangitis;
• GSD with a stone size of more than 15 mm;
• Obturation biliary tract(overlapping with stone);
• Hypomotor disorders in the gallbladder (decreased motor activity);
• Biliary colic;
• Lactation period;
• Children under 3 years of age (for the drug in capsule form);
• Liver cirrhosis, decompensation;
• Kidney failure;
• Liver failure.

Operating principle

Once in the systemic bloodstream, Ursofalk has hepatoprotective, cholelytic and immunomodulatory effects. The active ingredient of the drug reduces bile acids in bile and removes them through the intestines, which reduces bile stagnation in the liver and gallbladder. The drug also restores the membrane of hepatocytes, improves its ability to protect itself from toxins and other harmful substances. Ursofalk reduces inflammatory processes in the liver, gall bladder and bile ducts. In addition, Ursofalk promotes the dissolution of soft cholesterol stones.

Mode of application

Ursofalk in capsule form

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

• Dissolution of stones - for patient weights up to 60 kg - 2 capsules in the evening; 60-80 kg – 3 capsules; 80-100 kg – 4 capsules; from 100 kg – 5 capsules. 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; over 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 per kg of patient weight, divided into 2-3 doses. The course of treatment is about 1 year. Can be extended if necessary

Ursofalk in suspension form

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 calculations of dosages for specific pathologies, taking into account that 5 ml contains 250 mg of the drug, and 1 ml – 50 mg, respectively:

• Dissolving 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 ranges from 6 months to 1 year
• Biliary cirrhosis: with a weight of 5-7 kg – 1.25 ml once a day, in the evening; 8-12 kg – 1.25 ml day and evening; 13-18 kg – 1.25 ml three times a day; 19-25 kg – 2.5 ml morning and evening; 26-35 kg – 2.5 ml three times a day; 36-50 kg – 5 ml 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 patient weight, dividing the dose into 2-3 times. The course of treatment averages about 6 months, but can be extended to 2-3 years
• Steatohepatitis and alcoholic liver disease - 10-15 mg per kg of patient weight, divided into 2-3 doses. Course of treatment – ​​6-18 months
• Biliary dyskinesia – 10 mg per kg of weight, divided into 2 doses. Course of treatment – ​​from 2 weeks to 2 months

Side effects of Ursofalk

Ursofalk causes side effects extremely rarely, and all of them disappear after reducing the dosage of the drug or after its discontinuation:

• Abdominal pain;
• Loose stools;
• Itchy skin rash;
• Nausea.

There have been no reports of cases of overdose with this drug.

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, it is recommended to stop breastfeeding for the entire period of treatment, 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: Ursofalk

ursodeoxycholic acid;, ursodeoxycholic acid

Ursofalk release forms

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

Who is Ursofalk indicated for?

For the dissolution of radiopaque cholesterol gallstones no more than 15 mm in diameter in patients with a functioning gallbladder, regardless of the presence of gallstone(s) in it. 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 different 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, once a day, with a small amount of liquid, in the evening before bed. The time required for gallstones to dissolve is usually 6 - 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 using ultrasound or cholecystography every 6 months. It is necessary to conduct additional studies to identify possible calcification of stones, which should be the basis for discontinuation of treatment.

For the treatment of gastritis with bile reflux:
Take one capsule daily with a small amount of liquid in the evening before bed. Ursofalk capsules usually need to be taken for 10 to 14 days. As a rule, the duration of treatment depends on the course of the disease. The decision on the duration of treatment is made by the doctor on an individual basis.
For the symptomatic treatment of primary biliary cirrhosis (PBC):
The daily dose depends on body weight and ranges from approximately 2 to 6 capsules (approximately 10 - 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 for 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 an oral suspension.
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 with 1 capsule of Ursofalk per day, and then gradually increase the dose (by 1 capsule weekly) until the recommended dose is reached.

Features of application

Ursofalk capsules should be used under medical supervision. During the first three months of treatment, liver function parameters (AST (SGOT), ALT (SGPT) and g-gt) should be checked every 4 weeks, and then every 3 months.
To assess the progress of treatment and detect calcification of gallstones in advance, depending on the size of the stone, it is necessary to conduct a study of the general condition of the gallbladder (cholecystography) and possible obstruction in a standing and supine position (ultrasound control) 6 to 10 months from the start of treatment.
There were no effects on the ability to drive or use tools.

Side effects of Ursofalk

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

• In clinical trials, there have been reports of loose bowel movements or diarrhea during ursodeoxycholic acid therapy (common). During treatment of primary biliary cirrhosis, there was severe pain in the right upper abdominal cavity (very rare);
• liver and gallbladder disorders (very rare);
• When treated with ursodeoxycholic acid, calcification of gallstones may occur. When treating advanced stages of primary biliary cirrhosis, decompensation of hepatic cirrhosis was observed, which partially regressed after cessation of treatment.

Hypersensitivity reactions (very rare): A rash may occur.

Who is Ursofalk contraindicated for?

In case of 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
There is insufficient experience with the use of the drug during the first trimester of pregnancy in humans. Women of childbearing age can take the drug only if they are using reliable contraceptives. Before starting treatment, pregnancy should be excluded. Since there is insufficient data regarding the penetration of ursodeoxycholic acid into breast milk, it should not be taken during lactation.

Ursofalk interaction

Ursofalk capsules should not be used simultaneously with cholestyramine, colestipol or antacid drugs that contain 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 cyclosporine, it is necessary to check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine 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 from the only report of interaction with the substance dapsone (reduction of the 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, when concomitantly using drugs that are metabolized by this enzyme, caution must be exercised and it must be kept in mind that dosage adjustment may be necessary.

Overdose of Ursofalk

In case of overdose, diarrhea may occur. In general, overdose is unlikely because the absorption of ursodeoxycholic acid decreases with increasing doses and it is mostly excreted in the feces. If diarrhea occurs, the dose should be reduced, and if diarrhea continues, 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

According to the instructions, Ursofalk has a choleretic, cholesterol-lowering effect that destroys cholesterol stones.

The drug protects the membranes of liver and bile duct cells from damage by toxic bile acids, and also prevents the proliferation of connective tissue in the liver in case of damage to hepatocytes.

Ursofalk contains urodeoxycholic acid. It seems to delimit the smallest structures of bile acids with a structural shell - it forms so-called mixed micelles. Urodeoxycholic acid also interacts with the lipophilic structures of membranes, making them resistant to damage. Thus, it realizes 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 liver level it slows down the development of fibrosis in patients with cystic fibrosis, primary biliary cirrhosis, alcoholic liver disease, and reduces the likelihood of esophageal varicose veins. There are positive reviews about Ursofalk when it is included in a program for the treatment of malignant diseases of the 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 (bottles of 250 ml, urodeoxycholic acid content - 250 mg/5 ml).

Indications for use of Ursofalk

The drug is prescribed for the treatment of primary biliary cirrhosis in a compensated state, biliary reflux gastritis, for the dissolution of cholesterol stones in the gall bladder and in the case of cholestasis during parenteral nutrition, in the complex treatment of cystic fibrosis, biliary dyskinesia. It is also recommended for preventing 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 conjugative hyperbilirubinemia (jaundice).

The drug Ursofalk belongs to the group of hepatoprotectors. It contains ursodeoxycholic acid. Forms of release of the drug:

• Capsules – 250 mg of active substance each;
• Oral suspension, 250 ml – 250 mg of active substance in every 5 ml.

Indications for use of Ursofalk are quite extensive:

• Liver cirrhosis, primary biliary;
• Sclerosing cholangitis;
• GSD (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 due to cystic fibrosis;
• Consequences of liver transplant surgery;
• Long-term use of hepatotoxic and cholestatic drugs (hormones, including contraceptives, some antibiotics, etc.);
• Atresia of the bile ducts inside the liver.

Contraindications

Patient conditions in which Ursofalk is contraindicated:

• Allergy to the drug and its components;
• Acute cholecystitis;
• Acute cholangitis;
• GSD with a stone size of more than 15 mm;
• Obstruction of the bile ducts (blocking with a stone);
• Hypomotor disorders in the gallbladder (decreased motor activity);
• Biliary colic;
• Lactation period;
• Children under 3 years of age (for the drug in capsule form);
• Liver cirrhosis, decompensation;
• Kidney failure;
• Liver failure.

Operating principle

Once in the systemic bloodstream, Ursofalk has hepatoprotective, cholelytic and immunomodulatory effects. The active ingredient of the drug reduces bile acids in bile and removes them through the intestines, which reduces bile stagnation in the liver and gallbladder. The drug also restores the membrane of hepatocytes, improves its ability to protect itself from toxins and other harmful substances. Ursofalk reduces inflammatory processes in the liver, gall bladder and bile ducts. In addition, Ursofalk promotes the dissolution of soft cholesterol stones.

Mode of application

Ursofalk in capsule form

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

• Dissolution of stones - for patient weights up to 60 kg - 2 capsules in the evening; 60-80 kg – 3 capsules; 80-100 kg – 4 capsules; from 100 kg – 5 capsules. 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; over 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 per kg of patient weight, divided into 2-3 doses. The course of treatment is about 1 year. Can be extended if necessary

Ursofalk in suspension form

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 calculations of dosages for specific pathologies, taking into account that 5 ml contains 250 mg of the drug, and 1 ml – 50 mg, respectively:

• Dissolving 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 ranges from 6 months to 1 year
• Biliary cirrhosis: with a weight of 5-7 kg – 1.25 ml once a day, in the evening; 8-12 kg – 1.25 ml day and evening; 13-18 kg – 1.25 ml three times a day; 19-25 kg – 2.5 ml morning and evening; 26-35 kg – 2.5 ml three times a day; 36-50 kg – 5 ml 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 patient weight, dividing the dose into 2-3 times. The course of treatment averages about 6 months, but can be extended to 2-3 years
• Steatohepatitis and alcoholic liver disease - 10-15 mg per kg of patient weight, divided into 2-3 doses. Course of treatment – ​​6-18 months
• Biliary dyskinesia – 10 mg per kg of weight, divided into 2 doses. Course of treatment – ​​from 2 weeks to 2 months

Side effects of Ursofalk

Ursofalk causes side effects extremely rarely, and all of them disappear after reducing the dosage of the drug or after its discontinuation:

• Abdominal pain;
• Loose stools;
• Itchy skin rash;
• Nausea.

There have been no reports of cases of overdose with this drug.

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, it is recommended to stop breastfeeding for the entire period of treatment, 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.

gepatus.ru

Our liver is exposed to a lot of stress every day, and the functioning of all organs and systems largely depends on its proper functioning. In certain situations, liver function may be disrupted, and it begins to require increased attention and certain therapeutic measures. So, to eliminate and prevent a number of problems with this organ, special medicinal compositions - hepatoprotectors - can be used. One of the drugs of this type is Ursofalk. Today we will talk about the features of using this medication.

What does Ursofalk do?

According to the instructions, this medicinal composition has an effective choleretic effect, it destroys cholesterol-type stones and eliminates excess “bad” cholesterol in the body.

Consumption of the drug has a protective effect on the cell membrane of hepatocytes, as well as on the cells of the bile ducts, protecting them from injury by toxic bile acids. In addition, this medicine prevents connective tissues from growing inside the liver if for some reason its cells have been damaged.

What is the use of Ursofalk?

The drug is prescribed for the treatment of the primary type of biliary cirrhosis, if it is in a compensated state. It also relieves biliary reflux gastritis and dissolves cholesterol formations inside the gallbladder. Ursofalk can also be prescribed for cholestasis, if it is accompanied by parenteral nutrition, and as part of a complex therapy for cystic fibrosis and biliary dyskinesia. This medicinal composition is used to prevent the development of colon cancer in those people who are at high risk for this disease.

Urosofalk can be used in relation to various age groups without restrictions. It is often used to reduce the amount of indirect bilirubin in the blood of newborns with a diagnosis of conjugative hyperbilirubinemia.

The medicine is consumed once a day (immediately before bedtime) orally with some liquid. The drug is available in capsules that do not need to be opened. To calculate the average daily dose it is necessary to carry out a calculation - ten milligrams of the medicinal substance are used for every kilogram of body weight. If the dosage exceeds the average, it can be divided into two or three doses.

Ursofalk suspension is intended for the treatment of children from three years of age and those who weigh less than thirty-four kilograms, or for patients with difficulty swallowing. The use of this medicinal composition should be continued for a long time - from a couple of months to two years, without taking breaks in therapy.

If Ursofalk is designed to dissolve stones inside the gallbladder, then before starting therapy you need to make sure of their cholesterol composition (they are not visible during X-ray examination). In addition, the size of the formations should not exceed twenty millimeters, they should fill the gallbladder by less than half, and not interfere with the patency of the bile ducts. It is worth considering that the instructions for use do not recommend consuming Ursofalk in parallel with medications that increase the level of cholesterol in bile (clofibrate, estrogens, etc. have such properties). In addition, antacids significantly impair the absorption of the drug composition.

When treating urolithiasis, the duration of stone dissolution can range from six months to two years, however, if the consumption of Ursofalk does not lead to positive dynamics within one year, then treatment with its help is considered inappropriate. In order to monitor the processes of eliminating stones, it is worth systematically (every six months) to conduct x-ray and ultrasound examinations of the liver, as well as the biliary tract.

To correct biliary reflux gastritis or reflux esophagitis, the duration of consumption should be ten to fourteen days.

When treating Cystic Fibrosis, Ursofalk is prescribed twenty to thirty milligrams of the drug per kilogram of body weight (this is the daily amount). If the patient has a primary form of biliary cirrhosis, then the recommended dosage can range from fifteen to twenty milligrams per kilogram of weight.

What are Ursofalk's analogues?

Such medicinal compositions as Livodexa, Urdoxa, Urso 100, Ursodez, Ursodeoxycholic acid, Ursodex, Ursoliv, Ursorom Rompharm, Ursorom S, Ursosan, Choludexin, Exchol have a similar composition and effect.

If you plan to replace the composition prescribed to you with a similar one, do not forget to consult your doctor.

What are Ursofalk's contraindications?

This medicinal composition should not be used if the patient has an individual intolerance to its components. Ursofalk is not prescribed if the gallbladders are visible on x-ray, this indicates a high calcium content in them. Also, this drug is contraindicated if the patient has inflammatory lesions of the biliary tract or intestines, decompensated cirrhosis of the liver, non-functioning gallbladder, failure of the kidneys, liver or pancreas.

What are the side effects of Ursofalk?

Nausea, diarrhea, pain in the right hypochondrium or epigastric region, allergic reactions, calcification of gallstones.

As you can see, the use of Ursofalk should be carried out exclusively under doctor's supervision.

Ekaterina, www.rasteniya-lecarstvennie.ru
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Pharmacological action of Ursofalk

According to the instructions, Ursofalk has a choleretic, cholesterol-lowering effect that destroys cholesterol stones.

The drug protects the membranes of liver and bile duct cells from damage by toxic bile acids, and also prevents the proliferation of connective tissue in the liver in case of damage to hepatocytes.

Ursofalk contains urodeoxycholic acid. It seems to delimit the smallest structures of bile acids with a structural shell - it forms so-called mixed micelles. Urodeoxycholic acid also interacts with the lipophilic structures of membranes, making them resistant to damage. Thus, it realizes 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 liver level it slows down the development of fibrosis in patients with cystic fibrosis, primary biliary cirrhosis, alcoholic liver disease, and reduces the likelihood of esophageal varicose veins. There are positive reviews about Ursofalk when it is included in a program for the treatment of malignant diseases of the 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 (bottles of 250 ml, urodeoxycholic acid content - 250 mg/5 ml).

Indications for use of Ursofalk

The drug is prescribed for the treatment of primary biliary cirrhosis in a compensated state, biliary reflux gastritis, for the dissolution of cholesterol stones in the gall bladder and in the case of cholestasis during parenteral nutrition, in the complex treatment of cystic fibrosis, biliary dyskinesia. It is also recommended for preventing 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 conjugative hyperbilirubinemia (jaundice).

Contraindications

According to the instructions, Ursofalk is not used in case of individual intolerance to it, in the case of X-ray positive gallstones (they contain a lot of calcium), inflammatory diseases of the biliary tract and intestines, decompensated cirrhosis of the liver, non-functioning gallbladder, and disorders of the kidneys, liver or pancreas.

Instructions for use of Ursofalk

The drug is taken 1 time per day (at night) orally. The capsule is swallowed without opening the shell and washed down with water. The average daily dose of Ursofalk is calculated based on the patient’s body weight and is 10 mg/kg/day. If the dosage exceeds the average, you can divide the daily dose into 2 - 3 doses. Ursofalk suspension is recommended for the treatment of children under 3 years of age and patients weighing less than 34 kg, as well as for difficulty swallowing. It is recommended to take the drug for a long time - from several months to 2 years, without interruptions in treatment.

To dissolve stones in the gall bladder, before starting treatment, you should make sure that they are cholesterol (they are not visible on an x-ray), are no larger than 20 mm in size, fill the gallbladder no more than half, while maintaining the patency of the bile ducts. Like its analogues, Ursofalk is not recommended for use simultaneously with drugs that increase the cholesterol content in bile (clofibrate, estrogens, etc.). Antacids impair the absorption of the drug.

In the case of cholelithiasis, the duration of dissolution of stones is from 6 to 24 months, but if after 12 months from the start of treatment no positive dynamics are noted, Ursofalk can be discontinued, since further treatment with it is inappropriate. To monitor the effectiveness of treatment, the liver and biliary tract should be examined once every six months using ultrasound and x-ray.

For biliary reflux gastritis and reflux esophagitis, the course of treatment lasts on average 10–14 days.

For cystic fibrosis, the daily dose of Ursofalk reaches 20–30 mg/kg/day, for primary biliary cirrhosis up to 15–20 mg/kg/day.

Analogues of Ursofalk are Ursosan, Urdoxa and Ursodez.

Side effects

According to reviews, Ursofalk sometimes causes allergic reactions, diarrhea, dyspepsia, and calcification of gallstones.

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Composition and properties

The drug is available in the form of capsules and suspensions for oral administration.

The active substance of one capsule is ursodeoxycholic acid – 250 mg. Additional components:

• gelatin,
• titanium dioxide,
• magnesium stearate,
• purified water,
• maize starch,
• sodium dodecyl sulfate,
• silica.

The active component of 5 ml of suspension is ursodeoxycholic acid – 250 mg. Additional substances:

lemon flavoring,

• xylitol,
• benzoic acid,
• sodium chloride,
• purified water,
• Avicel RC 591,
• sodium citrate,
• glycerol,
• sodium cyclamate,
• propylene glycol.

The drug has the properties of a wide range of actions:

• lowers blood cholesterol levels and dissolves formed cholesterol gallstones,
• has a hepatoprotective, immunomodulatory effect,
• has a choleretic effect,
• reduces the absorption of toxins in the ileum,
• improves the protective properties of the cell membrane,
• reduces the amount of cholesterol in bile,
• has a preventive effect on the development of varicose veins of the esophagus.

Indications and contraindications

Indications for the use of the drug "Ursofalk" are: the following violations:

cystic fibrosis,

• primary biliary cirrhosis,
• acute hepatitis,
• cholestasis with parenteral nutrition,
• primary sclerosing cholangitis,
• biliary dyskinesia,
• cholesterol stones in the gall bladder (if they cannot be removed surgically),
• alcoholic liver damage,
• chronic active hepatitis,
• prevention of liver diseases,
• atresia of the intrahepatic biliary tract,
• prevention of colon cancer,
• liver damage with cholestasis in children.

When taking a drug to treat cholelithiasis, you must be examined by a doctor every six months.

Contraindications for use medicine:

• gallstones with high content calcium,
• hypersensitivity to the components of the drug,
• liver cirrhosis in the stage of decompensation,
• pregnancy and breastfeeding,
• non-functioning gallbladder,
• dysfunction of the liver, kidneys, pancreas,
• inflammatory diseases of the intestines, gall bladder, bile ducts in the acute stage.

The effect of the drug on the course of pregnancy has not been fully studied, however, the acid included in the composition penetrates the placental barrier.

Instructions for use

The method of using Ursofalk depends on the patient’s weight:

children and adults weighing less than 34 kilograms can only take the suspension,

• children weighing from 5 to 7 kg – 1.25 milligrams (0.25 scoop),
• from 8 to 12 kg – 2.5 milligrams,
• from 13 to 18 kg – 3.75 milligrams,
• from 19 to 25 kg – 5 milligrams,
• from 26 to 35 kg – 7.5 milligrams,
• from 36 to 50 kg – 10 milligrams (2 capsules morning and evening),
• adults from 51 to 65 kg – 12.5 ml (3 capsules three times a day),
• from 66 to 80 kg – 15 milligrams (4 capsules three times a day),
• from 81 to 100 kg – 20 milligrams (5 capsules three times a day),
• over 100 kg – 25 milligrams (6 capsules three times a day),
• usually the drug is prescribed once a day, preferably in the evening, shortly before bedtime,
• The capsule should not be chewed, but swallowed with water,
• drink the suspension with a small amount of water,
• the course of treatment is from 6 months to two years, depending on the disease and the prescription of the attending physician.

If, during the treatment of cholelithiasis, the size and number of stones does not decrease after a year, the use of the drug should be discontinued.

The following adverse reactions are rare: that disappear when the drug is discontinued:

• nausea, diarrhea,
• pain in the stomach area,
• calcification of gallstones,
• stool disorders,
• allergic reactions such as hives or itching,
• deterioration of general condition.

There is no evidence of an overdose of the drug; if any abnormal reactions of the body occur, you should consult a doctor. Especially if treatment does not have any effect, the disease worsens or adverse reactions occur.

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Active substance: ursodeoxycholic acid;

Ursofalk- hepatoprotector with choleretic, cholelitholytic, hypocholesterolemic and immunomodulatory effects. Neutralizes toxic bile acids. Stabilizes the membrane structures of hepatocytes. Causes the dissolution of cholesterol gallstones. Delays the progression of liver fibrosis. Used for cholelithiasis (to dissolve cholesterol stones), biliary cirrhosis, sclerosing cholangitis, liver fibrosis, hepatitis, toxic (including alcoholic) liver damage, biliary reflux gastritis/esophagitis, biliary dyskinesia, liver diseases with cholestatic syndrome (cholestasis), for the prevention of iatrogenic liver damage.

Latin name:
URSOFALK / URSOFALK.

Composition and release form:
Ursofalk capsules of 10, 50 or 100 pcs. packaged.
1 capsule Ursofalk
Ursofalk suspension for oral administration in 250 ml bottles of 1 or 2 pcs. in packaging, complete with measuring spoon.
5 ml suspension Ursofalk contains: ursodeoxycholic acid 250 mg.

Properties / Action:
Ursofalk- hepatoprotector with choleretic, cholelitholytic, hypocholesterolemic, immunomodulatory and antifibrotic effects.
Ursofalk has a direct cytoprotective effect on the membrane of hepatocytes and cholangiocytes. Suppresses cell death caused by toxic bile acids.
Ursofalk reduces the saturation of bile with cholesterol, increases the solubility of cholesterol in bile, and reduces the lithogenic index of bile. Causes partial or complete dissolution of cholesterol gallstones and prevents the formation of new stones.
Ursofalk affects immunological reactions in the liver. Delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis, reduces the risk of developing varicose veins of the esophagus.
Ursofalk has an antitumor effect against colon cancer. Inhibits the growth of colorectal cancer cells.

Indications: primary biliary cirrhosis of the liver; primary sclerosing cholangitis; chronic active hepatitis, chronic hepatitis of various etiologies with signs of cholestasis; cholesterol gallstones in the gallbladder; biliary reflux gastritis; biliary reflux esophagitis; cystic fibrosis of the liver (cystic fibrosis); alcoholic and toxic liver damage; atresia of the intrahepatic bile ducts, cholestatic liver diseases in children; cholestasis with parenteral nutrition; biliary dyskinesia; acute hepatitis; prevention of liver damage when using hormonal contraceptives, cytostatics; cholestasis after liver transplantation; prevention of colon cancer in patients at high risk of developing it.

Directions for use and dosage:
Ursofalk is taken daily, 1 time per day, before bedtime. A daily dose of Ursofalk more than 10 mg/kg/day can be divided into 2-3 doses. Do not chew the capsules with a small amount of liquid. The suspension is recommended for use in children and patients with difficulty swallowing.
Acute and chronic liver diseases: 10 mg/kg/day, continuously for a long time. In the treatment of chronic liver diseases, the duration of treatment with Ursofalk can range from several months to 2 years.
Gallstone disease (dissolution of cholesterol gallstones): 10 mg/kg/day, continuously for a long time. The duration of the process of dissolving gallstones is from 6 months to 2 years. If after 12 months from the start of using Ursofalk there is no reduction in gallstones, then it is not advisable to continue treatment.
Biliary reflux gastritis and reflux esophagitis: 250 mg before bedtime. The duration of use of Ursofalk is usually 10-14 days.
Toxic and alcoholic liver damage: 10-15 mg/kg/day for 6 months to several years.
Primary biliary cirrhosis, primary sclerosing cholangitis: 10-15 mg/kg/day; if necessary - up to 20 mg/kg for 6 months to several years.
Cystic fibrosis (cystic fibrosis of the liver): up to 20-30 mg/kg/day for 6 months to several years.

Overdose:
There have been no cases of Ursofalk overdose reported.

Contraindications: individual intolerance (including a history of hypersensitivity) to the components of Ursofalk; acute inflammatory diseases of the gallbladder and bile ducts.

Side effect:
When using Ursofalk, the following are possible: dyspeptic symptoms, diarrhea, calcification of gallstones, allergic reactions.

Special instructions and precautions:
When prescribing Ursofalk for the successful dissolution of gallstones, it is necessary that: the stones are purely cholesterol (do not give a shadow on the x-ray); their size did not exceed 15-20 mm; the gallbladder is no more than half filled with stones; patency of the cystic duct should be maintained; the common bile duct should be free of stones; The biliary tract and gallbladder fully retained their function.
To prevent relapses of cholelithiasis, treatment with Ursofalk must be continued for several months after the gallstones have dissolved.
To monitor the effectiveness of treatment for gallstone disease, it is recommended to conduct x-ray and ultrasound examination of the biliary tract every 6 months.
When prescribing Ursofalk for the purpose of dissolving cholesterol stones, you should not simultaneously use drugs that increase the cholesterol content in bile (for example, estrogens, clofibrate).
In case of cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in blood serum should be periodically determined.
There is data on the use of Ursofalk for cholestasis in pregnant women. The effectiveness and safety of Ursofalk during pregnancy have not been fully established. There is currently no data on the penetration of Ursofalk into breast milk.

Drug interactions:
Cholestyramine, colestipol or antacids containing aluminum hydroxide (Maalox, etc.) reduce the effectiveness of Ursofalk. Taking these drugs simultaneously with Ursofalk is not advisable.
When used simultaneously with Ursofalk, it is possible to increase the absorption of cyclosporine.

Storage conditions:
List B. Store in a dry place, protected from light, at room temperature (18-25°C).
Shelf life: 5 years.
Conditions for dispensing from a pharmacy - according to a doctor's prescription.

Description of the active substance of the drug Ursofalk: pharmacology, indications, application, etc.

A.05.A.A Bile acid preparations

Hepatoprotective agent, has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestines and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids; causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.

Dissolution of cholesterol gallstones,

Biliary reflux gastritis,

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)

Non-alcoholic steatohepatitis,

Alcoholic liver disease,

Biliary dyskinesia

X-ray positive (high calcium content) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; liver cirrhosis in the stage of decompensation; severe dysfunction of the kidneys, liver, pancreas; hypersensitivity to the components of the drug. There are no age restrictions for use, but children under 3 years of age are recommended to use Ursofalk in suspension, as difficulties may arise when swallowing capsules.

The drug is contraindicated during pregnancy. The drug can be used during pregnancy only in cases where the potential benefit to the mother outweighs the possible risk to the fetus.

There are no data on the excretion of ursodeoxycholic acid in breast milk. If it is necessary to use ursodeoxycholic acid during lactation, breastfeeding should be stopped.

Children and adults weighing less than 47 kg are recommended to use Ursofalk in suspension.

Dissolution of cholesterol gallstones

The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid. Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis

Treatment of biliary reflux gastritis

1 capsule of Ursofalk daily in the evening before bed, without chewing and with a small amount of water.

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

Symptomatic treatment primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight).

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

250 mg capsules

Capsules should be taken regularly, without chewing, with a small amount of liquid.

Application of Ursofalka for treatmentprimary biliary cirrhosis can be continued indefinitely.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms mayworsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking one capsule daily, then the dosage should be gradually increased, increasing the daily dose by one capsule weekly, until the recommended dosage regimen is achieved again.

Symptomatic treatment of chronic hepatitis of various origins - daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment is 6-12 months or more.

Primary sclerosing cholangitis - daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see section: "Special instructions").

Cystic fibrosis (cystic fibrosis) - daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20-30 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years.

Non-alcoholic steatohepatitis - average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Alcoholic liver disease - average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Biliary dyskinesia - average daily dose of 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.

The assessment of adverse events is based on the following classification:

Very common (≥1/10)

Frequent (≥1/100 -<1/10)

Uncommon (≥1/1,000 -<1/100)

Rare (≥1/10,000 -<1/1,000)

Very rare (<1/10,000).

Gastrointestinal disorders:

In clinical studies, loose stools or diarrhea were frequently observed during treatment with ursodeoxycholic acid.

During the treatment of primary biliary cirrhosis, acute pain in the right upper abdomen was very rarely observed.

Disorders of the liver and biliary tract:

In very rare cases, calcification of gallstones may occur during treatment with ursodeoxycholic acid.

When treating advanced stages of primary biliary cirrhosis, in very rare cases, decompensation of liver cirrhosis was observed, which disappears after discontinuation of the drug.

Disorders of the skin and subcutaneous tissues:

In very rare cases, urticaria may occur.

If any of the side effects indicated in the instructions get worse, or you notice other side effects not listed in the instructions, please inform your doctor.

No cases of overdose have been identified. In case of overdose, symptomatic treatment is carried out.

Cholestyramine, 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 still necessary, they should be taken at least 2 hours before taking Ursofalk.

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

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

Lipid-lowering drugs (especially clofibrate), estrogens, or progestins increase the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol gallstones.

Taking the drug Ursofalk shouldcarried out under the supervision of a doctor.

During the first three months of treatment, liver function parameters should be monitored: transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum every 4 weeks and then every 3 months. Monitoring these parameters makes it possible to identify liver dysfunction in the early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, this can quickly determine whether a patient with primary biliary cirrhosis is responding to treatment. treatment.

When used to dissolve cholesterol gallstones:

In order to assess progress in treatment and to promptly identify signs of calcification of stones depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine position (ultrasound) 6-10 months after the onset treatment.

If the gallbladder cannot be visualized on x-rays or in cases of calcified stones, poor contractility of the gallbladder or frequent attacks of colic, Ursofalk should not be used.

When treating patients in the later stages of primary biliary cirrhosis:

Cases of decompensation of liver cirrhosis have been reported extremely rarely. After cessation of therapy, a partial reverse development of the manifestations of decompensation was noted.

When used in patients with primary sclerosing cholangitis:

Long-term high dose therapyursodeoxycholic acid (28-30 mg/kg/day) in patients with this pathology can cause serious side effects phenomena.

In patients with diarrhea, the dosage of the drug should be reduced. If diarrhea persists, treatment should be discontinued.

There was no effect on the ability to drive vehicles and moving machinery.

Capsules 250 mg, 10 capsules in aluminum/PVC blister; 1 blister along with instructions for use in a cardboard pack.

Capsules 250 mg, 25 capsules in aluminum / PVC blister; 2 and 4 blisters along with instructions for use in a cardboard pack.

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

5 years. Do not use after the expiration date stated on the package.