Ursofalk instructions for use for newborns. Suspension "Ursofalk" for a newborn: instructions for use from jaundice, dosage and analogues

29.03.2020 -

Content

Gallstones are found in 80% of patients with gallstone disease. The danger of stones lies in the fact that they have the ability to move. If the stone gets stuck in the ducts of the gallbladder, then rupture of the organ and peritonitis is possible. To prevent this from happening, it is necessary to carry out treatment on time. The drug Ursofalk proved to be excellent - the instructions for use of which will indicate how to drink capsules for any pathologies of the liver and bile ducts.

What is Ursofalk

It is a hepatoprotective drug that promotes the dissolution of primary gallstones. Ursofalk has a broad spectrum of action, providing cholelitholytic, hypoglycemic and immunomodulatory effects. In addition, the drug leads to a decrease in cholesterol in the blood. The drug contains the active substance ursodeoxycholic acid, which is contained in a small amount in human bile, but with violations of the liver, its production is greatly reduced.

Compound

One capsule of the drug Ursofalk - instructions for use says it contains 250 mg of ursodeoxycholic acid. Auxiliary components of tablets - corn starch, gelatin, silicon dioxide and titanium, sodium lauryl sulfate, magnesium stearate, purified water. The same amount of active substance (250 mg) is contained in 5 ml of suspension. Additional components:

xylitol;
glycerol;
benzoic acid;
propylene glycol;
microcrystalline cellulose;
chloride, cyclamate and sodium citrate;
lemon flavor;
anhydrous citric acid;
purified water.

Release form

Ursofalk is produced in two forms: suspension and capsules. The first option is used, as a rule, to treat children or people who have difficulty swallowing. The suspension has a white color, a homogeneous consistency and contains air bubbles. Produced in dark glass bottles of 250 ml. The kit comes with instructions for use and a measuring spoon. Gelatin capsules are hard, white, opaque on top, and powder or granules inside. Produced in blisters of 10 and 25 pieces. A carton box may contain 1, 2 or 4 blister packs along with instructions.

pharmachologic effect

Ursofalk has a choleretic effect on the human body. The active ingredient reduces the synthesis of cholesterol in the liver, prevents its absorption by the intestines, and stimulates the secretion of bile. The hepatoprotective agent increases the content of bile acids, enhances the activity of lipase, causes an increase in pancreatic and gastric secretion. Regular intake of Ursofalk medication causes partial (sometimes complete) dissolution of cholesterol stones, reduces cholesterol saturation, which contributes to its removal.

Indications for use

Ursofalk - instructions for its use, proof of this, is prescribed to patients who have gallstones in the gallbladder that do not exceed 15 ml. Also, the medication is prescribed if any of the following conditions are present:

chronic hepatitis of various etiologies;
non-alcoholic steatohepatitis;
biliary reflux gastritis;
cystic fibrosis;
alcoholic liver disease;
biliary dyskinesia;
primary biliary cirrhosis of the liver;
malignant tumor of the colon.

Instructions for use

How to drink Ursofalk, the doctor will tell in each case. According to the instructions, the drug of any form of release is taken orally. If the doctor has prescribed the use of the drug once a day, then it is better to drink the suspension or tablets at bedtime. At a dosage of 2 times / day, the drug is drunk in the morning and evening. Ursofalk capsules are swallowed whole, it is not necessary to chew them. Adults weighing less than 34 kg, as well as children, are recommended to use the suspension form.

Suspension

One measuring spoon contains 5 ml of suspension or 250 mg of ursodeoxycholic acid. To dissolve gallstones, the drug should be used regularly for 6-24 months. If no improvement is observed after a year of taking, therapy should not be continued. According to the instructions, treatment should be stopped if x-ray or ultrasound showed calcification of stones. In primary biliary cirrhosis, the use of Ursofalk suspension in time can be unlimited.

Capsules

How to take Ursofalk capsules is described in detail in the instructions. For liver diseases, the daily dose of the drug is 10-15 mg per 1 kg of human weight. Medication Ursofalk for biliary dyskinesia and reflux esophagitis or reflux gastritis is taken 1 piece daily for 10 days. Patients with cystic fibrosis take the drug at a dose of 20-30 mg per kilogram of body weight for 1.5-2 years. With biliary cirrhosis and sclerosing cholangitis, Ursofalk is prescribed 10-15 mg per 1 kg of weight. If necessary, the dosage is increased to 20 mg.

Ursofalk for children

In newborn babies, jaundice is a common occurrence, therefore, in pediatric practice, the appointment of Ursofalk suspension to children is a frequent occurrence. The drug belongs to the class of hepatoprotectors, therefore it copes with many liver problems. The recommended dose for children of any age is 40 mg per 1 kg of body weight per day. The doctor may prescribe a different dosage that matches individual indicators. The duration of the course is also assigned in each case differently. On average, therapy for jaundice in a newborn with Ursofalk suspension ranges from 3 days to 2 weeks.

drug interaction

Reduce the absorption of ursodeoxycholic acid, reducing its effectiveness antacids, colestipol, cholestyramine containing smectite or aluminum hydroxide. If the use of these drugs is necessary, then they should be taken 2 hours before taking the medicine Ursofalk. The active substance of the drug can enhance the absorption of cyclosporine from the intestines, so the doctor should adjust the dose of the latter and check its concentration in the blood. Lipid-lowering drugs, progestins or estrogens reduce the ability of the hepatoprotector to dissolve stones.

Side effects

Ursofalk, like other drugs, can cause adverse reactions in the body. These include:

diarrhea, loose stools;
sharp pain in the right side of the abdomen;
hives;
the formation of calcifications;
decompensation of liver cirrhosis;
vomiting, nausea;
increased activity of hepatic transaminases.

Overdose

Incorrect use of the drug Ursofalk rarely leads to an overdose, since when the dose is exceeded, the absorption of ursodeoxycholic acid is reduced. Its excretion from the body is carried out together with feces and bile. If an overdose has occurred, then the person may experience diarrhea. In this case, the dose of the drug should be reduced. If the disorder continues, then it is necessary to stop using the drug and consult a doctor for symptomatic treatment.

Contraindications

According to the instructions for use, Ursofalk has the following contraindications:

hypersensitivity to components;
pregnancy;
the period of breastfeeding (lactation);
children's age up to 3 years (capsules);
disorders of the kidneys, liver, gallbladder, pancreas;
acute inflammation of the intestines, bile ducts / bladder;
stones with a high content of calcium;
cirrhosis of the liver at the stage of decompensation.

special instructions

Reception of the hepatoprotector Ursofalk is carried out exclusively under the supervision of a physician. During treatment, it is necessary to monitor liver samples, first every 4 weeks, then every 3 months. Serum control over the level of transaminases, alkaline phosphatase and GGTP will make it possible to detect liver dysfunction at an early stage. This is especially true for patients who have a severe form of biliary cirrhosis, in order to determine how their body reacts to the ongoing treatment.

If the use of the drug Ursofalk is indicated for the dissolution of gallstones, then in order to identify signs of their calcification, it is necessary to visualize the gallbladder six months after the start of treatment (oral cholecystography, ultrasound). In the treatment of the late stage of primary cirrhosis (biliary), a partial manifestation of decompensation may be observed. In patients, after the start of treatment, clinical symptoms sometimes increase, after which it is required to reduce the dosage of the drug.

Ursofalk during pregnancy and lactation

Instructions for use states that during the bearing and feeding of a child, the drug Ursofalk cannot be prescribed. Ursodeoxycholic acid does not have a toxic effect on the embryo and does not lead to deformities or mutations. However, its impact on the course of pregnancy has not been fully studied, because in many women the liver is extremely sensitive to hormonal changes.

Analogues

If Ursofalk is not suitable in terms of its effect on the body or in terms of cost, then the doctor may prescribe medications similar in pharmacological action to taking:

Ursosan. The main analogue of Ursofalk. The drug stabilizes the membranes of the cells of the digestive tract, biliary tract, liver. They are used for a wide range of hepatic pathologies.
Urdox. The drug is domestically produced, therefore it is lower in price. The main property of the drug is to protect the liver from harmful effects. Shows immunomodulatory, hypocholesterolemic, choleretic properties.
Exhol. It has a choleretic effect on the body, reduces the concentration of cholesterol in the blood.

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 oral contraceptives with a low estrogen content. In patients taking Ursofalk to dissolve gallstones, effective non-hormonal contraception should be used, 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:
The 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
Body weight [kg]	Daily dose (mg/kg body weight)
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.

Ursodeoxycholic acid

Dosage form

oral suspension

Composition of Ursofalk in the form of a suspension

5 ml suspension (1 measuring cup) contains 250 mg ursodeoxycholic acid. Excipients: benzoic acid 7.5 mg, purified water 2875.5 mg, xylitol 1600 mg, glycerol 500 mg, microcrystalline cellulose 100 mg, propylene glycol 50 mg, sodium citrate 25 mg, sodium cyclamate 25 mg, anhydrous citric acid 12.5 mg, sodium chloride 3 mg, lemon flavor (Givaudan PHL-134488) 1.5 mg.

Description

Homogeneous suspension of white color, containing small air bubbles, with lemon aroma.

Pharmacotherapeutic group

Hepatoprotective agent

Pharmacodynamics of the drug

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

Indications Ursofalk in the form of a suspension

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)

nonalcoholic steatohepatitis,

alcoholic liver disease,

Biliary dyskinesia

Contraindications Ursofalk in the form of a suspension

X-ray positive (high calcium) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; cirrhosis of the liver in the stage of decompensation; severe dysfunction of the kidneys, liver, pancreas; hypersensitivity to the components of the drug. Ursodeoxycholic acid has no age restrictions for use, but for children under the age of 3 years, it is recommended to use Ursofalk in suspension, as it may be difficult to swallow the capsules.

Pregnancy and lactation

The drug is contraindicated during pregnancy. 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.

There are no data on the excretion of ursodeoxycholic acid in breast milk. If necessary, the use of ursodeoxycholic acid during lactation should stop breastfeeding.

Dosage and administration Ursofalk in the form of a suspension

Children and adults weighing less than 34 kg are recommended to use Ursofalk in suspension.

Dissolution of cholesterol gallstones

Weight

body

Dimensional

cup

Corresponds

Over 100 kg

The drug must be taken daily in the evening, before bedtime.

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

Treatment of biliary reflux gastritis 1 measuring cup of Ursofalk daily in the evening before going to bed.

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

Symptomatic treatment of primary biliary cirrhosis

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

Measuring cups Ursofalk suspension inside 250 mg / 5 ml

First 3 months of treatment

Subsequently

Evening (1 time per day)

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

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

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

Side effects of the drug

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 have often been observed during treatment with ursodeoxycholic acid.

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

Liver and biliary tract disorders:

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

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

Skin and subcutaneous tissue disorders:

In very rare cases, urticaria may occur.

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

Overdose

Cases of overdose have not been identified. In case of overdose, symptomatic treatment is carried out.

Interaction

Colestyramine, colestipol, and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce intestinal absorption of ursodeoxycholic acid 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 cyclosporine, the physician 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, neomycin, or progestins increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol gallstones.

special instructions

Ursofalk should be taken under medical supervision.

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

When used to dissolve cholesterol gallstones:

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

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

In the treatment of patients in the late stages of primary biliary cirrhosis:

Cases of decompensated cirrhosis of the liver have been extremely rare. After the cessation of therapy, a partial regression of the manifestations of decompensation was noted.

When used in patients with primary sclerosing cholangitis:

Long-term therapy with high doses of ursodeoxycholic acid (28-30 mg / kg / day) in patients with this pathology can cause serious side effects.

In patients with diarrhea, the dosage of the drug should be reduced. With persistent diarrhea, treatment should be discontinued.

One measuring cup (equivalent to 5 ml) of Ursofalk Oral Suspension 250 mg/5 ml contains 0.50 mmol (11.39 mg) sodium. Patients controlling their sodium intake should be aware of this fact.

Influence on the ability to drive transport. cf. and fur.

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

Release form / dosage

Suspension for oral administration 250 mg / 5 ml.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf life

Suspension - 4 years. After opening - 4 months.

Do not use after the expiry date stated on the packaging.

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pharmachologic effect

According to the pharmacological group, it belongs to hepatoprotectors. It has a hepatoprotective (restores the protective function of liver cells - hepatocytes) and choleretic (stimulates the production of bile) action.

In the liver, there is a decrease in the synthesis of cholesterol, its absorption in the small intestine is inhibited. In the ducts of the biliary system, the solubility of cholesterol increases, its production and secretion increase.

The composition of bile changes due to a larger number of fatty acids, this contributes to a decrease in lithogenic properties (prevention of the formation of stones and the dissolution of those with a diameter of up to 1 mm). From the side of the pancreas and stomach, there is an increase in secretion, lipase has a greater activity and lowers the level of glucose in the blood (hypoglycemic effect).

As a result of a combination of all the described properties, cholesterol stones with a diameter of not more than 1 mm dissolve completely or partially. There is an outflow of cholesterol from gallstones into bile. Acts as an immunomodulator, has a positive effect on the course of immunological reactions.

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Composition, form of release, dispensing from pharmacies

As part of Ursofalk, the main active ingredient is ursodeoxycholic acid. 1 capsule or 1 measuring spoon of the suspension contains 250 mg of the substance. The capsule contains the following additional components: starch, E551, stearic acid, Ti dioxide, zoogen, distilled water, sodium salt of lauryl sulfuric acid.

The composition of the suspension includes the following additional components: monobasic carboxylic substance, distilled water, natural sweetener, glycerin alcohol, fiber, E1520, E331, E952, E330, lemon flavor.
The drug has a capsule and suspension form of release. For children under three years of age, a suspension dosage form is preferred to facilitate administration of the drug. Suspensions are also prescribed for people with an asthenic physique weighing less than 47 kg or for people suffering from a body weight deficit of less than 34 kg.

The drug in the form of capsules has the following description: solid, gelatinous, opaque; inside the capsule are white granules or powder. Available in blisters of 10 or 25 capsules. The carton contains 1, 2 or 4 blisters.

The suspension is white in color and has a smooth consistency, lemon flavor and contains small air bubbles.

The drug is dispensed by prescription.

Indications and contraindications for use

Indications

The drug is used for the lysis of stones in the gallbladder of the cholesterol composition, if their diameter does not exceed 1 mm. To mitigate and relieve symptoms, it is prescribed for biliary reflux esophagitis, biliary cirrhosis, if there is no decompensation syndrome. Also successfully used in the treatment of the following diseases:

inflammation of the liver of infectious and non-infectious genesis (chronic hepatitis);
sclerosing cholangitis (primary), cystic fibrosis;
non-alcoholic steatohepatitis;
alcoholism (alcoholic liver disease);
difficulty in motility of the gallbladder of the biliary tract.

Contraindications

positive x-ray studies of highly calcified gallstones;
absence or dysfunction of the gallbladder;
acute cholecystitis, cholangitis in the acute phase of the course, acute gastritis;
decompensatory stage of liver cirrhosis;
severe dysfunction of the liver and kidneys;
the period of pregnancy and breastfeeding (lactation);
hypersensitivity to the components of the drug.

Instructions for use for children and adults

Adults are prescribed Ursofalk in the form of capsules.

However, with insufficient muscle mass and weight less than 34 kg, adults are shown a suspension form of the drug.

The drug is dosed for adults and children, based on body weight.

Table of Ursofalk's intake in capsules for adults:

Table for taking Ursofalk in suspension for adults:

Children from 6 years of age may prescribe the drug in capsule form. But it is preferable to prescribe in the form of suspensions.

Table of application of Ursofalk in suspension for children:

Apply the drug once at night before meals, drink plenty of liquid. Capsules do not need to be chewed, swallowed whole.

Instructions for use for newborns

It is prescribed in the form of suspensions to eliminate the symptoms of physiological jaundice in newborns in order to lower the concentration of indirect bilirubin in the blood.

The dosage depends on the severity of the course and is prescribed individually from 5 ml to 10 ml per kg of the child's weight.

Treatment with the drug almost always gives a quick positive effect. Adverse reactions are extremely rare: allergies, regurgitation, dyspeptic disorders. Symptoms of side effects disappear when the dose is reduced or the drug is discontinued.

Side effects, overdose

Most often, the drug is well tolerated by the body. Very rarely there are side effects:

Laboratory and clinical studies have not identified cases of drug overdose. In case of excessive intake of the drug, the removal or mitigation of symptoms is indicated.

drug interaction

Preparations containing smectite or Al hydroxide reduce the absorption of ursodeoxycholic acid, therefore, the effectiveness of Ursofalk decreases.

In cases where treatment with such drugs is necessary, they should be taken at least 2-3 hours before Ursofalk.

Cyclosporine in combination with Ursofalk is absorbed more strongly. In these cases, it is necessary to control cyclosporine in the blood for adequate dosing of the drug. A decrease in the lithogenicity of Ursofalk (a decrease in its ability to dissolve cholesterol stones) was noted when the drug was taken together with progestins, estrogens, Clofibrate and neomycin.

special instructions

It is important to diagnose the composition and size of gallstones before starting the course of Ursofalk. This drug is effective only in relation to X-ray negative calculi of cholesterol origin, having a size of no more than 1-2 cm.

It is important to constantly monitor hepatic amylases during the course of the drug. Cholecystography is shown monthly. Once every six months, an ultrasound diagnostic is prescribed. With positive dynamics, therapy is prolonged for three months.

It is not recommended to take the drug when planning pregnancy. Clinical studies of the drug during pregnancy have not been conducted. The ability of ursodeoxycholic acid to cross the placental barrier has also not been studied.

The action of ursodeoxycholic acid does not lead to mutagenicity and teratogenicity of the fetus. It is possible to prescribe the drug to pregnant women if the expected effect is higher than the potential risks.

The price of the drug and analogues

The medicine with the original name URSOFALK is produced by German companies. The minimum price in Russia for a package with 1 blister (250 mg, 10 capsules) is 230 rubles, a package for 50 capsules costs from 939 rubles and 1870 rubles for 100 capsules. The cost of a suspension of 250 mg per 5 ml, 250 ml starts from 980-1190 rubles in Russia.

In Ukraine, the cost of capsules of the original drug 10 capsules of 250 mg starts from 130 UAH, 50 capsules - 600 UAH, 100 capsules - 1150 UAH. Prices for suspensions range from 740 UAH. (250 mg per 5 ml, 250 ml).

Ursofalk's analogues are Peponen (600 mg No. 60 from 650 rubles in Russia, from 330 UAH in Ukraine), Exhol (250 mg No. 10 from 140 rubles in Russia), Ursosan (250 mg No. 10 from 180 rubles in Russia and 115 UAH . in Ukraine), Heptral (930 UAH in Ukraine), Ursodez (250 mg No. 50 in Russia from 610 rubles).

Compound

The capsules contain the active ingredient ursodeoxycholic acid, as well as inactive ingredients: corn starch, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, gelatin, titanium dioxide, purified water.

Ursofalk suspension contains ursodeoxycholic acid as an active ingredient, as well as additional components: benzoic acid, xylitol, glycerol, MCC, sodium citrate, propylene glycol, anhydrous citric acid, sodium cyclamate, sodium chloride, flavor, water.

Release form

The medicine is produced in the form of capsules and suspensions.

Capsules are gelatinous, hard, white, opaque. Inside the capsules - white powder or granules. In a blister - 10 capsules, blisters fit in cardboard packs.
Suspension of a homogeneous consistency, has a white color, it may contain small bubbles. Has a lemon scent. It is contained in dark glass bottles of 250 ml, a measuring cup of 5 ml is also inserted into the cardboard box.

pharmachologic effect

This drug is a hepaprotector, that is, a drug that helps dissolve cholesterol gallstones, significantly lowering blood cholesterol levels. It has a wide range of effects, in particular, it acts as a hepatoprotective, cholelitholytic, immunomodulatory agent. There is also a hypoglycemic effect.

Ursodeoxycholic acid, the active ingredient in Ursofalk, is also present in bile in certain amounts. But if certain functions of the liver are impaired, the synthesis of this substance and its content in the composition of bile decreases. It has a positive effect on immunological reactions in the liver.

The following effects of ursodeoxycholic acid are distinguished:

has a choleretic effect, reducing the amount of bile acids in bile and increasing their excretion into the intestinal lumen, also reducing the absorption of toxic bile hydrophobic acids;
a cytoprotective effect is manifested, which consists in the ability of this substance to be incorporated into the lipid layer of the cell membrane, which leads to stabilization of the cell membrane and enhancement of its protective properties;
there is an immunomodulatory effect and a decrease in the synthesis of pro-inflammatory cytokines;
produces a hypercholesterolemic effect due to a decrease in the absorption of cholesterol in the ileum, a decrease in the synthesis of cholesterol in the liver, and also by activating the process of its excretion with bile.

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

Under the influence of the drug Ursofalk, gastric and pancreatic secretion increases.

Pharmacokinetics and pharmacodynamics

After taking the drug in the form of a suspension or capsules, the process of absorption of ursodeoxycholic acid in the small intestine occurs inside. In the general circulation, approximately 60-80% of the dose that was taken is determined. Metabolism of the active ingredient occurs in the liver. Partially active ingredient breaks down in the intestine, resulting in the formation of toxic 7-keto-lithocholic acid. This substance is slightly absorbed into the general circulation, its detoxification occurs in the liver.

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

Indications for use

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

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

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

Contraindications

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

gallstones are radio-positive (that is, stones with a high content of calcium);
acute inflammatory diseases of the bile ducts, intestines, gallbladder;
cirrhosis of the liver in the decompensation stage;
gallbladder non-functioning;
pronounced disturbances in the functions of the liver, pancreas, kidneys;
pregnancy and lactation;
pronounced sensitivity to the components of drugs.

Side effects

During treatment, the following side effects may occur:

digestive system: diarrhea, manifestation of acute abdominal pain on the right during the treatment of primary biliary cirrhosis;
liver and biliary tract: in rare cases - calcification of stones, decompensation of cirrhosis of the liver in those who are being treated for primary biliary cirrhosis;
skin, subcutaneous tissue: in rare cases - urticaria.

If the above side effects worsen or if any other negative symptoms appear during treatment, the patient must be informed of this by a specialist.

Instructions for use Ursofalk (Method and dosage)

Instructions for use of capsules

The drug for dissolving cholesterol gallstones should be used at a dose of 10 mg per 1 kg of the patient's weight 1 time per day.

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

The duration of taking the drug is from 6 to 12 months. To ensure high-quality prevention of recurrent cholelithiasis, it is recommended to take the remedy for several months after the stones have dissolved.

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

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

In the symptomatic treatment of chronic hepatitis of various origins, the dose of the drug per day is 10-15 mg per 1 kg of body weight, it should be taken in 2-3 doses. Reception lasts from 6 to 12 months.

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

In people with non-alcoholic steatohepatitis, as well as with alcoholic liver disease, a dose of 10-15 mg per 1 kg of body weight is used. Treatment lasts 6-12 months or longer.

Patients with biliary dyskinesia are prescribed 10 mg of the drug per 1 kg of weight per day, you need to take the medicine for 2 weeks. up to 2 months Treatment can be repeated if necessary.

Suspension Ursofalk, instructions for use

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

When treating other diseases, it should be taken into account that the content of 1 scoop corresponds to the content of the active substance in one capsule. How to take - before meals or after - does not matter.

Overdose

There were no cases of drug overdose. If necessary, practice symptomatic therapy.

Interaction

The absorption of ursodeoxycholic acid in the intestine and, accordingly, the effectiveness of the drug is reduced while taking colestipol, cholestyramine, and antacids, which contain aluminum hydroxide or aluminum oxide. If necessary, the use of these drugs should be drunk at least two hours before taking Ursofalk.

Under the influence of ursodeoxycholic acid, the absorption of cyclosporine from the intestine increases. That is, if you need to take cyclosporine, you need to control the concentration of cyclosporine in the blood and adjust the dose of the drug.

There is a possibility that the absorption of ciprofloxacin may decrease when taking Ursofalk.

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

Terms of sale

Ursofalk can be bought with a prescription.

Storage conditions

It is necessary to protect capsules and suspension from children, store at a temperature not exceeding 25 ° C.

Shelf life

Capsules can be stored for 5 years, suspension - 4 years. After the bottle with Ursofalk has been opened, the suspension can be used for 4 months.

special instructions

Ursofalk should be taken under the supervision of a specialist.

In the first 3 months of admission, it is very important to monitor liver function indicators, first every 4 weeks, then once every three months. It is important to detect liver dysfunction at the earliest stages. It is also important to determine as quickly as possible whether people with primary biliary cirrhosis are responding to treatment.

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

You should not prescribe Ursofalk if it is not possible to visualize the gallbladder during the x-ray process, if there is calcification of stones, bouts of colic.

In very rare cases, cases of decompensated liver cirrhosis have been reported.

People suffering from diarrhea need to reduce the dose of drugs. Patients with persistent diarrhea should stop therapy.

Ursofalk's analogues

Coincidence in the ATX code of the 4th level:

Analogues of this medication are Ursolit, Ursobil, Ursolvan, Holacid, Ursohol, Ursosan, Delursani etc.

The price of Ursofalk analogues depends on the manufacturer, packaging. The most optimal drug is prescribed by the attending physician individually.

Which is better: Ursofalk or Ursoliv?

The drug Ursoliv as an active ingredient contains, like Ursofalk, ursodeoxycholic acid. Therefore, their effect on the human body is similar. However, sometimes these drugs can work differently, depending on the individual. Therefore, the choice of the drug should be carried out by the doctor after a thorough study.

children

For children, it is prescribed in the form of a suspension, it must be used strictly according to the scheme described in the instructions.

Ursofalk for newborns

Reviews indicate that Ursofalk for newborns is prescribed for physiological jaundice, which manifests itself a few days after the birth of a child. However, the instruction does not contain data on such use of the drug. It should be noted that such treatment can only be carried out under the constant supervision of a specialist.

During pregnancy and lactation

It has been proven that the active component of Ursofalk does not have a mutagenic, teratogenic and embryotoxic effect, but there is still no accurate data on its penetration through the hematoplacental barrier, and on the effect of the drug on the course of pregnancy. Therefore, during pregnancy, it is prescribed only if indicated. There are no data on exposure to breastfeeding.

Reviews about Ursofalka

Those reviews about the treatment of Ursofalk that users leave on the forums are very different, but mostly positive opinions are written about the medicine. Many patients write that after the course of treatment, stones in the gallbladder were not detected by ultrasound, that is, the drug was effective. Reviews of doctors are less common, but experts also write about this medicine in a positive way.

Parents also leave favorable reviews for the suspension for children, noting that the medicine is pleasant to the taste for children and at the same time effective. Also, according to users, Ursofalk quickly helps with jaundice in newborns.

Prices for ursofalk in Yekaterinburg pharmacies

Reviews
29
Instruction
Prices in pharmacies
Analogues
12

Reviews of doctors

positive

negative

neutral

Patient reviews

Active substance:

Ursodeoxycholic acid* (Ursodeoxycholic acid*)

ATX

A05AA02 Ursodeoxycholic acid

Pharmacological groups

Hepatoprotective agent [Agents that prevent the formation and promote the dissolution of calculi]
Hepatoprotective agent [Hepatoprotectors]
Hepatoprotective agent [cholagogues and bile preparations]

Nosological classification (ICD-10)

E84.8 Cystic fibrosis with other manifestations
K29.9 Gastroduodenitis, unspecified
K70 Alcoholic liver disease
K73.9 Chronic hepatitis, unspecified
K74.3 Primary biliary cirrhosis
K76.0 Fatty liver, not elsewhere classified
K80 Cholelithiasis [cholelithiasis]
K82.8.0* Dyskinesia of gallbladder and biliary tract
K83.0 Cholangitis

Compound

Description of the dosage form

Hard, opaque gelatin No. 0; Lid and body are white. The contents of the capsule are white powder or granules.

Suspension for oral administration

Homogeneous, white in color, containing small air bubbles, with a lemon flavor.

Biconvex, oblong, film-coated white, with a risk on both sides.

pharmachologic effect

Pharmacological action - hepatoprotective.

Pharmacodynamics

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

Pediatric population

Cystic fibrosis (cystic fibrosis). According to clinical reports, there is a long-term experience (up to 10 years or more) in the treatment of UDCA in pediatric patients suffering from hepatobiliary disease associated with cystic fibrosis (CFAHD). There is evidence that UDCA therapy can reduce bile duct proliferation, slow the progression of histologic lesions, and even reverse the hepatobiliary system changes when therapy is initiated early in CFAHD. In order to optimize the effectiveness of treatment, UDCA therapy should be initiated as soon as possible after the diagnosis of CFAHD is established.

Pharmacokinetics

After oral administration, UDCA is rapidly absorbed in the jejunum and proximal ileum by passive diffusion, and in the distal ileum by active transport. Approximately 60-80% of the accepted volume is soaked up. After absorption, UDCA is almost completely conjugated in the liver with glycine and taurine and excreted in the bile. During the first passage through the liver, up to 60% is metabolized.

Depending on the daily dose, the type of disease and the condition of the liver, more or less UDCA accumulates in bile. At the same time, there is a relative decrease in the content of other, more lipophilic bile acids.

Under the action of intestinal bacteria, UDCA partially decomposes with the formation of 7-keto-lithocholic and lithocholic acids. Lithocholic acid is hepatotoxic; in some animal species, it causes damage to the liver parenchyma. In the human body, it is absorbed only in small quantities. In the process of metabolism, it is sulfated in the liver, due to which it is neutralized even before it is excreted into the bile, and is excreted from the body with feces. The half-life of UDCA is 3.5 to 5.8 days.

Indications for Ursofalk

dissolution of cholesterol gallstones in the gallbladder;

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) - as part of complex therapy;

non-alcoholic steatohepatitis;

alcoholic liver disease;

biliary dyskinesia.

Contraindications

hypersensitivity to the components of the drug;

X-ray positive (high in calcium) gallstones;

non-functioning gallbladder;

acute inflammatory diseases of the gallbladder, bile ducts and intestines;

cirrhosis of the liver in the stage of decompensation;

pronounced dysfunction of the kidneys, liver, pancreas.

For oral suspension and film-coated tablets, additionally

violation of the contractility of the gallbladder;

blockage of the bile ducts (blockage of the common bile duct or cystic duct);

frequent episodes of biliary colic;

severe hepatic and / or renal failure.

pediatric population. Failed portoenterostomy or failure to restore normal bile flow in children with biliary atresia.

For capsules and film-coated tablets, additionally

For children under the age of 3 years, as well as patients with difficulty in swallowing tablets, it is recommended to use the drug Ursofalk in the form of a suspension.

For film-coated tablets, additionally

children's age up to 3 years.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

There are limited or no data on the use of UDCA in pregnant women. Animal studies have shown reproductive toxicity early in pregnancy. Ursofalk should not be used during pregnancy unless clearly necessary.

According to animal studies, UDCA does not affect fertility. There are no data on the effect of UDCA treatment on human fertility.

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

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

Side effects

The evaluation of adverse events is based on the following classification: very often (≥1/10); often (≥1/100-

From the gastrointestinal tract: often - unformed stools or diarrhea; in the treatment of primary biliary cirrhosis, very rarely - acute pain in the right upper abdomen.

From the side of the liver and biliary tract: very rarely - calcification of gallstones. In the treatment of severe stages of primary biliary cirrhosis, very rarely - decompensation of cirrhosis of the liver, which disappears after discontinuation of the drug.

From the skin and subcutaneous tissues: very rarely - urticaria.

If any of the side effects listed in this description worsen or the patient notices other side effects not listed in the description, the doctor should be informed.

Interaction

Colestyramine, colestipol, and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce intestinal absorption of UDCA and thus reduce its absorption and effectiveness. If the use of preparations containing at least one of these substances is still necessary, they should be taken at least 2 hours before taking Ursofalk.

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

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

In a clinical study involving healthy volunteers, the simultaneous use of UDCA (500 mg / day) and rosuvastatin (20 mg / day) resulted in a slight increase in plasma levels of rosuvastatin. The clinical significance of this interaction, incl. for other statins is unknown.

In healthy volunteers, UDCA has been shown to reduce the Cmax and AUC of CCB-nitrendipine. In the case of simultaneous use of nitrendipine and UDCA, careful monitoring is recommended. An increase in the dose of nitrendipine may be required.

There are also reports of interaction with dapsone, which led to a decrease in the therapeutic effect of the latter. These observations, along with data from in vitro experiments, suggest that UDCA is able to induce isoenzymes of the cytochrome P450 CYP3A system. However, in a designed interaction study with budesonide, which is a known substrate of cytochrome P450 CYP3A, no induction was observed.

Estrogens and cholesterol-lowering drugs, such as clofibrate, increase cholesterol secretion in the liver and therefore may stimulate the formation of gallstones, which counteracts the effect of UDCA, which is used to dissolve gallstones.

Dosage and administration

inside. For children and adults weighing less than 47 kg, as well as patients who cannot swallow Ursofalk in the form of film-coated tablets, it is recommended to use Ursofalk in the form of a suspension.

Suspension for oral administration

Body weight, kg	Number of scoops	Corresponding amount, ml
5-7	0,25	1,25
8-12	0,5	2,5
13-18	0,75	3,75
19-25	1	5
26-35	1,5	7,5
36-50	2	10
51-65	2,5	12,5
66-80	3	15
81-100	4	20
Over 100	5	25

Film-coated tablets

The drug should be taken daily in the evening, at bedtime (capsules are not chewed), washed down with a small amount of liquid.

The duration of treatment is 6-24 months. If, after 12 months of treatment, the size of the stones does not decrease, then treatment should be discontinued. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the dissolution of the stones.

The effectiveness of treatment should be evaluated every 6 months by ultrasound or radiography. During the interim examination, it should be assessed whether calcification of the stones has occurred in the past period. In case of calcification of stones, treatment should be stopped.

Treatment of biliary reflux gastritis

1 capsule / 1 measuring cup / 0.5 tab. (250 mg) of the drug Ursofalk daily in the evening, before bedtime (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.

Treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 capsules / from 2 to 7 measuring cups / from 1.5 to 3.5 tablets. (from about (14±2) mg/kg UDCA).

In the first 3 months of treatment, the use of the drug Ursofalk (capsules, film-coated tablets) should be divided into several doses throughout the day. After improvement of liver parameters, the daily dose of the drug can be taken 1 time in the evening.

Body weight, kg	Daily dose (capsules, pcs.)	In the morning	Happy	In the evening
47-62	3	1	1	1
63-78	4	1	1	2
79-93	5	1	2	2
94-109	6	2	2	2
Over 110	7	2	2	3

Suspension for oral administration

Body weight, kg	Measuring cups Ursofalk, oral suspension 250 mg/5 ml
	first 3 months			subsequently
	morning	day	evening	evening (single dose)
8-11	—	0,25	0,25	0,5
12-15	0,25	0,25	0,25	0,75
16-19	0,5	—	0,5	1
20-23	0,25	0,5	0,5	1,25
24-27	0,5	0,5	0,5	1,5
28-31	0,25	0,5	1	1,75
32-39	0,5	0,5	1	2
40-47	0,5	1	1	2,5
48-62	1	1	1	3
63-80	1	1	2	4
81-95	1	2	2	5
96-115	2	2	2	6
Over 115 kg	2	2	3	7

Film-coated tablets

Body weight, kg	Daily dose, mg/kg
		first 3 months			subsequently
		morning	noon	evening	evening (single dose)
47-62	12-16	0,5	0,5	0,5	1,5
63-78	13-16	0,5	0,5	1	2
79-93	13-16	0,5	1	1	2,5
94-109	14-16	1	1	1	3
over 110	—	1	1	1,5	3,5

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

The use of Ursofalk for the treatment of primary biliary cirrhosis can be continued indefinitely.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking 1 capsule / 0.5 tab. daily, then the dosage should be gradually increased (increasing the daily dose weekly by 1 caps. / 0.5 tablets) until the recommended dosage regimen is reached again.

Symptomatic treatment of chronic hepatitis of various origins. The daily dose is 10-15 mg / kg in 2-3 doses. The 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 20-30 mg / kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see "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.

Body weight over 10 kg: UDCA dosage - 20-25 mg / kg / day. The measuring device is a measuring cup.

Body weight, kg	Daily dose of UDCA mg/kg	Number of measuring cups of Ursofalk suspension 250 mg/5 ml
Body weight, kg	Daily dose of UDCA mg/kg	Morning	Evening
11-12	21-23	0,5	0,5
13-15	21-24	0,5	0,75
16-18	21-23	0,75	0,75
19-21	21-23	0,75	1
22-23	22-23	1	1
24-26	22-23	1	1,25
27-29	22-23	1,25	1,25
30-32	21-23	1,25	1,5
33-35	21-23	1,5	1,5
36-38	21-23	1,5	1,75
39-41	21-22	1,75	1,75
42-47	20-22	1,75	2
48-56	20-23	2,25	2,25
57-68	20-24	2,75	2,75
69-81	20-24	3,25	3,25
82-100	20-24	4	4
>100		4,5	4,5

Conversion table

Children weighing up to 10 kg get sick very rarely. In this case, a disposable syringe should be used.

Single doses for children weighing up to 10 kg should be measured using a syringe, since the measuring cup provided is not designed for volumes less than 1.25 ml. Use a disposable 2 ml syringe with a 0.1 ml graduation. You should pay attention to the fact that disposable syringes are not included in the package with the drug, but can be purchased at a pharmacy.

How to measure the required dose with a syringe:

1. Shake the bottle before opening.

2. Pour a small amount of suspension into a measuring cup, which is included in the package with the drug.

3. Draw a slightly larger amount of the drug into the syringe than required.

4. Tap the syringe with your fingers to remove air bubbles from the drawn suspension.

5. Make sure that the required volume of suspension is in the syringe; if necessary, gain or lower excess volume.

6. Carefully pour the contents of the syringe directly into the child's mouth.

Do not insert the syringe into the vial. Do not pour the unused suspension from the syringe or measuring cup back into the vial.

Body weight up to 10 kg: UDCA dosage - 20 mg / kg / day. The measuring device is a disposable syringe.

Body weight, kg	Dose of Ursofalk suspension 250 mg / 5 ml, ml
Body weight, kg	Morning	Evening
4	0,8	0,8
4,5	0,9	0,9
5	1	1
5,5	1,1	1,1
6	1,2	1,2
6,5	1,3	1,3
7	1,4	1,4
7,5	1,5	1,5
8	1,6	1,6
8,5	1,7	1,7
9	1,8	1,8
9,5	1,9	1,9
10	2	2

Film-coated tablets

Body weight, kg	Daily dose, mg/kg	Ursofalk, film-coated tablets, 500 mg
Body weight, kg	Daily dose, mg/kg	morning	noon	evening
20-29	17-25	0,5	—	0,5
30-39	19-25	0,5	0,5	0,5
40-49	20-25	0,5	0,5	1
50-59	21-25	0,5	1	1
60-69	22-25	1	1	1
70-79	22-25	1	1	1,5
80-89	22-25	1	1,5	1,5
90-99	23-25	1,5	1,5	1,5
100-109	23-25	1,5	1,5	2
>110		1,5	2	2

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

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

Biliary dyskinesia. The average daily dose of 10 mg / kg in 2 doses for 2 weeks to 2 months. If necessary, the course of treatment is recommended to be repeated.

Overdose

Symptoms: diarrhea. As a rule, other symptoms of overdose are unlikely, since with increasing dose the absorption of UDCA decreases and, accordingly, more of it is excreted in the faeces.

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

special instructions

Ursofalk should be taken under medical supervision.

During the first 3 months of treatment, liver function tests (transaminases, GGTP and ALP in serum) should be monitored every 4 weeks, and then every 3 months. The control of these parameters makes it possible to detect violations of liver function in the early stages. This also applies to patients in the late stages of primary biliary cirrhosis. In addition, it is possible to quickly determine whether a patient with primary biliary cirrhosis is responding to ongoing treatment.

When using the drug to dissolve cholesterol gallstones

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

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

In the treatment of patients in the late stages of primary biliary cirrhosis

Cases of decompensated cirrhosis of the liver have been extremely rare. After the cessation of therapy, a partial regression of the manifestations of decompensation was noted.

In patients with primary biliary cirrhosis, in rare cases, at the beginning of treatment, an increase in clinical symptoms may occur, for example, itching may increase. In this case, the dose of the drug must be reduced, and then gradually increased again (see "Method of application and dose").

When used in patients with primary sclerosing cholangitis

Long-term therapy with high doses of UDCA (28-30 mg / kg / day) in patients with this pathology can cause serious side effects.

In patients with diarrhea, the dosage of the drug should be reduced. With persistent diarrhea, treatment should be discontinued.

Women of childbearing age should only take this medicine if they are using reliable contraception. Use of non-hormonal contraceptives or low-estrogen oral contraceptives is recommended because hormonal oral contraceptives may increase gallstone formation. Before starting treatment, a possible pregnancy should be excluded.

One measuring cup (equivalent to 5 ml) of Ursofalk Oral Suspension 250 mg/5 ml contains 0.5 mmol (11.39 mg) sodium. Patients controlling their sodium intake should be aware of this fact.

Influence on the ability to drive vehicles and moving mechanisms. UDCA does not affect the ability to drive vehicles and mechanisms, or this effect is minimal.

Release form

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

Ursofalk- hepatoprotector. Has a choleretic effect. 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 excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it. Causes increased gastric and pancreatic secretion, increases the activity of lipase. It has a hypoglycemic effect.

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

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

Compound

Ursodeoxycholic acid + excipients.

Indications

dissolution of cholesterol gallstones;
biliary reflux gastritis;
primary biliary cirrhosis of the liver in the absence of signs of decompensation (symptomatic treatment).

Release form

Capsules 250 mg (sometimes erroneously called tablets).

Suspension for oral administration (sometimes erroneously called syrup).

Instructions for use and dosage

For children and adults weighing less than 34 kg, it is recommended to use Ursofalk in the form of a suspension.

To dissolve cholesterol gallstones, it is prescribed at a dose of 10 mg / kg of body weight 1 time per day.

Capsules

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

Suspension for oral administration

body weight 8-12 kg - the number of scoops 0.50 per day;
body weight 51-65 kg - the number of measuring spoons 2.5 per day;
body weight 66-80 kg - the number of measuring spoons 3 per day;
body weight 81-100 kg - the number of measuring spoons 4 per day;
body weight over 100 kg - the number of measuring spoons 5 per day.

The drug should be taken daily in the evening, at bedtime (capsules are not chewed), washed down with a small amount of liquid.

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

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

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

Capsules

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

Suspension for oral administration

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

Side effect

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

Contraindications

X-ray positive (high in calcium) gallstones;
non-functioning gallbladder;
acute inflammatory diseases of the gallbladder, bile ducts and intestines;
cirrhosis of the liver in the stage of decompensation;
severe renal dysfunction;
severe liver dysfunction;
severe dysfunction of the pancreas;
pregnancy;
lactation period (breastfeeding);
hypersensitivity to the components of the drug.

Use during pregnancy and lactation

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

Use in children

Perhaps, according to the dosing regimen.

special instructions

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

In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be periodically determined.

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

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

drug interaction

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

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

Analogues of the drug Ursofalk

Structural analogues for the active substance:

Livodex;
Urdox;
Urso 100;
Ursodez;
Ursodeoxycholic acid;
Ursodex;
Ursoliv;
Ursor Rompharm;
Ursor C;
Ursosan;
Choludexan;
Exhol.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.