Capsules and suspension Ursofalk: instructions for use, price, reviews on the treatment of newborns, analogues

Compound

The capsules contain the active component ursodeoxycholic acid , as well as inactive components: corn starch, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, gelatin, titanium dioxide, purified water.
ursodeoxycholic acid as an active component , as well as additional components: benzoic acid, xylitol, glycerol, MCC, sodium citrate, propylene glycol, anhydrous citric acid, sodium cyclamate , sodium chloride, flavoring, water.

pharmachologic effect

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

Ursodeoxycholic acid , an active substance contained in the drug Ursofalk, is also present in certain quantities in bile. But if certain liver functions are impaired, the synthesis of this substance and its content in the bile decreases. Has a positive effect on immunological reactions in the liver.

The following effects of ursodeoxycholic acid are highlighted:

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 strengthening of its protective properties;
there is also an immunomodulatory effect and a decrease in the synthesis of proinflammatory 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.

of bile decreases . As a consequence, the transformation 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.

Interactions of the drug Ursofalk

The drug should not be used simultaneously with cholestyramine, colestipol or with aluminum hydroxide and other antacids containing smectite, since these drugs can form compounds with ursodeoxycholic acid in the intestinal lumen and interfere with its absorption. If the use of these drugs is necessary, they should be taken 2 hours before or 2 hours after Ursofalk. Ursofalk may increase the resorption of cyclosporine from the intestine, which requires monitoring the concentration of cyclosporine in the blood and, if necessary, adjusting its dosage regimen. In some cases, Ursofalk may reduce the resorption of ciprofloxacin.

Pharmacokinetics and pharmacodynamics

After taking the medicine in the form of a suspension or capsules orally, the process of absorption of ursodeoxycholic acid occurs in the small intestine. Approximately 60-80% of the dose that was taken is determined in the general bloodstream. Metabolism of the active component occurs in the liver. The active ingredient is partially broken down in the intestines, resulting in the formation of toxic 7-keto-lithocholic acid. This substance is slightly absorbed into the general bloodstream; its detoxification occurs in the liver.

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

Pharmacological properties of the drug Ursofalk

Ursodeoxycholic acid is present in small amounts in human bile. When taken orally, it reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine and reducing its secretion into bile, promoting the dissolution of cholesterol stones. The effect of ursodeoxycholic acid in liver diseases and cholestatic diseases is due to the relative replacement of lipophilic, detergent-like, toxic bile acids with hydrophilic, cytoprotective, non-toxic ursodeoxycholic acid, as well as an improvement in the secretory ability of hepatocytes and immunoregulatory processes. When taken orally, ursodeoxycholic acid is rapidly absorbed in the jejunum and upper ileum due to passive transport, and in the terminal ileum - active transport. The degree of absorption is 60–80%. After resorption in the intestine, it is almost completely conjugated in the liver with the amino acids glycine and taurine, and then again excreted in the bile. The effect of first pass through the liver is 60%. In the intestine, bacterial decomposition partially occurs into 7-keto-lithocholic acid. Lithocholic acid is hepatotoxic and in experiments can cause damage to the liver parenchyma. In humans, only a small part of it is resorbed; this part is sulfated and thus detoxified in the liver, then again excreted in bile and finally in feces. The half-life of ursodeoxycholic acid is 3.5–5.8 days.

Indications for use

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

primary biliary liver cirrhosis
primary sclerosing cholangitis;
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 no more than 15 mm, and the person does not have gallbladder dysfunction);
cystic fibrosis;
toxic liver damage (including alcohol poisoning);
atresia of the intrahepatic bile ducts.

Also, tablets and suspension are prescribed to eliminate bile stagnation 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 considered at risk.

Features of application

For successful treatment with Ursofalk you need to follow several rules:

cholesterol stones in the gall bladder should not appear as a shadow on the radiograph;
their size should not exceed 15 mm in diameter;
the gallbladder is no more than half filled with stones;
absence of stones in the bile duct.

It is necessary to carry out monthly monitoring of liver parameters for the first 3 months of treatment. Then - every 3 months.

Treatment for women of reproductive age is prescribed only with contraception. Before starting Ursofalk, pregnancy should be excluded.

According to the instructions, there are no age restrictions when taking Ursofalk for children.

Contraindications

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

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

Side effects

During treatment, the following side effects may occur:

digestive system: diarrhea , manifestation of acute pain in the upper abdomen on the right during the treatment of primary biliary cirrhosis ;
liver and biliary tract: in rare cases - calcification of stones, decompensation of liver cirrhosis in those undergoing treatment for primary biliary cirrhosis ;
skin, subcutaneous tissues: in rare cases - urticaria .

If the above side effects worsen or if any other negative symptoms appear during treatment, the patient must inform the specialist.

Instructions for use of Ursofalk (Method and dosage)

Instructions for use of capsules

The drug for dissolving gallstones should be used in a dose of 10 mg per 1 kg of patient weight once a day.

For a patient weighing up to 60 kg, 2 capsules per day is recommended, for a weight from 61 to 80 kg - 3 capsules, for a weight from 81 to 100 kg - 4 capsules, for a weight over 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 drug for several months after the stones have dissolved.

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

In the case of symptomatic treatment of primary biliary cirrhosis, the dose of the drug depends on the person’s weight. It can range from 2 to 7 tables. For the first three months of therapy, capsules should be taken several times throughout the day; then, when liver parameters improve, it is enough to drink 1 capsule. Ursofalk in the evening. Treatment of primary biliary cirrhosis can continue for an unlimited period of time. Please note that in rare cases, people with this condition may experience a worsening of symptoms when starting to take the drug. In this situation, you need to reduce the dose to 1 capsule per day, and after the condition improves, you need to gradually increase the dosage.

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

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

In people with non-alcoholic steatohepatitis , as well as with alcoholic liver disease, a dose of 10-15 mg per 1 kg of 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, the medicine must be taken for 2 weeks. up to 2 months Treatment can be repeated if necessary.

Ursofalk suspension, instructions for use

For newborns, children and adults whose weight does not exceed 47 kg, the drug is prescribed in the form of a suspension. To dissolve cholesterol stones , you need to take a suspension at a dose of 10 mg per 1 kg of weight once a day. Children weighing 5-7 kg receive 0.25 scoop; 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 measuring spoon corresponds to the content of the active substance in one capsule. How to take it - before or after meals - does not matter significantly.

Ursofalk

Ursofalk ®

(lat.
Ursofalk ®
) is a drug used in the treatment of cholelithiasis, biliary duodenogastric and duodenogastroesophageal reflux, biliary cirrhosis. ATX code A05AA02.

Composition and dosage forms of Ursofalk

The active substance of Ursofalk is ursodeoxycholic (ursodeoxycholic) acid. Ursofalk is available in the form of capsules and suspension for oral administration. Ursofalk capsules are white, hard, opaque, gelatinous. One capsule contains 250 mg of ursodeoxycholic acid. Ursofalk suspension is white in color and smells like lemon and may contain small air bubbles. One scoop of Ursofalk suspension contains 5 ml or 250 mg of ursodeoxycholic acid.

Indications for use of Ursofalk

Ursofalk is used in the treatment of:

cholelithiasis (dissolution of cholesterol gallstones)
gastritis type C caused by duodenogastric bile reflux
primary biliary cirrhosis of the liver in the absence of signs of decompensation

The mechanism of action of Ursofalk in the treatment of reflux diseases

The standard treatment for bile reflux is the drug ursodeoxycholic acid - Ursofalk. Ursodeoxycholic acid, being a non-toxic bile acid, replaces toxic bile acids involved in the enterohepatic circulation of bile acids in the human body. Under the influence of Ursofalk, the bile acids contained in the refluxate are converted into a water-soluble form, which is less irritating to the mucous membrane of the stomach and esophagus. When treated with Ursofalk, in most cases, symptoms such as bitter belching, abdominal discomfort, and vomiting of bile disappear or become less intense. Research in recent years has shown that for bile reflux, the optimal dose for Ursofalk should be considered to be 500 mg per day, 250 mg in 2 doses. The duration of therapy is two months or more (Babak O.Ya.).

Methods of using Ursofalk and dosage

Patients weighing less than 34 kg are recommended to use Ursofalk in the form of a suspension. When taken in capsule form, Ursofalk is not chewed and is washed down with a small amount of water. Ursofalk is taken daily, depending on the recommended dose, once, twice or three times a day. For a single dose, Ursofalk is taken before bedtime.

The use of Ursofalk in the treatment of gastritis caused by bile reflux

For reflux gastritis caused by bile reflux (chemical or type C gastritis), Ursofalk is taken once a day, before bed, in a dose of 250 mg, that is, either one capsule or one measuring spoon of Ursofalk is taken. The duration of therapy is from 10–14 days to six months, if necessary - up to 2 years.

Application and dose of Ursofalk for dissolving cholesterol gallstones.

The recommended dose is 10 mg of ursodeoxycholic acid per kilogram of patient weight per day. Based on this, depending on the dosage form, the daily dosage of Ursofalk is calculated (see table below).

Patient weight, kg	Daily number of capsules when taking Ursofalk in capsules containing 250 mg of ursodeoxycholic acid	Daily dose of Ursofalk in the form of a suspension
Patient weight, kg		number of measuring spoons	volume in ml
5–7	—	¼	1,25
8–12	—	½	2,5
13–18	—	¾	3,75
19–25	—	1	5,0
26–33	—	1½	7,5
34–35	2	1½	7,5
36–50	2	2	10,0
51–60	2	2½	12,5
61–65	3	2½	12,5
66–80	3	3	15,0
81–100	4	4	20,0
> 100	5	5	25,0

Duration of taking Ursofalk is from 6 to 12 months. In order to prevent the recurrence of gallstones, it is recommended to take Ursofalk for several months after their dissolution.

Symptomatic treatment of primary biliary cirrhosis with Ursofalk

The daily dose of Ursofalk depends on the patient’s body weight and dosage form and ranges from 2 to 6 capsules containing 250 mg of ursodeoxycholic acid or from ¼ to 6 scoops of 5 ml, based on the calculation of approximately 10 to 15 mg of ursodeoxycholic acid per kg patient's weight per day. Recommended daily and single doses (for one to three single doses) are indicated in the table below:

Patient weight, kg	Daily dose of Ursofalk			Single dose of Ursofalk
	number of capsules 250 mg	when taking the suspension		morning		day		evening
	number of capsules 250 mg	number of measuring spoons of 5 ml	corresponding volume of suspension, ml	capsules 250 mg	measuring spoons	capsules 250 mg	measuring spoons	capsules 250 mg	measuring spoons
5–7	—	¼	1,25	—	—	—	—	—	¼
8–12	—	½	2,5	—	—	—	¼	—	¼
13–18	—	¾	3,75	—	¼	—	¼	—	¼
19–25	—	1	5,0	—	½	—	—	—	½
26–33	—	1½	7,5	—	½	—	½	—	½
34–35	2	1½	7,5	1	½	—	½	1	½
36–50	2	2	10,0	1	1	—	—	1	1
51–65	3	3	15,0	1	1	1	1	1	1
66–80	4	4	20,0	1	1	1	1	2	2
81–85	4	5	25,0	1	1	1	2	2	2
86–100	5	5	25,0	1	1	2	2	2	2
101–110	5	6	30,0	1	2	2	2	2	2
> 110	6	6	30,0	2	2	2	2	2	2

Professional medical publications addressing the treatment of gastrointestinal diseases with Ursofalk

Babak O.Ya. Bile reflux: modern views on pathogenesis and treatment // Suchasna gastroenterology. – 2003. – No. 1 (11). — P. 28-30.
Gubergrits N.B., Lukashevich G.M., Fomenko P.G., Belyaeva N.V. Bile reflux: modern theory and practice. DNMU named after. M. Gorky. – Moscow // – Moscow: Forte print. 2014. p. 36.
Instructions for patients from the manufacturer for the UK (pdf, in English): “Ursofalk ® 250 mg. Capsules. Patient Information Leaflet,” Dr Falk Pharma GmbH, November 21, 2012.

On the website gastroscan.ru in the literature catalog there is a section “Gastroprotectors, cytoprotectors, hepatoprotectors”, containing articles concerning the treatment of the gastrointestinal tract with ursodeoxycholic acid preparations.

Use of Ursofalk during pregnancy and lactation

Ursofalk is contraindicated for use in pregnant women and while breastfeeding.

Side effects, contraindications, pharmacokinetics, interaction of Ursofalk with other drugs

Side effects of Ursofalk, contraindications, pharmacokinetics, as well as the interaction of Ursofalk with other drugs are determined by its active substance - ursodeoxycholic acid and are described in the article "Ursodeoxycholic acid".
Other medicines

based on ursodeoxycholic acid: Grinterol, Livodexa, Urdoxa, Urso 100, Ursodez, Ursodex, Uroliv, Ursorom Rompharm, Ursorom S, Ursodeoxycholic acid, Ursosan, Choludexan, Exhol.

Ursofalk has contraindications, side effects and application features; consultation with a specialist is necessary.

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Interaction

The absorption of ursodeoxycholic acid in the intestine and, accordingly, the effectiveness of the drug is reduced when taking colestipol, cholestyramine, as well as antacids that contain aluminum hydroxide or aluminum oxide. If it is necessary to use these medications, they should be taken at least two hours before taking Ursofalk.

Under the influence of ursodeoxycholic acid, the absorption of cyclosporine from the intestine is enhanced. That is, if it is necessary 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 when taking Ursofalk, the absorption of Ciprofloxacin .

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

Main characteristics of Ursofalk capsules

The drug belongs to the category of hepatoprotectors. It helps dissolve cholesterol stones in bile, thereby reducing blood cholesterol levels. Ursofalk also acts as an immunomodulatory drug.

Available in 2 forms:

Gelatin capsules containing powder or granules (10 pieces in one package).
Suspension with lemon scent. Produced in 250 ml bottles. They come with a 5 ml measuring spoon.

The active ingredient of the drug is ursodeoxycholic acid. Also contains: flavor, water, citric acid, sodium citrate and other auxiliary components.

Ursofalk can be purchased at a pharmacy in any form only with a prescription. Storage conditions are standard: room temperature up to 25 degrees and moderate humidity. The shelf life of capsules is 5 years, suspensions are 4 years from the date of production. After opening the bottle of suspension, it can be stored for up to 4 months.

special instructions

Ursofalk should be taken under the supervision of a specialist.

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

To determine whether there is any progress in the treatment of calcification of stones, it is necessary to conduct an oral cholecystography with examination in a standing position, as well as in a supine position, 6-10 months after the start of therapy.

Ursofalk should not be prescribed if it is not possible to visualize the gallbladder using an x-ray, if there is calcification of stones, or attacks of colic.

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

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

Special instructions for the use of the drug Ursofalk

In patients with primary biliary cirrhosis, in isolated cases, at the beginning of treatment, a worsening of clinical symptoms, such as increased skin itching, is noted. In this situation, it is recommended to continue treatment at a dose of 1 capsule daily, gradually increasing the dose (by 1 capsule per week) until the required dose is reached again. In the first 3 months of treatment, liver function parameters (AST, ALT and gamma-glutamyltransferase) should be monitored monthly and then every 3 months. For timely detection of calcification of gallstones, depending on their size, after 6–10 months from the start of treatment, it is necessary to perform a survey image, cholecystography with contrast in a standing and lying position, and also conduct ultrasound monitoring of the treatment process.

Analogues of Ursofalk

Level 4 ATC code matches:
Ursodex

Henofalk

Ursoliv

Choludexan

Ursohol

Ursodez

Urdoxa

Ursosan

Livodex

Analogues of this medicine are Ursolit , Ursobil , Ursolvan , Holacid , Ursohol , Ursosan , Delursan , etc.

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

Which is better: Ursofalk or Ursoliv?

The medicine Ursoliv contains, like Ursofalk, ursodeoxycholic acid as an active component. Therefore, their effect on the human body is similar. However, sometimes these medications can act differently depending on your individual body. Therefore, the choice of drug should be made by a doctor after careful research.

Reviews about Ursofalk

Those reviews about Ursofalk treatment that users leave on forums are very different, but mostly positive opinions are written about the medicine. Many patients write that after a course of treatment, gallstones were not detected by ultrasound, which means the drug turned out to be effective. Reviews from doctors are less common, but experts also write about this medicine in a positive way.

Parents also leave favorable reviews of the suspension for children, noting that the medicine tastes good for children and is also effective. Also, according to users, Ursofalk quickly helps with jaundice in newborns.

Note!

The description of the drug Ursofalk on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Ursofalk price, where to buy

You can buy the suspension and tablets at any pharmacy with a doctor's prescription. The price of 100 capsules of Ursofalk is on average 2,200 rubles. You can buy Ursofalk in Moscow for a price starting from 220 rubles (10 pcs.). The price of Ursofalk suspension in Novosibirsk and St. Petersburg averages 1,200 rubles per pack. 250 mg.

In Ukraine, you can buy capsules for an average price of 150 UAH. for 10 pcs. You can buy Ursofalk 500 mg at a price starting from 1800 UAH. for 50 capsules. You can purchase the suspension in Kyiv, Odessa, etc. at a price of 600 UAH.

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LuxPharma* special offer

Ursofalk 250mg/5ml suspension 250ml
RUB 2,990 order

Pharmacy Dialogue

Ursofalk (caps. 250 mg No. 50)Dr. Falk
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Ursofalk (tablet p/p/o 500 mg No. 50)Dr. Falk
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Ursofalk (susp. 250mg/5ml 250ml)Dr. Falk
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Pharmacy24

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