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.
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.
Overdose
In cases of overdose, diarrhea may occur. In general, other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore most of its amount is excreted in the feces.
If diarrhea occurs, the dose should be reduced, and if diarrhea is persistent, therapy should be discontinued.
There is no need for specific events. The effects of diarrhea must be treated symptomatically with restoration of fluid and electrolyte balance.
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.
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.
Contraindications and side effects
"Ursofalk" can only be used in consultation with a doctor. In some cases, the medicine cannot be used:
- cirrhosis occurring at the stage of decompensation;
- acute inflammations that are associated with the ducts and gallbladder;
- individual intolerance to individual components of the drug;
- gallbladder dysfunction;
- gallstones with a large proportion of calcium;
- any stage of pregnancy, as well as the lactation period.
With a long course of therapy, various side effects may occur:
- loose stools, digestive disorders;
- the progression of cirrhosis at the stage of decompensation is rarely recorded;
- hives.
If your general health worsens, or if there is no therapeutic effect, it is recommended to stop taking the drug and consult a doctor. No cases of drug overdose have been identified; in extreme cases, symptomatic treatment is indicated.
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 | |
| 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 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.
Mode of application
The tablets should be swallowed, chewed, and washed down with liquid. The drug must be used regularly.
The use of Ursofalk for primary biliary cirrhosis is possible for a long period.
In patients with primary biliary cirrhosis, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, treatment should be continued, taking half an Ursofalk tablet per day, and then gradually increase the dose (increasing the daily dose by half an Ursofalk tablet every week until the indicated dosage regimen is achieved).
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.
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.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
LuxPharma* special offer
- Ursofalk 250mg/5ml suspension 250ml
RUB 2,990 order
ZdravCity
- Ursofalk tablets p.p.o. 500 mg 50 pcs. Lozan Pharma GmbH
RUR 1,817 order
- Ursofalk capsules 250 mg 50 pcs. Lozan Pharma/Allfamed Fabril Arzneimittel/Dr. Falk Pharma GmbH
RUB 823 order
Pharmacy Dialogue
- Ursofalk (caps. 250 mg No. 50)Dr. Falk
RUR 842 order
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RUB 857 order
- Ursofalk (tablet p/p/o 500 mg No. 50)Dr. Falk
RUB 1,770 order
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RUB 1,596 order
- Ursofalk (susp. 250mg/5ml 250ml)Dr. Falk
RUR 1,138 order
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Pharmacy24
- Ursofalk 500 mg N25 tablets Dr. Falk Pharma GmbH, Germany
685 UAH. order - Ursofalk 500 mg No. 100 tablets Dr. Falk Pharma GmbH, Germany
2544 UAH. order
- Ursofalk 250 mg/5 ml suspension
1156 UAH. order
- Ursofalk 250 mg No. 10 capsules Dr.Falk Pharma GmbH,/Lozan Pharma GmbH/Kloquet Pharma-Service GmbH/allfamed Farbil Artsnaymit.,Nimechchina
134 UAH order
- Ursofalk 250 mg N100 capsules Dr.Falk Pharma GmbH,/Lozan Pharma GmbH/Kloquet Pharma-Service GmbH/allfamed Farbil Arznaymit.,Nimechchina
1235 UAH. order
PaniPharmacy
- Ursofalk capsule Ursofalk capsules 250 mg No. 10 Germany, Dr. Falk
157 UAH order
- Ursofalk capsule Ursofalk capsules 250 mg No. 100 Germany, Dr. Falk
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- Ursofalk capsule Ursofalk capsules 250 mg No. 50 Germany, Dr. Falk
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- Ursofalk tablets 500 mg No. 25 Ukraine, Doctor Falk
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- Ursofalk liquid Ursofalk suspension for oral use 250mg/5ml bottle 250ml Germany, Dr. Falk
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Note!
Description of the drug Ursofalk table. p/o 500 mg No. 100 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.
