Universal reference book for medicines
Product name: URSOFALK (URSOFALK)

Active substance: ursodeoxycholic acid

Type: A drug that dissolves cholesterol gallstones

Manufacturer: Dr.
FALK PHARMA (Germany) manufactured by LOSAN PHARMA (Germany)
Composition, form of production and packaging
Capsules
hard gelatinous, size №0, opaque, white;
the content of the capsules is a powder or granules of white color.
1 caps.

ursodeoxycholic acid 250 mg

Auxiliary substances: corn starch - 73 mg, silicon dioxide colloid - 5 mg, magnesium stearate - 2 mg, titanium dioxide - 1.94 mg, gelatin - 80.51 mg, sodium lauryl sulfate - 0.2 mg, purified water - 14.55 mg.

10 pieces.
- blisters (1) - packs of cardboard.
25 pcs.
- blisters (2) - packs of cardboard.
25 pcs.
- blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Hepatoprotector.
Has choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in the bile, increases the solubility of cholesterol in the bile excretory system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids. Causes an increase in gastric and pancreatic secretion, increases the activity of lipase.
Has hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when ingestion, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

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

PHARMACOKINETICS

Data on the pharmacokinetics of Ursofalk is not available.

INDICATIONS

- dissolution of gallstones cholesterol stones;

- Biliary reflux-gastritis;

- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

- chronic hepatitis of various genesis;

- primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis);

- non-alcoholic steatohepatitis;

- alcoholic liver disease;

- biliary dyskinesia.

DOSING MODE

Children and adults weighing less than 47 kg are advised to use Ursofalk in the form of a suspension.

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

Body weight Number of capsules

up to 60 kg 2

61-80 kg 3

81-100 kg 4

more than 100 kg 5

The drug should be taken daily in the evening, before going to bed (capsules are not chewed), squeezed with a small amount of liquid.

Duration of treatment is 6-12 months.
For the prevention of repeated cholelithiasis, the use of the drug is recommended for several months after the dissolution of the stones.
For the treatment of biliary reflux gastritis, 1 caps is prescribed.
Ursofalka daily in the evening before going to bed, washing down with a small amount of water. The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.
For symptomatic treatment of primary biliary cirrhosis, the daily dose depends on the body weight and is from 3 to 7 capsules (approximately 14 ± 2 mg / kg body weight).

In the first 3 months of treatment, taking the drug Ursofalk capsules 250 mg should be divided into several doses during the day.
After improving the liver function, the drug can be taken 1 time / day, in the evening. The following dosing regimen is recommended:
Body weight Daily dose in the morning in the afternoon

47-62 kg 3 caps.
1 caps. 1 caps. 1 caps.
63-78 kg 4 caps.
1 caps. 1 caps. 2 caps.
79-93 kg 5 caps.
1 caps. 2 caps. 2 caps.
94-109 kg 6 caps.
2 caps. 2 caps. 2 caps.
more than 110 kg 7 caps.
2 caps. 2 caps. 3 caps.
The use of Ursofalk for the treatment of primary biliary cirrhosis can be continued for an unlimited time.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase.
In this case, the treatment should continue, taking 1 capsule daily, then gradually increase the dose (increasing the daily dose weekly by 1 capsule) until the recommended dosage regimen is again achieved.
Symptomatic treatment of chronic hepatitis of different genesis is a daily dose of 10-15 mg / kg in 2-3 doses.
The duration of treatment is 6-12 months or more.
Primary sclerosing cholangitis is a daily dose of 12-15 mg / kg.
If necessary, the dose can be increased to 20-30 mg / kg in a 2-3-dose. The duration of therapy is from 6 months to several years.
Cystic fibrosis (cystic fibrosis) - daily dose of 12-15 mg / kg;
if necessary, the dose may be increased to 20-30 mg / kg in a 2-3-dose. The duration of therapy is from 6 months to several years.
Nonalcoholic steatohepatitis is an average daily dose of 10-15 mg / kg in 2-3 doses.
The duration of therapy is from 6-12 months or more.
Alcoholic liver disease - an average daily dose of 10-15 mg / kg in 2-3 doses The duration of therapy is from 6-12 months or more.

Dyskinesia of the bile ducts is an average daily dose of 10 mg / kg in 2 divided doses for 2 weeks to 2 months.
If necessary, the course of treatment is recommended to be repeated.
Capsules should be taken regularly, without chewing, with a small amount of liquid.

SIDE EFFECT

Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1 / 100- <1/10), infrequently (? 1 / 1000- <1/100), rarely (? 1/10 000- <1 / 1000), very rarely (<1/10 000).

From the digestive system: often in clinical studies - unformed stool or diarrhea;
very rarely in the treatment of primary biliary cirrhosis - acute pain in the right upper abdomen.
From the liver and bile ducts: very rarely - calcification of gallstones, in the treatment of advanced stages of primary biliary cirrhosis - decompensation of liver cirrhosis, which disappears after drug withdrawal.

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

If any of these adverse reactions are aggravated, or any other adverse reactions occur, the patient should inform the doctor.

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;

- pronounced violations of the liver function;

- pronounced impairment of pancreatic function;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

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

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in severe impairment of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe violations of liver function, cirrhosis in the stage of decompensation.

SPECIAL INSTRUCTIONS

Ursofalk is administered under the supervision of a doctor.

During the first 3 months of treatment, liver function parameters should be monitored: the activity of transaminases, aminotransferase and GGT in the serum every 4 weeks, and then every 3 months.
Control of these parameters allows us to identify 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 thus possible to determine more quickly if the patient reacts with primary biliary cirrhosis for ongoing treatment.
When used to dissolve cholesterol gallstones

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

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

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

Very rarely there were cases of decompensation of liver cirrhosis.
After cessation of therapy, a partial reverse development of manifestations of decompensation was noted.
Patients with diarrhea should reduce the dose of the drug.
With persistent diarrhea, treatment should be discontinued.
Impact on the ability to drive vehicles and manage mechanisms

Effects on the ability to drive vehicles and moving mechanisms were not identified.

OVERDOSE

Cases of an overdose have not been revealed.
In case of an overdose, symptomatic treatment is performed.
DRUG INTERACTION

Colestramine, colestipol and antacids, containing aluminum hydroxide or smectite (aluminum oxide), reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and efficacy.
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 can enhance the absorption of cyclosporine from the intestine.
Therefore, in patients receiving cyclosporine, the doctor should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine, if necessary.
In some cases, Ursofalk can reduce the absorption of ciprofloxacin.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of up to 25 ° C.
Shelf life of the capsules is 5 years.
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