Ursofalk - instructions for use, dose, side effects, contraindications

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

Description:

Hard, opaque gelatin capsules №0; The lid is white, the body is white. The contents of the capsule are white powder or granules.

Pharmacotherapeutic group:Hepatoprotective agent

ATX: & nbsp

A.05.A.A Preparations of bile acids

Pharmacodynamics:

Hepatoprotective agent, has a cholagogue 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 biliary system, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids; causes an increase in gastric and pancreatic secretion, increases lipase activity, and has a hypoglycemic effect.Causes partial or complete dissolution of cholesterol stones with enteral application, reduces the saturation of bile with cholesterol, which contributes to 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.

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

Contraindications:

X-ray positive (with a high content of calcium) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; cirrhosis of the liver in the stage of decompensation; marked violations of the kidneys, liver,pancreas; hypersensitivity to the components of the drug. Ursodeoxycholic acid has no age limitation in use, but children under 3 years of age are advised to use Ursofalk in suspension, since 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 those cases when the potential benefit of its use for the mother exceeds the possible risk to the fetus.

Data on the isolation of ursodeoxycholic acid with breast milk are absent. If ursodeoxycholic acid is needed during lactation, breastfeeding should be stopped.

Dosing and Administration:

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

Dissolution of cholesteric gallstones

The recommended dose is 10 mg ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:

Body mass	Capsule
Up to 60 kg	2
61 - 80 kg	3
81 - 100 kg	4
Over 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 recurrent cholelithiasis

recommended taking the drug for several months after the dissolution of stones.

Treatment of biliary reflux gastritis

1 capsule Ursofalk daily every night before going to sleep, without chewing and washing with not a lot of water.

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

Symptomatic treatment primary biliary cirrhosis

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

In the first 3 months of treatment, Ursofac 250 mg should be divided into several doses during the day. After improving liver function, the daily dose of the drug can be taken once, in the evening.

The following application mode is recommended:

250 mg capsules

Weight bodies	Daily dose	In the morning	In the afternoon	In the evening
47-62 kg	3	1	1	1
63-78 kg	4	1	1	2
79-93 kg	5	1	2	2
94 109 kg	6	2	2	2
Over 110kg	7	2	2	3

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

Application Ursofalka for treatment primary biliary cirrhosis can be continued for an unlimited time.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may To worsen at the beginning of treatment, for example, the itch can become frequent. In this case, the treatment should continue, taking one capsule daily, then gradually increase the dosage, increasing the daily dose weekly for one capsule, until the recommended dosage regimen is again achieved.

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

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

Cystic fibrosis (cystic fibrosis) - 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.

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

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

Biliary dyskinesia - 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.

Side effects:

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

Very frequent (≥1 / 10)

Frequent (≥1 / 100 - <1/10)

Infrequent (≥1 / 1,000 - <1/100)

Rare (≥1 / 10,000 - <1 / 1,000)

Very rare (<1 / 10,000).

Disorders from the gastrointestinal tract:

In clinical studies against the backdrop of treatment with ursodeoxycholic acid, an unformed stool or diarrhea was often observed.

In the treatment of primary biliary cirrhosis, very rarely there were acute pains in the right upper abdomen.

Disorders from the liver and bile ducts:

In very rare cases, against the background of treatment with ursodeoxycholic acid, calcification of gallstones can occur.

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

Disturbances from the skin and subcutaneous tissues:

In very rare cases, hives can be observed.

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

Overdose:

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

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 ciclosporin, 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 bile saturation with cholesterol and may decrease the ability to dissolve cholesterol bile stones.

Special instructions:

Ursofalk should take the drug carried out under the supervision of a doctor.

During the first three months of treatment, liver function tests should be monitored: transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in 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 quickly determine whether the patient reacts with primary biliary cirrhosis to the 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 the cessation of therapy, a partial reverse development of manifestations of decompensation was noted.

When used in patients with primary sclerosing cholangitis:

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

Patients with diarrhea should reduce the dosage of the drug. With persistent diarrhea, treatment should be discontinued.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:Capsules 250 mg.

Packaging:

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

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

Storage conditions:

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

Shelf life:

5 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014714 / 01

Date of registration:05.03.2009 / 19.05.2015

Expiration Date:Unlimited

The owner of the registration certificate: Dr. Falk Farma GmbH Dr. Falk Farma GmbH Germany

Manufacturer: & nbsp

Dr. FALK PHARMA, GmbH Germany

Representation: & nbspDOCTOR FALK PHARMA GmbH DOCTOR FALK PHARMA GmbH Germany

Information update date: & nbsp14.07.2016

Illustrated instructions

Instructions

Ursofalk (Ursofalk®)