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

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

Description:

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

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 cholesterol stones with enteral application, 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.

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 origins

- primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)

- nonalcoholic 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 34 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:

Weight bodies	Measured cup	Complies with (ml)
5 - 7 kg	1/4	1,25
8 - 12 kg	1/2	2,50
13 - 18 kg	3/4	3,75
19-25 kg	1	5,00
26 - 35 kg	1 1/2	7,50
36 - 50 kg	2	10,00
51 - 65 kg	2 1/2	12,50
66 - 80 kg	3	15,00
81 - 100 kg	4	20,00
Over 100 kg	5	25,00

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

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.

Treatment of biliary reflux gastritis 1 measuring cup Ursofalk daily in the evening before bedtime.

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 the body weight and ranges from 2 to 7 measuring cups (approximately from 14 mg ± 2 mg ursodeoxycholic acid per 1 kg of body weight).

The following application mode is recommended:

Weight bodies (kg)	Measuring cups Ursofalk suspension inwards 250 mg / 5ml
	The first 3 months of treatment			Subsequently
	Morning	In the afternoon	Evening	Evening (once a day)
8-11	-	1/4	1/4	1/2
12- 15	1/4	1/4	1/4	3/4
16- 19	1/2	-	1/2	1
20- 23	1/4	1/2	1/2	1 1/4
24- 27	1/2	1/2	1/2	1 1/2
28- 31	1/4	1/2	1	1 3/4
32- 39	1/2	1/2	1	2
40- 47	1/2	1	1	2 1/2
48- 62	1	1	1	3
63- 80	1	1	2	4
81 - 95	1	2	2	5
96- 115	2	2	2	6
More 115	2	2	3	7

Symptomatic treatment of chronic hepatitis of different 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 manual is aggravated, or if you notice other side effects not listed in the instructions, inform the doctor about it.

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 the primary biliary cirrhosis for ongoing treatment.

When used to dissolve cholesterol gallstones:

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

One measuring cup (equivalent to 5 ml) of Ursofalk oral suspension 250 mg / 5 ml contains 0.50 mmol (11.39 mg) of sodium. Patients who control sodium intake should take this fact into account.

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:Suspension for oral administration 250 mg / 5 ml.

Packaging:

Suspension for ingestion of 250 mg / 5 ml, 250 ml in a bottle of dark glass with a screw cap with the control of the first opening; 1 bottle together with a measuring cup and 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:

Suspension - 4 years. After autopsy - 4 months.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014714 / 02

Date of registration:05.03.2009 / 23.10.2013

Expiration Date:Unlimited

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

Manufacturer: & nbsp

VIFOR AG Switzerland

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

Information update date: & nbsp14.07.2016

Illustrated instructions

Instructions

Ursofalk (Ursofalk®)