Ursofalk caps 250mg #100

Ursofalk user manual

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Composition

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.
Suspension Ursofalk contains ursodeoxycholic acid as an active ingredient, as well as additional components: benzoic acid, xylitol, glycerol, MCC, sodium citrate, propylene glycol, anhydrous citric acid, sodium cyclamate, sodium chloride, flavor, water.

Form of issue

The medicine is made in the form of capsules and suspension.
    Capsules gelatinous, firm, white, opaque. Inside the capsules - powder white or granules. In the blister - 10 capsules, blisters fit into cardboard packs.
    Suspension of a homogeneous consistency, has a white color, it can contain small bubbles. Has a scent of lemon. Contained in bottles of dark glass of 250 ml, a cardboard box is also embedded measuring cup 5 ml.

pharmachologic effect

This drug is a hepatoprotector, that is, a drug that helps dissolve bile cholesterol stones, significantly lowering the cholesterol content in the blood. Has a wide range of effects, in particular, acts as a hepatoprotective, cholelitholytic, immunomodulating agent. There is also a hypoglycemic effect.
Ursodeoxycholic acid, the active substance found in Ursofalk's drug, is also present in certain amounts in bile. But if certain liver functions are violated, the synthesis of this substance and its content in the bile is reduced. Positively affects immunological reactions in the liver.
The following effects of ursodeoxycholic acid are distinguished:
    has a choleretic effect, reducing the amount of bile acids in the bile and increasing their excretion into the lumen of the intestine, also reducing the absorption of toxic bile hydrophobic acids;
    the cytoprotective effect is manifested, which consists in the ability of this substance to be inserted into the lipid layer of the cell membrane, which leads to the stabilization of the cell membrane and the enhancement of its protective properties;
    immunomodulating effect and decrease in the synthesis of proinflammatory cytokines;
    produces hypercholesterolemic effects due to a decrease in absorption of cholesterol in the ileum, a decrease in the synthesis of cholesterol in the liver, and also activating the process of its elimination with bile.
Also, under the influence of ursodeoxycholic acid, the lithogenicity of bile is reduced. As a consequence, the transformation of cholesterol compounds leads to a decrease in the formation of cholesterol and the dissolution of cholesterol stones.
Under the influence of the drug Ursofalk increased gastric and pancreatic secretion.

Pharmacokinetics and pharmacodynamics

After taking the drug as a suspension or capsules inside, the process of absorption of ursodeoxycholic acid in the small intestine occurs. In the total blood flow, approximately 60-80% of the dose that was taken is determined. Metabolism of the active component occurs in the liver. Partially, the active ingredient disintegrates in the intestine, resulting in the formation of toxic 7-keto-lithocholic acid. This substance is slightly absorbed into the total bloodstream, its detoxification occurs in the liver.
A characteristic for this drug is the effect of a percutaneous passage through the liver. The elimination half-life is 3-5 days. Excretion occurs with feces mainly in the form of metabolites, as well as a small part is output unchanged.

Indications for use

Those indications for the use of the drug Ursofalk, which are indicated in the manual, are associated with the use in diseases of the liver and gall bladder, in which there is cholestasis, an increase in cholesterol in the blood, and a decrease in a number of liver functions. The medicine is prescribed for such diseases:
    cirrhosis of the primary biliary tract;
    cholangitis primary sclerosing;
    Hepatitis of different origin (acute and chronic), accompanied by cholestasis;
    reflux-esophagitis and reflux-gastritis biliary;
    the presence of cholesterol stones in the gallbladder (provided that the stones are X-ray negative, their diameter is no more than 15 mm, the person has not had any dysfunction of the gallbladder);
    cystic fibrosis;
    liver damage of a toxic nature (including alcohol poisoning);
    atresia of the intrahepatic bile ducts.
Also, tablets and suspension are prescribed to eliminate stagnation of bile in people on parenteral nutrition. They are advisable to appoint patients who have undergone a liver transplant operation 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 to be at risk.

Contraindications

In the instruction, such contraindications to the use of tablets and suspension are noted:
    gallstones X-ray positive (that is, stones with a high calcium content);
    acute inflammatory diseases of the bile ducts, intestines, gallbladder;
    cirrhosis of the liver in the decompensation stage;
    the gallbladder is non-functioning;
    pronounced disorders in the functions of the liver, pancreas, kidneys;
    pregnancy and lactation;
    pronounced sensitivity to the components of drugs.

Side effects

During the treatment period, such side effects can be noted:
    digestive system: diarrhea, acute pain at the top of the abdomen on the right side of primary biliary cirrhosis;
    liver and biliary tract: in rare cases - calcination of stones, decompensation of liver cirrhosis in those who are being treated for primary biliary cirrhosis;
    skin, subcutaneous tissue: in rare cases - hives.
If the above side effects are aggravated or if any other negative symptoms appear during the treatment, the patient should always inform the specialist about it.

Instructions for use Ursofalk (Method and dosage)

Instructions for use of capsules

The drug for the dissolution of biliary cholesterol stones should be applied at a dose of 10 mg per 1 kg of the patient's weight once a day.
A patient weighing up to 60 kg shows the reception of 2 capsules per day, with a weight of 61 to 80 kg - 3 caps., Weight from 81 to 100 kg - 4 caps., Weighing more than 100 kg - 5 caps. Take the pill in the evening, before bedtime. Chew capsules are not recommended.
The duration of taking the drug is from 6 to 12 months. To ensure quality prevention of recurrent cholelithiasis, it is recommended to take the remedy for several months after the stones dissolve.
In the treatment of biliary reflux gastritis, you should apply 1 capsule of Ursofalk every day for 10 days to 6 months, sometimes up to 2 years.
In case of symptomatic therapy of primary biliary cirrhosis, the dose of the drug depends on the weight of the person. It can be from 2 to 7 tab. The first three months of therapy during the day of the capsule should be taken several times, then, when the liver is improving, it is enough to drink 1 capsule. Ursofalk in the evening. Treatment of primary biliary cirrhosis can continue for an unlimited period of time. It should be noted that in people with this disease, in rare cases, there may be a worsening of symptoms at the beginning of the drug. In this situation, you need to reduce the dose to 1 capsule per day, and after improving the condition, you need to gradually increase the dosage.
With symptomatic treatment of chronic hepatitis of different origin, the dose per day is 10-15 mg per 1 kg of body weight, it should be taken 2-3 times. Admission lasts from 6 to 12 months.
In patients with primary sclerosing cholangitis, 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 body 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 kg of body weight is used. Treatment lasts 6-12 months and longer.
Patients with dyskinesia of bile ducts are prescribed 10 mg per 1 kg of weight per day, it is necessary to take the medicine from 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, prescribe the agent 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 measuring spoons; 8-12 kg - half a measuring spoon; 13-18 kg - 0.75 tablespoons; 19-25 kg - 1 spoonful; 26-35 kg - 1.5 tablespoons; 36-50 kg - 2 tablespoons; 51-65 kg - 2.5 tablespoons; 66-80 kg - 3 tablespoons; 81-100 kg - 4 tablespoons; more than 100 kg - 4 tablespoons.
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 - before or after food - does not matter.

Overdose

No cases of drug overdose have been documented. If necessary, practice symptomatic therapy.

Interaction

The absorption of ursodeoxycholic acid in the intestine and, consequently, the effectiveness of the agent is reduced by the simultaneous administration of colestipol, colestyramine, and antacids, which contain aluminum hydroxide or aluminum oxide. If you need to use these drugs, they should be drunk, 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 you need to take cyclosporine, you need to monitor the concentration of cyclosporine in the blood and correct the dose of the medicine.
There is a possibility that when taking Ursofalk, the absorption of Ciprofloxacin may decrease.
It should be borne in mind that, when taking hypolipidemic drugs (especially clofibrate), neomycin, estrogens, progestins, bile saturation with cholesterol increases, so the ability of the active substance to dissolve cholesterol gallstones may decrease.

Terms of sale

You can buy Ursofalk without a prescription.

Storage conditions

Keep capsules and suspension from children, store at a temperature of no more than 25 ° C.

Shelf life

Capsules can be stored for 5 years, suspension - 4 years. After the Ursofalk vial has been opened, the suspension can be used for 4 months.

special instructions

Ursofalk should be taken under the supervision of a specialist.
In the first 3 months of admission, it is very important to monitor liver function tests, first every 4 weeks, then - once every three months. It is important to determine violations of liver function at the earliest stages. It is also important to determine as soon as possible whether there is a response to treatment in people with primary biliary cirrhosis.
To determine whether there has been some progress in the treatment of stone calcification, oral cholecystography should be performed with a standing and back-rest examination 6-10 months after the start of therapy.
You should not prescribe Ursofalk if you can not visualize the gallbladder during the X-ray, if there is calcification of stones, colic attacks.
In very rare cases, cases of decompensation of liver cirrhosis were documented.
People suffering from diarrhea need to reduce the dose of drugs. Patients with persistent diarrhea should suspend therapy.

Children

For children it is prescribed in the form of a suspension, it is necessary to apply strictly according to the scheme described in the instruction.

Ursofalk for newborns

The testimonies indicate that Ursofalk for newborns is prescribed for physiological jaundice, manifested a few days after the birth of the child. However, the instruction does not contain data on such use of the drug. It should be noted that such treatment can be carried out only under the constant supervision of a specialist.

In pregnancy and lactation

It is proved that the active component of Ursofalk does not have mutagenic, teratogenic and embryotoxic effects, but there is still no accurate data on its penetration through the hematoplacental barrier, and the effect of the drug on the course of pregnancy. Therefore, when pregnancy is prescribed only if there is evidence. There is no data on the effect of breastfeeding.

Reviews about Ursofalk

Those reviews about the treatment Ursofalk, which users leave on the forums, are very different, but mostly about the medicine they write positive opinions. Many patients write that after the course of treatment stones in the gallbladder with ultrasound were not detected, that is, the drug was effective. Less often there are responses of doctors, but experts also write about this medicine in a positive way.
Parents also leave approving reviews of the suspension for children, noting that the drug is palatable to children and yet effective. Also, according to users, Ursofalk quickly helps with jaundice in newborns.