ursodeoxycholic acid | Exhol capsules 250 mg 50 pcs.

Release form

Capsules.



packaging 50 pcs

Indications

uncomplicated gallstone disease (biliary sludge, dissolution of cholesterol gallstones in the gallbladder with a functioning gallbladder, prevention of recurrence of stone formation after cholecystectomy)

chronic active hepatitis

toxic (including medicinal) liver damage

non-alcoholic steatohepatitis

primary biliary cirrhosis

primary sclerosis pulmonary fibrosis biliary reflux gastritis and reflux esophagitis.

Contraindications

hypersensitivity

x-ray-positive (high calcium) gallstones

nonfunctional gallbladder

gall-gastric fistula

acute cholecystitis

acute cholangitis

cirrhosis cirrhosis cirrhosis and / or renal failure

obstruction of the biliary tract

empyema gallbladder

children under 3 years of age.

Caution: children aged 3-4 years, as difficulty swallowing capsules.

Use during pregnancy and lactation

Women of childbearing age are advised to use non-hormonal contraceptives during the period of use of the drug.

The use of UDCA during pregnancy is only possible if the expected benefit to the mother outweighs the potential risk to the fetus. There are currently no data on the allocation of UDCA with breast milk.

If necessary, the use of UDCA during lactation should decide on the termination of breastfeeding.

Composition

1 capsule contains:

active substance:

ursodeoxycholic acid 250 mg

excipients:

silicon dioxide colloidal (Aerosil A-200 or A-300),

calcium hydrogen phosphate dihydrate, srdlkd, sodium sulfide dihydrate, srdlkd -90 or collidone 90 F),

lactose monohydrate (milk sugar)

hard gelatin capsule composition: body - titanium dioxide,

gelatin cap - titanium dioxide, gelatin, indigo carmine.

Dosage and administration

Inside, without chewing, with plenty of water.

Diffuse liver disease, gallstone disease (cholesterol gallstones and biliary sludge): Exhol ® is prescribed continuously for a long time (from several months to several years) in a daily dose of 10 mg / kg to 12-15 mg / kg (2-5 caps.). Duration of administration for dissolving stones - until complete dissolution, plus another 3 months for the prevention of relapse of stone formation. In case of diffuse liver diseases, the daily dose of the Exhol® preparation is divided into 2-3 doses, the capsules are taken with food. In gallstone disease, the entire daily dose is taken once at night.

Biliary reflux gastritis and reflux esophagitis: the drug is prescribed at 250 mg / day (1 caps.), before bedtime. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

After cholecystectomy, for the prevention of repeated cholelithiasis: the recommended dose is 250 mg 2 times a day for several months.

Toxic, drug damage to the liver, alcoholic liver disease and atresia of the biliary tract: the daily dose is set at the rate of 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.

Primary biliary cirrhosis: the drug is prescribed at a rate of 10-15 mg / kg / day (if necessary, up to 20 mg / kg) in 2-3 doses. The duration of therapy is from 6 months to several years.

Primary sclerosing cholangitis: 12–15 mg / kg / day (up to 20 mg / kg) in 2–3 doses. The duration of therapy is from 6 months to several years.

Non-alcoholic steatohepatitis: 13–15 mg / kg / day in 2–3 doses. The duration of therapy is from 6 months to several years.

Cystic fibrosis: the dose is set at the rate of 20–30 mg / kg / day (up to 20 mg / kg) in 2–3 doses. The duration of therapy is from 6 months to several years. For children over 3 years of age, the dose of the drug is prescribed individually, at the rate of 10-20 mg / kg / day.

Side effects

Back pain, nausea, vomiting, diarrhea (may be dose-dependent), constipation, transient (transient) increased activity of hepatic transaminases, allergic reactions rarely - calcification of gallstones, exacerbation of previously existing psoriasis, alopecia.

Drug Interaction

Antacids, containing aluminum and ion exchange resins (colestyramine), reduce the absorption of the drug.

Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase the level of bile cholesterol and may reduce the ability to dissolve cholesterol bile nodules.

Overdose

No overdose has been detected.

In case of overdose, symptomatic treatment is performed.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 РC.

Keep out of the reach of children.

The Expiration of

is 3 years.

Active ingredient

Ursodeoxycholic acid

Pharmacy leave terms

Prescription

Dosage form

Dosage form

Capsules

Canonfarma, Russia