Medication info

Ursosan 100mg (Ursodeoxycholic Acid)

OTC medicationTablet경구Approval withdrawn
Ingredient · strength
Ursodeoxycholic Acid›200mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White round tablet
Packaging
100 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202005007 · Notified 2020.07.10

This product's status changed to Approval withdrawn on 2025.04.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunct treatment for bile secretion deficiency and chronic liver disease (improvement of liver function), and inflammatory bowel disease (dyspepsia)
Who takes it
Adults
Adult dose
As ursodeoxycholic acid, take 50-100mg per dose, three times a day.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Adjunct treatment for bile secretion deficiency and chronic liver disease (improvement of liver function), and inflammatory bowel disease (dyspepsia)

  • Bile secretion deficiency
  • liver disease
  • biliary tract disease
  • chronic liver disease
  • bowel resection sequelae
  • inflammatory bowel disease
  • dyspepsia
View approved original text

This medication is used as adjunct treatment for liver disease and biliary tract disease due to bile secretion deficiency. It also helps improve liver function in patients with chronic liver disease. It is effective for symptoms of dyspepsia resulting from bowel resection or inflammatory bowel diseases. Therefore, it may help with digestive improvement and liver function.

How to take

Adult dose

As ursodeoxycholic acid, take 50-100mg per dose, three times a day.

Precautions

This medication should not be taken by individuals with allergies to certain ingredients. Caution is required for patients with severe biliary obstruction that can obstruct the flow of bile, as this medication may worsen symptoms. Patients with acute hepatitis or fulminant hepatitis should avoid this medication as their condition may deteriorate upon intake. Patients with radiolucent calcified gallstones and those with a non-functioning gallbladder or acute cholecystitis should also refrain from taking this medication. Women who are pregnant, may become pregnant, or are breastfeeding, as well as children, should not take this medication. Patients with kidney disease and those with acute gastric or duodenal ulcers should exercise caution, as their symptoms may worsen. Patients with inflammatory bowel diseases such as Crohn's disease should also avoid this medication. This medication contains lactose, so patients with genetic disorders that impair lactose breakdown should refrain from taking it. During the use of this medication, certain medications like oral hypoglycemics may have their effects increased, so they should not be taken together. Additionally, it is advisable to avoid medications that hinder the absorption of this drug, such as cholestyramine, medicinal charcoal, and some antacids. Taking this medication alongside drugs that increase bile secretion in the liver may heighten the risk of gallstone formation and diminish the effectiveness of this drug. It is safe to avoid concurrent use with drugs that can cause liver damage. Patients with severe pancreatic disease or gallstones in the bile duct should consult a physician before taking this medication. Patients with esophageal variceal bleeding, hepatic coma, ascites, or requiring sudden liver transplantation should seek professional advice before use. While taking this medication, gastrointestinal symptoms like diarrhea, nausea, vomiting, abdominal pain, constipation, heartburn, or gastric discomfort may occur, so caution is advised. If allergic symptoms such as itching or rash develop, discontinue use immediately and consult healthcare professionals. If symptoms of interstitial pneumonia, including fever, cough, or shortness of breath, appear, stop taking the medication and consult a specialist immediately. Rarely, symptoms such as fatigue, dizziness, increased liver enzyme levels, and decreased white blood cells may occur, so report any abnormal symptoms immediately. During treatment, regular liver function tests are necessary, and additional liver function tests may be conducted if required. Elderly patients generally have reduced physical function, so dosage adjustments or caution may be necessary. Bile dissolution therapy takes a long time; therefore, imaging tests should be done every six months to check treatment progress, and if no effect is observed after 12 months, treatment should be discontinued. Keep this medication in a safe place out of the reach of children, and store it in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Fever, cough, shortness of breath, interstitial pneumonia accompanied by chest X-ray abnormalities

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • heartburn
  • gastric discomfort
  • itching
  • rash
  • general malaise
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  • dizziness
  • calcification of gallstones
  • increased liver enzyme levels
  • decreased white blood cells

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the efficacy and safety of the medication.

Appearance and packaging

Appearance

White round tablet

Package unit

100 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.