ETHSODOXY- 300 Tablets

10x10 Tablets

Ursodeoxycholic Acid is a medicine used to dissolve gallstones that are composed mainly of undissolved cholesterol. It is also used to improve the flow of bile in Primary Biliary Cirrhosis (a chronic condition in which the bile ducts in your liver are slowly damaged and destroyed). It works by breaking down the cholesterol in gallstones which helps in dissolving the stones. It improves the functioning of liver enzymes and protects liver cells. Ursodeoxycholic Acid may cause side effects like stomach ache, itching, nausea, vomiting, pain during passing urine, cough, etc. These side effects usually subside with time. However, consult your doctor for further assistance if they persist or worsen. Ursodeoxycholic Acid should be taken after a meal with a glass of milk or water. Your doctor will recommend the appropriate dose and duration of treatment based on your clinical condition and therapeutic response. Do not stop taking this medicine without consulting your doctor. Ursodeoxycholic Acid is not recommended if you are allergic to it. It should be avoided if you have any obstruction in your liver or gallbladder. Inform your doctor about all your clinical conditions and ongoing medications you are taking to avoid any interaction. It should be taken during pregnancy or breastfeeding only after consulting your doctor. It is not recommended for children below 18 years of age.

Side effects

Major & minor side effects for Ursodeoxycholic Acid

• Diarrhoea
• Indigestion
• Bladder pain
• Nausea or Vomiting
• Unusual bleeding
• Weakness

What is it prescribed for?

• Dissolution of cholesterol rich gallstones

  Ursodeoxycholic Acid is used to break down and dissolve stones of the gall bladder which are formed by excess cholesterol deposits. It is also used to prevent gall stone formation in some people.

• Primary biliary cirrhosis (bile acid associated liver damage)

  Primary biliary cirrhosis, also known as primary biliary cholangitis, is a chronic condition in which the bile ducts in your liver become inflamed, damaged, and are slowly destroyed. Ursodeoxycholic Acid is used to treat the symptoms and slow the progression of primary biliary cirrhosis.

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Commonly asked questions

• Onset of action

  The time taken for Ursodeoxycholic Acid to show its effect is variable and depends on stone size and composition. It may start showing its effect after six to 24 months after the administration.

• Duration of effect

  The time for which Ursodeoxycholic Acid remains effective in the body is subject to vary depending on the use.

• Safe with alcohol?

  Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

• Is it habit forming?

  No habit-forming tendencies were reported for Ursodeoxycholic Acid.

• Usage in pregnancy?

  Ursodeoxycholic Acid should be used by pregnant women only when clearly needed. Consult your doctor before taking this medicine.

• Usage while breast-feeding?

  It is unknown if the medicine passes into the breast milk or not. Ursodeoxycholic Acid should be used with caution if you are breastfeeding. Consult your doctor before taking this medicine.

Allergic reaction

Avoid taking Ursodeoxycholic Acid if you are allergic to it. Seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.

Biliary tract disorder

Ursodeoxycholic Acid is not recommended for use if you have a biliary tract disorder such as swelling, obstruction, deformation, or fistula of the bile tract.

Gallbladder disorder

Ursodeoxycholic Acid is not recommended for use if you have a non-functional gall bladder or conditions like swelling or impaired contractility of the gall bladder.

Presence of calcified gallstone

Ursodeoxycholic Acid is not recommended for use if you have gallstones that have formed due to a deposit of calcium. These stones are detectable through X-ray.

Chronic liver disease

Ursodeoxycholic Acid is not recommended for use if you have impaired liver function as it may worsen your condition.

Inflammatory bowel disease

Inflammatory bowel disease is a condition that causes chronic swelling, irritation, and pain of the intestine that may lead to bleeding. Ursodeoxycholic Acid is not recommended for use in people with an ongoing inflammatory disease of the bowel.

Patients requiring cholecystectomy

Ursodeoxycholic Acid is not recommended for use in people who require surgery to remove the gall bladder or need surgery to remove the stones.

Warnings for special population

Pregnancy

Ursodeoxycholic Acid should be used by pregnant women only when clearly needed. Consult your doctor before taking this medicine.

Breast-feeding

It is unknown if the medicine passes into the breast milk or not. Ursodeoxycholic Acid should be used with caution if you are breastfeeding. Consult your doctor before taking this medicine.

General warnings

Type of gallstones

Ursodeoxycholic Acid should be used only if the stone has high cholesterol content. Other stones formed due to calcium deposits or ones that are detectable in X-ray should not be treated with this medicine.

Liver disease

Ursodeoxycholic Acid should be used with caution in people with liver impairment. Your doctor may recommend close monitoring of your liver function and bilirubin levels before and during the course of treatment with this medicine.

Time taken for stone dissolution

Ursodeoxycholic Acid may take several months to dissolve the gall stone. Report any side effects you experience during this period to your doctor immediately. Do not discontinue treatment before the course is complete as it may result in the recurrence of stone formation.

Diarrhoea

Report any incidence of diarrhoea while taking Ursodeoxycholic Acid to your doctor immediately. Your doctor may recommend appropriate dose adjustments if this side effect is severe and persistent.

Initial worsening of symptoms

Use of Ursodeoxycholic Acid for primary biliary cirrhosis may worsen the symptoms initially. Report any such instance to the doctor as a dose adjustment may be needed in such cases.

Use in children

Ursodeoxycholic Acid is not recommended for use in children younger than 18 years of age since the safety and efficacy of use are not clinically established.

Missed Dose

Do not miss the dose of Ursodeoxycholic Acid. In case you miss a dose, take it as soon as you remember. However, if it is time for the next dose, then skip the missed dose. Do not double the dose to make up for the missed one.

Overdose

Do not take more than the prescribed dose of Ursodeoxycholic Acid. Seek emergency medical treatment in case of an overdose.

All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Interaction with Medicine

Disease interactions

Disease

Information not available.

Food interactions

Information not available.

Lab interactions

Information not available.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

Take Ursodeoxycholic Acid as instructed by your doctor. For tablet/capsule form: Do not break, chew, or crush the medicine in your mouth. Swallow as a whole with plenty of water. Follow all the instructions given on the prescription label or packing insert. For suspension/syrup: Shake the bottle well before use. Do not take it in larger or smaller quantities than recommended. Take the medicine for the recommended duration. Do not discontinue this medication abruptly without consulting your doctor as it may cause a recurrence of gallstones. Eat a healthy diet, exercise regularly, and avoid alcohol intake while undergoing treatment with Ursodeoxycholic Acid. Diarrhoea may occur as a side effect. Drink plenty of fluids and inform your doctor if diarrhoea persists or if you find blood in your stools. Your doctor may monitor your liver function and bilirubin levels every month for the next three months after the start of treatment, and every six months thereafter.

Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works

Ursodeoxycholic Acid works by inhibiting the production of cholesterol from the liver and also reducing the absorption of cholesterol from the intestine. It improves the functioning of liver enzymes and protects liver cells.

Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Gallstone solubilizing agents

Schedule

Schedule H

• References

  Medicines.org.uk. 2016. Ursodeoxycholic acid 250 mg capsules - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: [Accessed 13 January 2022].

  https://www.medicines.org.uk/emc/product/7253/smpc#gref

  Accessdata.fda.gov. 2009. URSO 250® / URSO Forte® (ursodiol) TABLETS. [online] Available at: [Accessed 13 January 2022].

  https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020675s017lbl.pdf

  Mayoclinic.org. 2021. Ursodiol (Oral Route) Description and Brand Names - Mayo Clinic. [online] Available at: [Accessed 13 January 2022].

  https://www.mayoclinic.org/drugs-supplements/ursodiol-oral-route/description/drg-20066618

  Cleveland Clinic. 2022. Ursodeoxycholic Acid, Ursodiol capsules or tablets. [online] Available at: [Accessed 13 January 2022].

  https://my.clevelandclinic.org/health/drugs/20178-ursodeoxycholic-acid-ursodiol-capsules-or-tablets

  (no date) Ursodeoxycholic acid 250 mg capsules - summary of product characteristics (SmPC) - (EMC). Available at: (Accessed: April 17, 2023).

  https://www.medicines.org.uk/emc/product/7253/smpc#:~:text=Adults%3A%20The%20usual%20dose