INTRODUCTION

URSOLID 300MG TABLET contains Ursodeoxycholic Acid that belongs to the group of medicines called Hepatoprotective agents. It is used to treat primary biliary cirrhosis (damage of bile ducts in liver leading to build up of bile).

URSOLID 300MG TABLET is also used to dissolve small gallstones which are not visible on X ray (less than 15mm diameter) in patients with a functioning gall bladder. Gall stones are hardened deposits mostly made up of cholesterol that can form in gallbladder and can cause sharp, intense pain in the upper right part of the abdomen.

URSOLID 300MG TABLET can also be used for liver disease associated with cystic fibrosis in children aged 6 to less than 18 years. Cystic fibrosis is a diseases affects the cells that produce mucus, sweat and digestive juices and causes these fluids to become thick and sticky resulting in plugged up tubes, ducts and passageways.

During or while the treatment with URSOLID 300MG TABLET, your doctor might ask you to get several diagnostic tests done such as liver function test and gall bladder scan.

URSOLID 300MG TABLET is not recommended for use in patients having allergy to bile acids, calcified gallstones, inflammation of the gallbladder or the bile ducts, blockage of common bile duct or cystic duct, frequent cramp like pains in upper abdomen, low bile flow in children or improper function of gall bladder. URSOLID 300MG TABLET should be used with caution in patients having liver diseases.

URSOLID 300MG TABLET should be taken during pregnancy only if clearly advised by the doctor and should be used with caution in breast-feeding women. Ask for your doctor’s advice before taking. URSOLID 300MG TABLET can be used in children, adolescents and elderly. Your doctor will decide the correct doe and duration of therapy with URSOLID 300MG TABLET for you.

The most common side effects of taking URSOLID 300MG TABLET are soft, loose stools or diarrhoea. Consult your doctor if the symptoms worsen or doesn’t improve.

USES OF URSOLID 300MG TABLET

Treats,

• primary biliary cirrhosis (PBC)
• gallstones (not visible on X ray in patients with a functioning gall bladder)
• liver disease associated with cystic fibrosis in children aged 6 to 18 years

HOW URSOLID 300MG TABLET WORKS

URSOLID 300MG TABLET helps in reducing raised liver enzyme levels by increasing the bile flow through the liver and protecting liver cells. URSOLID 300MG TABLET is concentrated in bile and decreases biliary cholesterol by suppressing the formation of new cholesterol by inhibiting its intestinal absorption. The reduced cholesterol levels lead to gradually solubilization of cholesterol from gallstones, resulting in their dissolution.

DIRECTIONS FOR USE

Always use URSOLID 300MG TABLET exactly as prescribed by your doctor. Take this medicine with or after meals.

For Tablet, Capsule: Swallow URSOLID 300MG TABLET with a glass of water or milk. Do not crush or chew the medicine.

For Dispersible Tablet: Disperse URSOLID 300MG TABLET in the specified quantity of water as mentioned in the label. Consume the mixture immediately after reconstitution.

Your doctor will decide the right dose and duration of therapy for you depending upon your age, body weight and severity of disease condition. Continue to take URSOLID 300MG TABLET for the stipulated duration prescribed by your doctor to achieve better results. If you feel that the effect of URSOLID 300MG TABLET is too strong or too weak for you, please talk to your doctor.

SIDE EFFECTS OF URSOLID 300MG TABLET

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Ask for your doctor’s advice if diarrhoea doesn’t improve.

WARNING & PRECAUTIONS

PREGNANCY

URSOLID 300MG TABLET should be used in pregnant women only if considered clearly necessary by the doctor. If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking URSOLID 300MG TABLET.

BREASTFEEDING

URSOLID 300MG TABLET should be used with caution in breastfeeding women as it is not known if it passes through breast milk. Consult your doctor if you are breastfeeding or about to start breastfeeding before taking URSOLID 300MG TABLET.

DRIVING AND USING MACHINES

URSOLID 300MG TABLET has no or negligible effect on driving or using machine.

LIVER

URSOLID 300MG TABLET should be used with caution in patients with liver diseases. Your doctor might advise you for frequent liver examination and tests during the treatment. Consult your doctor before taking the URSOLID 300MG TABLET.

ALLERGY

Do not take URSOLID 300MG TABLET if you are allergic to allergic to Ursodeoxycholic Acid or bile acids or any other components of this medicine.

INTERACTIONS

A. Drug-Drug interactions:

Before taking URSOLID 300MG TABLET, inform your doctor if you are taking any of the following medicine:

• medicine used for birth control (Ex.  levonorgestrel, ethinyl estradiol)
• medicines used to treat acidity (Ex.  aluminium hydroxide)
• medicines used to lower cholesterol levels (Ex. colestyramine, clofibrate, colestipol)
• medicines used to treat infections (Ex.  ciprofloxacin, dapsone)
• medicine used to treat hypertension (Ex. nitrendipine, rosuvastatin)
• medicines used to reduce the activity of the immune system (Ex. ciclosporin)

Overdosage:

If you or anyone else takes too much of URSOLID 300MG TABLET, consult your doctor immediately or visit the nearby hospital. The symptom of overdosage is diarrhoea.

SYNOPSIS

MORE INFORMATION

• Keep URSOLID 300MG TABLET out of reach of children
• Store URSOLID 300MG TABLET at room temperature below 30°C

FAQs ABOUT URSOLID 300MG TABLET

Why is URSOLID 300MG TABLET prescribed?

URSOLID 300MG TABLET is used to treat primary biliary cirrhosis (PBC), to dissolve cholesterol gallstones and to treat liver disease associated with cystic fibrosis in children aged 6 to 18 years.

Do I need to undergo any diagnostic tests before or while getting treated with URSOLID 300MG TABLET?

During or while the treatment with URSOLID 300MG TABLET, your doctor might ask you to get several diagnostic tests done such as liver function test and gall bladder scan.

Can I stop taking URSOLID 300MG TABLET on my own?

Do not stop taking URSOLID 300MG TABLET unless advised by your doctor. Your doctor might advise you on how long you should continue to take URSOLID 300MG TABLET. From time to time, you will need to consult your doctor to review your treatment and assess your symptoms.

Can URSOLID 300MG TABLET cause diarrhoea?

Diarrhoea is the most common side effect of URSOLID 300MG TABLET. It may occur as a result of overdose as well. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and electrolyte balance and stay hydrated. Stop taking URSOLID 300MG TABLET and inform your doctor immediately if you have persistent diarrhoea.

What is the best time to take URSOLID 300MG TABLET?

Take URSOLID 300MG TABLET with or after meals. For tablet, capsule, swallow URSOLID 300MG TABLET with a glass of water or milk. Do not crush or chew the medicine. For dispersible tablet, disperse URSOLID 300MG TABLET in the specified quantity of water as mentioned in the label. Consume the mixture immediately after reconstitution. If you feel that the effect of URSOLID 300MG TABLET is too strong or too weak for you, please talk to your doctor.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page - 671.

2. Jelena S Rudic, Goran Poropat, Miodrag N Krstic, Goran Bjelakovic, Christian Gluud, Cochrane Hepato-Biliary Group. Ursodeoxycholic acid for primary biliary cirrhosis. NIH National Library of Medicine National Centre for Biotechnology Information. Pubmed Central. December 2012. [Accessed on 21st October 2022]  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045744/

3. Keith D. Lindor, Kris V. Kowdley, Velimir A. C. Luketic, M. Edwyn Harrison, Timothy McCashland, Alex S. Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Jill Keach, Jody Mooney, Carol Sargeant, Julie Braaten, Tamara Bernard, Debra King, Ellen Miceli, Jeff Schmoll, Tanya Hoskin, Prabin Thapa, Felicity Enders. High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. NIH National Library of Medicine National Centre for Biotechnology Information. Pubmed Central. September 2009. [Accessed on 21st October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758780/

4. Gustav Paumgartner, Ulrich Beuers. Mechanisms of action and therapeutic efficacy of ursodeoxycholic acid in cholestatic liver disease. NIH National Library of Medicine National Centre for Biotechnology Information. Pubmed.gov. February 2004. [Accessed on 21st October 2022] https://pubmed.ncbi.nlm.nih.gov/15062194/

5. Mitsubishi Tanabe Pharma Corporation. Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C. NIH U.S. National Library of Medicine. ClinicalTrials.gov. March 2012. [Accessed on 21st October 2022] https://clinicaltrials.gov/ct2/show/NCT00200343

6. Glenmark Pharmaceuticals Europe Limited. Electronic Medicine Compendium (EMC). [Revised in March 2019] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.10064.pdf

7. ABC Farmaceutici S.p.A. Health Products Regulatory Authority (HPRA). [Revised in July 2021] [Accessed 21st October 2022] http://www.hpra.ie/img/uploaded/swedocuments/b76d4c90-5f5f-4056-9635-5c78f70ab1dd.pdf

8. Dr. Falk Pharma GmbH. Electronic Medicine Compendium (EMC). [Revised in November 2014]. [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.2980.pdf

9. Glenmark Pharmaceuticals Europe Limited. Electronic Medicine Compendium (EMC). [Revised in March 2019]. [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.10064.pdf

10. DM Pharma. Ursodeoxycholic Acid. [Accessed on 21st October 2022] http://www.dmpharma.co.in/ursodeoxycholic.html

11. MIMS. Ursodeoxycholic Acid (Ursodiol). [Accessed on 21st October 2022] https://www.mims.com/india/drug/info/ursodeoxycholic%20acid?mtype=generic

12. Drug Bank. Ursodeoxycholic Acid (Ursodiol). [Accessed on 21st October 2022] https://go.drugbank.com/drugs/DB01586

USEFUL DIAGNOSTIC TESTS

• Liver function tests
• Complete Blood Count
• Gall Bladder Scan

AUTHOR DETAILS

Written By Dr. Priyanka Goel, BDS
Last updated on 27 Oct 2022 | 01:37 PM(IST)