INTRODUCTION

URSOCOL 150MG contains Ursodeoxycholic acid (ursodiol) which belongs to the group of medicine called choleretic agents. It is used in the treatment of primary biliary cirrhosis in patients without decompensated cirrhosis. Primary biliary cholangitis is a chronic disease of the biliary tract, in which liver tissues are damaged by an impaired drainage of bile. It  is also used to dissolve gallstones caused by excess cholesterol in gall bladder where the gallstones are not visible on a plain x-ray. It can also be used for liver disease associated with cystic fibrosis (an inherited disorder in which, mucus is particularly tough in whole body) in children aged 6 to less than 18 years.

Ursodeoxycholic acid is a bile acid normally only found in small amounts in human bile. When administered orally, ursodeoxycholic acid decreases biliary cholesterol saturation and allows solubilization of cholesterol from gallstones, resulting in galls stone dissolution. Along with the treatment, your doctor might recommend you to eat foods that are high in fiber such as fruits, vegetables, beans, and peas.

Avoid eating unhealthy fats, like those found in desserts and fried foods. Try to exercise more regularly, which will improve your overall health, may also lower your chances of developing gallstones. The most common side effect of taking this medicine is diarrhea. Before taking this medicine, inform your doctor if you are pregnant. Do not take this medicine, if you have gastric or duodenal ulcer, narrowing or blockage of bile ducts or acute inflammation of gallbladder or bile ducts.

USES OF URSOCOL 150MG

• Treats primary biliary cirrhosis in patients without decompensated cirrhosis
• Dissolve gallstones not more than 15 mm in diameter
• Treats liver disease associated with cystic fibrosis in children aged 6 to less than 18 years

HOW URSOCOL 150MG WORKS

When administered orally, ursodeoxycholic acid enters the bile and decreases the biliary cholesterol saturation by suppressing hepatic synthesis and secretion of cholesterol, and by inhibiting its intestinal absorption. This reduced cholesterol saturation allows gradual solubilization of cholesterol from gallstones, resulting in galls stone dissolution.

DIRECTIONS FOR USE

Always take this medicine as directed by your physician. It can be taken after a meal with a glass of milk or a small snack. Your doctor will decide the correct dose for you depending upon your condition. Swallow the medicine as a whole with a glass of water. Do not crush or chew the medicine. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF URSOCOL 150MG

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines used to treat high cholesterol levels (e.g., colestipol, colestyramine, rosuvastatin, clofibrate)
• medicines used to treat stomach acid (such as antacids containing aluminium hydroxide or smectite)
• medicines used to treat infection (e.g., ciprofloxacin and dapsone)
• ciclosporin (reduces the chances of graft rejection)
• nitrendipine (used to treat high blood pressure)
• oral contraceptives (birth control pills)
• medicines used for menopause (oestrogenic hormones)

SYNOPSIS

MORE INFORMATION

Do not store above 30°C and keep out of reach of children.

FAQs ABOUT URSOCOL 150MG

Can URSOCOL 150MG cause weight loss?

This medicine suppresses hepatic synthesis of cholesterol. So, it is believed to cause weight loss. But there are not enough studies to address its effect of weight management.

Can we breastfeed while taking URSOCOL 150MG?

This medicine should be used with caution in breastfeeding women. Consult your doctor before taking.

Can URSOCOL 150MG be given to children?

Yes. It can be used to treat liver disease associated with cystic fibrosis in children aged 6 to less than 18 years.

REFERENCES

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

2. Keith A. Sharkey and John L. Wallace. Treatment of disorders of bowel motility and water flux; Antiemetics; Agents used in biliary and pancreatic disease. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1347.

3. University of Sao Paulo General Hospital. Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on October 2018] [Accessed 17th November 2020] https://clinicaltrials.gov/ct2/show/NCT03489889

4. 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. [Revised on March 2012] [Accessed 17th November 2020] https://clinicaltrials.gov/ct2/show/NCT00200343

5. 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 and Felicity Enders. High Dose Ursodeoxycholic Acid for the Treatment of Primary Sclerosing Cholangitis. NCBI; PMC US National Library of Medicine, National Institute of Health. September 2010. [Accessed 17th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758780/

6. Glenmark Pharmaceuticals Europe Limited. Electronic Medicines Compendium (EMC); [Revised on March 2019] [Accessed 17th November 2020] https://www.medicines.org.uk/emc/files/pil.10064.pdf

7. Almac Pharma Services Limited. Electronic Medicines Compendium (EMC); [Revised on January 2018] [Accessed 17th November 2020] https://www.medicines.org.uk/emc/files/pil.8241.pdf

8. Strides Pharma UK Ltd. Heads of Medical Agency. MR Index. [Revised on November 2018] [Accessed 17th November 2020] https://mri.cts-mrp.eu/human/downloads/NL_H_2516_001_FinalPL.pdf

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Abdominal ultrasound