Specification

INTRODUCTION
URSODIL SUSPENSION 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).
URSODIL SUSPENSION 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.
URSODIL SUSPENSION can also be used for liver disease associated with cystic fibrosis in children aged 1 month to 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 URSODIL SUSPENSION, your doctor might ask you to get several diagnostic tests done such as liver function test and gall bladder scan.
URSODIL SUSPENSION 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. URSODIL SUSPENSION should be used with caution in patients having liver diseases.
URSODIL SUSPENSION 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. URSODIL SUSPENSION can be used in children, adolescents and elderly. Your doctor will decide the correct doe and duration of therapy with URSODIL SUSPENSION for you.
The most common side effects of taking URSODIL SUSPENSION are soft, loose stools or diarrhoea. Consult your doctor if the symptoms worsen or doesn?t improve.
USES OF URSODIL SUSPENSION
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 1 month to 18 years

HOW URSODIL SUSPENSION WORKS
URSODIL SUSPENSION helps in reducing raised liver enzyme levels by increasing the bile flow through the liver and protecting liver cells. URSODIL SUSPENSION 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
Take URSODIL SUSPENSION as advised by your physician. Shake the bottle well before using URSODIL SUSPENSION. Your doctor will decide the correct dose of therapy for you depending upon your age, body weight and severity of disease condition. If you feel that the effect of URSODIL SUSPENSION is too strong or too weak for you, please talk to your doctor.
SIDE EFFECTS OF URSODIL SUSPENSION

COMMON

Soft, loose stools

Diarrhoea

RARE
Stop taking URSODIL SUSPENSION and contact your doctor immediately if you experience any of the following side effects:
Persistent diarrhoea

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
URSODIL SUSPENSION is not recommended in pregnant women unless deemed necessary. If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking URSODIL SUSPENSION.
BREASTFEEDING
URSODIL SUSPENSION should be used with caution in breastfeeding. Consult your doctor if you are breastfeeding or about to start breastfeeding before taking URSODIL SUSPENSION.
DRIVING AND USING MACHINES
?URSODIL SUSPENSION has no or negligible effect on driving or using machine.
LIVER
URSODIL SUSPENSION should be used with caution in patients with liver diseases. Frequent liver examination and tests are. recommended during the treatment. Consult your doctor before taking URSODIL SUSPENSION.
ALLERGY
Do not take URSODIL SUSPENSION if you are allergic to allergic to Ursodeoxycholic Acid or bile acids or any other components of this medicine.
OTHERS
URSODIL SUSPENSION is not recommended for use if you have:
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

Improperly functioning gall bladder
Use in paediatrics:
URSODIL SUSPENSION is not recommended for use in children with biliary atresia (blockage in bile duct) and who have poor bile flow, even after surgery. It can be used in other children. Your doctor will decide the correct dose and duration of URSODIL SUSPENSION for your child depending on his weight, age, and diseases condition. Consult with your child?s doctor before giving it to your child.
Use in geriatrics:
URSODIL SUSPENSION can be used in elderly patients. However, consult with your doctor before taking URSODIL SUSPENSION.
INTERACTIONS
A. Drug-Drug interactions:
Before taking URSODIL SUSPENSION, 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 URSODIL SUSPENSION, consult your doctor immediately or visit the nearby hospital. The symptom of overdosage is diarrhoea.
SYNOPSIS

Drug :?? Ursodeoxycholic Acid

Pharmacological Category :?? Cholagogues and Choleretics

Therapeutic Indication :?? Biliary cirrhosis, Gallstones, Liver diseases associated with?cystic fibrosis

Dosage Forms :?? Tablet, Dispersible tablet, Syrup, Suspension

MORE INFORMATION

Keep URSODIL SUSPENSION out of reach of children

Store URSODIL SUSPENSION at room temperature below 30?C

FAQs ABOUT URSODIL SUSPENSION
Why is URSODIL SUSPENSION prescribed?
URSODIL SUSPENSION 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 URSODIL SUSPENSION?
During or while the treatment with URSODIL SUSPENSION, your doctor might ask you to get several diagnostic tests done such as liver function test and gall bladder scan.
Can I stop taking URSODIL SUSPENSION on my own?
Do not stop taking URSODIL SUSPENSION unless advised by your doctor. Your doctor might advise you on how long you should continue to take URSODIL SUSPENSION. From time to time, you will need to consult your doctor to review your treatment and assess your symptoms.
Can URSODIL SUSPENSION cause diarrhoea?
Diarrhoea is the most common side effect of URSODIL SUSPENSION. 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 URSODIL SUSPENSION and inform your doctor immediately if you have persistent diarrhoea.
What is the best time to take URSODIL SUSPENSION?
Take URSODIL SUSPENSION with or after meals. Shake the bottle well before using URSODIL SUSPENSION. Your doctor will decide the correct dose of therapy for you depending upon your age, body weight and severity of disease condition. If you feel that the effect of URSODIL SUSPENSION 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. Oriana Boscolo, Leandro Salvo,?Cecilia Dobrecky,?Eliana N Fissore,?Fabian Buontempo,?Valeria Tripodi,?Silvia E Lucangioli. Pharmaceutical suspensions of ursodeoxycholic acid for pediatric patients:?in?vitro?and?in?vivo?studies. NIH National Library of Medicine National Centre for Biotechnology Information. Pubmed.gov. June 2021. [Accessed on 21st October 2022] https://pubmed.ncbi.nlm.nih.gov/33759695/
6. Dr. Falk Pharma GmbH. Electronic Medicine Compendium (EMC). [Revised in August 2020]. [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.146.pdf
7. Intralife Pvt. Ltd. Udbest (Ursodeoxycholic Acid). [Accessed on 21st October 2022] https://intralifeindia.com/product_detail.php?id=2432576
8. Stellar Biolabs. Nextlife (Ursodeoxycholic Acid). [Accessed on 21st October 2022] https://www.myrralifecare.in/pharmaceutical-syrup.html
9. MIMS. Ursodeoxycholic Acid (Ursodiol). [Accessed on 21st October 2022] https://www.mims.com/india/drug/info/ursodeoxycholic%20acid?mtype=generic
10. 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
11. 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

PRODUCT DETAILS

Net Qty

1 N

Item Weight

120 g

Ingredient

URSODEOXYCHOLIC ACID(URSODIOL) 450MG

Hsn Code

30049036

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Additional information

Weight
120 g

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