Know the basics
What is ursodeoxycholic acid used for?
Ursofalk capsules are used:
- to dissolve gallstones caused by excess cholesterol in the gall bladder where the gallstones are not visible on a plain x-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s).
- for the treatment of a condition where the bile ducts in the liver become damaged leading to a build-up of bile. This may cause scarring of the liver. The liver should not be so damaged that it is not functioning properly. This condition is called primary biliary cirrhosis.
How should I take ursodeoxycholic acid?
Swallow the capsules whole with a drink of water or other liquid. Take the capsules in the evening at bedtime. Take the capsules regularly.
How do I store ursodeoxycholic acid?
Ursodeoxycholic acid is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store ursodeoxycholic acid in the bathroom or the freezer. There may be different brands of ursodeoxycholic acid that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush ursodeoxycholic acid down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
Know the precautions & warnings
What should I know before using ursodeoxycholic acid?
Do NOT take Ursofalk capsules if:
- you are, or have been told you are allergic (hypersensitive) to bile acids like ursodeoxycholic acid or to any of the other ingredients of Ursofalk capsules.
- your gall bladder does not work properly
- you have gallstones that are visible on an x-ray
- you have acute inflammation of the gall bladder or biliary tract
- you have an obstruction of the biliary tract (blockage of the common bile duct or a cystic duct)
- you suffer from frequent cramp-like pains in the upper abdomen (biliary colic)
- you have hardening of the gallstones caused by a build-up of calcium.
Please ask your doctor about any of the conditions mentioned above. You should also ask if you have previously had any of these conditions or if you are unsure whether you have any of them.
Is it safe to take ursodeoxycholic acid during pregnancy or breast-feeding?
There isn’t enough information about the safety of using this medication during pregnancy and breast-feeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication.
Know the side effects
What are the side effects of ursodeoxycholic acid?
Like all medicines, Ursofalk capsules can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following symptoms after taking
Common side effects (occurring in less than 1 in 10 but more than 1 in 100 patients):
soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and salt balance.
Diarrhoea may also occur as a result of overdose.
Very rare side effects (occurring in less than 1 in 10,000 patients):
During the treatment of primary biliary cirrhosis: severe right-sided upper abdominal pain, severe worsening of liver scarring – this partially improves after treatment is stopped.
There are no additional symptoms of this but it will show up in tests.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
Know the interactions
What drugs may interact with ursodeoxycholic acid?
Ursodeoxycholic acid may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Does food or alcohol interact with ursodeoxycholic acid?
Usodeoxycholic acid may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with ursodeoxycholic acid?
Ursodeoxycholic acid may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
Understand the dosage
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this medication.
What is the dose of ursodeoxycholic acid for an adult?
Dissolution of cholesterol-rich gallstones
6-12 mg/kg daily as a single dose at bedtime or in 2-3 divided doses continued for 3-4 mth after radiological disappearance of stones. Doses may be divided unequally with a higher dose given before bedtime to counteract increase in biliary cholesterol saturation which occurs in early morning. Max: 15 mg/kg.
Hepatic impairment: Chronic liver disease (except primary biliary cirrhosis): use with caution.
Primary biliary cirrhosis
10-15 mg/kg daily in 2-4 divided doses.
Prophylaxis of gallstones in patients undergoing rapid weight loss
300 mg bid.
What is the dose of ursodeoxycholic acid for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is ursodeoxycholic acidavailable?
Ursodeoxycholic acid is available in the following dosage forms and strengths:
Capsule 250 mg
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of ursodeoxycholic acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.
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