Equivalent Medicinal Product

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 What is in this leaflet

1. What Ursodeoxycholic acid is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
7. What is and what it is used for

is a preparation containing bile acids present naturally in the body, which can solubilize cholesterol in bile.

This medicine is used to treat alterations in bile production by the liver and to improve the solubility of cholesterol, to avoid the formation of calculi and to facilitate their dissolution if they are present.

This medicine is not effective against all types of calculi, but only against those which cannot be visualized on X-ray images (radiotransparent), in particular cholesterol      gallstones (gallbladder functioning) and gallstones in the bile duct.

It is also used to treat digestive problems due to malfunction of the gallbladder (biliary dyspepsia).

2. What you need to know before you take

Do not take Ursodeoxycholic acid

-if you are allergic (hypersensitive) to Ursodeoxycholic acid, to bile acids, or to any component of this medicine:

-if you have an acute inflammation of the gallbladder or biliary tract;

-if you have an obstruction of the biliary tract (occlusion of the common bile duct or cystic dust);

-if you have frequent pains in the upper abdomen (biliary colic);

-if you have calcified gallstones visible on a X-ray;

-if your gall bladder does not work properly;

-if you suffer from stomach or intestinal lesions (gastric or duodenal ulcer) in active phase;

-if you have a yellowish skin colour (obstructive jaundices);

-if you have severe liver  or intestinal problems which may alter the blood flow of bile salts.

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medicine.

This medicinal product should be taken under medical supervision.

Before starting a long-term therapy, you should monitor liver function parameters (transaminases and alkaline phosphatase). Your liver functions parameters will be monitored by your physician every 4 weeks during the first 3 months of treatment, thereafter every 3 months. This monitoring would also enable to evaluate response to therapy (for a primary biliary cirrhosis) and to diagnose a potential hepatic deterioration.

During treatment of gallstones of biliary tract, the gall bladder should be visualised (oral cholecystography) by ultrasound, 6-10 months after the beginning of treatment, in order to assess therapeutic progress.

If you have problems with diarrhoea talk to your doctor, who may decide to reduce the dose or interrupt treatment.

 

This medicine is not suitable for the treatment of all types of gallstones; calculi with a higher probability of dissolution are those which cannot be visualized on X-ray images (radiotransparent), and in small size with gallbladder functioning.

Other medicines and Ursodeoxycholic acid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid taking Ursodeoxycholic acid together with the following medicines because effectiveness may be reduced:

-bile acid sequestrants used to lower cholesterol levels as cholestyramine and colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because they reduce its effectiveness. If you should take these medicines, it must be taken 2 hours before or after Ursodeoxycholic acid

-cyclosporine, a medicine that reduces the activity of the immune system. In this case the doctor will check the amount of ciclosporin in your blood and adjust the dose;

-ciprofloxacin and dapsone, antibiotics used against infections;

-nitrendipine, a medicine used to lower blood pressure, in this case you may need a dose increase;

-estrogens and agents that lower blood cholesterol such as clofibrate that can increase the risk for gallstone formation;

-medicinal products that increase the biliary elimination of cholesterol (hormonal contraceptives, some lipid-lowering agents). Women taking Ursodeoxycholic acid for dissolving cholesterol calculi must use

effective non-hormonal contraceptive, as hormonal contraceptives may increase biliary

lithiasis (see sections “Interactions” and “Pregnancy and lactation”) rosuvastatin (medicinal product used to treat hypercholesterolemia)

-budesonide (active substance used for the treatment of inflammations, especially those of allergic origin.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby

ask your doctor or pharmacist for advice before taking this medicine.

Do not use this medicine during pregnancy unless it is absolutely necessary. Before start treatment, ensure you are not pregnant.

If you are a female of childbearing age you can begin treatment only if you are using an effective method of contraception (non-hormonal or low dose estrogen oral contraceptives). If you are receiving treatment for the dissolution of gallstones, use an effective non-hormonal contraceptive, since hormonal oral contraceptives can increase the formation of gallbladder stones.

The ursodeoxycholic acid levels are very low and are not expected to cause any adverse effects in breastfed infants.

Driving and using machines

Ursodeoxycholic acid has no or negligible influence on the ability to drive and use machines.

Ursodeoxycholic acid tablets contain lactose.

This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ursodeoxycholic acid

Do not use it arbitrarily or change the dose and stop suddenly this medicine without consulting your doctor

The exact dose of this drug is adjust by the doctor.

Take this medicine during or after meals.

To maintain the right conditions for the dissolution of existing gallstones, the duration of treatment should be at least 4-6 months, which can last up to 12 months. Treatment however should not exceed 2 years.

Treatment of dyspepsia and maintenance therapy: the recommended dose is 300 mg a day, even divided in 2-3 doses.

If you take more Ursodeoxycholic acid than you should

Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces.

Overdose should be treated symptomatically with restoration of fluid and electrolyte balance. In case of intoxication administer cholestyramine, as capable of chelate bile acids.

In case of ingestion/accidental intake of an overdose of this medicine tell your doctor immediately or go to the nearest hospital.

If you forget to take Ursodeoxycholic acid

Do not take a double dose to make up for a missed dose. Take your next dose at its regular time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Following side effects may occur:

Common (may affect up to 1 in 10 people)

– pasty stools or diarrhoea.

Rare (may affect up to 1 in 1,000 people)

-irregularities in bowel habits, which usually disappear during continued treatment.

Very rare (may affect up to 1 in 10,000 people)

-severe right upper abdominal pain;

-calcification of gallstones;

-severe liver problems (liver cirrhosis), regressing partially after discontinuation of therapy;

-urticaria.

Not known: nausea and vomit

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system to website http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Long-term, high-dose therapy with ursodeoxycholic acid (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.

5. How to store Ursodeoxycholic acid

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after “EXP”.

The expiry date refers to the last day of that month and the sealed pack, correctly preserved.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Store below 30°C and protect from light & moisture.

Dosage form:

Each Ursobil®300 tablet, contain 300 mg Ursudoxycholic acid.

Each Bilodiol®500 Scored tablet, contain 500 mg Ursudoxycholic acid.