URSOBIL 150 mg Hard Capsule

Зміст інструкції

1. URSOBIL 150 mg hard capsules, 250 mg hard capsules
   1. What is URSOBIL and what is it used for
   2. What you need to know before taking URSOBIL
   3. How to take URSOBIL
   4. Possible side effects
   5. How to store URSOBIL
   6. Contents of the pack and other information
2. URSOBIL 300 mg tablets
   1. What is URSOBIL and what is it used for
   2. What you need to know before taking URSOBIL
   3. How to take URSOBIL
   4. Possible side effects
   5. How to store URSOBIL
   6. Contents of the pack and other information
   7. What is URSOBIL and what is it used for
   8. What you need to know before taking URSOBIL
   9. How to take URSOBIL
   10. Possible side effects
   11. How to store URSOBIL
   12. Contents of the pack and other information

URSOBIL 150 mg hard capsules, 250 mg hard capsules

Ursodesoxycholic acid

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is URSOBIL and what is it used for

URSOBIL is a preparation based on bile acids naturally present in the body, which is able to
solubilize cholesterol in bile.
This medicine is used to treat alterations in the production of bile by the liver and to
improve the solubility of cholesterol, both to prevent the formation of gallstones and to facilitate their
dissolution. This medicine is not effective against all types of gallstones, but only against those not
visible on X-rays (radiotransparent); in particular, cholesterol stones in the gallbladder (functioning gallbladder)
and stones in the bile duct.
It is also used to treat digestive problems due to dysfunction of the gallbladder (biliary dyspepsia).

2. What you need to know before taking URSOBIL

Do not take URSOBIL

• if you are allergic (hypersensitive) to ursodesoxycholic acid, bile acids or any of the ingredients of this medicine (listed in section 6);
• if you have an acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
• if you frequently suffer from pain in the upper abdomen (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from impaired contractility of the gallbladder;
• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase;
• if you have a yellowish discoloration of the skin (obstructive jaundice);
• if you have severe liver or intestinal alterations that may affect the blood circulation of bile salts.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, check your liver function (checking transaminases
and alkaline phosphatase). During the first 3 months of treatment with this medicine, your doctor will
check your liver function parameters every 4 weeks. After this period, every 3
months. This allows you to assess your response to therapy (for primary biliary cirrhosis) and to
diagnose potential liver damage.
In the treatment of gallstones, you should undergo an imaging of the gallbladder
(oral cholecystography) via ultrasound, 6-10 months after the start of treatment, to assess the
improvement of your condition.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher
probability of dissolving are those that are not visible on X-rays (radiotransparent) and of small
size in a functioning gallbladder.

Other medicines and URSOBIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Avoid taking URSOBIL together with the following medicines because there may be a reduction
in effectiveness:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce their effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking URSOBIL;
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check its concentration in the blood and adjust the dose;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure, in which case a dose increase may be necessary;
• estrogens and agents that lower cholesterol in the blood such as clofibrate, which may promote the formation of gallstones;
• medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipidemic agents). Women taking URSOBIL for the dissolution of cholesterol gallstones should use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase the formation of gallstones (see paragraphs “Interactions” and “Pregnancy and breastfeeding”);
• Rosuvastatin (medicine used to treat hypercholesterolemia);
• Budesonide (active ingredient used for the treatment of inflammatory manifestations, especially of allergic origin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary. Make sure you are not pregnant before starting
treatment.
If you are of childbearing potential, you can only start treatment if you are using a safe contraceptive method
(non-hormonal oral contraceptives or low-dose estrogen).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.
Levels of ursodesoxycholic acid are very low and adverse effects in breastfed infants are unlikely to be predictable.

Driving and using machines
Ursodesoxycholic acid does not alter or negligibly alters the ability to drive vehicles and use
machinery

URSOBIL 150 mg hard capsules contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

3. How to take URSOBIL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.

Treatment of biliary calculi:to prevent the formation of stones, the recommended daily dose is
between 5-10 mg/kg (300 and 600 mg) per day, in 2-3 administrations, for a prolonged treatment.
Take the medicine during or after meals.
To maintain the suitable conditions for dissolving existing stones, the duration of treatment must be
at least 4-6 months, which can increase up to 12 months. The treatment should not, however,
exceed 2 years.

Treatment of dyspepsia and maintenance therapy:the recommended dose is 300 mg per day,
also divided into 2-3 administrations.

If you take more URSOBIL than you should
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodesoxycholic acid decreases with increasing dose and
therefore is more excreted with the feces.
Treatment of overdose involves rehydration and replenishment of fluids and mineral salts. In case of
intoxication, administer cholestyramine, as it is capable of chelating bile acids.
In case of accidental ingestion of an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take URSOBIL
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled
time.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• soft stools or diarrhoea.

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

• intestinal irregularities, which generally disappear with continued treatment.

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

• severe pain in the upper right abdomen;
• calcification of gallstones;
• serious liver problems (liver cirrhosis), which partially regress with discontinuation of therapy;
• urticaria. Not Known: nausea and vomiting

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the 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) has been associated with higher rates of serious adverse events.

5. How to store URSOBIL

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 packaging after “Expiry”.
The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What URSOBIL contains
URSOBIL 150 mg hard capsules

• The active ingredient is ursodeoxycholic acid. Each tablet contains 150 mg of ursodeoxycholic acid.
• The other ingredients are: lactose, magnesium stearate, colloidal silicon dioxide, polyvinylpyrrolidone, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

URSOBIL 250 mg hard capsules

• The active ingredient is ursodeoxycholic acid. Each tablet contains 300 mg of ursodeoxycholic acid.
• The other ingredients are: magnesium stearate, colloidal silicon dioxide, polyvinylpyrrolidone, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of URSOBIL and contents of the pack
Pack of 20 and 40 hard capsules of 150 mg.
Pack of 20 and 30 hard capsules of 250 mg.

Marketing Authorisation Holder
ABC FARMACEUTICI S.P.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Italy

Exclusive distributor for sale in Italy
SOFAR S.p.A.
Trezzano Rosa (MI)

Manufacturer
ABC FARMACEUTICI S.p.A.
Canton Moretti n° 29
10090 San Bernardo d’Ivrea
Turin
Italy

URSOBIL 300 mg tablets

Ursodesoxycholic acid

Generic Medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is URSOBIL and what is it used for

URSOBIL is a preparation based on bile acids naturally present in the body, which is able to
solubilize cholesterol in bile.
This medicine is used to treat alterations in the production of bile by the liver and to
improve the solubility of cholesterol, both to prevent the formation of gallstones and to facilitate their
dissolution. This medicine is not effective against all types of gallstones, but only against those not
visible on X-rays (radiotransparent); in particular, cholesterol stones in the gallbladder (functioning gallbladder)
and stones in the bile duct.
It is also used to treat digestive problems due to dysfunction of the gallbladder (biliary dyspepsia).

2. What you need to know before taking URSOBIL

Do not take URSOBIL

• if you are allergic (hypersensitive) to ursodesoxycholic acid, bile acids or any of the ingredients of this medicine (listed in section 6);
• if you have an acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
• if you frequently suffer from pain in the upper abdomen (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from impaired contractility of the gallbladder;
• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase:
• if you have a yellowish discoloration of the skin (obstructive jaundice)
• if you have severe liver or intestinal disorders that may alter the blood circulation of bile salts.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, check your liver function (checking transaminases
and alkaline phosphatase). During the first 3 months of treatment with this medicine, your doctor will
check your liver function parameters every 4 weeks. Following this period, every 3
months. This allows you to assess your response to therapy (for primary biliary cirrhosis) and to
diagnose potential liver damage.
In the treatment of gallstones, you should undergo a visualization of the gallbladder
(oral cholecystography) via ultrasound, 6-10 months after the start of treatment, to assess the
improvement of your condition.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher
probability of dissolving are those that are not visible on X-rays (radiotransparent) and of small
size in a functioning gallbladder.

Other medicines and URSOBIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Avoid taking URSOBIL together with the following medicines because there may be a reduction
in efficacy:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce their effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking URSOBIL;
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check its concentration in the blood and adjust the dose;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure, in which case an increase in the dose may be necessary;
• estrogens and agents that lower cholesterol in the blood such as clofibrate, which may promote the formation of gallstones;
• medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipemic agents). Women taking URSOBIL for the dissolution of cholesterol gallstones should use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase the formation of gallstones in the bile ducts (see sections “Interactions” and “Pregnancy and breastfeeding”);
• Rosuvastatin (medicine used to treat hypercholesterolemia)
• Budesonide (active ingredient used for the treatment of inflammatory manifestations, especially of allergic origin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary. Make sure you are not pregnant before starting
treatment.
If you are of childbearing potential, you can only start treatment if you are using a safe contraceptive method
(non-hormonal oral contraceptives or low in estrogen). If you are being treated for the dissolution of
gallstones, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may
increase the formation of gallstones.
Levels of ursodesoxycholic acid are very low and adverse effects in breastfed infants are unlikely.

Driving and using machines
Ursodesoxycholic acid does not alter or negligibly alters the ability to drive vehicles and operate
machinery

URSOBIL 300 mg tablets contains lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

3. How to take URSOBIL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.

Treatment of biliary calculi:to prevent the formation of stones, the recommended daily dose is
between 5-10 mg/kg (300 and 600 mg) per day, in 2-3 administrations, for a prolonged treatment.
Take the medicine during or after meals.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment must be
at least 4-6 months, which can increase up to 12 months. The treatment, however, should not
exceed 2 years.

Treatment of dyspepsia and maintenance therapy:the recommended dose is 300 mg per day,
also divided into 2-3 administrations.

If you take more URSOBIL than you should
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and
therefore is more excreted with the feces.
Treatment of overdose involves rehydration and electrolyte replacement. In case of
intoxication, administer cholestyramine, as it is capable of chelating bile acids.
In case of accidental ingestion of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take URSOBIL
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled
time.
If you have any doubts about 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.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• soft stools or diarrhoea.

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

• intestinal irregularities, which generally disappear with continued treatment.

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

• severe pain in the upper right abdomen;
• calcification of gallstones;
• serious liver problems (liver cirrhosis), which partially regress with discontinuation of therapy;
• urticaria.

Not Known: nausea and vomiting

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 and high-dose therapy with Ursodeoxycholic Acid (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) has been associated with higher rates of serious adverse events.

5. How to store URSOBIL

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 packaging after “Scad”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What URSOBIL contains
URSOBIL 300 mg tablets

• The active ingredient is ursodeoxycholic acid. Each tablet contains 300 mg of ursodeoxycholic acid.
• The other ingredients are: lactose, corn starch, polyvinylpyrrolidone, talc, magnesium stearate.

Description of the appearance of URSOBIL and contents of the pack
Pack of 20 and 30 tablets of 300 mg

Marketing Authorisation Holder
ABC FARMACEUTICI S.P.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Italy

Exclusive distributor for sale in Italy
SOFAR S.p.A.
Trezzano Rosa (MI)

Manufacturer
ABC FARMACEUTICI S.p.A.
Canton Moretti n° 29
10090 San Bernardo d’Ivrea
Turin
Italy

URSOBIL®
SYRUP
DROPS
Ursodeoxycholic acid

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is URSOBIL and what is it used for

URSOBIL is a preparation based on bile acids naturally present in the body, which is able to
solubilize cholesterol in bile.
This medicine is used to treat alterations in the production of bile by the liver and to
improve the solubility of cholesterol, both to prevent the formation of gallstones and to facilitate their
dissolution. This medicine is not effective against all types of gallstones, but only against those not
visible on X-rays (radiotransparent); in particular, cholesterol stones in the gallbladder (functioning gallbladder)
and stones in the bile duct.
It is also used to treat digestive problems due to dysfunction of the gallbladder (biliary dyspepsia).

2. What you need to know before taking URSOBIL

Do not take URSOBIL

• if you are allergic (hypersensitive) to ursodeoxycholic acid, bile acids or any of the ingredients of this medicine (listed in section 6);
• if you have an acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
• if you frequently suffer from pain in the upper abdomen (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from impaired gallbladder contractility;
• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase:
• if you have a yellowish discoloration of the skin (obstructive jaundice)
• if you have severe liver or intestinal disorders that may alter the blood circulation of bile salts.
• if the patient is a child.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, check liver function (checking transaminases
and alkaline phosphatase). During the first 3 months of treatment with this medicine, your doctor will
check your liver function parameters every 4 weeks. After this period, every 3
months. This allows you to assess your response to therapy (for primary biliary cirrhosis) and to
diagnose potential liver damage.
In the treatment of gallstones of the bile ducts, you should undergo a visualization of the gallbladder
(oral cholecystography) via ultrasound, 6-10 months after the start of treatment, to assess the
improvement of your condition.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher
probability of dissolution are those not visible on X-rays (radiotransparent) and of small
size in a functioning gallbladder.

Other medicines and URSOBIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Avoid taking URSOBIL together with the following medicines because there may be a reduction
in effectiveness:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce their effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking URSOBIL;
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check its concentration in the blood and adjust the dose;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure, in which case a dose increase may be necessary;
• estrogens and agents that lower blood cholesterol such as clofibrate, which can promote the formation of gallstones;
• medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipidemic agents). Women taking URSOBIL for the dissolution of cholesterol gallstones should use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase biliary calculus (see paragraphs “Interactions” and “Pregnancy and breastfeeding”)
• Rosuvastatin (medicine used to treat hypercholesterolemia)
• Budesonide (active ingredient used for the treatment of inflammatory manifestations, especially of allergic origin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary. Make sure you are not pregnant before starting
treatment.
If you are of childbearing potential, you can only start treatment if you are using a safe contraceptive method
(non-hormonal oral contraceptives or low-estrogen).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.
Levels of ursodeoxycholic acid are very low and adverse effects in breastfed infants are unlikely.
The administration of this medicine is contraindicated in pregnancy due to its alcohol content.

Driving and using machines
Ursodeoxycholic acid does not alter or negligibly alters the ability to drive vehicles and operate
machinery

URSOBIL DROPS and SYRUPcontain methyl parahydroxybenzoate
These medicines contain methyl parahydroxybenzoate, which may cause allergic reactions (including
delayed reactions).

URSOBIL SYRUP contains sorbitol and ethyl alcohol
This medicine contains sorbitol, a type of sugar. If your doctor has diagnosed you with an intolerance
to certain sugars, contact him before taking this medicine.
This medicine contains up to 8 vol% ethanol (alcohol), e.g. up to 1.92 g per maximum dose (3 measuring spoons
of 8 ml per day), equivalent to 48.4 ml of beer, 20.5 ml of wine per maximum dose.
It may be harmful to alcoholics. To be considered in pregnant or breastfeeding women,
in children and in high-risk groups such as people with liver or epilepsy.
.

URSOBIL DROPScontains lycasin (liquid maltitol)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take URSOBIL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.

Treatment of biliary calculi:to prevent the formation of stones, in prolonged use:
Syrup: the recommended dose per day is 15.75 mg/Kg, equivalent to 10 mg/Kg, (2-3 measuring spoons of 8 ml).
Drops: the recommended dose is 15.75 mg/Kg, equivalent to 10 mg/Kg (25 drops), 2-3 times a day.

Treatment of dyspepsia and maintenance therapy:the recommended dose is 300 mg per day,
also divided into 2-3 administrations.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment must be
at least 4-6 months, which can increase up to 12 months. The treatment must not, however,
exceed 2 years.
Take the medicine during or after meals.

Use in children
The use of the medicine in children is not foreseen.

If you take more URSOBIL than you should
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and
therefore is more excreted with the feces.
Treatment of overdose involves rehydration and electrolyte replacement. In case of
intoxication, administer cholestyramine, as it is capable of chelating bile acids.
In case of accidental ingestion of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take URSOBIL
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled
time.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• soft stools or diarrhoea.

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

• intestinal irregularities, which generally disappear with continued treatment.

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

• severe pain in the upper right abdomen;
• calcification of gallstones;
• serious liver problems (liver cirrhosis), which partially regress with discontinuation of therapy;
• urticaria. Not known:nausea, vomiting

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the 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 and high-dose therapy with Acido Ursodesossicolico 28-30 mg/kg/day) in patients with
primary sclerosing cholangitis (off-label use) has been associated with higher rates of serious adverse events.

5. How to store URSOBIL

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 packaging after “Expiry”.
The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What URSOBIL contains
URSOBIL SYRUP 100 ml solution

• The active ingredient is ursodeoxycholic acid. 100 ml of solution contains ursodeoxycholic acid sulfate ester, sodium ursulcolate salt, 5 g (equivalent to 3.1 g of ursodeoxycholic acid).
• The other ingredients are: sorbitol, ethyl alcohol, sodium dehydroacetate, methyl p-hydroxybenzoate, alpine herbs, purified water.

URSOBIL DROPS 100 ml solution

• The active ingredient is ursodeoxycholic acid. 100 ml of solution contains ursodeoxycholic acid sulfate ester, sodium ursulcolate salt, 40 g (equivalent to 25.40 g of ursodeoxycholic acid).
• The other ingredients are: lycasin, sodium saccharin, sodium dehydroacetate, methyl p-hydroxybenzoate, Dutch cream, purified water.

Description of the appearance of URSOBIL and contents of the pack
URSOBIL SYRUP 100 ml solution
200 ml bottle of solution.

URSOBIL DROPS 100 ml solution
20 ml bottle of solution.

Marketing Authorisation Holder
ABC FARMACEUTICI S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Italy

Exclusive Distributor for the Italian Market
SOFAR S.p.A.
Trezzano Rosa (MI)

Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti, 29
10090 San Bernardo d’Ivrea (TO)
Italy