Deursil

Patient Information Leaflet

Deursil 50 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules

ursodeoxycholic acid
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Deursil is and what it is used for
2. What you need to know before taking Deursil
3. How to take Deursil
4. Possible side effects
5. How to store Deursil
6. Package contents and other information

1. What Deursil is and what it is used for

Deursil contains bile acids.
Deursil is indicated for the treatment of:

• Cholesterol gallstones (cholesterol stones present in the bile)
• Chronic cholestatic liver disease affecting bile production by the liver: primary biliary cirrhosis, sclerosing cholangitis
• Liver damage caused by cystic fibrosis (a genetic disease) in adults and children aged 6 years and older
• Biliary dyspepsia (digestive problems due to impaired gallbladder function)

2. What you need to know before taking Deursil

Do not take Deursil

• if you are allergic to ursodeoxycholic acid, bile acids, or any of the other ingredients of this medicine (listed in section 6)
• if you have active stomach or intestinal diseases (gastric or duodenal ulcer)
• if you have 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 episodes of upper abdominal pain (biliary colic)
• if you have radiopaque calcified gallstones
• if you have impaired gallbladder function (reduced gallbladder motility)
• if the person to be treated is a child with congenital malformations of the biliary system (biliary atresia), in whom surgical intervention to restore bile flow (portoenterostomy) has failed to restore adequate bile flow

Warnings and precautions
Talk to your doctor or pharmacist before taking Deursil.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting treatment, your doctor will perform liver function tests, namely transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When Deursil is prescribed to dissolve cholesterol gallstones, you will also be scheduled for monitoring of the gallbladder and bile ducts (oral cholecystography and ultrasound).
If you are of childbearing age, your doctor will advise you to use an effective non-hormonal contraceptive method before prescribing Deursil.
If you have an advanced stage liver disease called primary biliary cirrhosis, in rare cases your symptoms may worsen at the beginning of treatment. Your doctor will determine the dosage of the medicine based on your clinical condition and tolerance to the medicine.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue treatment.

Other medicines and Deursil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking Deursil together with the following medicines:

• bile acid-binding drugs used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminium hydroxide and/or smectite (aluminium oxide)
• cyclosporine, a medicine that reduces the activity of the immune system
• ciprofloxacin and dapsone, antibiotics used to treat bacterial infections
• nitrendipine, a medicine used to lower blood pressure
• certain drugs that reduce cholesterol levels in the blood (such as clofibrate), estrogens, and hormonal contraceptives
• medicines that may be harmful to the liver (potentially hepatotoxic)
• rosuvastatin, a medicine used to lower cholesterol in the blood

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary, particularly during the first trimester. Before starting treatment, ensure that you are not pregnant.
If you are of childbearing age, you may begin treatment only if you are using a reliable contraceptive method (non-hormonal contraceptives or low-dose estrogen contraceptives). If you are undergoing therapy for gallstone dissolution, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the risk of gallstone formation.
Levels of ursodeoxycholic acid in breast milk are very low and are unlikely to cause adverse effects in the breastfed infant.
Animal studies have not shown any effect of ursodeoxycholic acid on fertility.
There are insufficient data available on the effects on fertility in humans following treatment with ursodeoxycholic acid.

Driving and using machines
Deursil has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

3. How to take Deursil

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dosage of the medicine based on your clinical condition and your tolerance to the medicine.

Cholesterol gallstones
The recommended daily dose is 10 mg/kg, divided into 2–3 doses per day.
The duration of treatment should be at least 4–6 months and may be extended up to 24 months continuously, and should continue for 3–4 months after the disappearance of the stones, as confirmed by radiographic or ultrasound examinations. However, treatment must not exceed 2 years.

Chronic cholestatic liver disease:

• Primary biliary cirrhosis and sclerosing cholangitis
  The recommended dose is 13–15 mg/kg/day, divided into two separate doses in the morning and evening, taken with meals. The dose should be gradually increased by increments to reach the optimal dose after 4–8 weeks of treatment.
• Cholestatic liver disease due to liver damage caused by cystic fibrosis
  The recommended dose is 20 mg/kg/day, divided into two or three doses, with a possible further increase to 30 mg/kg/day if necessary.

Biliary dyspepsia
The recommended dose is 300 mg per day, divided into 2–3 administrations.

If you take more Deursil than you should
If you take too much of this medicine, contact your doctor immediately or go to the nearest hospital.
Cases of overdose exceeding 4 g per day are not known.
In case of overdose, diarrhea may occur.

If you forget to take Deursil
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

4. Possible side effects

Like all medicines, this medicine may 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

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

• Pain in the upper right abdomen
• Bowel disturbances (frequency and quality of bowel movements)
• Worsening of liver condition in case of hepatic cirrhosis (a severe liver disease)
• Skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deursil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, undamaged packaging,
stored correctly.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deursil contains
Deursil 50 mg hard capsules

• The active substance is ursodeoxycholic acid.
• Each hard capsule contains 50 mg of ursodeoxycholic acid (UDCA).
• The other components are: starch, magnesium stearate, colloidal silica, gelatin, titanium dioxide (E171), iron oxide red (E172).

Deursil 150 mg hard capsules

• The active substance is ursodeoxycholic acid.
• Each hard capsule contains 150 mg of ursodeoxycholic acid (UDCA).
• The other components are: starch, magnesium stearate, colloidal silica, gelatin, titanium dioxide (E171), iron oxide red (E172).

Deursil 300 mg hard capsules

• The active substance is ursodeoxycholic acid.
• Each tablet contains 300 mg of ursodeoxycholic acid (UDCA).
• The other components are: starch, magnesium stearate, colloidal silica, gelatin, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Deursil and contents of the pack
Pack containing 20, 40 or 60 hard capsules of 50 mg.
Pack containing 20, 30 or 40 hard capsules of 150 mg.
Pack containing 10 or 20 hard capsules of 300 mg.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH – Ziegelhof 24 - 17489 Greifswald - Germany

Manufacturers

Deursil 50 mg hard capsules
SANOFI-AVENTIS S.A. - Riells Y Viabrea - Girona (Spain)

Deursil 150 mg hard capsules
SANOFI-AVENTIS S.A. - Riells Y Viabrea - Girona (Spain)
Aesica Pharmaceuticals GmbH - Alfred-Nobel-Str. 10 - 40789 Monheim am Rhein (Germany)

Deursil 300 mg hard capsules
SANOFI-AVENTIS S.A. - Riells Y Viabrea - Girona (Spain)
CHEPLAPHARM Arzneimittel GmbH – Ziegelhof 23-24 - 17489 Greifswald (Germany)
Aesica Pharmaceuticals GmbH - Alfred-Nobel-Str. 10 - 40789 Monheim am Rhein (Germany)

Patient Information Leaflet

Deursil 450 mg prolonged-release hard capsules, 225 mg prolonged-release hard capsules

ursodeoxycholic acid
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Deursil is and what it is used for

Deursil contains bile acids.
Deursil is indicated for the treatment of:

• Cholesterol gallstones (cholesterol stones present in the bile)
• Biliary dyspepsia (digestive problems due to impaired gallbladder function)

2. What you need to know before taking Deursil

Do not take Deursil

• if you are allergic to ursodeoxycholic acid, bile acids, or any of the other ingredients of this medicine (listed in section 6)
• if you have active stomach or intestinal diseases (gastric or duodenal ulcer)
• if you have 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 episodes of upper abdominal pain (biliary colic)
• if you have calcified gallstones visible on X-ray
• if you have impaired gallbladder function (reduced gallbladder motility)

Warnings and precautions
Talk to your doctor before taking Deursil.
Treatment with this medicine must be carried out under close medical supervision.
Before starting treatment, your doctor will check your liver function tests, specifically transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When Deursil is prescribed to dissolve cholesterol stones, monitoring of the gallbladder and bile ducts (oral cholecystography and ultrasound) will also be required.
If you are of childbearing age, your doctor will advise you to use an effective non-hormonal contraceptive method before prescribing Deursil.
If you have a liver disease called advanced primary biliary cirrhosis, in rare cases your symptoms may worsen at the beginning of treatment.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue treatment.

Other medicines and Deursil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking Deursil together with the following medicines:

• bile acid-binding drugs used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminium hydroxide and/or smectite (aluminium oxide)
• cyclosporine, a medicine that reduces the activity of the immune system
• ciprofloxacin and dapsone, antibiotics used to treat bacterial infections
• nitrendipine, a medicine used to lower blood pressure
• certain drugs that reduce cholesterol levels in the blood (such as clofibrate), estrogens, and hormonal contraceptives
• medicines that may be harmful to the liver (potentially hepatotoxic)
• rosuvastatin, a medicine used to lower cholesterol in the blood

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Fertility and pregnancy
Do not use this medicine during pregnancy unless absolutely necessary, particularly during the first trimester.
Before starting treatment, ensure that you are not pregnant.
If you are of childbearing age, you may begin treatment only if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen hormonal contraceptives).
If you are undergoing therapy for gallstone dissolution, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the risk of gallstone formation.
Animal studies have not shown any effect of ursodeoxycholic acid on fertility.
There are inadequate data on the effects on fertility in humans following treatment with ursodeoxycholic acid.

Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and are unlikely to cause adverse effects in the breastfed infant.
If you are breastfeeding, consult your doctor before taking this medicine.

Driving and use of machines
Deursil has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Deursil contains methyl parahydroxybenzoate, sodium and sorbitol
Deursil prolonged-release hard capsules contain methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".
Deursil 225 mg prolonged-release hard capsules contain 1.5 mg of sorbitol per capsule.
Deursil 450 mg prolonged-release hard capsules contain 3 mg of sorbitol per capsule.

3. How to take Deursil

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure,
consult your doctor or pharmacist.
Your doctor will determine the dosage of the medicine based on your clinical condition and your tolerance to
the medicine.
Cholesterol gallstones
The recommended daily dose is 450 mg per day.
In obese patients or in the presence of other significant factors favouring stone formation, the daily dose should be
increased to 675 mg.
The duration of treatment should be at least 4–6 months, which may be extended up to 24 months continuously,
and should be continued for a further 3–4 months after disappearance of the stones, as confirmed by radiographic or
ultrasound examinations. However, treatment should not exceed 2 years.
Take Deursil as a single dose in the evening, preferably before going to sleep.
Biliary dyspepsia
The recommended dose is 225 mg per day.
If you take more Deursil than you should
In case of accidental ingestion of an excessive dose of this medicine, inform your doctor immediately
or go to the nearest hospital.
There are no known cases of overdose exceeding 4 g per day.
In case of overdose, diarrhoea may occur.
If you forget to take Deursil
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• soft stools or diarrhoea

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

• pain in the upper right abdomen
• bowel irregularity (frequency and quality of bowel movements)
• worsening of liver condition in case of hepatic cirrhosis (a serious liver disease)
• skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deursil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and applies to the product in its original, undamaged packaging,
when stored correctly.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deursil contains
Deursil 225 mg prolonged-release hard capsules

• The active substance is ursodeoxycholic acid. Each capsule contains 225 mg of ursodeoxycholic acid (UDCA).
• The other components are: microcrystalline cellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, sorbitol, gelatin, methyl p-hydroxybenzoate, talc, magnesium stearate, titanium dioxide (E171), methacrylic acid copolymers, tributyl citrate, red iron oxide (E172), polyethylene glycol 6000.

Deursil 450 mg prolonged-release hard capsules

• The active substance is ursodeoxycholic acid. Each capsule contains 450 mg of ursodeoxycholic acid (UDCA).
• The other components are: microcrystalline cellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, sorbitol (E420), gelatin, methyl p-hydroxybenzoate, talc, magnesium stearate, titanium dioxide (E171), methacrylic acid copolymers, tributyl citrate, red iron oxide (E172), polyethylene glycol 6000.

Description of the appearance of Deursil and package contents

Pack containing 10, 20, 30 or 40 prolonged-release hard capsules of 225 mg.
Pack containing 10 or 20 prolonged-release hard capsules of 450 mg.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH – Ziegelhof 24 - 17489 Greifswald - Germany

Manufacturers
Deursil 225 mg prolonged-release hard capsules
SANOFI-AVENTIS S.A. – Riells Y Viabrea – Girona (Spain)
Deursil 450 mg prolonged-release hard capsules
SANOFI-AVENTIS S.A. – Riells Y Viabrea – Girona (Spain)
CHEPLAPHARM Arzneimittel GmbH – Ziegelhof 23-24 - 17489 Greifswald - Germany