DEURSIL 50 mg Hard Capsules

Зміст інструкції

1. Deursil 50 mg hard capsules, 150 mg hard capsules, 300 mg hard capsules
   1. What is Deursil and what is it 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
2. Deursil 450 mg prolonged-release hard capsules, 225 mg prolonged-release hard capsules
   1. What is Deursil and what is it used for
   2. What you need to know before you take Deursil
   3. How to take Deursil
   4. Possible side effects
   5. How to store Deursil
   6. Contents of the pack and other information

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

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 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 Deursil is and what it is used for
• 2. What you need to know before you take 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 is Deursil and what is it used for

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

• Cholesterol cholelithiasis (cholesterol stones present in the bile)
• Chronic cholestatic liver disease that alters the production of bile 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 over
• 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 suffer from stomach or intestinal diseases (gastric or duodenal ulcer) in an active phase
• 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 episodes of pain in the upper abdomen (biliary colic)
• if you have calcified gallstones visible on X-ray
• if you suffer from a malfunctioning gallbladder (reduced motility of the gallbladder)
• if the person who is to take this medicine is a child with malformations of the biliary system (biliary atresia), in whom surgical intervention to restore bile flow (portoenterostomy) has failed to restore good bile flow

Warnings and precautions
Talk to your doctor or pharmacist before taking Deursil.
Treatment with this medicine must occur under strict medical supervision.
Before starting treatment, your doctor will check liver tests, namely
transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When you are prescribed Deursil to dissolve cholesterol gallstones, you will also be prescribed checks of the gallbladder and bile ducts (oral cholecystography and ultrasound).
If you are of childbearing potential, your doctor will indicate an effective non-hormonal contraceptive method before
prescribing Deursil.
If you suffer from a liver disease called advanced primary biliary cirrhosis, in rare cases your
symptoms may worsen at the beginning of treatment. Your doctor will decide the doses of the medicine based on
your clinical condition and your tolerability to the medicine.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.

Other medicines and Deursil
Tell 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:

• medicines that bind bile acids, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide)
• cyclosporine, a medicine that reduces the activity of the immune system
• ciprofloxacin and dapsone, antibiotics used for infections caused by bacteria
• nitrendipine, a medicine used to lower blood pressure
• some drugs that reduce cholesterol levels in the blood (such as clofibrate), estrogens, and hormonal contraceptives
• medicines that can 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, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary, especially in
the first trimester. 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 contraceptives or low-estrogen contraceptives). If you are undergoing therapy for dissolving gallstones,
use an effective non-hormonal contraceptive, as oral hormonal contraceptives may increase the
formation of gallbladder stones.
Levels of ursodeoxycholic acid in breast milk are very low and should not cause adverse
effects in the infant.
Studies conducted on animals have not shown any influence of ursodeoxycholic acid on fertility.
Adequate data regarding the effects on fertility in humans after treatment
with ursodeoxycholic acid are not available.

Driving and operating machinery
Deursil does not affect or has a negligible effect on the ability to drive vehicles or operate
machinery.

3. How to take Deursil

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

Cholesterolic cholelithiasis
The recommended average daily dose is 10 mg/kg in 2-3 times a day.
The duration of treatment should be at least 4-6 months, which may increase up to 24,
continuously, and must be continued for 3-4 months after the disappearance of the stones themselves, verified by
radiographic or ultrasound examinations. The treatment should not, however, exceed 2 years.

Chronic cholestatic liver disease:

• primary biliary cirrhosis and sclerosing cholangitisThe recommended dose is 13-15 mg/kg/ in two separate doses, in the morning and in the evening, with meals. The dose should be gradually increased by increments to reach this optimal dose after 4-8 weeks of treatment
• cholestatic liver disease due to liver damage caused by cystic fibrosisthe recommended dose is 20 mg/kg/day divided into two - three doses, with a 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
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
No cases of overdose exceeding 4 g per day are known.
Diarrhea may occur in case of overdose.

If you forget to take Deursil
Do not take a double dose to make up for a 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 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)
• pain in the upper right abdomen
• irregular bowel movements (frequency and quality of evacuation)
• worsening of liver conditions in case of hepatic cirrhosis (a serious liver disease)
• skin rash (urticaria)

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 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 that is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water 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 Deursil contains
Deursil 50 mg hard capsules

• The active ingredient is ursodeoxycholic acid.
• Each hard capsule contains 50 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: starch, magnesium stearate, colloidal silicon dioxide, gelatin, titanium dioxide (E171), red iron oxide (E172). Deursil 150 mg hard capsules
• The active ingredient is ursodeoxycholic acid.
• Each hard capsule contains 150 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: starch, magnesium stearate, colloidal silicon dioxide, gelatin, titanium dioxide (E171), red iron oxide (E172). Deursil 300 mg hard capsules
• The active ingredient is ursodeoxycholic acid.
• Each capsule contains 300 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: starch, magnesium stearate, colloidal silicon dioxide, gelatin, titanium dioxide (E171), red iron oxide (E172).

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

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

Manufacturers

Deursil 50 mg hard capsules and Deursil 150 mg hard capsules
SANOFI-AVENTIS S.A. - Riells Y Viabrea -Girona (Spain)

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)

Deursil 450 mg prolonged-release hard capsules, 225 mg prolonged-release 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 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 Deursil is and what it is used for
• 2. What you need to know before you take 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 is Deursil and what is it used for

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

• Cholesterolic cholelithiasis (cholesterol stones present in the bile)
• Biliary dyspepsia (digestive problems due to impaired functioning of the gallbladder)

2. What you need to know before you take 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 suffer from stomach or intestinal diseases (gastric or duodenal ulcer) in an active phase
• 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 episodes of pain in the upper abdomen (biliary colic)
• if you have calcified gallstones visible on X-rays
• if you suffer from impaired gallbladder function (reduced motility of the gallbladder)

Warnings and precautions
Talk to your doctor before taking Deursil.
Treatment with this medicine must occur under strict medical supervision.
Before starting treatment, your doctor will check liver tests, namely
transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When you are prescribed Deursil to dissolve cholesterol stones, you will also be prescribed checks of the gallbladder and bile vessels (oral cholecystography and ultrasound).
If you are of childbearing potential, your doctor will indicate an effective non-hormonal contraceptive method before
prescribing Deursil. If you suffer from a liver disease called advanced primary biliary cirrhosis, in
rare cases, your symptoms may worsen at the beginning of treatment.
If you have problems with diarrhea, see your doctor, who may decide to reduce the dose or stop therapy.

Other medicines and Deursil
Tell 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:

• medicines that bind bile acids, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide)
• cyclosporine, a medicine that reduces the activity of the immune system
• ciprofloxacin and dapsone, antibiotics used for infections caused by bacteria
• nitrendipine, a medicine used to lower blood pressure
• some 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Fertility and pregnancy
Do not use this medicine during pregnancy unless absolutely necessary, especially in
the first trimester.
Before starting treatment, make sure you are not pregnant.
If you are of childbearing potential, you can only start treatment if you are using a reliable contraceptive method
(non-hormonal contraceptives or low-dose estrogen).
If you are undergoing therapy to dissolve stones, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallbladder stones.
Studies conducted on animals have not shown any influence of ursodeoxycholic acid on fertility.
There is no adequate data regarding the effects on fertility in humans after treatment
with ursodeoxycholic acid.
Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and should not cause adverse effects
in the infant.
If you are breastfeeding, ask your doctor for advice before taking the medicine.

Driving and operating machinery
Deursil does not affect or has a negligible effect on the ability to drive vehicles or operate
machinery.

Deursil contains methyl parahydroxybenzoate, sodium and sorbitol
Deursil prolonged-release 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 capsules contain 1.5 mg of sorbitol per capsule.
Deursil 450 mg prolonged-release capsules contain 3 mg of sorbitol per capsule.

3. How to take Deursil

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

Cholesterolic cholelithiasis
The recommended average daily dose is 450 mg per day.
In obese patients or in the presence of other important factors that favor the formation of gallstones, it is
advisable to increase the daily dose to 675 mg.
The duration of treatment should be at least 4-6 months, which may increase up to 24,
continuously, and should be continued for 3-4 months after the disappearance of the gallstones themselves, verified by
radiographic or ultrasound examinations. The treatment should not, however, exceed 2 years.
Take Deursil in a single dose in the evening, preferably before going to bed.

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, immediately inform your
doctor or go to the nearest hospital.
No cases of overdose beyond 4 g per day are known.
In case of overdose, diarrhea may occur.

If you forget to take Deursil
Do not take a double dose to make up for a 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 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)

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

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 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 which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature below 30 °C
Do not dispose of any medicine in waste water 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 Deursil contains
Deursil 225 mg prolonged-release hard capsules

• The active ingredient is ursodeoxycholic acid. Each capsule contains 225 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, sorbitol, gelatin, methyl p-hydroxybenzoate, talc, magnesium stearate, titanium dioxide (E171), methacrylic acid copolymers, tributyl citrate, iron oxide red (E172), polyethylene glycol 6000. Deursil 450 mg prolonged-release hard capsules
• The active ingredient is ursodeoxycholic acid. Each capsule contains 450 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, sorbitol (E420), gelatin, methyl p-hydroxybenzoate, talc, magnesium stearate, titanium dioxide (E171), methacrylic acid copolymers, tributyl citrate, iron oxide red (E172), polyethylene glycol 6000.

Description of the appearance of Deursil and contents of the pack
Pack of 10, 20, 30 or 40 prolonged-release hard capsules of 225 mg.
Pack of 10 or 20 prolonged-release hard capsules of 450 mg.

Marketing Authorisation 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