Dozurso

Package leaflet: Information for the user

Dozurso 250 mg film-coated tablets

Ursodeoxycholic acid
Please read all of 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Dozurso 250 mg film-coated tablets are and what they are used for
2. What you need to know before taking Dozurso 250 mg film-coated tablets
3. How to take Dozurso 250 mg film-coated tablets
4. Possible side effects
5. How to store Dozurso 250 mg film-coated tablets
6. Contents of the pack and other information

1. What Dozurso 250 mg film-coated tablets is and what it is used for

Dozurso contains the active substance ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical substance naturally present in the body and helps control the amount of cholesterol in the blood.
Dozurso is used

• To dissolve gallstones caused by excess cholesterol in the gallbladder (in patients for whom surgery is not an option), when the gallstones are not visible on plain X-rays (gallstones that are visible will not dissolve) and are no larger than 15 mm in diameter. The gallbladder must still be functioning despite the presence of gallstones.
• For the treatment of a condition in which the bile ducts in the liver become damaged, leading to bile accumulation. This may cause liver lesions. The liver must not be so damaged as to have lost its proper function. This condition is called primary biliary cholangitis.
• For the treatment of liver disease associated with a condition called cystic fibrosis in children and adolescents aged 6 to 18 years.

2. What you need to know before taking Dozurso 250 mg film-coated tablets

Do not take Dozurso

• if you are allergic to bile acids such as ursodeoxycholic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to peanuts or soy, as Dozurso contains soy lecithin;
• if your gallbladder is not functioning properly;
• if you have radiopaque gallstones;
• if you have acute inflammation of the gallbladder or bile ducts;
• if you have an obstruction of the biliary tract (obstruction of the common bile duct or cystic duct);
• if you suffer from frequent cramping pains in the upper abdomen (biliary colic);
• if you have calcified gallstones caused by calcium accumulation;
• if you are a child with biliary atresia and have poor bile flow, even after surgical intervention.
  Consult your doctor if any of the above conditions apply to you. You should also consult your doctor if you have previously had any of these conditions or if you are unsure whether any of them apply.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Dozurso.
Dozurso must be used under medical supervision.
Your doctor should regularly check your liver function every 4 weeks for the first 3 months of treatment. After this period, monitoring should continue at 3-month intervals.
If you are taking Dozurso for gallstone dissolution, you must use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase the risk of gallstone formation (see "Other medicines and Dozurso" and "Pregnancy, breastfeeding and fertility").
Inform your doctor immediately if you develop diarrhoea, as this may require a dose reduction or discontinuation of treatment.
Cholestyramine, charcoal, colestipol (used to lower blood lipids), or antacids containing aluminium hydroxide or smectite (aluminium oxide) must not be taken at the same time as Dozurso (see "Other medicines and Dozurso").

Other medicines and Dozurso
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Treatment with Dozurso may still be permitted. Your doctor will know what is appropriate for you.

A reduction in the effect of the following medicines may occur when taken with Dozurso:

• Cholestyramine, charcoal, colestipol (used to lower blood lipids), or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you need to take medicines containing any of these ingredients, take them at least two hours before or after Dozurso.
• Ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). Your doctor may need to adjust the dose of these medicines.

An increase in the effect of the following medicines may occur when taken with Dozurso:

• Cyclosporine (used to reduce immune system activity). If you are being treated with cyclosporine, your doctor must monitor the level of cyclosporine in your blood and adjust the dose if necessary.

Inform your doctor if you are taking medicines to lower blood cholesterol such as clofibrate, or medicines containing oestrogens, especially if you are taking Dozurso for gallstone dissolution, as these medicines may promote gallstone formation.

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.

• You must not take this medicine during pregnancy unless your doctor considers it absolutely necessary. Use of Dozurso during the first three months of pregnancy may affect the fetus.
• Check that you are not pregnant before taking this medicine.
• Use a reliable contraceptive method – non-hormonal contraceptives (barrier methods) or low-dose oestrogen oral contraceptives are recommended. If you are taking this medicine for gallstone dissolution, use only non-hormonal contraceptives, as hormonal oral contraceptives may promote gallstone formation.
• Do not take this medicine while breastfeeding, as the active ingredient may pass into breast milk. If treatment with Dozurso is necessary, breastfeeding must be discontinued.
• Available data to date do not suggest any effect of this treatment on fertility.

Driving and using machines
No special precautions are required.

Important information about some of the ingredients of Dozurso
Dozurso contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicinal product.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Dozurso 250 mg film-coated tablets

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with a glass of water or other liquid. Take the tablets regularly. The daily dose
indicated below serves as an example of how you may take the tablets.
Use in patients with liver tissue damage due to reduced bile flow (primary biliary cholangitis)
Dosage
Your doctor will determine your dose according to your body weight. During the first 3 months of
treatment, you must take 3–7 tablets divided into several doses throughout the day with meals.
Once liver function has improved, the total daily dose may be taken as a single dose in the evening.

If you do not experience any problems at this dose (after blood tests and/or clinical assessment), your doctor will prescribe a higher dose (dosing according to treatment stages I-III).
Duration of treatment
Your doctor will determine the duration of treatment. Regular blood monitoring at the laboratory may be required. Dozurso may be continued indefinitely in cases of primary biliary cholangitis.
Note:
In patients with primary biliary cholangitis, symptoms may worsen at the beginning of treatment; for example, pruritus may increase. This occurs only rarely. If this happens, therapy may be continued with a lower daily dose of Dozurso. Each week, your doctor will gradually increase the daily dose until you reach the required dose.
Use in patients with gallstones
Dosage
The recommended dose is approximately 10 mg of ursodeoxycholic acid per kg of body weight per day, taken as follows:

Duration of treatment
It usually takes 6–24 months to dissolve gallstones. The duration of your treatment
depends on the size of the gallstones present at the start of treatment. Even if symptoms
have disappeared, you must continue the treatment. Stopping treatment may result in a
prolongation of the total treatment time. After the gallstones have dissolved, treatment
should be continued for 3–4 months. If there is no reduction in gallstone size after 12 months,
therapy should be discontinued.
Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up
examinations, it should be assessed whether calcium accumulation has occurred since the last check-up,
causing hardening of the stones. If this occurs, your doctor will stop the treatment.
If you feel that the effect of Dozurso is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents (aged 6 to 18 years) for the treatment of
liver disease associated with cystic fibrosis

Dosage
The recommended daily dose is 20 mg/kg body weight, divided into 2–3 doses. If necessary, your doctor may
consider increasing the dose further to 30 mg per kg body weight per day.

Daily dose Dozurso 250 mg film-coated tablets

| Body weight (kg) | Dose (mg/kg body weight) | Morning | Noon | Evening | |------------------|--------------------------|--------|------|--------| | 20 – 29 kg | 17–25 | 1 | — | 1 | | 30 – 39 kg | 19–25 | 1 | 1 | 1 | | 40 – 49 kg | 20–25 | 1 | 1 | 2 | | 50 – 59 kg | 21–25 | 1 | 2 | 2 | | 60 – 69 kg | 22–25 | 2 | 2 | 2 | | 70 – 79 kg | 22–25 | 2 | 2 | 3 | | 80 – 89 kg | 22–25 | 2 | 3 | 3 |

If you think that the effect of Dozurso is too strong or too weak, consult your doctor or pharmacist.
The administration of Dozurso film-coated tablets is based on body weight and medical condition. If the patient is unable to swallow the tablets or has a body weight below 47 kg, the availability of other pharmaceutical forms containing ursodeoxycholic acid (suspension) should be verified.
If you take more Dozurso than you should
If you or anyone else takes too many film-coated tablets, seek immediate medical advice.
If you forget to take Dozurso
Do not take a double dose to make up for the missed dose.
If you stop taking Dozurso
Always speak with your doctor before deciding to stop treatment with Dozurso film-coated tablets or to discontinue treatment earlier than expected. If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following symptoms after taking
Dozurso:
Common side effects (may affect up to 1 in 10 people):

• Soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose of the medicine. If you have diarrhoea, make sure you drink enough fluids to restore your body's fluid and electrolyte balance.

Diarrhoea may also occur as a result of overdose.
Very rare side effects (may affect up to 1 in 10,000 people):

• During treatment of primary biliary cholangitis: severe pain in the upper right quadrant of the abdomen, severe worsening of liver damage – these symptoms partially improve after treatment is stopped.
• Hardening of gallstones due to calcium accumulation. This phenomenon does not cause other symptoms but is revealed by tests.
• Urticaria.

Frequency not known (frequency cannot be estimated from the available data):

• Vomiting.
• In patients with cirrhosis, worsening (increase in severity) of pruritus at the beginning of treatment cannot be completely excluded.
• In patients with stage IV primary biliary cholangitis, there may be an increase in the concentration of certain enzymes (alkaline phosphatase, gamma-glutamyltransferase) and bilirubin.
• Jaundice.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 Dozurso 250 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack label and on the box following the term “EXP/Scad.”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Dozurso 250 mg film-coated tablets contain

• The active substance is ursodeoxycholic acid. Each film-coated tablet contains 250 mg of ursodeoxycholic acid.
• The other components are: Core Maize starch, sodium lauryl sulfate, povidone K30 (E1201), colloidal anhydrous silica, magnesium stearate. Film coating Lecithin (soy) (E322), macrogol 3350 (E1521), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171).

Description of the appearance of Dozurso 250 mg film-coated tablets and pack sizes

Dozurso 250 mg film-coated tablets are white, round and biconvex.
Pack sizes: 20, 30, 50, 60 or 100 tablets in blister packs (PVC / PVDC / Aluminium).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LABORATOIRES MAYOLY SPINDLER
3 Place Renault
92500 Rueil-Malmaison
FRANCE

Manufacturer

CENEXI
52, Rue Marcel et Jacques Gaucher
94120 Fontenay sous Bois
FRANCE

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, France, Hungary, Italy: Dozurso
Ireland, United Kingdom (Northern Ireland): Cholurso.

Package leaflet: information for the user

Dozurso 500 mg film-coated tablets

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, pharmacist, or nurse.
• 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Dozurso 500 mg film-coated tablets are and what they are used for
2. What you need to know before taking Dozurso 500 mg film-coated tablets
3. How to take Dozurso 500 mg film-coated tablets
4. Possible side effects
5. How to store Dozurso 500 mg film-coated tablets
6. Contents of the pack and other information

1. What Dozurso 500 mg film-coated tablets are and what they are used for

Dozurso contains the active substance ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical substance naturally present in the body and helps control the amount of cholesterol in the blood.
Dozurso is used

• To dissolve gallstones caused by excess cholesterol in the gallbladder (in patients for whom surgery is not an option), when the gallstones are not visible on plain X-rays (gallstones that are visible will not dissolve) and are no larger than 15 mm in diameter. The gallbladder must still be functioning despite the presence of gallstones.
• For the treatment of a condition in which the bile ducts in the liver become damaged, leading to bile accumulation. This may cause liver lesions. The liver must not be so damaged that it no longer functions properly. This condition is called primary biliary cholangitis.
• For the treatment of liver disease associated with a condition called cystic fibrosis in children and adolescents aged 6 to 18 years.

2. What you need to know before taking Dozurso 500 mg film-coated tablets

Do not take Dozurso

• if you are allergic to bile acids such as ursodeoxycholic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to peanuts or soya, as Dozurso contains soya lecithin;
• if your gallbladder is not functioning properly;
• if you have radiopaque gallstones;
• if you have acute inflammation of the gallbladder or biliary tract;
• if you have a biliary obstruction (obstruction of the common bile duct or cystic duct);
• if you suffer from frequent cramp-like pains in the upper abdomen (biliary colic);
• if you have calcified gallstones due to calcium accumulation;
• if you are a child with biliary atresia and have poor bile flow, even after surgery.

Consult your doctor if any of the conditions listed above apply to you. You should also consult your doctor if you have previously had any of these conditions or if you are unsure whether you have any of them.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Dozurso.
Dozurso must be used under medical supervision.
Your doctor should regularly check your liver function every 4 weeks during the first 3 months of treatment. After this period, monitoring should continue at 3-month intervals. If you are taking Dozurso for the dissolution of gallstones, you must use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase the risk of gallstone formation (see “Other medicines and Dozurso” and “Pregnancy, breastfeeding and fertility”). Inform your doctor immediately if you develop diarrhoea, as this may require a dose reduction or discontinuation of treatment.
Cholestyramine, charcoal, colestipol (used to lower blood lipids), or antacids containing aluminium hydroxide or smectite (aluminium oxide) must not be taken at the same time as Dozurso (see “Other medicines and Dozurso”).

Other medicines and Dozurso

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Treatment with Dozurso may still be permitted. Your doctor will know what is appropriate for you.

A reduction in the effects of the following medicines may occur when taking Dozurso:

• Cholestyramine, charcoal, colestipol (used to lower blood lipids), or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you need to take medicines containing any of these substances, they should be taken at least two hours before or after Dozurso.
• Ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). Your doctor may need to adjust the dose of these medicines.

An increase in the effects of the following medicine may occur when taking Dozurso:

• Cyclosporine (used to reduce immune system activity). If you are being treated with cyclosporine, your doctor must monitor the level of cyclosporine in your blood and adjust the dose if necessary.

Inform your doctor if you are taking lipid-lowering drugs such as clofibrate or medications containing oestrogens, especially if you are taking Dozurso for gallstone dissolution, as these drugs may promote gallstone formation.

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.

• Do not take this medicine during pregnancy unless your doctor considers it absolutely necessary. The use of Dozurso during the first three months of pregnancy may affect the fetus.
• Make sure you are not pregnant before taking this medicine.
• Use a reliable contraceptive method – non-hormonal contraceptives (barrier methods) or low-dose oestrogen oral contraceptives are recommended. If you are taking this medicine for gallstone dissolution, use only non-hormonal contraceptives, as hormonal oral contraceptives may promote gallstone formation.
• Do not take this medicine while breastfeeding, as the active ingredient may pass into breast milk. If treatment with Dozurso is necessary, you must stop breastfeeding.
• Available data so far do not suggest any effect of this treatment on fertility.

Driving and using machines
No special precautions are required.

Important information about some of the ingredients of Dozurso
Dozurso contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicinal product.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Dozurso 500 mg film-coated tablets

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The tablet can be divided into equal doses.
Swallow the tablets with a glass of water or another liquid. Do not crush or chew the tablets.
Take the tablets regularly.
The daily dosage shown below serves as an example of how you may take the tablets.
Use in patients with liver tissue damage due to reduced bile flow (primary biliary cholangitis)
Dosage
Your doctor will determine your dose based on your body weight. During the first 3 months of
treatment, you must take 1 ½ - 3 ½ tablets divided into doses throughout the day, taken with meals.
Once liver function improves, the total daily dose may be taken as a single dose in the evening.

If you do not experience any problems at this dose (after blood tests and/or clinical assessment), your doctor will prescribe a higher dose (dosing according to stage I-III treatment).
Duration of treatment
Your doctor will determine the duration of treatment. Regular blood monitoring at the laboratory may be required. Dozurso may be continued indefinitely in cases of primary biliary cholangitis.
Note:
In patients with primary biliary cholangitis, symptoms may worsen at the beginning of treatment; for example, pruritus may increase. This occurs only rarely. If this happens, therapy may be continued with a lower daily dose of Dozurso. Each week, your doctor will gradually increase the daily dose until you reach the required dose.
Use in patients with gallstones
Dosage
The recommended dose is approximately 10 mg of ursodeoxycholic acid per kg of body weight per day, taken as follows:

Duration of treatment
It generally takes 6–24 months to dissolve gallstones. The duration of your treatment depends on the size of the gallstones present at the start of treatment. Even if symptoms have disappeared, you must continue the treatment. Stopping treatment may result in a prolongation of the total treatment time. After the gallstones have dissolved, treatment should be continued for 3–4 months. If there is no reduction in gallstone size after 12 months, therapy should be discontinued.

Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up examinations, it should be assessed whether calcium accumulation has occurred since the last examination, causing hardening of the stones. If this occurs, your doctor will discontinue treatment.

If you feel that the effect of Dozurso is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents (aged 6 to 18 years) for the treatment of liver disease associated with cystic fibrosis

Dosage
The recommended daily dose is 20 mg/kg of body weight, divided into 2–3 doses. If necessary, your doctor may consider further increasing the dose to 30 mg per kg of body weight per day.

If you think that the effect of Dozurso is too strong or too weak, consult your doctor or pharmacist.
The administration of Dozurso film-coated tablets is based on body weight and medical condition. If the patient is unable to swallow the tablets or has a body weight below 47 kg, the availability of other pharmaceutical forms containing ursodeoxycholic acid (e.g. suspension) should be considered.
If you take more Dozurso than you should
If you or anyone else takes too many film-coated tablets, seek immediate medical attention.
If you forget to take Dozurso
Do not take a double dose to make up for the missed dose.
If you stop taking Dozurso
Always speak with your doctor before deciding to stop treatment with Dozurso or to discontinue treatment earlier than planned. If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms after taking
Dozurso:

Common side effects (may affect up to 1 in 10 people):

• Soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose of the medicine. If you have diarrhoea, make sure you drink enough fluids to maintain your body's fluid and electrolyte balance.

Diarrhoea may also occur as a result of overdose.

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

• During treatment of primary biliary cholangitis: severe pain in the upper right quadrant of the abdomen, severe worsening of liver damage – these symptoms partially improve after treatment is discontinued.
• Hardening of gallstones due to calcium accumulation. This phenomenon does not cause other symptoms but is detected by tests.
• Urticaria.

Frequency not known (frequency cannot be estimated from the available data):

• Vomiting.
• In patients with cirrhosis, worsening (increase in severity) of pruritus at the beginning of treatment cannot be completely ruled out.
• In patients with stage IV primary biliary cholangitis, there may be an increase in the concentration of certain enzymes (alkaline phosphatase, gamma-glutamyl transferase) and bilirubin.
• Jaundice.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Dozurso 500 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and on the outer carton after the words “Exp/Scad.”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Dozurso 500 mg film-coated tablets contain

• The active substance is ursodeoxycholic acid. Each film-coated tablet contains 500 mg of ursodeoxycholic acid.
• The other components are: Core Maize starch, sodium lauryl sulfate, povidone K30 (E1201), anhydrous colloidal silica, magnesium stearate. Film coating Lecithin (soy) (E322), macrogol 3350 (E1521), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171).

Description of the appearance of Dozurso 500 mg film-coated tablets and pack sizes
Dozurso 500 mg film-coated tablets are white, oblong tablets with a score line on each side. The tablet can be divided into equal doses.
Pack sizes: 20, 30, 50, 60 or 100 film-coated tablets in blister packs (PVC / PVDC / Aluminium).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
LABORATOIRES MAYOLY SPINDLER
3 Place Renault
92500 Rueil-Malmaison
FRANCE

Manufacturer
CENEXI
52, Rue Marcel et Jacques Gaucher
94120 Fontenay sous Bois
FRANCE

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, France, Hungary, Italy: Dozurso
Ireland, United Kingdom (Northern Ireland): Cholurso.