DOZURSO 250 mg Film-Coated Tablets

Зміст інструкції

1. Dozurso 250 mg film-coated tablets
   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. Package Contents and Other Information
2. Dozurso 500 mg film-coated tablets
   1. What is Dozurso 500 mg film-coated tablets and what is it 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

Dozurso 250 mg film-coated tablets

Ursodeoxycholic acid

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Dozurso 250 mg film-coated tablets is and what it is used for
• 2. What you need to know before you take 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 are and what they are used for

Dozurso contains the active substance ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical substance that occurs naturally in the body and helps to
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), in cases where the gallstones are not visible on simple X-rays (gallstones that are visible will not dissolve) and are no more than 15 mm in diameter. The gallbladder must still be functioning despite the gallstones.
• For the treatment of a condition in which the bile ducts in the liver become damaged leading to an accumulation of bile. This can cause the formation of lesions in the liver. The liver must not be so damaged as to not function correctly. This condition is called primary biliary cholangitis.

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 ursodesoxycholic 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 gallstones visible on X-rays;
• if you have an acute inflammation of the gallbladder or bile duct;
• if you have an obstruction of the bile duct (obstruction of the common bile duct or the cystic duct);
• if you suffer from frequent cramp-like pains in the upper abdomen (biliary colic);
• if you have hardening of gallstones caused by an accumulation of calcium.

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 you have them.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Dozurso.
Dozurso must be used under medical supervision.
Your doctor should check your liver function regularly every 4 weeks for the first 3 months of treatment. After this period, it should be monitored at intervals of 3 months. If you are taking Dozurso to dissolve gallstones, you should use an effective non-hormonal contraceptive method, as hormonal contraceptives may increase biliary lithiasis (see “Other medicines and Dozurso” and “Pregnancy, breastfeeding and fertility”). Immediately inform your doctor if you have diarrhoea as a dose reduction or interruption of treatment may be necessary.
Cholestyramine, charcoal, colestipol (to lower blood lipids) or antacids containing aluminium hydroxide or smectite (aluminium oxide) should 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 available without a prescription. Treatment with Dozurso may still be permitted. Your doctor will know what is right for you.

Areduction in the effectsof the following medicines is possible when taking Dozurso:

• Cholestyramine, charcoal, colestipol (to lower blood lipids) or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you need to take medicines containing any of these ingredients, you should 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 change the dose of these medicines. Anincrease in the effectsof the following medicines is possible when taking Dozurso:
• Cyclosporine (to reduce the activity of the immune system). If you are being treated with cyclosporine, your doctor should check the amount of cyclosporine in your blood. The doctor will adjust the dose, if necessary.

Tell your doctor if you are taking medicines to lower blood cholesterol such as clofibrate or medicines containing oestrogens, especially if you are taking Dozurso to dissolve gallstones, as these medicines can stimulate the formation of gallstones.

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.

• You should 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 foetus.
• Check that you are not pregnant before taking this medicine.
• Use a reliable contraceptive method - non-hormonal contraceptives (barrier methods) or oral contraceptives with a low level of oestrogens are recommended. If you are taking this medicine to dissolve gallstones, use only non-hormonal contraceptives, as hormonal oral contraceptives can stimulate the formation of gallstones.
• Do not take this medicine if you are breastfeeding as the active ingredient in this medicine can pass into breast milk. If treatment with Dozurso is necessary, stop breastfeeding.
• Data available so far do not suggest any effect of this treatment on fertility.

Driving and operating machinery
No special precautions are necessary.

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.

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

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablets whole with a glass of water or other liquid. Take the tablets regularly. The daily dose shown below serves as an example of how you can take the tablets.

Dosage
Use in patients with impaired hepatic tissue due to reduced bile flow (primary biliary cholangitis)
The doctor will determine your dose depending on your body weight. During the first 3 months of treatment, you must take 3-7 tablets in divided doses throughout the day, at mealtimes.
As soon as liver function improves, the total daily dose can be taken once, in the evening.

If you do not experience any problems at this dose (after blood tests and/or according to an assessment), your doctor will prescribe you a higher dose (dosage according to the treatment of stage I-III).

Duration of treatment
The doctor will determine the duration of treatment. It may be necessary to have your blood checked regularly by the laboratory. Dozurso can 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, itching may increase. This happens only in rare cases. If this happens, therapy can be continued with a lower daily dose of Dozurso. Each week, the doctor will gradually increase the daily dose, until you reach the required dose.

Use in patients with gallstones
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 beginning of treatment. Even if the symptoms have disappeared, you must continue with the treatment. Stopping the treatment may result in a prolongation of the total treatment time. After the gallstones have been dissolved, the treatment must be continued for 3-4 months. If there is no reduction in the size of the gallstones after 12 months, therapy must be stopped.
Every 6 months, the doctor must check that the treatment is working. At each of these follow-up examinations, it must be checked whether calcium has accumulated since the last time, causing the hardening of the stones. If this happens, the 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
Dozurso 250 mg film-coated tablets are not intended for children.
The administration of Dozurso film-coated tablets is based on body weight and medical condition. If the patient cannot 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 attention.

If you forget to take Dozurso
Do not take a double dose to make up for a missed dose.

If you stop taking Dozurso
Always talk to your doctor before deciding to stop treatment with Dozurso film-coated tablets or before stopping treatment prematurely. If you have any doubts about using this medicine, ask 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 1 in 10 people):

• Soft, loose or watery stools. Tell your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose of the medicine. If you suffer from diarrhoea, make sure to drink enough fluids to replenish the fluid and electrolyte balance.

Diarrhoea may also occur as a result of an 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 improve partially after treatment is stopped.
• Hardening of gallstones due to calcium accumulation. This phenomenon does not cause any other symptoms, but is revealed by tests.
• Urticaria.

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

• Vomiting.
• In patients with cirrhosis, worsening (increased severity) of itching at the start of treatment cannot be ruled out.
• 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 get any side effects, talk to your doctor, pharmacist or nurse. 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 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 which is stated on the blister pack label and on the
box after the wording “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 in 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 ingredient is ursodeoxycholic acid. Each film-coated tablet contains 250 mg of ursodeoxycholic acid.
• The other components are: CoreCorn starch, sodium lauryl sulfate, povidone K30 (E1201), anhydrous colloidal silica, magnesium stearate. Film coatingLecithin (soya) (E322), macrogol 3350 (E1521), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171).

Description of the appearance of Dozurso 250 mg film-coated tablets and package contents
Dozurso 250 mg film-coated tablets are white, round and biconvex.
Package 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
6 AVENUE DE L'EUROPE
78400 CHATOU
FRANCE

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

This medicinal product is authorised in the Member States of the EEA (European Economic
Area) with the following names:
Austria, Belgium, Finland, France, Germany, Greece, Italy, Portugal, Sweden, Hungary: Dozurso
Ireland, United Kingdom: Cholurso.

Dozurso 500 mg film-coated tablets

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

• 7. What Dozurso 500 mg film-coated tablets is and what it is used for
• 8. What you need to know before you take Dozurso 500 mg film-coated tablets
• 9. How to take Dozurso 500 mg film-coated tablets
• 10. Possible side effects
• 11. How to store Dozurso 500 mg film-coated tablets
• 12. Contents of the pack and other information

1. What is Dozurso 500 mg film-coated tablets and what is it used for

Dozurso contains the active substance ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical substance that occurs naturally in the body and helps to
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), in cases where the gallstones are not visible on simple X-rays (gallstones that are visible will not dissolve) and are no more than 15 mm in diameter. The gallbladder must still be functioning despite the gallstones.
• For the treatment of a condition in which the bile ducts in the liver become damaged leading to an accumulation of bile. This can cause the formation of lesions in the liver. The liver must not be so damaged as to no longer function correctly. This condition is called primary biliary cholangitis.

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 ursodesoxycholic 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 gallstones visible on X-rays;
• if you have an acute inflammation of the gallbladder or bile duct;
• if you have an obstruction of the bile duct (obstruction of the common bile duct or the cystic duct);
• if you suffer from frequent, cramp-like pains in the upper abdomen (biliary colic);
• if you have hardening of gallstones caused by a build-up of calcium.

Talk to your doctor if any of the above conditions apply to you. You should also talk to your
doctor if you have had any of these conditions before or if you are unsure whether any of them
apply to you.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dozurso.
Dozurso must be used under medical supervision.
Your doctor should check your liver function regularly every 4 weeks for the first 3 months
of treatment. After this period, it should be monitored at intervals of 3 months. If you are
taking Dozurso to dissolve gallstones, you should use a non-hormonal effective contraceptive method, as hormonal contraceptives may increase gallstone formation (see “Other
medicines and Dozurso” and “Pregnancy, breastfeeding and fertility”). Immediately inform your
doctor if you have diarrhoea as in this case a dose reduction or
discontinuation of treatment may be necessary.
Cholestyramine, charcoal, colestipol (to lower blood lipids) or antacids containing
aluminium hydroxide or smectite (aluminium oxide) should 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 available without a prescription. Treatment with
Dozurso may still be permitted. Your doctor will know what is right for you.

Areduction in the effectsof the following medicines is possible when taking Dozurso:

• Cholestyramine, charcoal, colestipol (to lower blood lipids) or antacids containing aluminium hydroxide or smectite (aluminium oxide). If you need to take medicines containing any of these ingredients, you should 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 change the dose of these medicines. Anincrease in the effectsof the following medicines is possible when taking Dozurso:
• Cyclosporine (to reduce the activity of the immune system). If you are being treated with cyclosporine, your doctor should check the amount of cyclosporine in your blood. The doctor will adjust the dose, if necessary.

Tell your doctor if you are taking medicines to lower blood cholesterol such as clofibrate or
medicines that contain oestrogens, especially if you are taking Dozurso to dissolve
gallstones, as these medicines can stimulate the formation of gallstones.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

• You should 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 foetus.
• Check that you are not pregnant before taking this medicine. Use a reliable contraceptive method - non-hormonal contraceptives (barrier methods) or oral contraceptives with a low level of oestrogens are recommended. If you are taking this medicine to dissolve gallstones, use only non-hormonal contraceptives, as hormonal oral contraceptives can stimulate the formation of gallstones.
• Do not take this medicine if you are breastfeeding as the active ingredient in this medicine can pass into breast milk. If treatment with Dozurso is necessary, stop breastfeeding.
• Data available so far do not suggest any effect of this treatment on fertility.

Driving and operating machinery
No special precautions are necessary.

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 product
medicine.

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

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablets whole with a glass of water or other liquid. Take the tablets regularly. The daily dose shown below serves as an example of how you can take the tablets.

Dosage
Use in patients with impaired hepatic bile flow (primary biliary cholangitis)
The doctor will determine your dose according to your body weight. During the first 3 months of treatment, you should take 1 ½ - 3 ½ tablets in divided doses throughout the day with meals.
As soon as liver function improves, the total daily dose can be taken once, in the evening.

If you have no problems with this dose (after blood tests and/or according to an assessment), your doctor will prescribe a higher dose (dosage according to treatment for stage I-III).

Duration of treatment
The doctor will determine the duration of treatment. It may be necessary to have your blood checked regularly by the laboratory. Dozurso can 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, itching may increase. This only happens in rare cases. If this happens, therapy can be continued with a lower daily dose of Dozurso. Each week, the doctor will gradually increase the daily dose, until you reach the required dose.

Use in patients with gallstones
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 existing gallstones at the start of treatment. Even if the symptoms have disappeared, you must continue with the treatment. Stopping the treatment may result in a prolongation of the total treatment time. After the gallstones have been dissolved, the treatment should be continued for 3-4 months. If there is no reduction in the size of the gallstones after 12 months, therapy should be discontinued.
Every 6 months, the doctor should check that the treatment is working. At each of these follow-up examinations, it should be checked whether calcium has accumulated since the last time, causing the stones to harden. If this happens, the 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
Dozurso 500 mg film-coated tablets are not intended for children.
The administration of Dozurso film-coated tablets is based on body weight and medical condition. If the patient cannot swallow the tablets or has a body weight below 47 kg, the availability of other pharmaceutical forms containing ursodeoxycholic acid (suspension) should be checked.

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 a missed dose.

If you stop taking Dozurso

Always talk to your doctor before deciding to stop treatment with Dozurso or stopping treatment prematurely. If you have any doubts about using this medicine, ask 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 1 in 10 people):

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

You may also experience diarrhea as a result of an 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 improve partially after treatment is stopped.
• Hardening of gallstones due to calcium accumulation. This phenomenon does not cause any other symptoms, but is revealed by tests.
• Urticaria.

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

• Vomiting.
• In patients with cirrhosis, worsening (increased severity) of itching at the beginning of treatment cannot be ruled out.
• 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 get any side effects, talk to your doctor, pharmacist or nurse. 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
about 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 which is stated on the blister pack and the
outer packaging after the wording “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 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 Dozurso 500 mg film-coated tablets contain

• The active ingredient is ursodeoxycholic acid. Each film-coated tablet contains 500 mg of ursodeoxycholic acid.
• The other components are: CoreCorn starch, sodium lauryl sulfate, povidone K30 (E1201), anhydrous colloidal silica, magnesium stearate. Film coatingLecithin (soya) (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 contents
Dozurso 500 mg film-coated tablets are white, oblong with a
grooved line on each side. The tablet can be divided into equal doses.
Pack size: 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
6 AVENUE DE L'EUROPE
78400 CHATOU
FRANCE

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

This medicinal product is authorised in the Member States of the EEA (European
Economic Area) with the following names:
Austria, Belgium, Finland, France, Germany, Greece, Italy, Portugal, Sweden, Hungary: Dozurso
Ireland, United Kingdom: Cholurso.