Ursodeoxycholic acid ABC

Package leaflet: Information for the user

ACIDO URSODESOSSICOLICO ABC 250 mg hard capsules

Ursodeoxycholic acid
Equivalent medicine
Please read this leaflet carefully before using 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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO URSODESOSSICOLICO ABC is and what it is used for

ACIDO URSODESOSSICOLICO ABC contains ursodeoxycholic acid, a bile acid
naturally present in small amounts in human bile.
ACIDO URSODESOSSICOLICO ABC is used:

• To dissolve cholesterol gallstones. These stones must not be visible on plain X-rays (must be radiolucent) and must not exceed 15 mm in diameter, otherwise they would not dissolve with UDCA. The gallbladder must still be functioning despite the presence of gallstones.
• For the treatment of primary biliary cholangitis (PBC), a condition in which the bile ducts in the liver become damaged, leading to bile accumulation. This may cause liver damage (liver cirrhosis). The liver must not be so damaged as to have lost its proper function.
• For the treatment of a liver disease associated with a condition called cystic fibrosis in children aged between 6 and 18 years.

2. What you need to know before using ACIDO URSODESOSSICOLICO ABC

Do not use ACIDO URSODESOSSICOLICO ABC

• if you are allergic to bile acids or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute inflammation of the gallbladder or bile ducts;
• if you have frequent episodes of upper abdominal pain (symptoms of biliary colic);
• if you have an obstruction of the bile ducts;
• if you have reduced gallbladder motility;
• if you have radiopaque (visible on X-ray) calcified gallstones;
• if you are administering this medicine to a child with narrowed bile ducts (biliary atresia, a rare congenital condition in which the bile ducts in the liver are blocked or do not develop properly) and/or who has poor bile flow, even after surgical intervention.

Contact your doctor if any of the conditions listed above apply to you. You should also consult your doctor
if you have previously experienced any of these conditions or if you are unsure whether you have any of them.
Warnings and precautions
Talk to your doctor or pharmacist before taking ACIDO URSODESOSSICOLICO ABC. This
medicine should 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 a woman taking this medicine to dissolve gallstones, you must use only effective non-hormonal contraceptive methods, because certain hormonal contraceptives (the “pill”) containing
estrogens may promote the formation of gallstones (see also section Pregnancy, breastfeeding and fertility).
When used in the treatment of PBC, symptoms may rarely worsen at the beginning of therapy. If this occurs, consult your doctor about reducing the initial dose.
If you are taking this medicine to dissolve gallstones, your doctor will arrange an ultrasound examination of the gallbladder after the first 6–10 months of treatment.
If you are taking ACIDO URSODESOSSICOLICO ABC for gallstone dissolution,
inform your doctor if you are also taking medicines containing estrogen hormones or agents that lower blood cholesterol such as clofibrate, since these medicines may promote gallstone formation.
Inform your doctor immediately if you develop diarrhea, as this may require a reduction in dose or discontinuation of treatment with ACIDO URSODESOSSICOLICO ABC.
Children and adolescents
ACIDO URSODESOSSICOLICO ABC is not indicated in children under 6 years of age due to the pharmaceutical form and capsule dosage.
Other medicines and ACIDO URSODESOSSICOLICO ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
The use of other medicines may interfere with this medicine.
This is particularly important if you are taking the following medicines:
cholestyramine, colestipol (used to reduce blood lipids), or antacids containing
aluminum hydroxide or smectite (aluminum oxide). If you need to take medicines containing any of these components, you must take them at least two hours before or after ACIDO URSODESOSSICOLICO ABC.
ciclosporine (to reduce immune system activity in transplant patients)
ciprofloxacin (for infections)
nitrendipine (for high blood pressure)
dapsone (for HIV)
estrogens (in certain oral contraceptives and menopausal hormone therapies)
clofibrate (for high cholesterol)
rosuvastatin (for high cholesterol)
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should undergo pregnancy testing before starting treatment.
Do not take ACIDO URSODESOSSICOLICO ABC during pregnancy unless your doctor considers it strictly necessary.
If you are a woman of childbearing age, use this medicine only if you are simultaneously using an effective non-hormonal contraceptive method, because oral hormonal contraception may stimulate gallstone formation.
Breastfeeding
It is not known whether this medicine passes into breast milk.
If you are breastfeeding, consult your doctor before using ACIDO URSODESOSSICOLICO ABC capsules.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to take UDCA ABC

Take this medicine exactly as prescribed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
The dose and frequency with which you should take UDCA ABC depend on your body weight and your medical condition. Other formulations (e.g., oral suspension) are available if a lower dose is required or if you are unable to swallow UDCA ABC 250 mg capsules.

Dissolution of gallstones:
The recommended dose is 10–12 mg per kg of body weight per day, divided into 2 doses.
On average, it takes between 6 and 24 months for gallstones to dissolve.
If the size of the gallstones has not decreased after 12 months, treatment must be discontinued.
During treatment for gallstone dissolution, you will undergo a test after 6–10 months of therapy to assess whether the treatment is effective.

Primary biliary cholangitis:
The recommended dose is 12–16 mg per kg of body weight per day.
For the first 3 months after starting treatment, UDCA ABC should be taken in divided doses throughout the day.
Once liver values have improved, the dose may be taken once daily, preferably in the evening.
There are no restrictions on the duration of treatment with this medicine for primary biliary cholangitis.
In patients with primary biliary cholangitis, symptoms may rarely worsen at the beginning of treatment, e.g., pruritus.
In such cases, treatment may be continued with a lower dose of UDCA ABC.
Subsequently, your doctor will increase the daily dose weekly until the recommended daily dose is reached.

The capsules must be swallowed whole with plenty of fluid.
The medicine should be taken regularly to achieve maximum effectiveness.

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

Dosage:
The recommended dose for children with cystic fibrosis aged 6 to under 18 years is 20 mg per kg of body weight per day, divided into 2–3 doses.
Your doctor may further increase the dose up to 30 mg per kg of body weight per day, if necessary.
Your doctor will determine the appropriate dose for your child based on body weight.

If you take more URSODEOXYCHOLIC ACID ABC than you should
If you ingest or take an excessive dose of this medicinal product, contact your doctor immediately or go to the nearest hospital.
Single episodes of overdose with ursodeoxycholic acid are not harmful. However, ingestion of an excessive dose of this medicinal product may cause diarrhoea.

If you forget to take URSODEOXYCHOLIC ACID ABC
Do not take a double dose to make up for the missed dose.

If you stop taking URSODEOXYCHOLIC ACID ABC
Always consult your doctor before stopping treatment with URSODEOXYCHOLIC ACID ABC.

If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• soft stools or diarrhoea.

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

• severe pain in the upper right part of the abdomen during treatment of liver disease (primary biliary cholangitis).
• Calcification of gallstones.
• Worsening of liver function during treatment of liver disease (primary biliary cholangitis), which may return to normal if treatment is discontinued.
• Urticaria.

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

• Pruritus;
• Nausea, vomiting.

Reporting of side effects
If you experience any side effects, 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 ACIDO URSODESOSSICOLICO ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
Do not dispose of medicines 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 ACIDO URSODESOSSICOLICO ABC contains
The active substance is ursodeoxycholic acid. Each capsule contains 250 mg of ursodeoxycholic acid.
The other components are: maize starch, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172) and gelatin.
Description of the appearance of ACIDO URSODESOSSICOLICO ABC and contents of the pack
Yellow capsules.
Pack sizes: 20, 25, 30, 50, 60 and 100 hard capsules in PVC/Aluminum blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Manufacturer
ABC Farmaceutici S.p.A.
Via Cantone Moretti, 29
Loc. San Bernardo - 10015 Ivrea (TO)

Package leaflet: Information for the user

ACIDO URSODESOSSICOLICO ABC 500 mg hard capsules

ursodeoxycholic acid
Generic medicinal product
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO URSODESOSSICOLICO ABC is and what it is used for

ACIDO URSODESOSSICOLICO ABC contains ursodeoxycholic acid, a bile acid
naturally present in small amounts in human bile.
ACIDO URSODESOSSICOLICO ABC is used:

• To dissolve cholesterol gallstones. These stones must not be visible on plain X-rays (must be radiotransparent) and must not exceed 15 mm in diameter, otherwise they will not dissolve with UDCA. The gallbladder must still be functioning despite the presence of gallstones.
• For the treatment of primary biliary cholangitis (PBC), a condition in which the bile ducts in the liver become damaged, leading to bile accumulation. This may cause liver damage (liver cirrhosis). The liver must not be so severely damaged as to have lost its function.
• For the treatment of a liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.

2. What you need to know before using ACIDO URSODESOSSICOLICO ABC

Do not use ACIDO URSODESOSSICOLICO ABC

• if you are allergic to bile acids or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute inflammation of the gallbladder or bile ducts;
• if you have an obstruction of the gallbladder or bile ducts;
• if you experience frequent episodes of upper abdominal pain (a symptom of biliary colic);
• if you have reduced gallbladder function;
• if you have radiopaque (calcified) gallstones visible on X-ray;
• if you intend to administer this medicine to a child with narrowed bile ducts (biliary atresia, a rare congenital disease in which bile ducts in the liver are blocked or do not develop properly) and/or who has poor bile flow, even after surgical intervention.

Consult your doctor if any of the conditions listed above apply to you. You should also consult your doctor
if you have previously experienced any of these conditions or if you are unsure whether you have any of them.
Warnings and precautions
Talk to your doctor or pharmacist before taking ACIDO URSODESOSSICOLICO ABC. This
medicine 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 a woman taking this medicine to dissolve gallstones, you must use only effective non-hormonal
contraceptive methods, because some hormonal contraceptives (the “pill”) containing
estrogens may promote the formation of gallstones (see also section Pregnancy,
breast-feeding and fertility).
When used in the treatment of PBC, symptoms may rarely worsen at the beginning of therapy.
If this occurs, consult your doctor to reduce the initial dose.
If you are taking this medicine for gallstone dissolution, your doctor will arrange an ultrasound of the
gallbladder after the first 6–10 months of treatment.
If you are taking ACIDO URSODESOSSICOLICO ABC for gallstone dissolution,
inform your doctor if you are taking medicines containing estrogen hormones or agents that lower blood
cholesterol such as clofibrate, as these medicines may promote gallstone formation.
Inform your doctor immediately if you develop diarrhea, as the dose may need to be reduced or
treatment with ACIDO URSODESOSSICOLICO ABC may need to be discontinued.
Children and adolescents
ACIDO URSODESOSSICOLICO ABC is not indicated in children under 6 years of age due to
the pharmaceutical form and dosage of the capsule.
Other medicines and ACIDO URSODESOSSICOLICO ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those not requiring a prescription.
The use of other medicines may interfere with this medicine.
This is particularly important if you are taking the following medicines:
cholestyramine, colestipol (to reduce blood lipids) or antacids containing
aluminum hydroxide or smectite (aluminum oxide). If you need to take medicines containing
any of these components, they should be taken at least two hours before or after
ACIDO URSODESOSSICOLICO ABC.
ciclosporine (to reduce immune system effects in transplant patients)
ciprofloxacin (for infections)
nitrendipine (for high blood pressure)
dapsone (for HIV)
estrogens (in some oral contraceptives and menopausal treatments)
clofibrate (for high cholesterol)
rosuvastatin (for high cholesterol)
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breast-feeding,
please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Pregnancy tests should be performed to rule out pregnancy before starting treatment.
Do not take ACIDO URSODESOSSICOLICO ABC during pregnancy unless your doctor considers it
strictly necessary. Even if you are not pregnant, consult your doctor. If you are a woman of childbearing
age, use this medicine only if you are also using an effective non-hormonal contraceptive method, because
oral hormonal contraception may promote gallstone formation.
Breast-feeding
It is not known whether this medicine passes into breast milk.
If you are breast-feeding, consult your doctor before using ACIDO URSODESOSSICOLICO
ABC capsules.
Driving and using machines
This medicine does not affect the ability to drive or use machinery.

3. How to take ACIDO URSODESOSSICOLICO ABC

Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
The dose and frequency with which you should take ACIDO URSODESOSSICOLICO ABC depend on
your body weight and your medical condition. Other formulations (e.g., oral suspension) are available if a
lower dose is required or if you are unable to swallow ACIDO URSODESOSSICOLICO ABC 500 mg capsules.

Dissolution of gallstones:
The recommended dose is 10–12 mg per kg of body weight per day, divided into 2 doses.
On average, it takes between 6 and 24 months for gallstones to dissolve.
If the size of the gallstones has not decreased after 12 months, you must stop treatment.
During treatment for gallstone dissolution, you will undergo a test after 6–10 months of treatment to
assess whether the treatment is effective.

Primary biliary cholangitis:
The recommended dose is 12–16 mg per kg of body weight per day.
For the first 3 months after starting treatment, ACIDO URSODESOSSICOLICO ABC should be taken
in divided doses throughout the day.
Once liver values have improved, the dose may be taken once daily, preferably in the evening.
There are no restrictions on the duration of treatment with this medicine for primary biliary cholangitis.
In patients with primary biliary cholangitis, symptoms may rarely worsen at the beginning of treatment,
e.g. pruritus.
In such cases, treatment may be continued with a lower dose of ACIDO URSODESOSSICOLICO ABC.
Subsequently, your doctor will increase the daily dose weekly until the recommended daily dose is
reached.

The capsules must be swallowed whole with plenty of liquid.
The medicine should be taken regularly to achieve maximum effectiveness.

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

Dosage
The recommended dose for children with cystic fibrosis aged 6 to under 18 years is 20 mg per kg of body weight per day, divided into 2–3 doses.
Your doctor may further increase the dose up to 30 mg per kg of body weight per day, if necessary.
Depending on body weight, your doctor may also prescribe ursodeoxycholic acid 250 mg capsules (e.g., ACIDO URSODESOSSICOLICO ABC 250 mg) in addition to ACIDO URSODESOSSICOLICO ABC 500 mg hard capsules.
Your doctor will determine the appropriate dose for your child based on body weight.

If you take more ACIDO URSODESOSSICOLICO ABC than you should
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Single episodes of overdose with ursodeoxycholic acid are not harmful. However, ingestion of an excessive dose of this medicine may cause diarrhoea.

If you forget to take ACIDO URSODESOSSICOLICO ABC
Do not take a double dose to make up for the missed dose.

If you stop taking ACIDO URSODESOSSICOLICO ABC
Always consult your doctor before stopping treatment with ACIDO URSODESOSSICOLICO ABC.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• soft stools or diarrhoea.

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

• severe pain in the upper right side of the abdomen during treatment of liver disease (primary biliary cholangitis).
• Calcification of gallstones.
• Worsening of liver function during treatment of liver disease (primary biliary cholangitis), which may return to normal if treatment is stopped.
• Urticaria.

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

• Pruritus;
• Nausea, vomiting.

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 ACIDO URSODESOSSICOLICO ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 ACIDO URSODESOSSICOLICO ABC contains
The active substance is ursodeoxycholic acid. Each capsule contains 500 mg of ursodeoxycholic acid.
The other components are: maize starch, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E 171) and gelatin.
Description of the appearance of ACIDO URSODESOSSICOLICO ABC and package contents
White capsules.
Pack sizes: 20, 25, 30, 50, 60 and 100 hard capsules in PVC/Aluminum blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Torino
Manufacturer
ABC Farmaceutici S.p.A.
Via Cantone Moretti, 29
Loc. San Bernardo - 10015 Ivrea (TO)