ACIDO 250 mg Hard Capsule

Содержание инструкции

1. ACIDO URSODESOSSICOLICO ABC 250 mg hard capsules
   1. What is ACIDO URSODESOSSICOLICO ABC and what is it used for
   2. What you need to know before using URSODEOXYCHOLIC ACID 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
2. ACIDO URSODESOSSICOLICO ABC 500 mg hard capsules
   1. What is ACIDO URSODESOSSICOLICO ABC and what is it used for
   2. What you need to know before using 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

ACIDO URSODESOSSICOLICO ABC 250 mg hard capsules

ursodesoxycholic acid

Generic medicine

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

1. What is ACIDO URSODESOSSICOLICO ABC and what is it 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 simple X-rays (being radiolucent) and must not be more than 15 mm in diameter, otherwise they would not dissolve with UDCA. The gallbladder must still be functioning despite the gallstones.
• For the treatment of primary biliary cholangitis (PBC), a condition in which the bile ducts in the liver become damaged leading to a buildup of bile. This can cause the formation of lesions in the liver (liver cirrhosis). The liver must not be so damaged as to not function properly.
• For the treatment of a liver disease associated with a condition called cystic fibrosis in children between 6 and 18 years of age

2. What you need to know before using URSODEOXYCHOLIC ACID ABC

Do not use URSODEOXYCHOLIC ACID ABC

• if you are allergic to bile acids or any of the other components 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 bile ducts
• if you have frequent episodes of upper abdominal pain (symptom of biliary colic)
• if you have calcified gallstones visible on X-rays
• if you have reduced gallbladder function
• if you need to administer this medicine to a child with narrowed bile ducts (biliary atresia, a rare congenital disease in which the bile ducts in the liver are blocked or do not develop properly) and/or who has poor bile flow, even after surgery

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 or pharmacist before taking URSODEOXYCHOLIC ACID ABC. This
medicine should be used under the supervision of a doctor.
The 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 a woman and are taking this medicine to dissolve gallstones, you should only use
effective non-hormonal contraceptive measures because some 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 worsen in rare cases at the beginning of
therapy. If this happens, consult your doctor to reduce the initial dose.
If you are taking the medicine to dissolve gallstones, your doctor will perform
an ultrasound of the gallbladder after the first 6-10 months of treatment.
If you are taking URSODEOXYCHOLIC ACID ABC to dissolve gallstones,
inform your doctor if you are taking medicines that contain estrogenic hormones or agents that
lower blood cholesterol, such as clofibrate, as these medicines stimulate the formation
of gallstones.
Immediately inform your doctor if you have diarrhea, as in this case a
reduction in the dose or discontinuation of treatment with URSODEOXYCHOLIC ACID ABC may be necessary.

Children and adolescents
URSODEOXYCHOLIC ACID ABC is not indicated in children under 6 years of age due to
the pharmaceutical form and dosage of the capsule

Other medicines and URSODEOXYCHOLIC ACID ABC
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The use of other medicines may interfere with this medicine.
This is particularly important if you are taking the following medicines:
cholestyramine, colestipol (to lower lipids in the blood) or antacids containing
aluminum hydroxide or smectite (aluminum oxide). If you need to take medicines that
contain any of these components, you should take them at least two hours before or after
URSODEOXYCHOLIC ACID ABC
cyclosporine (to reduce the effects of the immune system on transplants)
ciprofloxacin (for infections)
nitrendipine (for high blood pressure)
dapsone (against HIV)
estrogens (in some birth control pills and medicines used in relation to menopause)
clofibrate (for high cholesterol)
rosuvastatin (for high cholesterol)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should perform tests to rule out pregnancy before starting treatment.
Do not take URSODEOXYCHOLIC ACID 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 also using an effective
non-hormonal contraceptive method, because oral hormonal contraception may stimulate
the formation of gallstones.
Breastfeeding
It is not known whether this medicine passes into breast milk.
If you are breastfeeding, consult your doctor before using URSODEOXYCHOLIC ACID
ABC capsules.

Driving and operating machinery
This medicine does not impair the ability to drive and operate machinery.

3. How to take ACIDO URSODESOSSICOLICO ABC

Take this medicine following exactly the instructions of your doctor.
If you have doubts, consult your doctor or pharmacist.
The quantity and frequency with which you must take ACIDO URSODESOSSICOLICO ABC depend
on your body weight and your medical conditions. Other formulations (e.g.,
oral suspension) are available if a lower dose is needed or if you are unable to swallow ACIDO
URSODESOSSICOLICO ABC 500 mg capsules
Dissolution of bile stones
The recommended dose is 10-12 mg per kg of body weight per day, divided into 2 doses.
On average, between 6 and 24 months are needed for the bile stones to dissolve.
If the size of the bile stones does not decrease after 12 months, you must stop the treatment.
During the treatment to dissolve bile stones, you will undergo a test after 6-10 months of
treatment, to verify if the treatment is successful.
Primary biliary cirrhosis
The recommended dose is 12-16 mg per kg of body weight per day.
For the first 3 months after starting treatment, you must distribute the intake of ACIDO
URSODESOSSICOLICO ABC throughout the day.
When liver values have improved, the dose can be taken once a day, preferably
in the evening.
There are no restrictions on the duration of treatment with this drug for primary biliary cirrhosis.
If you suffer from primary biliary cirrhosis, in rare cases, you may experience a worsening of symptoms
at the beginning of treatment, e.g. itching.
In this case, you can continue the treatment with a lower dose of ACIDO URSODESOSSICOLICO
ABC.
Subsequently, the doctor will increase the daily dose every week until the recommended daily
dose.
Swallow the capsules whole with plenty of liquid.
Take the medicine regularly to obtain maximum efficacy.
Use in children (6-18 years) with cystic fibrosis
The recommended dose for children with cystic fibrosis aged between 6 and 18 years is 20 mg per kg
of body weight per day, divided into 2-3 doses.
The doctor may further increase the dose to 30 mg per kg of body weight per day, if necessary.
The doctor will decide which dose to administer to your child based on body weight.

If you take more than ACIDO URSODESOSSICOLICO ABCthan you should
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital. Ingesting an excessive dose of this medicine can
cause diarrhea.

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

If you stop taking ACIDO URSODESOSSICOLICO ABC
Always consult your doctor before stopping taking ACIDO URSODESOSSICOLICO
ABC
If you have any doubts 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 (affects more than 1 in 100 people):

• diarrhea,
• pale stools.

Very rare (affects less than 1 in 10,000 people):

• severe pain in the upper right quadrant of the abdomen during treatment of primary biliary cholangitis
• Calcification of gallstones
• Decompensation of hepatic cirrhosis which may be reduced if treatment is discontinued
• Urticaria

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 ACIDO URSODESOSSICOLICO ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
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 ACIDO URSODESOSSICOLICO ABC contains
The active ingredient is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.
The other ingredients are: corn starch, anhydrous colloidal silica, magnesium stearate, titanium dioxide
(E 171), yellow iron oxide (E172) 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

AIC 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)

ACIDO URSODESOSSICOLICO ABC 500 mg hard capsules

acido ursodesossicolico

Generic medicine

Read this leaflet carefully before using 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 ACIDO URSODESOSSICOLICO ABC is and what it is used for
• 2. What you need to know before you use ACIDO URSODESOSSICOLICO ABC
• 3. How to use ACIDO URSODESOSSICOLICO ABC
• 4. Possible side effects
• 5. How to store ACIDO URSODESOSSICOLICO ABC
• 6. Contents of the pack and other information

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

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

• To dissolve cholesterol gallstones. These stones must not be visible on simple X-rays (be radiotransparent) and must not be more than 15 mm in diameter, otherwise they will not dissolve with UDCA. The gallbladder must still be functioning despite the gallstones.
• For the treatment of primary biliary cholangitis (PBC), 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 (liver cirrhosis). The liver must not be so damaged as to not function properly.
• For the treatment of a liver disease associated with a condition called cystic fibrosis in children between 6 and 18 years of age

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 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 bile ducts
• if you have frequent episodes of upper abdominal pain (a symptom of biliary colic)
• if you have calcified gallstones visible on X-rays
• if you have reduced gallbladder function
• if you need to administer this medicine to a child with narrowed bile ducts (biliary atresia, a rare congenital disease in which the bile ducts in the liver are blocked or do not develop properly) and/or who has

poor bile flow, even after surgery
Consult your doctor if any of the above conditions apply to you. You should also consult your doctor
if you have had any of these conditions before or if you are unsure whether you have them.

Warnings and precautions
Consult your doctor or pharmacist before taking ACIDO URSODESOSSICOLICO ABC. This
medicine should be used under the supervision of a doctor.
The doctor must 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 a woman and are taking this medicine to dissolve gallstones, you should only use
effective non-hormonal contraceptives because some hormonal contraceptives (the “pill”) containing
estrogens may promote the formation of gallstones (see also the Pregnancy,
breastfeeding and fertility section).
When used in the treatment of PBC, symptoms may worsen in rare cases at the beginning of
therapy. If this happens, consult your doctor to reduce the initial dose.
If you are taking the medicine to dissolve gallstones, your doctor will perform
an ultrasound of the gallbladder after the first 6-10 months of treatment.
If you are taking ACIDO URSODESOSSICOLICO ABC to dissolve gallstones,
inform your doctor if you are taking medicines that contain estrogen hormones or agents that
lower blood cholesterol, such as clofibrate, as these medicines stimulate the formation
of gallstones.
Immediately inform your doctor if you have diarrhea, as a dose reduction or interruption of treatment with ACIDO URSODESOSSICOLICO ABC may be necessary.

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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The use of other medicines may interfere with this medicine.
This is particularly important if you are taking the following medicines:
cholestyramine, colestipol (to lower lipids in the blood) or antacids containing
aluminum hydroxide or smectite (aluminum oxide). If you need to take medicines that
contain any of these ingredients, you should take them at least two hours before or after
ACIDO URSODESOSSICOLICO ABC
cyclosporine (to reduce the effects of the immune system on transplants)
ciprofloxacin (for infections)
nitrendipine (for high blood pressure)
dapsone (against HIV)
estrogens (in some birth control pills and medicines used in relation to menopause)
clofibrate (for high cholesterol)
rosuvastatin (for high cholesterol)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice 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 potential, use this medicine only if you are also using an effective non-
hormonal contraceptive method, because oral hormonal contraception can stimulate the formation of gallstones.
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 vehicles and operate machinery.

3. How to take ACIDO URSODESOSSICOLICO ABC

Take this medicine following exactly the instructions of your doctor.
If you have doubts, consult your doctor or pharmacist.
The quantity and frequency with which you must take ACIDO URSODESOSSICOLICO ABC depend
on your body weight and your medical conditions. Other formulations (e.g.,
oral suspension) are available if a lower dose is needed or if you are unable to swallow ACIDO
URSODESOSSICOLICO ABC 500 mg capsules
Dissolution of bile stones:
The recommended dose is 10-12 mg per kg of body weight per day, divided into 2 doses.
On average, between 6 and 24 months are needed for the bile stones to dissolve.
If the size of the bile stones does not decrease after 12 months, you must stop the treatment.
During the treatment to dissolve the bile stones, you will undergo a test after 6-10 months of
treatment to verify if the treatment is successful.
Primary biliary cirrhosis:
The recommended dose is 12-16 mg per kg of body weight per day.
For the first 3 months after starting treatment, you must distribute the intake of ACIDO
URSODESOSSICOLICO ABC throughout the day.
When liver values have improved, the dose can be taken once a day, preferably
in the evening.
There are no restrictions on the duration of treatment with this drug for primary biliary cirrhosis.
If you suffer from primary biliary cirrhosis, in rare cases, you may experience a worsening of symptoms
at the beginning of treatment, e.g. itching.
In this case, you can continue the treatment with a lower dose of ACIDO URSODESOSSICOLICO
ABC.
Subsequently, the doctor will increase the daily dose every week until the recommended daily
dose.
Swallow the capsules whole with plenty of liquid.
Take the medicine regularly to obtain maximum efficacy.
Use in children (6-18 years) with cystic fibrosis
The recommended dose for children with cystic fibrosis aged between 6 years and under 18 years is
20 mg per kg of body weight per day, divided into 2-3 doses.
The doctor may further increase the dose to 30 mg per kg of body weight per day, if necessary.
Depending on body weight, the 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.
The doctor will decide which dose to administer to your child based on body weight.

If you take moreACIDO URSODESOSSICOLICO ABCthan you should
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital. Ingesting an excessive dose of this medicine can
cause diarrhea.

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 taking ACIDO URSODESOSSICOLICO
ABC
If you have any doubts 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 will experience them.
Common (affects more than 1 in 100 people):

• diarrhea,
• pale stools.

Very rare (affects less than 1 in 10,000 people):

• severe pain in the upper right quadrant of the abdomen during treatment of primary biliary cholangitis
• Calcification of gallstones
• Decompensation of hepatic cirrhosis which may be reduced if treatment is discontinued
• Urticaria

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 ACIDO URSODESOSSICOLICO ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
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 ACIDO URSODESOSSICOLICO ABC contains
The active ingredient is ursodeoxycholic acid. One capsule contains 500 mg of ursodeoxycholic acid.
The other ingredients are: corn starch, anhydrous colloidal silica, magnesium stearate, titanium dioxide
(E 171) and gelatin
Description of the appearance of ACIDO URSODESOSSICOLICO ABC and contents of the pack
White capsules.
Pack sizes: 20, 25, 30, 50, 60 and 100 hard capsules in PVC/Aluminum blisters.
Marketing authorization holder and manufacturer

AIC 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)