ACIDO 450 mg Extended-Release Tablet

Зміст інструкції

1. ACIDO URSODESOSSICOLICO EG 300 mg hard capsules
   1. What is ACIDO URSODESOSSICOLICO EG and what it is used for
   2. What you need to know before taking ACIDO URSODESOSSICOLICO EG
   3. How to take ACIDO URSODESOSSICOLICO EG
   4. Possible side effects
   5. How to store ACIDO URSODESOSSICOLICO EG
   6. Contents of the pack and other information
2. URSODESOXYCHOLIC ACID EG 450 mg prolonged-release tablets
   1. What ACIDO URSODESOSSICOLICO EG is and what it is used for
   2. What you need to know before taking ACIDO URSODESOSSICOLICO EG
   3. How to take ACIDO URSODESOSSICOLICO EG
   4. Possible side effects
   5. How to store ACIDO URSODESOSSICOLICO EG
   6. Contents of the pack and other information

ACIDO URSODESOSSICOLICO EG 300 mg hard capsules

Equivalent Medicinal Product
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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ACIDO URSODESOSSICOLICO EG is a preparation based on bile acids naturally present
in the body, which is able to solubilize cholesterol in bile.
This medicine is used in adults to treat alterations in bile production by
the liver and to improve the solubility of cholesterol, both to prevent the formation of gallstones
and to facilitate their dissolution. This medicine is not effective against all types of gallstones, but
only against those not visible on X-rays (radiotransparent); in particular, cholesterol
gallstones in the gallbladder (functioning gallbladder) and gallstones in the bile duct.
It is also used to treat digestive problems due to malfunctioning of the gallbladder
(biliary dyspepsia).

2. What you need to know before taking ACIDO URSODESOSSICOLICO EG

Do not take ACIDO URSODESOSSICOLICO EG

• if you are allergic to ursodesoxycholic acid, bile acids or any of the other ingredients of this medicine (listed in section 6);
• if you have an acute inflammation of the gallbladder (cholecystitis) or the bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
• if you frequently suffer from pain in the upper abdomen (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from reduced motility of the gallbladder;
• if you are pregnant or breastfeeding;
• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase;
• if you have liver problems (obstructive jaundice, severe hepatopathy);
• if you have severe alterations of the pancreas or intestine that may alter the blood circulation of bile salts;

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, your doctor will prescribe blood tests to
check the functionality of your liver (checking of transaminases and alkaline phosphatase).
During the first 3 months of treatment with this medicine, your doctor will check your
liver function parameters every 4 weeks. Following this period, every 3 months. This
allows to evaluate your response to therapy (for primary biliary cirrhosis) and to diagnose
potential liver damage.
In the treatment of gallstones of the bile ducts, you will need to perform a visualization of the gallbladder
(oral cholecystography) via ultrasound, 6-10 months after the start of treatment, to assess the
improvement of your condition.
When this medicine is used for the treatment of advanced stage primary biliary cirrhosis, decompensation of hepatic cirrhosis has been observed very rarely, which has partially
regressed after discontinuation of treatment.
Consult your doctor if after starting treatment for primary biliary cirrhosis you experience an
increase in symptoms such as itching. In this case, the doctor will reduce the dose of ursodeoxycholic acid and then gradually increase it.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop
therapy.
This medicine should not be used for the treatment of all types of gallstones; those that
have a higher probability of dissolution are those not visible on X-rays
(radiotransparent) and of small size in a functioning gallbladder.

Children
ACIDO URSODESOSSICOLICO EG should not be used in children.

Other medicines and ACIDO URSODESOSSICOLICO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO EG together with the following medicines:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce its effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking ACIDO URSODESOSSICOLICO EG.
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check its concentration in the blood and adjust the dose;
• ciprofloxacin and dapsone, antibiotics used against infections;
• nitrendipine, a medicine used to lower blood pressure, in this case a dose increase may be necessary;
• estrogens and agents that lower cholesterol in the blood such as clofibrate, which can promote the formation of gallstones;
• medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipemic agents);
• medicines harmful to the liver (hepatotoxic).
• rosuvastatin, a medicine used to lower cholesterol in the blood

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary,
especially in the first trimester. Make sure you are not
pregnant before starting treatment.
Do not use this medicine if you are breastfeeding.
If you are of childbearing potential, you can only start treatment if you are using a reliable contraceptive method
(non-hormonal or low-estrogen oral contraceptives).
If you are undergoing therapy for dissolving gallstones, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallbladder stones.

Driving and using machines
This medicine does not alter or negligibly alters the ability to drive vehicles and operate
machinery.

3. How to take ACIDO URSODESOSSICOLICO EG

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.

Treatment of gallstones:the recommended daily dose is between 5-10 mg/kg (300 and
600 mg) per day, for a prolonged treatment.
Take the medicine during or after meals.
The duration of treatment must be at least 4-6 months, which can increase up to 9 or
even more, continuously, and must be continued for 3-4 months after the radiological or ultrasound disappearance
of the stones themselves. The treatment should not, however, exceed 2 years.

Treatment of dyspepsia and maintenance therapy:the recommended dose is 300 mg per
day.

If you take more ACIDO URSODESOSSICOLICO EG than you should
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodeoxycholic acid decreases with increasing
dose and is therefore more excreted with the feces.
In case of accidental ingestion of an excessive dose of this medicine, inform
your doctor immediately or go to the nearest hospital.

If you forget to take ACIDO URSODESOSSICOLICO EG
Do not take a double dose to make up for a missed dose. Take the next
dose at the scheduled time.
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.
The following side effects may occur:
The following have been commonly reported:

• soft stools or diarrhoea.

Occasionally, the following have been observed:

• intestinal irregularities, which generally disappear with continued treatment.

Very rarely, during the treatment of primary biliary cirrhosis the following have occurred:

• severe abdominal pain in the upper right quadrant;
• calcification of gallstones;
• serious liver problems (hepatic cirrhosis), which partially regress with discontinuation of therapy;
• 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:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store ACIDO URSODESOSSICOLICO EG

Keep this medicine out of sight and reach of children.
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 and to the product in intact packaging,
correctly stored.
Do not store at a temperature above 30°C.
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 EG contains
The active ingredient is ursodeoxycholic acid. Each hard capsule contains 300 mg of ursodeoxycholic acid.

• The other ingredients are: corn starch, precipitated silica, magnesium stearate.
• Capsule composition: gelatin, titanium dioxide (E171), yellow iron oxide (E172)

Description of the appearance of ACIDO URSODESOSSICOLICO EG and contents of the pack
Pack of 20 hard capsules of 300 mg

Marketing Authorisation Holder
EG S.p.A. – Via Pavia, 6 – 20136 MILANO, Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Strada Paduni 240, 03012 Anagni (FR) - Italy

URSODESOXYCHOLIC ACID EG 450 mg prolonged-release tablets

Generic Medicine
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 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 URSODESOXYCHOLIC ACID EG is and what it is used for
• 2. What you need to know before you take URSODESOXYCHOLIC ACID EG
• 3. How to take URSODESOXYCHOLIC ACID EG
• 4. Possible side effects
• 5. How to store URSODESOXYCHOLIC ACID EG
• 6. Contents of the pack and other information

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

ACIDO URSODESOSSICOLICO EG is a preparation based on bile acids naturally present
in the body, which is able to solubilize cholesterol in bile.
This medicine is used in adults to treat alterations in bile production by
the liver and to improve the solubility of cholesterol, both to prevent the formation of gallstones
and to facilitate their dissolution. This medicine is not effective against all types of gallstones, but
only against those not visible on X-rays (radiotransparent); in particular, cholesterol gallstones
in the gallbladder (functioning gallbladder) and gallstones in the bile duct.
It is also used to treat digestive problems due to gallbladder dysfunction
(biliary dyspepsia).

2. What you need to know before taking ACIDO URSODESOSSICOLICO EG

Do not take ACIDO URSODESOSSICOLICO EG

• if you are allergic to ursodeoxycholic acid, bile acids or any of the other ingredients of this medicine (listed in section 6);
• if you have an acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile duct or cystic duct);
• if you frequently suffer from upper abdominal pain (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from reduced motility of the gallbladder;
• if you are pregnant or breastfeeding;
• if you suffer from lesions of the stomach or intestine (gastric or duodenal ulcer) in an active phase;
• if you have liver problems (obstructive jaundice, severe hepatopathy);
• if you have severe alterations of the pancreas or intestine that may alter the blood circulation of bile salts.

Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, your doctor will prescribe blood tests to
check your liver function (checking transaminases and alkaline phosphatase).
During the first 3 months of treatment with this medicine, your doctor will check your
liver function parameters every 4 weeks. After this period, every 3 months. This
allows to evaluate your response to therapy (for primary biliary cirrhosis) and to diagnose
potential liver damage.
In the treatment of gallstones, you should undergo a visualization of the gallbladder
(oral cholecystography) via ultrasound, 6-10 months after the start of treatment, to assess the
improvement of your condition.
When this medicine is used for the treatment of advanced stage primary biliary cirrhosis, decompensation of hepatic cirrhosis has been observed very rarely, which has partially
regressed after discontinuation of treatment.
Consult your doctor if, after starting treatment for primary biliary cirrhosis, you experience an
increase in symptoms such as itching. In this case, the doctor will reduce the dose of ursodeoxycholic acid and then gradually increase it.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop
therapy.
This medicine should not be used to treat all types of gallstones; those that
have a higher probability of dissolution are those not visible on X-rays
(radiotransparent) and of small size in a functioning gallbladder.

Children
ACIDO URSODESOSSICOLICO EG should not be used in children.

Other medicines and ACIDO URSODESOSSICOLICO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO EG together with the following medicines:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because they reduce their effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking ACIDO URSODESOSSICOLICO EG.
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor will need to check its concentration in the blood and adjust the dose;
• ciprofloxacin and dapsone, antibiotics used against infections;
• nitrendipine, a medicine used to lower blood pressure, in this case an increase in the dose may be necessary;
• estrogens and agents that lower blood cholesterol such as clofibrate, which can promote the formation of gallstones;
• medicines that increase biliary cholesterol excretion (hormonal contraceptives, some hypolipemic agents);
• medicines harmful to the liver (hepatotoxic).
• rosuvastatin, a medicine used to lower blood cholesterol

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary,
especially during the first trimester. Before starting treatment, make sure you are not
pregnant.
Do not use this medicine if you are breastfeeding.
If you are of childbearing potential, you can only start treatment if you are using a reliable
contraceptive method (non-hormonal oral contraceptives or low-dose estrogen).
If you are undergoing therapy to dissolve gallstones, use a non-hormonal effective contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.

Driving and operating machinery
This medicine does not alter or negligibly alters the ability to drive vehicles and operate
machinery.

ACIDO URSODESOSSICOLICO EG contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take ACIDO URSODESOSSICOLICO EG

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The doctor will adjust the dosage based on your clinical condition and your tolerability to the
medicine.

Treatment of gallstones:the recommended daily dose is 450 mg per day, for a
prolonged treatment. In obese patients and those with stones larger than 2 cm in diameter, higher
dosages are used.
Take the medicine in a single dose in the evening, before bedtime.
The duration of treatment should be at least 4-6 months, which may increase up to 9 or
even more, continuously, and must be continued for 3-4 months after the radiological or
ultrasonic disappearance of the stones themselves. The treatment should not, however, exceed 2 years.

Treatment of dyspepsia and maintenance therapy:lower doses are sufficient, which the
doctor may increase based on the tolerability of the medicine.

If you take more ACIDO URSODESOSSICOLICO EG than you should
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely because the absorption of ursodesoxycholic acid decreases with increasing
dose and therefore is more excreted with the feces.
In case of accidental ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take ACIDO URSODESOSSICOLICO EG
Do not take a double dose to make up for a missed dose. Take the next
dose at the scheduled time.
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.
The following side effects may occur:
The following have been commonly reported:

• soft stools or diarrhoea.

Occasionally, the following have been observed:

• intestinal irregularities, which generally disappear with continued treatment.

Very rarely, during the treatment of primary biliary cirrhosis the following have occurred:

• severe abdominal pain in the upper right quadrant;
• calcification of bile stones;
• serious liver problems (liver cirrhosis), which partially regress with discontinuation of therapy;
• 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:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store ACIDO URSODESOSSICOLICO EG

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 packaging after “Scad”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at room temperature.
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 EG contains

• The active ingredient is ursodeoxycholic acid. Each tablet contains 450 mg of ursodeoxycholic acid.
• The other ingredients are: microcrystalline cellulose, methylcellulose, lactose, povidone, polyethylene glycol, talc, magnesium stearate, titanium dioxide.

Description of the appearance of ACIDO URSODESOSSICOLICO EG and contents of the pack
Pack of 20 prolonged-release tablets containing 450 mg.

Marketing Authorisation Holder
EG S.p.A. – Via Pavia, 6 – 20136 MILANO, Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Strada Paduni 240, 03012 Anagni (FR) - Italy