ACIDO 300 mg Hard Capsule

Зміст інструкції

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

ACIDO URSODESOSSICOLICO DOC Generici 300 mg hard capsules

Ursodesoxycholic acid

Generic Equivalent Medicine
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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ACIDO URSODESOSSICOLICO DOC Generici and what is it used for

ACIDO URSODESOSSICOLICO DOC Generici is a preparation based on bile acids naturally present
in the body, which is able to solubilize cholesterol in bile.
This medicine is used to treat alterations in the production of bile 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 stones in the gallbladder (in a functioning
gallbladder) and stones in the bile duct.
It is also used to treat digestive problems due to dysfunction of the gallbladder (biliary dyspepsia).

2. What you need to know before taking ACIDO URSODESOSSICOLICO DOC Generici

Do not take ACIDO URSODESOSSICOLICO DOC Generici

• if you are allergic (hypersensitive) 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 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting long-term therapy, check your liver function (transaminase and alkaline phosphatase levels). 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.
In the treatment of gallstones, you should undergo an overall visualization of the gallbladder (oral cholecystography) and a visualization of the occluded ducts in the supine and upright position (ultrasound control), 6-10 months after the start of treatment, to assess the improvement of your condition and detect any calcification of the gallbladder in time.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or discontinue therapy.

Other medicines and ACIDO URSODESOSSICOLICO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking ACIDO URSODESOSSICOLICO DOC Generici together with the following medicines because they can affect or be affected by treatment with ursodesoxycholic acid:

• bile acid sequestrants, used to lower cholesterol levels such as cholestyramine and colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide). If the use of such medicines is necessary, they must be taken 2 hours before or after taking ACIDO URSODESOSSICOLICO DOC Generici.
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor must check the concentration of cyclosporine in the blood and adjust the dose, if necessary;
• ciprofloxacin and dapsone, antibiotics used to treat 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, because they can promote the formation of gallstones;
• medicines harmful to the liver (hepatotoxic);
• rosuvastatin, a medicine used to lower blood cholesterol, because levels of rosuvastatin in the blood may increase.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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. Before starting treatment, make sure you are not pregnant.
If you are of childbearing potential, you can only start treatment if you are using a safe contraceptive method (non-hormonal or oral contraceptives with a low estrogen content).
If you are undergoing therapy to dissolve gallstones, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the formation of gallstones.

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

3. How to take ACIDO URSODESOSSICOLICO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Treatment of gallstones:to prevent the formation of stones, the recommended daily dose is
between 5-10 mg/kg (in most cases it is between 300 and 600 mg, equivalent to 1-2 capsules
per day) per day, for a prolonged treatment.
Take the medicine during or after meals and in the evening.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment must be
at least 4-6 months, which may increase to 12 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
exceed 2 years.

Treatment of dyspepsia and maintenance therapy:the recommended dose is 300 mg per day,
also divided into 2-3 administrations.

Use in children
The use of the medicine in children is not foreseen.

If you take more ACIDO URSODESOSSICOLICO DOC Generici than you should
In case of accidental ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.
In case of overdose, diarrhea may occur. In general, other symptoms of overdose are
unlikely as the absorption of ursodeoxycholic acid decreases with increasing dose and
therefore more is excreted in the stool.
Treatment of overdose involves rehydration and electrolyte replacement.
In case of accidental ingestion of ursodeoxycholic acid in highly superior doses, it is suggested to
administer cholestyramine, as it is capable of chelating bile acids.

If you forget to take ACIDO URSODESOSSICOLICO DOC Generici
Do not take a double dose to compensate for the 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:

Very common(may affect more than 1 in 10 people)

• soft stools or diarrhoea.

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

• calcification of bile stones;
• 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 the Website: http://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 DOC Generici

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 package and on the blister after
“Expiry”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular 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 ACIDO URSODESOSSICOLICO DOC Generici contains
ACIDO URSODESOSSICOLICO DOC Generici 300 mg hard capsules

• The active ingredient is ursodeoxycholic acid. Each hard capsule contains 300 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: starch; magnesium stearate; colloidal silicon dioxide.
• Capsule components: gelatin; titanium dioxide.

Description of the appearance of ACIDO URSODESOSSICOLICO DOC Generici and pack contents
Pack of 20 hard capsules.

Marketing Authorisation Holder
DOC Generici Srl – Via Turati 40 - 20121 MILAN, Italy

Manufacturer
ABC Farmaceutici S.p.A. – via Cantone Moretti 29 (località San Bernardo) - 10090 Ivrea (TO) - Italy

ACIDO URSODESOSSICOLICO DOC Generici 450 mg modified-release hard capsules

Ursodeoxycholic acid

Generic Equivalent Medicine
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 their symptoms are the same as yours, as it could 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 DOC Generici is and what it is used for
• 2. What you need to know before you take ACIDO URSODESOSSICOLICO DOC Generici
• 3. How to take ACIDO URSODESOSSICOLICO DOC Generici
• 4. Possible side effects
• 5. How to store ACIDO URSODESOSSICOLICO DOC Generici
• 6. Contents of the pack and other information

1. What is ACIDO URSODESOSSICOLICO DOC Generici and what is it used for

ACIDO URSODESOSSICOLICO DOC Generici is a preparation based on bile acids naturally present
in the body, which is able to solubilize cholesterol in bile.
This medicine is used to treat alterations in the production of bile 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 (in a 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 DOC Generici

Do not take ACIDO URSODESOSSICOLICO DOC Generici

• if you are allergic (hypersensitive) to ursodesoxycholic acid, bile acids or any of the 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 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;

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, 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.
In the treatment of gallstones, you should perform an overview of the gallbladder
(oral cholecystography) and a visualization of the obstructed ducts in the supine and upright position (control with
ultrasound), 6-10 months after the start of treatment, to assess the improvement of your condition and
detect any calcification of the gallbladder in time.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.

Other medicines and ACIDO URSODESOSSICOLICO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Avoid taking ACIDO URSODESOSSICOLICO DOC Generici together with the following medicines because
they can influence or be influenced by treatment with ursodesoxycholic acid

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

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. Before starting the
treatment, make sure you are not pregnant.
If you are of childbearing potential, you can only start treatment if you are using a safe contraceptive method
(non-hormonal or oral contraceptives with a low estrogen content).
If you are undergoing therapy to dissolve gallstones, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.

Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.

3. How to take ACIDO URSODESOSSICOLICO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Treatment of gallstones:to prevent the formation of stones, 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, up to 675 mg.
Take the medicine in a single dose in the evening, before bedtime.
To maintain the conditions suitable for dissolving existing stones, the duration of treatment must be
at least 4-6 months, which may increase 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
exceed 2 years.

Treatment of dyspepsia and maintenance therapy:lower doses, of 225 mg per day, are sufficient.

Use in children
The use of this medicine is not intended for children.

If you take more ACIDO URSODESOSSICOLICO DOC Generici than you should
In case of accidental ingestion of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
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
therefore more is excreted in the feces.
Treatment of overdose involves rehydration and mineral salt replacement. In case of accidental ingestion of ursodeoxycholic acid in highly superior doses, it is suggested to administer
cholestyramine, as it is capable of chelating bile acids.

If you forget to take ACIDO URSODESOSSICOLICO DOC Generici
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, ask 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:

Very common(may affect more than 1 in 10 people)

• soft stools or diarrhoea.

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

• calcification of gallstones;
• 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 the Website: http://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 DOC GENERICI

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Expiry”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACIDO URSODESOSSICOLICO DOC Generici 450 mg modified-release hard capsules contain

• The active ingredient is ursodeoxycholic acid. Each capsule contains 450 mg of ursodeoxycholic acid (UDCA).
• The other ingredients are: hydroxypropylcellulose; microcrystalline cellulose.
• Capsule components: gelatin; titanium dioxide.

Description of the appearance of ACIDO URSODESOSSICOLICO DOC Generici and contents of the pack
Pack of 20 modified-release hard capsules containing 450 mg.

Marketing Authorisation Holder
DOC Generici Srl - Via Turati 40 - 20121 Milano- Italy

Manufacturer
ABC Farmaceutici S.p.A. – via Cantone Moretti 29 (località San Bernardo) - 10090 Ivrea (TO) - Italy