Ursodeoxycholic acid EG

Package leaflet: information for the patient

URSODESOXYCHOLIC ACID EG 300 mg hard capsules

Generic medicine
Please read all of 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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 disorders in bile production by the liver and to improve cholesterol solubility, both to prevent gallstone formation and to facilitate the dissolution of existing stones. This medicine is not effective against all types of gallstones, but only against those not visible on X-rays (radiolucent stones); in particular, cholesterol stones in the gallbladder (with functioning gallbladder) and stones in the bile duct.
It is also used to treat digestive problems caused by gallbladder dysfunction (biliary dyspepsia).

2. What you should 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 acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common or cystic bile duct);
• if you frequently suffer from upper abdominal pain (biliary colic);
• if you have calcified gallstones visible on X-ray;
• if you have reduced gallbladder motility;
• if you are pregnant or breastfeeding;
• if you have active gastric or intestinal lesions (gastric or duodenal ulcer);
• if you have liver problems (obstructive jaundice, severe liver diseases);
• if you have severe pancreatic or intestinal disorders that may affect the circulation of bile salts;

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting long-term therapy, your doctor will prescribe blood tests to monitor your liver function (monitoring 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. After this period, checks will be performed every 3 months. This allows assessment of your response to therapy (in primary biliary cirrhosis) and early detection of potential liver damage.
When treating gallstones, an ultrasound imaging of the gallbladder (oral cholecystography) should be performed 6–10 months after starting treatment to evaluate improvement in your condition.
When this medicine is used to treat advanced-stage primary biliary cirrhosis, decompensation of liver cirrhosis has very rarely been observed, which partially resolved after discontinuation of treatment.
Contact your doctor if, after starting treatment for primary biliary cirrhosis, you experience worsening symptoms such as pruritus. In this case, your doctor will reduce the dose of ursodeoxycholic acid and then gradually increase it again.
If you experience diarrhea, contact your doctor, who may decide to reduce the dose or discontinue therapy.
This medicine should not be used to treat all types of gallstones; those most likely to dissolve are radiolucent (not visible on X-ray), small stones in a functioning gallbladder.

Children
ACIDO URSODESOSSICOLICO EG must not be used in children.

Other medicines and ACIDO URSODESOSSICOLICO EG
Inform 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 aluminium hydroxide and/or smectite (aluminium oxide), as they reduce its effectiveness. If use of these medicines is necessary, they should be taken 2 hours before or after ACIDO URSODESOSSICOLICO EG.
• cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must monitor its blood concentration and adjust the dose accordingly;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure, in which case a dose increase might be necessary;
• estrogens and cholesterol-lowering agents such as clofibrate, which may promote gallstone formation;
• drugs that increase biliary cholesterol excretion (hormonal contraceptives, some lipid-lowering agents);
• medicines that are harmful to the liver (hepatotoxic agents);
• rosuvastatin, a medicine used to lower blood cholesterol

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary, particularly during the first trimester. Before starting treatment, ensure you are not pregnant.
Do not use this medicine if you are breastfeeding.
If you are of childbearing age, you may only start treatment if you are using a reliable contraceptive method (non-hormonal contraceptives or low-estrogen hormonal contraceptives).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, since hormonal oral contraceptives may increase the risk of gallstone formation.

Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

3. How to take ACIDO URSODESOSSICOLICO EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to your clinical condition and your tolerance to the medicine.

Treatment of gallstones: The recommended daily dose ranges 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 should be at least 4–6 months, which may be extended up to 9 months or longer, continuously, and should be continued for 3–4 months after the radiological or ultrasonographic disappearance of the stones. However, treatment should not 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
Diarrhea may occur in case of overdose. Generally, other symptoms of overdose are unlikely, since the absorption of ursodeoxycholic acid decreases with increasing dose, and therefore more is excreted in the feces.
If you accidentally ingest 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 the missed dose. Take the next dose at the scheduled time.

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.
The following side effects may occur:
The following have been commonly reported:

• soft stools or diarrhoea.

Occasionally observed:

• intestinal disturbances, which generally resolve with continued treatment.

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

• severe pain in the upper right quadrant of the abdomen;
• calcification of gallstones;
• severe liver problems (hepatic cirrhosis), which partially improves upon discontinuation of therapy;
• urticaria.

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 the following website:
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 UDCA EG

Keep this medicine out of the sight and reach of children.
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 and to the product in its original packaging,
intact and properly stored.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ACIDO URSODESOSSICOLICO EG contains
The active substance is ursodeoxycholic acid. Each hard capsule contains 300 mg of ursodeoxycholic acid.

• The other components are: maize 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: 20 hard capsules of 300 mg
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 MILAN, Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A., Strada Paduni 240, 03012 Anagni (FR) - Italy

Patient Information Leaflet

URSEDEOXYCHOLIC ACID EG 450 mg prolonged-release tablets

Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 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

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

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

2. What you should 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 acute inflammation of the gallbladder (cholecystitis) or bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common or cystic bile duct);
• if you frequently suffer from upper abdominal pain (biliary colic);
• if you have calcified gallstones visible on X-ray;
• if you have reduced gallbladder motility;
• if you are pregnant or breastfeeding;
• if you have active lesions of the stomach or intestine (gastric or duodenal ulcer);
• if you have liver problems (obstructive jaundice, severe liver disease);
• if you have severe pancreatic or intestinal disorders that may alter the circulation of bile salts.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting long-term therapy, your doctor will prescribe blood tests to monitor your liver function (monitoring 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. After this period, checks will be performed every 3 months. This allows assessment of your response to therapy (in primary biliary cirrhosis) and detection of any potential liver damage.
When treating gallstones, an ultrasound imaging of the gallbladder (oral cholecystography) should be performed 6–10 months after starting treatment to evaluate improvement.
When this medicine is used to treat advanced-stage primary biliary cirrhosis, hepatic decompensation has very rarely been observed, which partially regressed after discontinuation of treatment.
Contact your doctor if, after starting treatment for primary biliary cirrhosis, you experience worsening symptoms such as pruritus. In this case, the doctor may reduce the dose of ursodeoxycholic acid and then gradually increase it again.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue therapy.
This medicine should not be used to treat all types of gallstones; those most likely to dissolve are non-calcified (radiolucent) stones of small size in a functioning gallbladder.

Children
ACIDO URSODESOSSICOLICO EG must not be used in children.

Other medicines and ACIDO URSODESOSSICOLICO EG
Inform 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), as they reduce its effectiveness. If use of these medicines is necessary, they should be taken at least 2 hours before or after ACIDO URSODESOSSICOLICO EG.
• cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must monitor its blood concentration and adjust the dose accordingly;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure; in this case, a dose increase may be required;
• estrogens and cholesterol-lowering agents such as clofibrate, which may promote gallstone formation;
• drugs that increase biliary cholesterol excretion (hormonal contraceptives, some lipid-lowering agents);
• medicines that are harmful to the liver (hepatotoxic);
• rosuvastatin, a medicine used to lower blood cholesterol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary, particularly during the first trimester. Confirm that you are not pregnant before starting treatment.
Do not use this medicine if you are breastfeeding.
If you are of childbearing age, you may only start treatment if you are using a reliable contraceptive method (non-hormonal oral contraceptives or low-estrogen hormonal contraceptives).
If you are undergoing treatment for gallstone dissolution, use an effective non-hormonal contraceptive, as hormonal oral contraceptives may increase the risk of gallstone formation.

Driving and using machines
This medicine does not affect, or has a negligible effect on, the ability to drive vehicles or operate machinery.

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

3. How to take URSODESOXYCHOLIC ACID EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dose according to your clinical condition and your tolerance to the medicine.

Treatment of gallstones: The recommended daily dose is 450 mg per day, for long-term treatment. In obese patients and in patients with stones larger than 2 cm in diameter, higher doses are used.
Take the medicine as a single dose in the evening, before going to bed.
The treatment duration should be at least 4–6 months, which may be extended up to 9 months or longer, continuously, and should continue for 3–4 months after radiological or ultrasonographic disappearance of the stones. However, treatment must not exceed 2 years.

Treatment of dyspepsia and maintenance therapy: Lower doses are sufficient; your doctor may increase the dose according to your tolerance to the medicine.

If you take more URSEDESOXYCHOLIC ACID EG than you should
Diarrhea may occur in case of overdose. Generally, other overdose symptoms are unlikely, as the absorption of ursodesoxycholic acid decreases with increasing dose, resulting in greater excretion in the feces.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take URSEDESOXYCHOLIC ACID EG
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

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.
The following side effects may occur:

Commonly reported are:

• soft stools or diarrhoea.

Occasionally observed are:

• intestinal disturbances, which usually resolve while continuing treatment.

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

• severe pain in the upper right quadrant of the abdomen;
• calcification of gallstones;
• serious liver problems (hepatic cirrhosis), which partially improves upon discontinuation of therapy;
• urticaria.

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:
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 URSODESOXYCHOLIC ACID EG

Keep this medicine out of the sight and reach of children.
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 and to the product in its original packaging,
intact and properly stored.
Store at room temperature.
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 EG contains

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

Description of the appearance of ACIDO URSODESOSSICOLICO EG and package contents
Box containing 20 prolonged-release tablets of 450 mg.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 MILAN, Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A., Strada Paduni 240, 03012 Anagni (FR) - Italy