Urdes

Package leaflet: Information for the patient

Urdès 150 mg tablets
Urdès 300 mg tablets
Ursodeoxycholic acid
Generic medicinal product
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Urdès is and what it is used for

Urdès is a preparation based on naturally occurring bile acids present in the body, capable of solubilizing cholesterol in bile.
This medicine is used 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 radiolucent stones (not visible on X-ray); in particular, cholesterol gallstones in a functioning gallbladder and gallstones in the bile duct.
It is also used to treat digestive problems caused by gallbladder dysfunction (biliary dyspepsia).

2. What you need to know before taking Urdès

Do not take Urdès

• if you are allergic to ursodeoxycholic acid, bile acids, or any of the 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 bile or cystic 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 gastrointestinal lesions (gastric or duodenal ulcer);
• if you have liver (severe hepatopathies) or kidney problems;
• if you have yellowish discoloration of the skin (obstructive jaundice);
• if you have severe pancreatic or intestinal disorders that may affect bile salt circulation;
• if the person to take this medicine is a child.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse 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 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 (particularly in advanced primary biliary cirrhosis) and helps diagnose any potential liver damage.
When treating gallstones, an ultrasound examination of the gallbladder (oral cholecystography) should be performed 6–10 months after starting treatment to evaluate improvement.
Contact your doctor if, after starting treatment for primary biliary cirrhosis, you experience worsening symptoms such as itching. In this case, the dosage of ursodeoxycholic acid should be reduced to 225 mg once daily and then gradually increased (see section 3). Your doctor will advise you on which other commercially available formulations are suitable for this dose.
When used to treat advanced-stage primary biliary cirrhosis, very rare cases of hepatic decompensation have been observed, which partially resolved after discontinuation of treatment.
If you experience diarrhea, consult your doctor, who may decide to reduce the dose or discontinue therapy.
If you suffer from frequent biliary colic, biliary infections, or severe pancreatic or intestinal disorders that may affect bile salt circulation, the use of Urdès should be avoided.
This medicine is not suitable for treating all types of gallstones; those most likely to dissolve are radiolucent (not visible on X-ray), small stones in a functioning gallbladder.

Other medicines and Urdès
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Urdès 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 2 hours before or after Urdès.
• cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must adjust the dose;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure; in this case, a dose increase may be needed;
• estrogens, hormonal contraceptives, 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). Inform your doctor if you are taking rosuvastatin, a medicine used to lower blood cholesterol, as levels of rosuvastatin in the blood may increase.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary. Before starting treatment, ensure you are not pregnant.
If you are breastfeeding, take this medicine only under medical supervision.
If you are of childbearing age, you may start treatment only if using a reliable contraceptive method (non-hormonal or low-estrogen hormonal contraceptives).
If you are undergoing therapy 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.

Urdès contains lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Urdès

Take this medicine exactly as directed by your doctor or pharmacist. 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: to prevent stone formation, the recommended daily dose is
between 5–10 mg/kg (300 and 600 mg) per day, for long-term treatment.
Take the medicine during or after meals, in the evening.
The treatment duration should be at least 4–6 months, which may extend up to 12 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: the recommended dose is 300 mg per day,
which may be divided into two daily doses.
Use in children
Use of this medicine is not recommended in children.
If you take more Urdès than you should
In case of overdose, diarrhea may occur. Generally, other symptoms of overdose are
unlikely because absorption of ursodeoxycholic acid decreases as the dose increases,
and therefore more is excreted in the feces.
Management of overdose includes rehydration and replacement of fluids and electrolytes. In case of
poisoning, administer cholestyramine, as it is capable of binding bile acids.
In the event 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 Urdès
Do not take a double dose to make up for the forgotten dose. Take the next dose at the scheduled time.
If you stop treatment with Urdès
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
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;
• calcification of gallstones;
• serious liver problems (decompensation of hepatic cirrhosis), which partially improves upon discontinuation of treatment;
• urticaria.

Occasionally, intestinal disturbances have been reported, which generally resolve while continuing treatment.
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: 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 Urdès

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 sealed packaging,
properly stored.
Store this medicine 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 Urdès contains
Urdès 150 mg oral tablets

• The active substance is ursodeoxycholic acid. Each tablet contains 150 mg of ursodeoxycholic acid.
• The other components are: lactose, microcrystalline cellulose, starch, magnesium stearate.

Urdès 300 mg oral tablets

• The active substance is ursodeoxycholic acid. Each tablet contains 300 mg of ursodeoxycholic acid.
• The other components are: lactose, microcrystalline cellulose, starch, magnesium stearate.

Description of the appearance of Urdès and pack contents
Packages containing blisters of 20 tablets of 150 mg.
Packages containing blisters of 20 tablets of 300 mg.
Marketing Authorization Holder
S.F. Group S.r.l – Via Tiburtina, 1143 – 00156 Rome
Manufacturers
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Follereau 25, 24027 Nembro (BG)
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)

Package leaflet: Information for the patient

Urdès 225 mg gastro-resistant tablets
Urdès 450 mg gastro-resistant tablets
Ursodesoxycholic acid
Generic medicine
Please read all of this leaflet carefully before you take 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Urdès is and what it is used for

Urdès is a preparation based on natural bile acids normally 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 radiolucent stones (not visible on X-ray) when already present; in particular, cholesterol stones in the gallbladder (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 need to know before taking Urdès

Do not take Urdès

• if you are allergic to ursodeoxycholic acid, bile acids, or any of the 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 impaired gallbladder function (reduced gallbladder motility);
• if you are pregnant;
• if you have active stomach or intestinal disorders (gastric or duodenal ulcer);

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting treatment, your doctor will perform liver function tests, namely transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When you are prescribed Deursil for dissolving cholesterol stones, you will also be scheduled for monitoring of the gallbladder and bile ducts (oral cholecystography and ultrasound).
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 (particularly in advanced primary biliary cirrhosis) and detection of potential liver damage.
If you are of childbearing age, your doctor will advise you to use an effective non-hormonal contraceptive method before prescribing Urdès.
Contact your doctor if, after starting treatment for advanced primary biliary cirrhosis, you experience worsening symptoms such as pruritus. In this case, the dose of ursodeoxycholic acid should be reduced to 225 mg once daily and then gradually increased (see section 3).
When used to treat advanced-stage primary biliary cirrhosis, hepatic decompensation has been observed very rarely, which partially regressed after discontinuation of treatment.
If you experience diarrhea, contact your doctor, who may decide to reduce the dose or discontinue therapy.
If you suffer from frequent biliary colic, biliary infections, or severe pancreatic or intestinal disorders that may affect the circulation of bile salts, it is advisable to avoid using Urdès.
This medicine is not suitable for treating all types of gallstones; those most likely to dissolve are radiolucent (not visible on X-ray), small stones in a functioning gallbladder.

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

• medicines that bind bile acids, 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;
• cyclosporine, a medicine that reduces the activity of the immune system;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure;
• certain medicines that reduce cholesterol levels in the blood (such as clofibrate), estrogens, and oral contraceptives;
• medicines that may be harmful to the liver (potentially hepatotoxic);
• rosuvastatin, a medicine used to lower cholesterol in the blood.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility and pregnancy
Do not use this medicine during pregnancy unless absolutely necessary, particularly during the first trimester.
Before starting treatment, ensure you are not pregnant.
If you are of childbearing age, you may only start treatment if you are using a reliable contraceptive method (non-hormonal or low-estrogen oral 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.
Animal studies have not shown any effect of ursodeoxycholic acid on fertility.
There are no adequate data available on effects on fertility in humans following treatment with ursodeoxycholic acid.
Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and are unlikely to cause adverse effects in the breastfed infant.
If you are breastfeeding, consult your doctor before taking this medicine.

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

Urdès 225 mg contains 11.61 mg of sodium (the main component of table salt) per tablet.
This corresponds to 0.58% of the maximum daily intake of sodium recommended in the adult diet.

Urdès 450 mg contains 23.22 mg of sodium (the main component of table salt) per tablet.
This corresponds to 1.16% of the maximum daily intake of sodium recommended in the adult diet.

3. How to take Urdès

Take this medicine exactly as directed by your doctor or pharmacist. 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
medicinal product.
Treatment of gallstones
The recommended daily dose is 450 mg per day.
In obese patients or in the presence of other significant factors favouring gallstone formation, it is
advisable to increase the daily dose to 675 mg.
The duration of treatment should be at least 4–6 months, which may be extended up to 24 months
continuously, and should be continued for 3–4 months after the disappearance of gallstones, as confirmed by
radiographic or ultrasound examinations. However, treatment must not exceed 2 years.
Take the medicine during meals and in a single administration.
Treatment of dyspepsia and maintenance therapy
The recommended dose is 225 mg per day.
Use in children
This medicine is not recommended for use in children.
If you take more Urdès than you should
In case of overdose, diarrhoea may occur.
Generally, other symptoms of overdose are unlikely, as the absorption of ursodeoxycholic acid
decreases with increasing dose and is therefore more extensively excreted in faeces.
Management of overdose includes replacement of fluids and electrolytes. In case of
poisoning, administer cholestyramine, as it is capable of chelating bile acids.
In the event 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 Urdès
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.
If you stop taking Urdès
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.
The following adverse reactions may occur:
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 abdomen;
• bowel disturbances (frequency and quality of bowel movements);
• worsening of liver condition in case of hepatic cirrhosis (a serious liver disease);
• skin rash (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 may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Urdès

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, unopened packaging,
properly stored.
This medicine does not require any special storage conditions.
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 Urdès contains
Urdès 225 mg gastro-resistant tablets for oral use

• The active substance is ursodeoxycholic acid. Each tablet contains 225 mg of ursodeoxycholic acid.
• The other components are: microcrystalline cellulose, magnesium stearate, sodium starch glycolate, precipitated silica, methacrylic acid copolymer, talc, triethyl citrate, titanium dioxide, polyvinylpyrrolidone.

Urdès 450 mg gastro-resistant tablets for oral use

• The active substance is ursodeoxycholic acid. Each tablet contains 450 mg of ursodeoxycholic acid.
• The other components are: microcrystalline cellulose, magnesium stearate, sodium starch glycolate, precipitated silica, methacrylic acid copolymer, talc, triethyl citrate, titanium dioxide, polyvinylpyrrolidone.

Description of the appearance of Urdès and package contents
Pack sizes containing blisters of 20 gastro-resistant 225 mg tablets.
Pack sizes containing blisters of 20 gastro-resistant 450 mg tablets.
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma
Manufacturers
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Follereau 25, 24027 Nembro (BG)
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)