URDES 150 mg Tablets

Зміст інструкції

1. What is Urdès and what is it 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. Package Contents and Other Information
7. What is Urdès and what is it used for
8. What you need to know before taking Urdès
9. How to take Urdès
10. Possible side effects
11. How to store Urdès
12. Contents of the pack and other information

Urdès 150 mg tablets
Urdès 300 mg tablets
Ursodeoxycholic acid

Generic 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, pharmacist or nurse.
• 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 you get any side effects, even 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 you take 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 is Urdès and what is it used for

Urdès 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 if gallstones are already present that are radiotransparent (not visible on X-rays); in particular, cholesterol stones in the gallbladder (functioning gallbladder) and stones 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 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 duct or cystic duct);
• if you frequently suffer from upper abdominal pain (biliary colic);
• if you have calcified gallstones visible on X-ray;
• 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 (severe hepatopathies) or kidney problems;
• if you have a yellowish discoloration of the skin (obstructive jaundice);
• if you have severe alterations of the pancreas or intestine that may alter the circulation of bile salts;
• if the person who is to take this medicine is a child

Warnings and precautions
Consult your doctor, pharmacist or nurse 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 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 you to assess your response to therapy (in particular for advanced 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.
Consult your doctor if, after starting treatment for primary biliary cirrhosis, you experience an increase in symptoms such as itching. In this case, the dose of ursodeoxycholic acid should be reduced to 225 mg once a day and then gradually increased (see section 3). Your doctor will tell you which other formulations available on the market are suitable for this dose.
When used for the treatment of advanced primary biliary cirrhosis, in very rare cases, decompensation of hepatic cirrhosis has been observed, which has partially regressed after discontinuation of treatment.
If you have problems with diarrhea, consult your doctor, who may decide to reduce the dose or stop therapy.
If you suffer from frequent biliary colic, bile infections, or severe alterations of the pancreas or intestine that may alter the circulation of bile salts, it is advisable to avoid using Urdès.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher probability of dissolution are those that are not visible on X-ray (radiotransparent) and of small size in a functioning gallbladder.

Other medicines and Urdès
Tell 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), because they reduce its effectiveness. If the use of such medicines is necessary, they must be taken 2 hours before or after taking Urdès.
• cyclosporine, a medicine that reduces the activity of the immune system. In this case, the doctor must adjust the dose;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure, in which case a dose increase may be necessary;
• estrogens, hormonal contraceptives and agents that lower blood cholesterol such as clofibrate, which may promote the formation of gallstones;
• medicines that increase biliary excretion of cholesterol (hormonal contraceptives, some hypolipemic agents);
• medicines harmful to the liver (hepatotoxic). Tell your doctor if you are taking rosuvastatin, a medicine used to lower blood cholesterol, because they may increase rosuvastatin levels in the blood.

Pregnancy, breastfeeding and fertility
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. Make sure you are not pregnant before starting treatment.
If you are breastfeeding, take this medicine under medical supervision.
If you are of childbearing potential, you can only start treatment if you are using a reliable non-hormonal contraceptive method (non-hormonal oral contraceptives or low-dose estrogen).
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 operating machinery
This medicine does not or mildly impairs the ability to drive vehicles and operate machinery.

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

3. How to take Urdès

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

Treatment of gallstones:to prevent the formation 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 and in the evening.
The duration of treatment should be at least 4-6 months, which may increase up 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, however, exceed 2 years.

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

Use in children
The use of this medicine in children is not recommended.

If you take more Urdès 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
therefore is more excreted with the feces.
Treatment of overdose involves rehydration and electrolyte replacement. In case of
intoxication, administer cholestyramine, as it is capable of chelating bile acids.
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 Urdès
Do not take a double dose to make up for a 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, 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)

• severe abdominal pain in the upper right portion;
• calcification of gallstones;
• serious liver problems (decompensation of hepatic cirrhosis), which partially regresses with discontinuation of therapy;
• urticaria.

Occasionally, intestinal irregularity has been reported, which generally disappears with continued
treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 Urdès

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 this medicine at room temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
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 ingredient is ursodeoxycholic acid. Each tablet contains 150 mg of ursodeoxycholic acid.
• The other ingredients are: lactose, microcrystalline cellulose, starch, magnesium stearate.

Urdès 300 mg oral tablets

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

Description of the appearance of Urdès and package contents
Packs containing blisters, of 20 tablets of 150 mg.
Packs containing blisters, of 20 tablets of 300 mg.

Marketing Authorisation 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)

Urdès 225 mg gastro-resistant tablets
Urdès 450 mg gastro-resistant tablets
Ursodeoxycholic acid

Generic 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, 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 could be harmful.
• If you get any side effects, even 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 you take Urdès
• 3. How to take Urdès
• 4. Possible side effects
• 5. How to store Urdès
• 6. Package Contents and Other Information

1. What is Urdès and what is it used for

Urdès 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 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 if they are already present as radiolucent stones (not visible on X-rays); in particular, cholesterol stones in the gallbladder (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 Urdès

Do not take Urdès

• 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 pain in the upper abdomen (biliary colic);
• if you have calcified gallstones visible on X-rays;
• if you suffer from poor gallbladder function (reduced gallbladder motility);
• if you are pregnant;
• if you suffer from stomach or intestinal diseases (gastric or duodenal ulcer) in an active phase;

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine.
Treatment with this medicine must occur under strict medical supervision.
Before starting treatment, your doctor will check your liver function tests, namely
transaminases (AST or SGOT and ALT or SGPT) and alkaline phosphatase.
When you are prescribed Deursil to dissolve cholesterol gallstones, you will also be prescribed
gallbladder and bile duct checks (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, every 3 months. This allows to
assess your response to therapy (in particular for advanced primary biliary cirrhosis) and to
diagnose potential liver damage.
If you are of childbearing potential, your doctor will indicate an effective non-hormonal contraceptive method before
prescribing Urdès.
Talk to your doctor if, after starting treatment for advanced primary biliary cirrhosis, you experience
an increase in symptoms such as itching. In this case, the dose of ursodeoxycholic acid must be
reduced to 225 mg once a day and then gradually increased (see section 3).
When used for the treatment of advanced primary biliary cirrhosis, decompensation of hepatic cirrhosis has been observed in very rare cases, which has partially regressed after discontinuation of
treatment.
If you have problems with diarrhea, talk to your doctor, who may decide to reduce the dose or stop therapy.
If you suffer from frequent biliary colic, biliary infections, or severe alterations to the pancreas or intestine that
can alter the blood circulation of bile salts, it is advisable to avoid using Urdès.
This medicine is not suitable for the treatment of all types of gallstones; those that have a higher
probability of dissolution are those that are not visible on X-rays (radiotransparent) and are small in
a functioning gallbladder.

Other medicines and Urdès
Tell 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), because they reduce their effectiveness;
• cyclosporine, a medicine that reduces the activity of the immune system;
• ciprofloxacin and dapsone, antibiotics used against infections;
• nitrendipine, a medicine used to lower blood pressure;
• some drugs that reduce cholesterol levels in the blood (such as clofibrate), estrogens and oral contraceptives;
• medicines that can be harmful to the liver (potentially hepatotoxic);
• rosuvastatin, a medicine used to lower cholesterol levels in the blood

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Fertility and pregnancy
Do not use this medicine during pregnancy unless absolutely necessary, especially in
the first trimester.
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 oral contraceptives or low-dose estrogen).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, as
hormonal oral contraceptives may increase the formation of gallstones.
Studies conducted on animals have not shown any influence of ursodeoxycholic acid on fertility.
There is no adequate data regarding the effects on fertility in humans after treatment
with ursodeoxycholic acid.
Breastfeeding
Levels of ursodeoxycholic acid in breast milk are very low and should not cause adverse effects
in the infant.
If you are breastfeeding, ask your doctor for advice before taking the medicine.

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

Urdès 225 mg contains 11.61 mg of sodium(the main component of table salt) per tablet.
This is equivalent to 0.58% of the recommended daily intake with the diet of an adult.

Urdès 450 mg contains 23.22 mg ofsodium (the main component of table salt) per tablet.
This is equivalent to 1.16% of the recommended daily intake with the diet of an adult.

3. How to take Urdès

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your 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.
In obese patients or in the presence of other important factors that favor the formation of gallstones, it is
advisable to increase the daily dose to 675 mg.
The duration of treatment should be at least 4-6 months, which may increase up to 24,
continuously, and must be continued for 3-4 months after the disappearance of the gallstones themselves, verified by
radiographic or ultrasound examinations. The treatment should not, however, 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
The use of this medicine in children is not recommended.

If you take more Urdès 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 in the feces.
Treatment of overdose involves rehydration and electrolyte replacement. In case of
intoxication, administer cholestyramine, as it is capable of chelating bile acids.
If you accidentally ingest an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take Urdès
Do not take a double dose to make up for a 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 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)

• severe pain in the upper right abdomen;
• irregular bowel movements (frequency and quality of evacuation);
• worsening of liver conditions in case of hepatic cirrhosis (a serious liver disease);
• skin rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 Urdès

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 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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Urdès contains
Urdès 225 mg gastro-resistant tablets for oral use

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

Urdès 450 mg gastro-resistant tablets for oral use

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

Description of the appearance of Urdès and content of the pack
Packs containing blisters, of 20 gastro-resistant tablets of 225 mg.
Packs containing blisters, of 20 gastro-resistant tablets of 450 mg.

Marketing Authorisation 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)