Ursilon

Patient Information Leaflet: Information for the User

Ursilon 150 mg hard capsules, 300 mg hard capsules, 150 mg granules for oral suspension in sachet, 300 mg granules for oral suspension in sachet

Ursodeoxycholic acid
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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ursilon is and what it is used for

Ursilon contains the active substance ursodeoxycholic acid and is indicated for the treatment of:

• Cholesterol gallstones (cholesterol stones present in bile, a fluid produced by the liver that aids digestion) in adults;
• Chronic cholestatic liver disease (long-term liver disease characterized by reduced or blocked bile flow), such as cholestasis associated with cystic fibrosis and familial intrahepatic cholestasis in children aged 6 years and older;
• Biliary dyspepsia (digestive problems due to impaired gallbladder function) in adults.

2. What you need to know before taking Ursilon

Do not take Ursilon

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute inflammation of the gallbladder or bile ducts (gallbladder or biliary tract)
• if you have a blockage of the bile ducts
• if you frequently experience abdominal cramps in the upper abdomen (biliary colic)
• if you have gallstones visible on X-rays
• if you have impaired contractility of the gallbladder
• if you have a lesion in the stomach or first part of the intestine wall (active gastric or duodenal ulcer)
• if you are hypersensitive to bile acids

Warnings and precautions
Talk to your doctor or pharmacist before taking Ursilon. Take Ursilon only under medical supervision.
When Ursilon is used for the treatment of cholesterol gallstones
To monitor therapeutic progress, your doctor will prescribe diagnostic tests 6–10 months after starting treatment.
During the first three months of treatment, your doctor will prescribe laboratory tests every 4 weeks to assess liver function, and thereafter every 3 months. Additionally, to evaluate treatment effectiveness, your doctor will prescribe diagnostic tests every 6 months (see "How to take Ursilon").
If you are a woman of childbearing age and are taking Ursilon to dissolve gallstones, you must use an effective non-hormonal method of contraception, as hormonal methods may promote gallstone formation (see "Other medicines and Ursilon" and "Fertility, pregnancy and breastfeeding").
When Ursilon is used for the treatment of advanced stages of primary biliary cirrhosis
(chronic liver inflammation)
At the beginning of treatment, itching may increase; in this case, your doctor will reduce the dose to 300 mg per day and prescribe a gradual dose increase.
If diarrhea develops, your doctor will reduce the dose; if diarrhea persists, treatment will be discontinued.

Other medicines and Ursilon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ursilon must not be taken at the same time as:

• medicines that reduce blood lipids (cholestyramine, colestipol)
• medicines that reduce stomach acidity (antacids containing aluminium hydroxide and/or aluminium oxide)

If you need to take any of these medicines, take them at least 2 hours before or after Ursilon.
Ursilon may alter the intestinal absorption of certain antibiotics (ciprofloxacin, cyclosporine).
Ursilon may reduce the effect of certain medicines such as:

• dapsone (an antibiotic)
• nitrendipine (a medicine used to control high blood pressure)

Medicines that may reduce the effect of Ursilon:

• female sex hormones (estrogens), see "Warnings and precautions" and "Fertility, pregnancy and breastfeeding"
• medicines that reduce blood lipids (clofibrate).

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will prescribe Ursilon only if clearly necessary.
Breastfeeding
Available data are limited.
If you are breastfeeding, your doctor will prescribe Ursilon only if clearly necessary.
Fertility
If you are of childbearing age and your doctor has prescribed this medicine to dissolve gallstones, you must use an effective non-hormonal contraceptive method or one containing low-dose estrogens (female hormones).

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

3. How to take Ursilon

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Cholesterol gallstones
Adults
The recommended daily dose ranges between 300 and 600 mg per day (5-10 mg/kg), taken after or
during meals and in the evening.
To promote dissolution of existing stones, treatment should last at least 4-6 months, up to 12 months or longer, without interruption, and should continue for 3-4 months after disappearance of the stones. However, treatment must not exceed 2 years.
Dosage may be adjusted at the discretion of the physician, who will prescribe radiographic,
ultrasonographic, and laboratory tests to monitor treatment efficacy (see "Warnings and
precautions").
For maintenance therapy, a daily dose of 300 mg, divided into two administrations, is sufficient.
Cholestasis associated with cystic fibrosis
Children aged 6 years and older
The recommended dose is 20 mg/kg per day, divided into two to three doses, with a possible increase to
30 mg/kg per day, if necessary.
Biliary dyspepsia
Adults
The recommended dose is 300 mg per day, divided into two administrations.
Method of administration
Ursilon 150 mg and 300 mg granules for oral suspension in sachets
Dissolve the contents of the sachet in half a glass of water.
If you take more Ursilon than you should
In case of accidental ingestion/overdose of Ursilon, contact your doctor immediately or go to the nearest hospital.
If you take more Ursilon than you should, you may experience diarrhoea.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take Ursilon
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ursilon
If you have any doubts about how to use 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.
Common (may affect 1 in 10 people)
soft stools and diarrhoea
Very rare (may affect 1 in 10,000 people)

• severe pain in the upper right side of the abdomen*
• calcification of stones
• worsening of primary biliary cirrhosis, which partially regressed after discontinuation of treatment
• urticaria Rare (may affect fewer than 1 in 1,000 people)
• bowel irregularity (alterations in intestinal function that may present as alternating diarrhoea and constipation, and increased or decreased frequency of bowel movements)** *: observed during treatment of primary biliary cirrhosis; **: this effect tends to disappear during treatment.

Reporting of side effects
If you experience any side effects, 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 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 Ursilon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
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.
Ursilon hard capsules: store below 30°C.

6. Package contents and other information

What Ursilon contains
Ursilon 150 mg hard capsules
The active substance is: ursodeoxycholic acid 150 mg
Other components: talc (E553b), sodium carboxymethylamide, anhydrous colloidal silica, hydrated silica, maize starch, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide (E171).

Ursilon 300 mg hard capsules
The active substance is: ursodeoxycholic acid 300 mg
Other components: talc (E553b), sodium carboxymethylamide, anhydrous colloidal silica, hydrated silica, maize starch, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide (E171), erythrosine (E127).

Ursilon 150 mg oral suspension granules in sachets
The active substance is: ursodeoxycholic acid 150 mg
Other components: methacrylic acid-ethyl acrylate copolymer (1:1), triacetin (E1518), talc (E553b), mannitol (E421), citric acid monohydrate (E330), sodium saccharin (E954), maize starch, microcrystalline cellulose (E460), cream flavor, sodium lauryl sulfate.

Ursilon 300 mg oral suspension granules in sachets
The active substance is: ursodeoxycholic acid 300 mg
Other components: methacrylic acid-ethyl acrylate copolymer (1:1), triacetin (E1518), talc (E553b), mannitol (E421), citric acid monohydrate (E330), sodium saccharin (E954), maize starch, microcrystalline cellulose (E460), cream flavor, sodium lauryl sulfate.

Description of the appearance of Ursilon and contents of the pack
Hard capsules for oral use
20 hard capsules of 150 mg
20 hard capsules of 300 mg

Oral suspension granules in sachets
20 sachets of 150 mg
20 sachets of 300 mg

Marketing Authorization Holder
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT)
e-mail: [email protected]

Manufacturer of Ursilon hard capsules
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Via Fossignano, 2 – 04011 Aprilia (LT)

Manufacturer of Ursilon oral suspension granules in sachets
Special Product's Line S.p.A.
Via Fratta Rotonda, Vado Largo 1
03012 Anagni (FR)

Package leaflet: information for the user

Ursilon Retard 450 mg prolonged-release hard capsules, Retard 225 mg prolonged-release hard capsules

Ursodeoxycholic Acid
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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ursilon Retard is and what it is used for

• Ursilon Retard contains the active substance ursodeoxycholic acid and is used for qualitative or quantitative alterations in bile production, including forms due to excess cholesterol.
• It promotes the dissolution of gallstones, particularly those located in the bile-containing sac (gallbladder), in the bile duct, and those present after biliary tract surgery.
• It is used in biliary tract dysfunction (biliary dyspepsia).

2. What you should know before taking Ursilon Retard

Do not take Ursilon Retard

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute inflammation of the gallbladder or bile ducts
• if you have a blockage of the bile ducts
• if you frequently suffer from cramps in the upper abdomen (biliary colic)
• if you have gallstones visible on X-rays
• if you have impaired contractility of the gallbladder
• if you have a lesion in the wall of the stomach or the first part of the intestine (active gastric or duodenal ulcer)
• if you have hypersensitivity to bile acids

Warnings and precautions
Talk to your doctor or pharmacist before taking Ursilon Retard. Take Ursilon Retard only under medical supervision.
During the first three months of treatment, your doctor will monitor your liver function with blood tests every 4 weeks; thereafter, every 3 months.

When Ursilon Retard is used for the treatment of cholesterol gallstones:
Ursilon Retard must not be used to dissolve cholesterol stones:

• if the gallbladder is not visible on X-rays
• if you have calcified stones due to calcium accumulation (calcification of stones)
• if you have impaired contractility of the gallbladder
• if you frequently suffer from cramps in the upper abdomen (biliary colic)

Women taking Ursilon Retard to dissolve gallstones must use an effective non-hormonal method of contraception, since hormonal contraceptives may promote the formation of gallstones (lithiasis).

When Ursilon Retard is used for the treatment of advanced stages of chronic liver bile duct inflammation (primary biliary cirrhosis):
In very rare cases, worsening of primary biliary cirrhosis has been observed, which partially improved after discontinuation of treatment.
In patients with primary biliary cirrhosis, symptoms may rarely worsen at the beginning of treatment; for example, itching may increase. In such cases, the doctor will decide whether to reduce the initial dose of Ursilon Retard.
If you develop diarrhea, the dose should be reduced; if diarrhea persists, treatment must be suspended.

Other medicines and Ursilon Retard
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ursilon Retard must not be taken at the same time as:

• medicines that reduce blood lipids (cholestyramine, colestipol)
• medicines that reduce stomach acidity (antacids containing aluminium hydroxide and/or aluminium oxide). If you need to take any of these medicines, take them at least 2 hours before or after Ursilon Retard.

Ursilon may alter the intestinal absorption of certain antibiotics (ciprofloxacin, cyclosporine).
Ursilon may reduce the effect of certain medicines such as:

• dapsone (an antibiotic)
• nitrendipine (a medicine used to control high blood pressure)

Medicines that may reduce the effect of Ursilon Retard:

• female sex hormones (estrogens)
• lipid-lowering medicines (clofibrate)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Ursilon Retard during pregnancy unless your doctor considers it necessary.
Before starting treatment, pregnancy must be ruled out. If you are of childbearing age and your doctor has prescribed this medicine, you must take adequate contraceptive precautions; the use of non-hormonal contraceptives or low-dose oral contraceptives (containing low levels of estrogens) is recommended.
There are no data indicating that this medicine passes into breast milk; however, if you are breastfeeding, it is advisable not to take this medicine.

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

3. How to take Ursilon Retard

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

• 450 mg per day, i.e. one capsule of Ursilon Retard 450
• 675 mg, i.e. three capsules of 225 mg or one 450 mg capsule plus one 225 mg capsule, in obese patients or in patients who have other risk factors for gallstone formation
• 225 mg per day, i.e. one capsule of Ursilon Retard 225 per day, as maintenance therapy and for the treatment of biliary tract dysfunction (biliary dyspepsia). The duration of treatment should be 4–6 months and may last up to 9 months or longer.

Take Ursilon Retard 450 or Ursilon Retard 225 in the evening before going to bed. Swallow the capsules
without chewing.
If you take more Ursilon Retard than you should
In case of accidental ingestion/overdose of Ursilon Retard, contact your doctor immediately or go to the nearest hospital.
If you take more Ursilon Retard than prescribed, you may experience diarrhoea.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take Ursilon Retard
Do not take a double dose to make up for the missed dose.
If you stop treatment with Ursilon Retard
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Common (may affect up to 1 in 10 people):

• loose stools or diarrhoea

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

• severe pain in the upper abdomen
• hardening of gallstones due to calcium accumulation (calcification of gallstones)
• worsening of chronic inflammation of the liver's bile ducts (primary biliary cirrhosis)
• 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 Ursilon Retard

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.
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.
Store below 30°C.

6. Package contents and other information

What Ursilon Retard contains
Active substance:
Ursilon Retard 450 mg: ursodeoxycholic acid 450 mg
Ursilon Retard 225 mg: ursodeoxycholic acid 225 mg
Other components:
Xanthan gum, barium sulfate, microcrystalline cellulose, cross-linked polyvinylpyrrolidone,
hydroxypropylmethylcellulose, carbomer, triacetin, eudragit L100, talc.
225 mg hard capsule: gelatin, titanium dioxide, yellow iron oxide, indigotine.
450 mg hard capsule: gelatin, titanium dioxide, red iron oxide, black iron oxide, erythrosine.
Description of the appearance of Ursilon Retard and contents of the pack
Prolonged-release hard capsules
20 capsules of 450 mg
20 capsules of 225 mg
Marketing Authorization Holder and Manufacturer
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
via Fossignano, 2 – 04011 Aprilia (LT)
Manufacturer
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
via Fossignano 2 Aprilia (Lt) – 04011 (LT)