URSILON 450 mg Extended-Release Hard Capsule

Зміст інструкції

1. Ursilon 150 mg hard capsules, 300 mg hard capsules, 150 mg oral suspension granules in sachets, 300 mg oral suspension granules in sachets
   1. What is Ursilon and what is it 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. Package Contents and Other Information
2. Ursilon Retard 450 mg prolonged-release hard capsules, Retard 225 mg prolonged-release hard capsules
   1. What is Ursilon Retard and what is it 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

Ursilon 150 mg hard capsules, 300 mg hard capsules, 150 mg oral suspension granules in sachets, 300 mg oral suspension granules in sachets

Ursodeoxycholic acid

Read this leaflet carefully before you start to take 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 may be harmful.
• If you get any side effects, even 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 you take 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 is Ursilon and what is it used for

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

• Cholesterol cholelithiasis (cholesterol stones present in the bile, a fluid produced by the liver that aids digestion) in adults;
• Chronic cholestatic liver disease (a long-term liver disease characterized by a reduction or blockage of 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 ingredient or any of the other ingredients of this medicine (listed in section 6)
• if you have an acute inflammation of the gallbladder or bile ducts
• if you have a blockage of the bile ducts
• if you have frequent cramps in the upper abdomen (biliary colic)
• if you have gallstones that are visible on X-rays
• if you have impaired contractility of the gallbladder
• if you have a lesion of the stomach wall or the first part of the intestine (active gastric or duodenal ulcer)
• if you have hypersensitivity to bile acids

Warnings and precautions
Consult your doctor or pharmacist before taking Ursilon. Take Ursilon only under the
supervision of your doctor.

When Ursilon is used for the treatment of cholesterol gallstones
To verify the therapeutic progress, 6-10 months after the start of treatment, your doctor will prescribe
diagnostic tests.
During the first three months of treatment, your doctor will prescribe laboratory tests to evaluate
liver function every 4 weeks and subsequently every 3 months. In addition, to verify
the effectiveness of the treatment, your doctor will prescribe diagnostic tests every 6 months (see “How to take
Ursilon”).
If you are a woman of childbearing potential and are taking Ursilon to dissolve gallstones, you should use an effective
method of contraception that is not hormone-based, as hormone-based methods may
promote the formation of gallstones (see “Other medicines and Ursilon” and “Fertility, pregnancy and
breastfeeding”).

When Ursilon is used for the treatment of advanced stages of primary biliary cirrhosis

(long-lasting 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 increase.
If diarrhea occurs, your doctor will reduce the dose; if it persists, therapy will be
discontinued.

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

• medicines that lower blood fats (cholestyramine, colestipol)
• medicines that reduce stomach acid (antacids containing aluminum hydroxide and/or aluminum oxide) If you need to take one of these medicines, take it at least 2 hours before or after Ursilon. Ursilon may alter the intestinal absorption of some antibiotics (ciprofloxacin, cyclosporine). Ursilon may decrease the effect of some medicines such as:
• dapsone (an antibiotic)
• nitrendipine (a medicine for controlling high blood pressure) Medicines that may decrease the effect of Ursilon:
• female sex hormones (estrogens), see “Warnings and precautions” and “Fertility, pregnancy and breastfeeding”)
• medicines that lower blood fats (clofibrate).

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will prescribe Ursilon only if absolutely necessary.
Breastfeeding
Limited data are available.
If you are breastfeeding, your doctor will prescribe Ursilon only if absolutely
necessary.
Fertility
If you are of childbearing potential and your doctor has prescribed this medicine to dissolve gallstones
you should use an effective non-hormonal or low-estrogen (female hormones) contraceptive method.

Driving and operating machinery
This medicine has no, or negligible influence on the ability to drive or operate
machinery.

3. How to take Ursilon

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

Cholesterinic calculus
Adults
The recommended daily dose is between 300 and 600 mg per day (5-10 mg/kg), after or
during meals and in the evening.
To promote the dissolution of existing stones, the duration of treatment must be at least
4-6 months, up to 12 or more months, without interruption and must continue for 3-4 months after the disappearance
of the stones. The treatment should not, however, exceed 2 years.
The doses may be modified at the doctor's discretion, who will prescribe radiological,
ultrasound and laboratory tests to verify the effectiveness of the treatment (see “Warnings and
precautions”).
For maintenance therapy, doses of 300 mg per day, divided into 2
administrations, are sufficient.

Cholestasis associated with cystic fibrosis
Children aged 6 years and over
The recommended dose is 20 mg/kg per day divided into two - three doses, with a further increase to
30 mg/kg per day, if necessary.

Biliary dyskinesia
Adults
The recommended dose is 300 mg per day, divided into 2 administrations.
Method of administration

Ursilon 150 mg and 300 mg granules for oral suspension in sachets
Dissolve the sachet in half a glass of water.

If you take more Ursilon than you should
In case of accidental ingestion/intake of an excessive dose of Ursilon, immediately notify
your doctor or go to the nearest hospital.
If you take more Ursilon than you should, you may experience diarrhea.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take Ursilon
Do not take a double dose to make up for a missed dose.

If you stop taking Ursilon
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.

Common(may affect up to 1 in 10 people)
soft stools and diarrhoea

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

• severe pain in the upper right side of the abdomen*
• calcification of the gallstones
• worsening of primary biliary cirrhosis, partially regressed after discontinuation of treatment
• urticaria Rare(may affect less than 1 in 1,000)
• irregular bowel movements (changes in intestinal function that may manifest with alternating diarrhoea and constipation and an increase or decrease in the frequency of bowel movements)** *: observed during the treatment of primary biliary cirrhosis; **: the effect tends to disappear during treatment.

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 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 which is stated on the pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 at a temperature below 30°C

6. Package Contents and Other Information

What Ursilon contains
Ursilon 150 mg hard capsules
The active ingredient is: ursodeoxycholic acid 150 mg
The other ingredients are: talc (E553b), sodium carboxymethylcellulose, anhydrous colloidal silica, hydrated silica,
corn starch, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide
(E171).

Ursilon 300 mg hard capsules
The active ingredient is: ursodeoxycholic acid 300 mg
The other ingredients are: talc (E553b), sodium carboxymethylcellulose, anhydrous colloidal silica, hydrated silica,
corn starch, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide
(E171) erythrosine (E127).

Ursilon 150 mg granules for oral suspension in sachets
The active ingredient is: ursodeoxycholic acid 150 mg
The other ingredients are: methacrylic acid-ethyl acrylate copolymer (1:1), triacetin (E1518), talc
(E553b), mannitol (E421), citric acid monohydrate (E330), sodium saccharin (E954), corn starch,
microcrystalline cellulose (E460), cream flavour, sodium lauryl sulfate.

Ursilon 300 mg granules for oral suspension in sachets
The active ingredient is: ursodeoxycholic acid 300 mg
The other ingredients are: methacrylic acid-ethyl acrylate copolymer (1:1), triacetin (E1518), talc
(E553b), mannitol (E421), citric acid monohydrate (E330), sodium saccharin (E954), corn starch,
microcrystalline cellulose (E460), cream flavour, 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

Granules for oral suspension in sachets
20 sachets of 150 mg
20 sachets of 300 mg

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

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

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

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

Ursodeoxycholic acid

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ursilon Retard and what is it used for

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

2. What you need to know before taking Ursilon Retard

Do not take Ursilon Retard

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have an acute inflammation of the sac containing the bile (gallbladder) or of the bile ducts
• if you have a blockage of the bile ducts
• if you have frequent cramps in the upper part of the abdomen (biliary colic)
• if you have gallstones that are visible on X-rays
• if you have impaired contractility of the sac containing the bile (gallbladder)
• if you have a lesion of 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
Consult 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 with blood tests every 4
weeks, subsequently every 3 months.

When Ursilon Retard is used for the treatment of cholesterol gallstones:
Ursilon Retard should not be used to dissolve gallstones due to excess cholesterol:

• if the sac containing the bile (gallbladder) cannot be seen on X-rays
• if you have hardening of the gallstones caused by an accumulation of calcium (gallstone calcification)
• if you have impaired contractility of the sac containing the bile (gallbladder)
• if you have frequent cramps in the upper part of the abdomen (biliary colic)

Women taking Ursilon Retard to dissolve gallstones must use an effective method to
avoid pregnancy, not based on hormones, as hormone-based methods may promote the formation
of gallstones (lithiasis).

When Ursilon Retard is used for the treatment of advanced stages of chronic inflammation of the bile

ducts of the liver (primary biliary cirrhosis):
In very rare cases, a worsening of primary biliary cirrhosis has been observed, which improved partially after
discontinuation of treatment.
In patients with cirrhosis biliaryprimitive, in rare cases symptoms may worsen at the beginning of treatment;
itching, for example, may increase. In these cases, the doctor will decide whether to reduce the initial dose of Ursilon
Retard.
If you have diarrhea, the dose should be reduced and in case of persistent diarrhea, therapy should be discontinued.

Other medicines and Ursilon Retard
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Ursilon Retard should not be administered simultaneously with:

• medicines that reduce blood fats (cholestyramine, colestipol)
• medicines that reduce stomach acid (antacids containing aluminum hydroxide and/or aluminum oxide) If you need to take one of these medicines, take it at least 2 hours before or after Ursilon Retard.

Ursilon can alter the intestinal absorption of some antibiotics (ciprofloxacin, cyclosporine).
Ursilon can decrease the effect of some medicines such as:

• dapsone (an antibiotic)
• nitrendipine (a medicine for controlling high blood pressure)

Medicines that can decrease the effect of Ursilon Retard:

• female sex hormones (estrogens)
• medicines that reduce blood fats (clofibrate).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, you should not use Ursilon Retard unless your doctor considers it necessary.
Pregnancy should be ruled out before starting treatment. If you are of childbearing potential and your doctor has
prescribed this medicine, you should take adequate precautions to avoid pregnancy; the use of non-hormonal medicines or medicines for oral use with a low content of female hormones
(estrogens) is recommended.
There is no data to suggest that this medicine passes into breast milk, however, if you are breastfeeding, it is
advisable that you do not 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is:

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

Take Ursilon Retard 450 or Ursilon Retard 225 in the evening before going to bed. Take the capsules without
chewing.

If you take more Ursilon Retard than you should
In case of accidental ingestion/intake of an excessive dose of Ursilon Retard, immediately
inform your doctor or go to the nearest hospital.
If you take more Ursilon Retard than you should, you may experience diarrhoea.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you forget to take Ursilon Retard
Do not take a double dose to make up for a missed dose.

If you stop taking Ursilon Retard
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.

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 abdomen
• hardening of stones caused by a build-up of calcium (stone calcification)
• worsening of chronic inflammation of the bile ducts of the liver (biliary cirrhosis)
• 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
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 sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after "Scad." The expiry
date refers to the last day of that month.
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.
Store at a temperature below 30°C

6. Contents of the pack and other information

What Ursilon Retard contains

The active ingredient is:
Ursilon Retard 450 mg: ursodeoxycholic acid mg 450
Ursilon Retard 225 mg: ursodeoxycholic acid mg 225

The other ingredients are:
Xanthan gum, barium sulfate, microcrystalline cellulose, cross-linked polyvinylpyrrolidone,
hydroxypropylmethylcellulose, carbomer, triacetin, Eudragit L100, talc.
Hard capsule 225 mg: gelatin, titanium dioxide, yellow iron oxide, indigotin.
Hard capsule 450 mg: gelatin, titanium dioxide, red iron oxide, black iron oxide, erythrosine.

Description of the appearance of Ursilon Retard and contents of the pack
Hard prolonged-release capsules
20 capsules of 450 mg
20 capsules of 225 mg

Marketing authorisation 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)