Package leaflet: Information for the user

Proursan
( Acidum ursodeoxycholicum )
250 mg hard capsules
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Proursan is and what it is used for
Important information before taking Proursan
How to take Proursan
Possible side effects
How to store Proursan
Contents of the pack and other information

1. What Proursan is and what it is used for

Proursan is a medicine containing ursodeoxycholic acid as the active substance. It is one of the bile acids naturally present, among others, in human bile. After oral administration, the substance is absorbed in the small intestine and transported via blood to the liver, undergoing enterohepatic circulation, resulting in enrichment of bile with ursodeoxycholic acid. The medicine reduces cholesterol secretion into bile, prevents formation of gallstones, and causes their dissolution.

Indications for use:

Primary biliary cholangitis in patients without decompensated liver cirrhosis
Treatment of liver diseases of various etiologies when there are no indications for other recommended therapies
Gastric mucosal inflammation caused by bile reflux
Dissolution of radiolucent cholesterol gallstones not exceeding 15 mm in diameter in patients with preserved gallbladder function

Children and adolescents
Liver and biliary tract dysfunction associated with cystic fibrosis in children and adolescents aged 6 to 18 years

2. Information before using Proursan

When not to use Proursan

if the patient is allergic to bile acids (i.e. ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6);
if the patient has acute inflammation of the gallbladder or bile ducts;
if the patient has obstruction of the common bile duct or cystic duct;
if the patient experiences frequent upper abdominal pain resembling spasms (episodes of biliary colic);
if the patient has radiopaque calcified gallstones;
if the patient has impaired gallbladder contractility.

If in doubt about the above symptoms, consult a doctor. If any of the above symptoms occurred in the past, inform the doctor.
Children and adolescents
Failed surgical anastomosis of intrahepatic bile ducts to the small intestine or bile duct stenosis without adequate bile flow.
Warnings and precautions

Proursan should be used under medical supervision.
During treatment, the doctor may recommend monitoring liver function parameters every 4 weeks for the first 3 months, and then every 3 months.
If chronic diarrhoea occurs, seek medical advice immediately, as it may be necessary to reduce the dose or discontinue treatment with Proursan.

Proursan and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Proursan may reduce the effectiveness of the following medicines:

colestyramine, colestipol (a drug that lowers blood cholesterol levels), or aluminium hydroxide, aluminium-containing compounds (aluminium oxide) with acid-neutralizing properties (acid-binding agents). If treatment with a medicine containing any of these substances is necessary, it should be taken two hours before or two hours after taking Proursan.
ciprofloxacin, dapsone (antibiotics), nifedipine (used to lower blood pressure), and other drugs metabolized in a similar way. If necessary, the doctor may adjust the doses of these medicines.

Proursan may enhance the effects of the following medicines:

cyclosporine (reduction of immunosuppressive effect). In patients treated with cyclosporine, the doctor may recommend monitoring its blood concentration and, if necessary, reducing the cyclosporine dose.

If the patient is using Proursan to dissolve gallstones, they should inform the doctor about taking medicines containing oestrogen hormones or cholesterol-lowering drugs such as clofibrate. These medicines may promote gallstone formation, which counteracts the therapy with Proursan.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Proursan should not be used during pregnancy unless the doctor considers it absolutely necessary.
Women of childbearing age should take this medicine only in combination with effective contraception. It is recommended to use non-hormonal methods or low-dose oestrogen oral contraceptives. However, in patients taking Proursan to dissolve gallstones, effective non-hormonal contraception should be used, as hormonal oral contraceptives may exacerbate cholelithiasis.
Before starting treatment, pregnancy should be ruled out.
There is insufficient data on the use of Proursan in pregnant women, especially during the first trimester. Animal studies have shown a risk of fetal damage in early pregnancy.
Proursan should not be used during breastfeeding. There are insufficient data on the passage of ursodeoxycholic acid into breast milk. If treatment with Proursan is necessary, breastfeeding should be discontinued.

Driving and operating machinery
There are no known reports regarding the effect of the medicine on the ability to drive or operate machinery.

3. How to use Proursan

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
Recommended dose
Adults
Dissolution of cholesterol gallstones
The recommended dose for dissolving cholesterol gallstones in adults is 2 to
5 capsules per day depending on body weight (10 mg/kg body weight per day). The entire daily dose should be taken
once daily before bedtime.
Body weight up to 60 kg – 2 capsules
Body weight up to 80 kg – 3 capsules
Body weight up to 100 kg – 4 capsules
Body weight over 100 kg – 5 capsules
The duration of treatment and its effectiveness depend on the size of the gallstones. Treatment lasts from six
months to two years. The medicine should be discontinued if the stones have not decreased in size within one year. The physician
will order blood serum aminotransferase activity tests during the first three months
of treatment at four-week intervals. If test results are outside the normal range, a reduction
in the dose of Proursan is recommended. The dissolution process should be monitored
ultrasonographically every six months. After dissolution of the stones, it is recommended
to continue treatment for 3 months to ensure complete dissolution of deposits.
Gastritis caused by bile reflux
For the treatment of gastritis caused by bile reflux, it is recommended to take
one capsule per day (250 mg), administered in the evening before bedtime. The duration of treatment for this
indication is 10–14 days.
Treatment of liver diseases of various etiologies
For the treatment of liver diseases of various etiologies in the absence of indications for other
recommended therapies, the following dosing is recommended:
Body weight (kg) Daily dose Number of capsules
(mg/kg body weight) Initial therapy Subsequent therapy
(once daily in the evening)
Morning Noon Evening Evening
47 – 62 12 – 16 1 1 1 3
63 – 78 13 – 16 1 1 2 4
79 – 93 13 – 16 1 2 2 5
94 – 109 14 – 16 2 2 2 6
Over 110 2 2 3 7
Primary biliary cholangitis
For primary biliary cholangitis, the dose is 14 ± 2 mg/kg body weight per day, administered in three divided doses.
When liver function parameters improve, the daily dose may be taken
once daily in the evening.
In rare cases, patients with primary biliary cholangitis may experience a worsening of clinical symptoms (e.g., pruritus) at the beginning
of treatment. If this occurs, treatment should be continued using half the recommended daily dose of Proursan, then the dose should be gradually
increased (increasing the dose by one capsule weekly) until the recommended dose is reached.
Use in children and adolescents
In children over 2 years of age, individual dosing is used; the recommended dose is
10–20 mg/kg body weight per day.
Children and adolescents aged 6 to 18 years with cystic fibrosis: 20 mg/kg body weight per day in 2–3 divided doses. If necessary, the dose may be increased to 30 mg/kg body weight per day.
Capsules should be swallowed whole, without chewing, with an adequate amount of fluid.
Taking more Proursan than recommended
If more than the recommended dose of Proursan is taken, diarrhea may occur.
In case of chronic diarrhea, consult a doctor immediately. Fluids and electrolytes should be replenished
during episodes of diarrhea. Persistent diarrhea is an indication to discontinue treatment.
Missing a dose of Proursan
Do not take a double dose to make up for a missed dose.
Stopping Proursan treatment
Before stopping therapy with Proursan, consult your doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in more than 1 in 100 patients):

Pale stools or diarrhoea.

Very rare adverse reactions (may occur in 1 in 10,000 patients):

During treatment of primary biliary cirrhosis, severe pain in the right upper quadrant of the abdomen has occurred.
During treatment of severe primary biliary cirrhosis, very rare cases of worsening symptoms of liver cirrhosis have been observed, which partially resolved after discontinuation of the medicine.
Calcification of gallstones.
Urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, PL 02-222 Warsaw, Tel. +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Proursan

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister:
“Expiry date” or “EXP”. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Proursan contains

The active substance is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.
The other ingredients are: maize starch, pregelatinised maize starch, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E 171), gelatin.

What Proursan looks like and contents of the pack
Proursan is a white, hard gelatin capsule containing white granules.
Proursan capsules are packed in clear PVC/Aluminium blisters, 1, 2, 3, 4, 5, 6, 8, 9, 10
blister packs with 10 capsules in each pack.
Marketing Authorisation Holder and Manufacturer:
PRO.MED.CS Praha a.s.
Telčská 377/1, Michle
140 00 Praha 4
Czech Republic