Proursan

Patient Information Leaflet: Instructions for the User

Proursan, 500 mg, coated tablets
Ursodeoxycholic acid
Please read this leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

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

1. What Proursan is and what it is used for

Ursodeoxycholic acid, the active substance in Proursan, is a naturally occurring bile acid. Small amounts are normally present in human bile.
Proursan is used:

• to dissolve gallstones formed due to excessive cholesterol accumulation in the gallbladder (in patients for whom surgical treatment is not possible), which are not visible on standard X-ray imaging (radiolucent stones; radiopaque stones will not dissolve), with a diameter not exceeding 15 mm. The gallbladder must retain its function despite the presence of stones.
• for the treatment of primary biliary cirrhosis, a disease characterized by damage to the bile ducts in the liver, leading to bile accumulation. This may result in liver scarring (liver cirrhosis). The liver must not be so damaged that normal liver function is impaired.
• in liver disease associated with cystic fibrosis (mucoviscidosis) in children aged 6 to 18 years.

2. Important information before using Proursan

When not to use Proursan:

• if the patient is allergic to bile acids (such as ursodeoxycholic acid) or 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 (biliary obstruction);
• if the patient experiences frequent upper abdominal pain resembling spasms (episodes
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of biliary colic);

• if the patient has calcified gallstones;
• if the patient has impaired gallbladder function;
• if the patient is a child with diagnosed biliary atresia and insufficient bile flow, even after surgical intervention.

If in doubt about any of the above symptoms, consult a doctor.
If the patient has previously experienced any of the symptoms listed above, inform the doctor.
Warnings and precautions
Before starting treatment with Proursan, discuss it with your doctor or pharmacist.
During treatment, your doctor should arrange regular liver function tests every 4 weeks during the first 3 months, and then every 3 months thereafter.
If Proursan is used to dissolve gallstones, your doctor should perform an imaging examination of the gallbladder after the first 6–10 months of treatment.
If the patient is taking Proursan to dissolve gallstones, they should inform the doctor about any concomitant use of estrogen-containing medicines, as these drugs promote gallstone formation.
In the treatment of primary biliary cirrhosis, symptoms may rarely worsen at the beginning of therapy. In such cases, consult your doctor about reducing the initial dose.
If diarrhea occurs, contact your doctor immediately, as it may be necessary to reduce the dose or discontinue treatment.
Children
Proursan can be used regardless of age. The use of Proursan depends on body weight and the type of disease.
Proursan and other medicines
Inform your doctor if the patient is currently taking or using any medicines containing the following active substances. The effect of these medicines may be altered (interactions):
Concomitant use of the following medicines may reduce the effect of Proursan:

• colestyramine, colestipol (a lipid-lowering agent) or antacids containing aluminium hydroxide or aluminium compounds (aluminium oxide) (acid-binding agents): If treatment with any of these substances is necessary, they should be taken at least two hours before or after Proursan.

Proursan may reduce the effect of the following medicines:

• ciprofloxacin and dapsone (antibiotics), nitrendipine (used in the treatment of hypertension), and other drugs metabolized in a similar manner. If necessary, the doctor may adjust the doses of the above medicines.

Proursan may alter the effect of the following medicines:

• cyclosporine (an immunosuppressive agent). In patients treated with cyclosporine, the doctor should monitor blood cyclosporine levels. If necessary, the doctor will adjust the dose accordingly.
• rosuvastatin (used in the treatment of high cholesterol and related conditions).
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If the patient is taking Proursan to dissolve gallstones, they should inform the doctor about any concomitant use of estrogen-containing medicines or lipid-lowering agents such as clofibrate. These drugs promote gallstone formation and therefore act in opposition to Proursan.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown harmful effects on reproduction. Proursan should not be used during pregnancy unless clearly necessary.
Women of childbearing potential
The patient should consult her doctor, even if she is not pregnant.
Women of childbearing potential should take this medicine only in combination with effective contraception: non-hormonal methods or low-dose estrogen oral contraceptives are recommended. However, if the patient is taking Proursan to dissolve gallstones, effective non-hormonal contraceptive methods should be used, as oral hormonal contraceptives may promote gallstone formation.
Before starting treatment, the doctor must exclude pregnancy in the patient.
Breastfeeding
In several documented cases, the concentration of ursodeoxycholic acid in breast milk has been shown to be very low; therefore, no adverse effects are expected in breastfed infants.
Fertility
Animal studies have not shown any effect of ursodeoxycholic acid on fertility.
There are no available data from human studies on the effect of ursodeoxycholic acid treatment on fertility.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.
Proursan contains sodium starch glycolate type A
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet; therefore, the medicine is considered "sodium-free."

3. How to use Proursan

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
For dissolving cholesterol gallstones
Dosage
The recommended dose of ursodeoxycholic acid is approximately 10 mg per kg of body weight per day,
as follows:

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up to 60 kg: 1 tablet
61–80 kg: 1½ tablets
81–100 kg: 2 tablets
over 100 kg: 2½ tablets
For patients weighing less than 47 kg or unable to swallow Proursan tablets, other formulations (suspension) containing ursodeoxycholic acid are available.
Administration method
Tablets should be swallowed whole with water or another liquid. The tablets should be taken in the
evening, before bedtime. The medicine should be taken regularly.
Duration of treatment
Dissolution of gallstones usually takes from 6 to 24 months. If the diameter of the gallstones has not
decreased after 12 months, treatment should be discontinued.
Your doctor should assess treatment effectiveness every six months. During follow-up visits, it is
important to monitor whether calcification of the stones has occurred since the last visit. If this occurs,
your doctor will discontinue treatment.
Treatment of primary biliary cirrhosis (chronic cholangitis)
Dosage
During the first 3 months of treatment, Proursan should be taken in the morning, at midday, and in the
evening.
Once liver function parameters have improved, the daily dose may be taken once daily in the evening.
Proursan 500 mg, coated tablets
Body weight First 3 months Later therapy
(kg) evening
morning midday evening
(once daily)
47–62 ½ ½ ½ 1½
63–78 ½ ½ 1 2
79–93 ½ 1 1 2½
94–109 1 1 1 3
above 110 1 1 1½ 3½
For patients weighing less than 47 kg or unable to swallow Proursan tablets, other formulations (suspension) containing ursodeoxycholic acid are available.
Administration method
Tablets should be swallowed whole (without chewing), with water or another liquid. The medicine
should be taken regularly.
Duration of treatment
There are no time limitations for the use of Proursan in primary biliary cirrhosis.
Note:
In patients with primary biliary cirrhosis, symptoms may worsen at the beginning of treatment. One of
the symptoms may be increased itching. This occurs, however, only rarely. If this occurs, treatment
may be continued using a lower daily dose of Proursan. The doctor will then gradually increase the
daily dose by weekly increments until the recommended dose is reached again.

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Use in children (from 6 to 18 years of age) for the treatment of liver disease in cystic fibrosis
(cystic fibrosis liver disease)
A dose of approximately 20 mg per kg of body weight per day, divided into 2–3 doses, is recommended.
If necessary, the doctor may increase the dose up to 30 mg per kg of body weight per day.

If you feel that the effect of the medicine Proursan is too strong or too weak, consult your
doctor or pharmacist.
Use of a higher than recommended dose of Proursan
In case of overdose, diarrhoea may occur. If chronic diarrhoea develops, inform your doctor
immediately. During diarrhoea, drink adequate amounts of fluids to replenish water and electrolytes
in the body.
Missed dose of Proursan
Do not use a double dose to make up for a missed dose; continue treatment according to the
prescribed dosing schedule.
Stopping treatment with Proursan
Always consult your doctor before stopping treatment with Proursan or ending therapy early.
If you have any further questions 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 side effects (may occur in up to 1 in 10 people)

• Pale, loose stools or diarrhoea

Very rare side effects (occur in 1 in 10,000 patients)

• During treatment of primary biliary cirrhosis: severe pain in the upper right quadrant of the abdomen, serious worsening of liver fibrosis symptoms, which partially improves after discontinuation of the drug.
• Calcification of gallstones due to calcium accumulation.
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• Urticaria.

Frequency unknown (frequency cannot be estimated from available data)

• Itching
• Nausea, vomiting.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of
the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects 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.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Proursan contains

• The active substance is ursodeoxycholic acid. Each tablet contains 500 mg of ursodeoxycholic acid.
• Other ingredients are:
  • tablet core: maize starch, pregelatinized maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate,
  • tablet coating: hypromellose 6, titanium dioxide, macrogol 400.

What Proursan looks like and contents of the pack
Proursan is an almost white, elongated, biconvex coated tablet with a deep score line on one side and a shallow score line on the other side. The tablet can be divided into equal doses.
Proursan is available in packs containing 10, 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
PRO.MED.PL Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Ursonorm 500 mg Filmtabletten
Austria: Ursonorm 500 mg Filmtabletten
Czech Republic: URSOSAN FORTE
Poland: Proursan
Slovakia: URSOSAN FORTE 500 mg filmom obalené tablety

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