Proursan

Package Leaflet: Information for the User

Proursan

(Ursodeoxycholic Acid)

250 mg Hard Capsules

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What is Proursan and what is it 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 is Proursan and what is it used for

Proursan is a medicine that contains ursodeoxycholic acid as the active substance. It is one of the bile acids, which occur naturally in human bile. After oral administration, the substance is absorbed in the small intestine and transported to the liver with the blood, undergoing constant enterohepatic circulation, resulting in the saturation of bile with ursodeoxycholic acid. The medicine reduces the secretion of cholesterol into bile, prevents the formation of gallstones, and causes their dissolution.

Indications for use:

• Primary biliary cirrhosis in patients without decompensated liver cirrhosis
• Treatment of liver diseases of various etiologies in the absence of indications for other recommended therapies.
• Gastritis caused by bile reflux.
• Dissolution of cholesterol gallstones with a diameter not exceeding 15 mm, permeable to X-rays, in patients in whom, despite the presence of stones, the function of the gallbladder is preserved.

Children and adolescents
Functional disorders of the liver and bile ducts associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

2. Important information before taking Proursan

When not to take Proursan

• if you are allergic to bile acids (i.e., ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute cholecystitis and biliary tract inflammation;
• if you have a blockage of the common bile duct or the cystic duct;
• if you have frequent pain in the upper abdomen, similar to colic (biliary colic episodes);
• if you have calcified gallstones that give a shadow in X-rays;
• if you have reduced gallbladder contractility.

In case of doubts about the above symptoms, you should consult a doctor. If you have had any of the above symptoms in the past, you should inform your doctor.
Children and adolescents
Failed surgical anastomosis of intrahepatic bile ducts with the small intestine or narrowing of the bile ducts without proper bile flow.

Warnings and precautions

Proursan should be taken under medical supervision.
During treatment, your doctor may recommend monitoring liver function parameters every 4 weeks for the first 3 months, and then every 3 months.
If you experience chronic diarrhea, you should immediately consult your doctor, as it may be necessary to reduce the dose or discontinue treatment with Proursan.

Proursan and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Proursan may reduce the effectiveness of the following medicines:

• cholestyramine, colestipol (a medicine that lowers blood cholesterol levels) or aluminum hydroxide, aluminum compounds (aluminum oxide) containing antacids. If it is necessary to take a medicine containing one of these substances, you should take it 2 hours before or 2 hours after taking Proursan.
• ciprofloxacin, dapsone (an antibiotic), nifedipine (used to lower blood pressure), and other medicines metabolized in a similar way. If necessary, your doctor may adjust the doses of these medicines.

Proursan may enhance the effects of the following medicines:

• cyclosporine (reduced effect on the immune system). In patients treated with cyclosporine, your doctor may recommend monitoring its blood levels and, if necessary, reducing the dose of cyclosporine.

If you are taking Proursan to dissolve gallstones, you should inform your doctor about any medicines you are taking that contain estrogen hormones or cholesterol-lowering medicines, such as clofibrate. These medicines may stimulate the formation of stones, which is contrary to the effect of Proursan therapy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Proursan should not be taken during pregnancy, unless your doctor considers it absolutely necessary.
Women of childbearing age should take this medicine only with the simultaneous use of effective contraceptive methods. Non-hormonal methods or low-estrogen oral contraceptives are recommended. However, in patients taking Proursan to dissolve gallstones, non-hormonal methods should be used, as oral hormonal contraceptives may exacerbate gallstones.
Before starting treatment, you should check if you are not pregnant.
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 taken during breastfeeding. There is insufficient data on the penetration of ursodeoxycholic acid into breast milk. If treatment with Proursan is necessary, you should stop breastfeeding.

Driving and using machines

There are no known reports of the effect of the medicine on the ability to drive and use machines.

3. How to take Proursan

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask 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 dose should be taken once, 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. It lasts from 6 months to 2 years. The medicine should be discontinued if the stones do not decrease in size within a year. Your doctor will prescribe liver enzyme tests in the blood every 4 weeks for the first 3 months of treatment, at 4-week intervals. If the results are not normal, it is recommended to reduce the dose of Proursan. The state of stone dissolution should be monitored ultrasonographically at 6-month intervals. After dissolution of the stones, it is recommended to continue treatment for 3 months to ensure complete dissolution of the stones.
Gastritis caused by bile reflux
In 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
In 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
(mg/kg body weight)
number of capsules

First 3 months Later therapy

morning
noon
evening evening
(1 x daily)

• 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 cirrhosis
In primary biliary cirrhosis, 14 ± 2 mg/kg body weight per day is administered in three divided doses. When liver function parameters improve, the daily dose may be taken once, in the evening.
In rare cases, in patients with primary biliary cirrhosis, at the beginning of treatment, there may be an exacerbation of clinical symptoms (e.g., itching). If this occurs, you should continue treatment using half the daily dose of Proursan, and then gradually increase the dose of the medicine (increasing the dose by one capsule every week) 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 can be increased to 30 mg/kg body weight per day.
Capsules should be swallowed without chewing, with a sufficient amount of liquid.

Overdose of Proursan

In case of taking a higher dose of Proursan than recommended, diarrhea may occur.
If you experience chronic diarrhea, you should immediately consult your doctor. During diarrhea, you should replenish fluids and electrolytes. Persistence of diarrhea is an indication to discontinue treatment.

Missed dose of Proursan

You should not take a double dose to make up for a missed dose.

Discontinuation of Proursan

Before discontinuing treatment with Proursan, you should consult your doctor.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Proursan can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 100 people):

• Light-colored stools or diarrhea.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Proursan

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Proursan contains

• The active substance of the medicine is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: corn starch, pregelatinized corn 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 a white granulate.
Proursan capsules are packaged in colorless PVC/Aluminum blisters, 1, 2, 3, 4, 5, 6, 8, 9, 10 blisters per pack, each containing 10 capsules.

Marketing authorization holder and manufacturer:

PRO.MED.CS Praha a.s.
Telčská 377/1, Michle
140 00 Prague 4
Czech Republic
Date of last revision of the leaflet:06.03.2023