Proursan

Package Leaflet: Information for the Patient

Proursan, 400 mg, Coated Tablets

Ursodeoxycholic Acid

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the 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

Ursodeoxycholic acid, the active substance of Proursan, is a naturally occurring bile acid. It is found in small amounts in the human body, in bile. Proursan is used:

• to dissolve cholesterol gallstones, resulting from excessive cholesterol accumulation in the gallbladder (in patients for whom surgical treatment is not possible), not visible in a standard X-ray examination (stones that are visible will not be dissolved), with a diameter not exceeding 15 mm. The gallbladder function should be preserved despite the presence of stones.
• to treat primary biliary cirrhosis of the liver, a disease that progresses with liver bile duct damage, leading to bile accumulation. This can cause liver scarring (liver cirrhosis). The liver should not be damaged enough to impair its normal function.

Children and Adolescents

• -in liver disease in the course of a disease called cystic fibrosis (fibrocystic disease) in children aged 6 to 18 years.

2. Important information before taking Proursan

When not to take Proursan

• if you are allergic to bile acids (such as ursodeoxycholic acid) or any of the other ingredients of this medicine (listed in section 6);
• if you have acute inflammation of the gallbladder and bile ducts;
• if you have a blockage of the common bile duct or the gallbladder duct (bile duct obstruction);
• if you experience frequent pain in the upper abdomen, resembling colic (episodes of biliary colic);

if you have calcified gallstones;

• if you have impaired gallbladder function;
• if you are a child with a diagnosed atresia (obstruction) of the bile ducts and insufficient bile flow, even after surgical intervention.

Warnings and precautions

Before starting to take Proursan, discuss it with your doctor or pharmacist. Proursan can only be taken under medical supervision. During treatment, the doctor should recommend regular monitoring of liver function parameters every 4 weeks for the first 3 months, and then every 3 months. If the medicine is used to dissolve gallstones, the doctor should perform an imaging examination of the gallbladder after the first 6-10 months of treatment. If you are taking Proursan to dissolve gallstones, you should inform your doctor about any medications you are taking that contain estrogen hormones, such as hormonal contraceptives, as these medications stimulate the formation of gallstones. In the case of treatment of primary biliary cirrhosis of the liver, in rare cases, worsening of symptoms may occur at the beginning of treatment. In such a situation, you should consult your doctor to reduce the initial dose.

Children and Adolescents

Proursan can be used regardless of age. The use of Proursan depends on body weight and the type of disease.

Proursan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. The action of these medicines may be affected: The simultaneous use of the following medicines may reduce the effectof Proursan:

• cholestyramine, cholestyramine (a medicine that lowers blood fat levels) or antacids containing aluminum hydroxide or aluminum compounds (aluminum oxide) (medicines that bind stomach acid): If the use of a medicine containing any of these substances is necessary, it should be taken at least two hours before or after the administration of Proursan.

Proursan may reduce the effectof the following medicines:

• ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines metabolized in a similar way. If necessary, the doctor may change the doses of these medicines.

Proursan may affect the actionof the following medicines:

• cyclosporin (an immunosuppressive medicine). In patients treated with cyclosporin, the doctor should monitor the cyclosporin level in the blood. If necessary, the doctor will adjust the dose accordingly.
• rosuvastatin (used to treat high cholesterol and similar diseases).

If you are taking Proursan to dissolve gallstones, you should inform your doctor about any medications you are taking that contain estrogen hormones or cholesterol-lowering medications, such as clofibrate. These medications stimulate the formation of gallstones, i.e., they act against Proursan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyThere is no sufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown a harmful effect on reproduction. Proursan should not be used during pregnancy without clear necessity. Women of childbearing ageYou should consult your doctor, even if you are not pregnant. Women of childbearing age should only take this medicine with simultaneous use of effective contraceptive methods: non-hormonal methods or low-estrogen oral contraceptives are recommended. However, if you are taking Proursan to dissolve gallstones, you should use effective non-hormonal contraceptive methods, as oral hormonal contraceptives may stimulate the formation of gallstones. Before starting treatment, your doctor must rule out pregnancy. BreastfeedingIt has been shown in a few documented cases that the level of ursodeoxycholic acid in breast milk is very low, so no adverse effects are expected in breastfed infants. FertilityAnimal studies have not shown any effect of ursodeoxycholic acid on fertility. There are no available data from studies on the effect of ursodeoxycholic acid treatment on human fertility.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Proursan contains sodium (sodium carboxymethylcellulose type A)

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Proursan

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. The recommended dose is:

For dissolving cholesterol gallstones

Dosage

The recommended dose of ursodeoxycholic acid is about 10 mg per kilogram of body weight per day, as follows:

For patients with a body weight of less than 47 kg or unable to swallow Proursan, other forms of the medicine (suspension) containing ursodeoxycholic acid are available.

Method of administration

Tablets should be swallowed whole, with water or another liquid. Tablets should be taken in the evening, before bedtime. The medicine should be taken regularly.

Duration of treatment

Usually, the dissolution of gallstones takes from 6 to 24 months. If the diameter of the gallstones has not decreased after 12 months, treatment should be discontinued. The doctor should assess the effectiveness of treatment every six months. During subsequent visits, it should be checked whether the stones have not calcified since the last visit. If this happens, the doctor will discontinue treatment.

Treatment of primary biliary cirrhosis of the liver (chronic bile duct inflammation)

Dosage

The daily dose depends on body weight and ranges from 2 to 4 coated tablets. Proursan, 400 mg, coated tablets first 3 months

Later

Body weight (kg) therapymorning in the afternoon evening (once a day)

• 47-50 ½ ½ ½ 1 ½
• 51-62 ½ ½ 1 2
• 63-78 ½ ½ 1 ½ 2 ½
• 79-93 ½ 1 1 ½ 3
• 94-109 1 1 1 ½ 3 ½ Over 110 1 1 2 4

For patients with a body weight of less than 47 kg or unable to swallow Proursan, other forms of the medicine (suspension) containing ursodeoxycholic acid are available.

Method of administration

Tablets should be swallowed whole (without chewing), with water or another liquid. For the first 3 months of treatment, Proursan should be taken in the morning, in the afternoon, and in the evening. Once the liver function parameters have improved, the daily dose can be taken once a day, in the evening. The medicine should be taken regularly.

Duration of treatment

There is no time limit for taking Proursan in primary biliary cirrhosis of the liver. Note:In patients with primary biliary cirrhosis of the liver, worsening of symptoms may occur at the beginning of treatment. One of the symptoms may be increased itching. This happens in rare cases. If this occurs, treatment can be continued with a reduced daily dose of Proursan. Then, the doctor will increase the daily dose every week until the recommended dose is reached again.

Use in children and adolescents (from 6 to 18 years) in the treatment of liver disease in the course of cystic fibrosis (fibrocystic disease)

A dose of about 20 mg/kg body weight per day, divided into 2-3 doses, is recommended. If necessary, the doctor may increase the dose to 30 mg per kilogram of body weight per day.

Body weight Dose per day (mg/kg body weight)

Proursan, 400 mg, coated tablets morning

in the afternoonevening(kg)

• 20-23
• 17-20 ½
• ½
• 24-32
• 19-25 ½ ½ ½
• 33-39
• 21-24 ½ ½ 1
• 40-49
• 20-25 ½ ½ 1 ½
• 50-59
• 20-24 ½ 1 1 ½
• 60-69
• 20-23 1 1 1 ½
• 70-79
• 20-23 1 1 ½ 1 ½
• 80-89
• 20-23 1 ½ 1 ½ 1 ½
• 90-99
• 20-22 1 ½ 1 ½ 2
• 100-109
• 20-22 1 ½ 2 2 >110 ≤22 2 2 2

For patients unable to swallow Proursan, other forms of the medicine (suspension) containing ursodeoxycholic acid are available. If you feel that the effect of Proursan is too strong or too weak, ask your doctor or pharmacist.

Taking a higher dose of Proursan than recommended

In case of overdose, diarrhea may occur. If chronic diarrhea occurs, inform your doctor immediately. During diarrhea, drink plenty of fluids to replenish water and electrolytes in the body.

Missing a dose of Proursan

Do not take a double dose to make up for a missed dose, just continue treatment as prescribed.

Stopping Proursan treatment

Before stopping treatment with Proursan or finishing therapy early, always consult your doctor. If you have any further questions about the use of this medicine, 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 10 people)

• light, loose stools or diarrhea.

Rare side effects(may affect up to 1 in 10,000 people)

• during treatment of primary biliary cirrhosis of the liver: severe pain in the right upper quadrant of the abdomen, severe worsening of liver cirrhosis symptoms, which partially subsides after discontinuation of the medicine.

calcification of gallstones due to calcium accumulation. urticarial rash (hives).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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 authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Proursan

Keep this medicine out of the 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: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Proursan contains

• The active substance of Proursan is ursodeoxycholic acid. Each tablet contains 400 mg of ursodeoxycholic acid.
• Other ingredients are:
• tablet core: corn starch, corn starch paste, sodium carboxymethylcellulose (type A), colloidal silica anhydrous, magnesium stearate,
• tablet coating: hypromellose 2910/6cP, titanium dioxide (E 171), macrogol 400.

What Proursan looks like and contents of the pack

Almost white, round, biconvex coated tablets, with a dividing line on both sides. The tablet can be divided into equal doses. Proursan is available in packs containing 10, 20, 30, 50, 60, 90, or 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic. For more detailed information on this medicine, please contact the local representative of the marketing authorization holder: PRO.MED.PL Sp. z o.o. e-mail: biuro@promedcs.com

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Ursonorm 400 mg Filmtabletten Germany Ursonorm 400 mg Filmtabletten Poland Proursan Czech Republic URSOSAN Slovakia URSOSAN 400 mg film-coated tablets

Date of last revision of the leaflet: