Ursofalk

Leaflet attached to the packaging: information for the user

Ursofalk, 500 mg, coated tablets

Ursodeoxycholic acid

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ursofalk 500 mg coated tablets and what is it used for
• 2. Important information before using Ursofalk 500 mg coated tablets
• 3. How to use Ursofalk 500 mg coated tablets
• 4. Possible side effects
• 5. How to store Ursofalk 500 mg coated tablets
• 6. Contents of the packaging and other information

1. What is Ursofalk 500 mg coated tablets and what is it used for

The active substance is ursodeoxycholic acid, a naturally occurring bile acid, which is found in small amounts in the human body in bile.

Indications for use

• Dissolving cholesterol gallstones in the gallbladder in patients who have contraindications for surgical treatment. The diameter of the stones must not exceed 15 mm, the stones must be radiolucent (cholecystography - no shadow on the X-ray), and the gallbladder function should be preserved despite the presence of stones.
• Treatment of primary biliary cirrhosis (a chronic inflammation of the bile ducts associated with liver cirrhosis), provided that there is no decompensated liver cirrhosis (acute liver disease at a stage where the remaining liver tissue is no longer able to compensate for the limited liver function).
• Liver disorders in the course of a disease called cystic fibrosis (mucoviscidosis) in children aged 6 to 18 years.

2. Important information before using Ursofalk 500 mg coated tablets

When not to use Ursofalk coated tablets

In case of doubts about the above symptoms, you should consult a doctor. If any of the above symptoms have occurred in the past, you should inform your doctor.

Warnings and precautions

Ursofalk 500 mg coated tablets should be used under medical supervision. During therapy, the doctor may recommend liver function tests every 4 weeks for the first 3 months of treatment, and then every 3 months. If Ursofalk 500 mg coated tablets are used to dissolve gallstones, the doctor should perform a gallbladder examination after the first 6-10 months of treatment. In patients taking Ursofalk 500 mg coated tablets to dissolve gallstones, it is recommended to use effective non-hormonal methods of contraception, as hormonal contraceptives may exacerbate gallstone formation. When using Ursofalk 500 mg coated tablets for the treatment of primary biliary cirrhosis (PBC), in rare cases, symptoms such as itching may worsen at the beginning of treatment. In such a situation, you should contact your doctor to reduce the initial dose. If chronic diarrhea occurs, you should immediately consult your doctor, as it may be necessary to reduce the dose or discontinue treatment with Ursofalk.

Ursofalk 500 mg coated tablets and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The effects of the following medicines may be altered (interactions). Ursofalk 500 mg coated tablets may weaken the effectof the following medicines: cholestyramine, colestipol (medicines that lower cholesterol levels in the blood), or aluminum hydroxide, aluminum oxide (medicines that bind stomach acid). If it is necessary to use a medicine containing one of these substances, it should be taken 2 hours before or after using Ursofalk 500 mg coated tablets; ciprofloxacin, dapsone (antibiotic), nitrendipine (a medicine used to lower blood pressure), and other medicines metabolized in a similar way. If necessary, the doctor may change the doses of these medicines. Ursofalk 500 mg coated tablets may change the effectof the following medicines: cyclosporine (a medicine that reduces the activity of the immune system). In patients treated with cyclosporine, the doctor may recommend monitoring its blood levels and, if necessary, reducing the dose of cyclosporine; rosuvastatin (a medicine used to lower high cholesterol levels in the blood). If you are taking Ursofalk 500 mg coated tablets 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 gallstones, i.e., they may work against the therapy with Ursofalk 500 mg coated tablets. You should tell your doctor about all medicines you have taken recently, including those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Fertility Animal studies have not shown any effect of this medicine on fertility. There are no available data on the effect of this medicine on fertility in humans. Pregnancy There are insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown a risk of fetal damage. Ursofalk 500 mg coated tablets should not be used during pregnancy, unless the doctor considers it absolutely necessary. Women of childbearing age should only take this medicine with simultaneous use of effective contraception methods. Non-hormonal methods or oral contraceptives with low estrogen content are recommended. However, in patients taking Ursofalk 500 mg coated tablets to dissolve gallstones, effective non-hormonal methods should be used, as oral hormonal contraceptives may exacerbate gallstone formation. Before starting therapy with Ursofalk 500 mg coated tablets, it should be checked whether the woman is not pregnant. Breastfeeding There are only a few documented cases of the use of ursodeoxycholic acid during breastfeeding. The concentration of ursodeoxycholic acid in breast milk is very low, so it is unlikely that side effects will occur in breastfed children.

Driving and using machines

Ursofalk 500 mg coated tablets do not affect the ability to drive and use machines.

3. How to use Ursofalk 500 mg coated tablets

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist. The dosage depends on the indication and is as follows:

Dissolving cholesterol gallstones

Dosage About 10 mg/kg body weight per day, which corresponds to: body weight up to 60 kg 1 coated tablet body weight 61-80 kg 1 ½ coated tablets body weight 81-100 kg 2 coated tablets body weight over 100 kg 2 ½ coated tablets Administration of Ursofalk 500 mg coated tablets The coated tablets should not be crushed, they should be swallowed with a small amount of water or other liquid. The medicine should be taken in the evening, before bedtime. The medicine should be taken regularly. Duration of treatment Usually, dissolving gallstones takes 6-24 months. If the diameter of the stones does not decrease within 12 months, treatment should be discontinued. The doctor should assess the effectiveness of treatment every 6 months. During subsequent visits, it should be checked whether the stones have not calcified. The presence of calcifications is an indication to discontinue treatment.

Treatment of primary biliary cirrhosis (chronic inflammation of the bile ducts)

Dosage For the first 3 months of treatment, Ursofalk 500 mg coated tablets should be taken in the morning, at noon, and in the evening. When liver function parameters improve, the daily dose can be taken once a day, in the evening.

Patients with swallowing difficulties or patients with a body weight below 47 kg can be given Ursofalk in the form of an oral suspension. Administration of Ursofalk 500 mg coated tablets The coated tablets should be swallowed without crushing, with a small amount of water or other liquid. The medicine should be taken regularly. Duration of treatment There are no time limits for taking Ursofalk 500 mg coated tablets in primary biliary cirrhosis. Other recommendations In rare cases, in patients with primary biliary cirrhosis, symptoms such as itching may worsen at the beginning of treatment. If this occurs, the doctor may reduce the daily dose of Ursofalk, and then gradually increase the dose (every week) until the recommended dose is reached.

Use in children (aged 6 to 18 years) for the treatment of liver disorders in the course of cystic fibrosis (mucoviscidosis)

Dosage The recommended daily dose is 20 mg per kg body weight, divided into 2-3 doses. If necessary, the doctor may recommend further increasing the dose to 30 mg per kg body weight per day.

If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Use of a higher than recommended dose of Ursofalk 500 mg coated tablets

As a result of using too high a dose of the medicine, diarrhea may occur. If chronic diarrhea occurs, you should immediately consult your doctor. During diarrhea, you should replenish fluids and electrolytes.

Missing a dose of Ursofalk 500 mg coated tablets

You should not take a double dose to make up for a missed dose, just continue treatment with the prescribed dose.

Stopping the use of Ursofalk 500 mg coated tablets

Before stopping therapy with Ursofalk 500 mg coated tablets or ending it prematurely, you should consult your doctor. If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Frequent:no more than 1 in 10 treated patients

• light, loose stools or diarrhea.

Very rare:no more than 1 in 10,000 treated patients

• during treatment of primary biliary cirrhosis: severe pain in the right upper quadrant of the abdomen, worsening of liver disease symptoms, which partially resolve after discontinuation of treatment;
• calcification of gallstones;
• hives.

Frequency not known:frequency cannot be estimated from the available data

• itching;
• nausea, vomiting.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309; Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ursofalk 500 mg coated tablets

The medicine should be stored out of sight and reach of children. Do not use Ursofalk 500 mg coated tablets after the expiry date stated on the blisters and carton after: EXP. The expiry date refers to the last day of the month stated. 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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Ursofalk 500 mg coated tablets contain

• The active substance of the medicine is ursodeoxycholic acid. One coated tablet contains 500 mg of ursodeoxycholic acid.
• The other ingredients are: microcrystalline cellulose, povidone K25, crospovidone (type A), magnesium stearate, colloidal anhydrous silica, polysorbate 80, talc, hypromellose, macrogol 6000.

What Ursofalk 500 mg coated tablets look like and what the pack contains

Ursofalk 500 mg coated tablets are white, oval, biconvex with a dividing line on both sides. Ursofalk 500 mg coated tablets are available in packs containing 50 or 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany For more detailed information, you should contact the representative of the marketing authorization holder in Poland: Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71.

Date of last revision of the leaflet: 11/2024