Ursofalk

Package leaflet: Information for the user

Ursofalk 250 mg, capsules
Acidum ursodeoxycholicum
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 pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

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

1. What Ursofalk capsules are and what they are used for

Active substance: ursodeoxycholic acid is a naturally occurring bile acid,
present in small amounts in human bile.
Indications

• Dissolution of cholesterol gallstones in patients for whom surgical treatment is contraindicated. The stones must not exceed 15 mm in diameter, must be radiolucent (no shadowing on X-ray imaging – cholecystography), and gallbladder function must be preserved despite the presence of stones.
• Treatment of symptomatic primary biliary cholangitis (a chronic inflammatory disease of the bile ducts associated with liver cirrhosis), provided that decompensated cirrhosis is absent (acute liver disease stage in which remaining liver tissue is no longer able to compensate for impaired function).
• Liver disorders associated with cystic fibrosis (mucoviscidosis) in children aged 6 to 18 years.

2. Important information before using Ursofalk capsules

When not to use Ursofalk capsules

• if the patient has hypersensitivity (allergy) to bile acids (i.e. ursodeoxycholic acid) or to any of the other ingredients of this medicine (see 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 visible on X-ray;
• if the patient has impaired gallbladder contractility;
• if the child has biliary atresia and insufficient bile flow, despite prior surgical intervention.

If in doubt about the above symptoms, consult a physician. If any of the above conditions occurred in the past, inform your doctor.

Warnings and precautions

Ursofalk capsules should be used under medical supervision.

During treatment, your doctor may recommend monitoring liver function parameters every 4 weeks during the first 3 months of treatment, and thereafter every 3 months.

If Ursofalk capsules are used to dissolve gallstones, your doctor should perform an ultrasound examination of the gallbladder after the first 6–10 months of treatment.

Female patients taking Ursofalk capsules for gallstone dissolution should use effective non-hormonal contraceptive methods, since hormonal contraceptives may promote gallstone formation.

When Ursofalk capsules are used in the treatment of primary biliary cholangitis (PBC), symptoms such as itching may occasionally worsen at the beginning of treatment. In such cases, contact your doctor to consider reducing the initial dose.

If chronic diarrhoea occurs, seek medical advice immediately, as it may be necessary to reduce the dose or discontinue treatment with Ursofalk capsules.

Ursofalk capsules and other medicines

Inform your doctor about all medicines currently used, recently taken, or planned for use.

The following medicines may have altered effects (interactions).

Ursofalk capsules may reduce the effectiveness of the following medicines:

§ cholestyramine, colestipol (medicines that lower blood cholesterol levels), or aluminium hydroxide, aluminium compounds (aluminium oxide), or antacids (acid-binding agents). If treatment with a medicine containing any of these substances is necessary, it should be taken at least two hours before or after taking Ursofalk capsules.

§ ciprofloxacin, dapsone (antibiotics), nitrendipine (used to lower blood pressure), and other drugs metabolized in a similar manner. If necessary, your doctor may adjust the doses of these medicines.

Ursofalk capsules may alter the effect of the following medicines:

§ cyclosporine (reduced immunosuppressive effect). In patients treated with cyclosporine, your doctor may recommend monitoring blood cyclosporine levels and, if necessary, reducing the cyclosporine dose;

§ rosuvastatin (a medicine used to lower high blood cholesterol levels).

If the patient is taking Ursofalk capsules to dissolve gallstones, they should inform the doctor about any concomitant use of oestrogen-containing hormonal medicines or cholesterol-lowering agents such as clofibrate. These medicines may promote gallstone formation, which counteracts the therapeutic effect of Ursofalk capsules.

Inform your doctor about all medicines taken recently, including those available without a prescription.

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.

Effect on fertility:

Animal studies have shown no effect of this medicine on fertility. There are no available data on the effect of this medicine on human fertility.

Pregnancy:

There is insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have indicated a risk of fetal harm.

Ursofalk capsules should not be used during pregnancy unless the doctor considers it absolutely necessary.

Women of childbearing potential should only take this medicine if using effective contraception simultaneously. Non-hormonal methods or low-dose oestrogen oral contraceptives are recommended. However, in female patients taking Ursofalk capsules for gallstone dissolution, effective non-hormonal contraceptive methods should be used, since hormonal oral contraceptives may promote gallstone formation.

Before starting treatment with Ursofalk capsules, pregnancy should be ruled out.

Breastfeeding:

There are only a few documented cases of ursodeoxycholic acid use during breastfeeding. The concentration of ursodeoxycholic acid in breast milk remains very low; therefore, adverse effects in breastfed infants are unlikely.

Driving and operating machinery

Ursofalk capsules have no influence on the ability to drive or operate machinery.

3. How to use Ursofalk capsules

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
The dosage depends on the indication and is as follows:

Dissolution of cholesterol gallstones
Dosage
Approximately 10 mg/kg body weight/day, corresponding to:
Body weight up to 60 kg: 2 capsules
Body weight 61–80 kg: 3 capsules
Body weight 81–100 kg: 4 capsules
Body weight above 100 kg: 5 capsules

Administration of Ursofalk capsules
The capsules should be swallowed whole 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
Gallstone dissolution usually occurs within 6–24 months. If the diameter of the stones has not decreased within 12 months, treatment should be discontinued.
The physician should evaluate treatment efficacy every 6 months. During follow-up visits, it should be verified whether calcification of the stones has occurred. The presence of calcifications is an indication to discontinue therapy.

Treatment of symptomatic primary biliary cholangitis (chronic cholangitis)
Dosage
During the first 3 months of treatment, Ursofalk capsules should be taken in the morning, at midday, and in the evening. When liver function parameters have improved, the daily dose may be administered once daily in the evening.

For patients who have difficulty swallowing capsules or for patients with body weight below 47 kg, Ursofalk may be administered as an oral suspension.
Administration of Ursofalk capsules
Capsules should be swallowed whole with a small amount of water or other liquid. The medicine should be taken regularly.
Duration of therapy
There are no time limitations regarding the administration of Ursofalk capsules in primary biliary cholangitis.
Other recommendations
In rare cases, patients with primary biliary cholangitis may experience worsening of symptoms (e.g. pruritus) at the beginning of treatment. If this occurs, the physician may reduce the daily dose of Ursofalk capsules and then gradually increase the dose (weekly) until the recommended dose is reached.
Use in children (aged 6 to 18 years) for the treatment of liver disorders in cystic fibrosis
Dosage:
The recommended daily dose is 20 mg per kg of body weight, divided into 2–3 doses. If necessary, the physician may recommend further increasing the dose up to 30 mg per kg of body weight per day.

If you feel that the effect of Ursofalk capsules is too strong or too weak, consult your doctor or
pharmacist.
Use of a higher than recommended dose of Ursofalk capsules
Diarrhea may occur as a result of taking an excessive dose of the medicine. If chronic diarrhea develops,
seek medical advice immediately. During diarrhea, replenish fluids and electrolytes.
Missed dose of Ursofalk capsules
Do not use a double dose to make up for a missed dose; simply continue treatment with the prescribed dose.
Discontinuation of Ursofalk capsules
Before stopping treatment with Ursofalk capsules or discontinuing it prematurely, consult your doctor.
If you have any doubts concerning 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 everybody will experience them.
Common: not more often than in 1 out of 10 treated patients

• soft, loose stools or diarrhoea.

Very rare: not more often than in 1 out of 10,000 treated patients

• during therapy for primary biliary cholangitis: severe pain in the upper right quadrant of the abdomen, worsening of liver disease symptoms, which partially resolve after discontinuation of therapy,
• calcification of gallstones,
• urticaria.

Frequency not known: frequency cannot be estimated based on available data

• itching,
• nausea, vomiting.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety.

5. How to store Ursofalk capsules

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use Ursofalk capsules after the expiry date stated on the blisters and
the cardboard box following: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What Ursofalk capsules contain

• The active substance is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, purified water.

What Ursofalk capsules look like and contents of the pack
Ursofalk capsules are white and opaque. They contain a white powder or granules.
Ursofalk capsules are available in packs containing 50 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany
For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71