Ursofalk

Leaflet attached to the packaging: information for the user

Ursofalk, 250 mg/5 ml, oral suspension

Ursodeoxycholic acid

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

• You should keep this leaflet, so that 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ursofalk oral suspension 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 to 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.
• Treating primary biliary cirrhosis (which is a chronic inflammation of the bile ducts associated with liver cirrhosis), provided that there is no uncontrolled liver cirrhosis (acute liver disease at a stage when the remaining liver tissue is no longer able to compensate for the limited liver function).
• Treating liver disorders in cystic fibrosis (mucoviscidosis) in children from 1 month to 18 years of age.

2. Important information before using Ursofalk oral suspension

When not to use Ursofalk oral suspension

In case of doubts about the above symptoms, you should talk to your doctor. If you have had any of the above symptoms in the past, you should inform your doctor.

Warnings and precautions

Ursofalk oral suspension 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 oral suspension is used to dissolve gallstones, the doctor should perform a gallbladder examination after the first 6-10 months of treatment.
In female patients taking Ursofalk oral suspension to dissolve gallstones, it is recommended to use effective non-hormonal methods of contraception, as hormonal contraceptives may exacerbate gallstone formation.
In the case of using Ursofalk oral suspension to treat 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.
In the event of chronic diarrhea, you should immediately contact your doctor, as it may be necessary to reduce the dose or discontinue treatment with Ursofalk.

Ursofalk oral suspension 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 oral suspension may weaken the effectof the following medicines:
§
cholestyramine, cholestypol (medicines that lower cholesterol levels in the blood) or aluminum hydroxide, aluminum oxide (medicines that bind stomach acid). If it is necessary to take a medicine containing one of these substances, it should be taken 2 hours before or after taking Ursofalk oral suspension.
§
ciprofloxacin, dapsone (antibiotic), nitrendipine (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 oral suspension may change the effectof the following medicines:
§
cyclosporine (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 (medicine used to lower high cholesterol levels in the blood).
If you are taking Ursofalk oral suspension 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., act against the therapy with Ursofalk oral suspension.
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.
Effect on fertility
Animal studies have not shown any effect of this medicine on fertility. There is no available data on the effect of this medicine on fertility in humans.
Pregnancy
There is insufficient data on the use of ursodeoxycholic acid in pregnant women.
Animal studies have shown a risk of fetal harm.
Ursofalk oral suspension should not be used during pregnancy, unless the doctor considers it absolutely necessary.
Women of childbearing age should only take this medicine with concurrent use of effective contraception methods. Non-hormonal methods or low-estrogen oral contraceptives are recommended. However, in patients taking Ursofalk oral suspension to dissolve gallstones, effective non-hormonal methods should be used, as hormonal oral contraceptives may exacerbate gallstone formation.
Before starting therapy with Ursofalk oral suspension, it should be checked whether the woman is pregnant.
Breastfeeding
There are only a few documented cases of using ursodeoxycholic acid during breastfeeding. The concentration of ursodeoxycholic acid in breast milk is very low, so it is unlikely to cause side effects in breastfed children.

Driving and using machines

Ursofalk oral suspension does not affect the ability to drive and use machines.

Ursofalk oral suspension contains benzene acid, propylene glycol, sodium, and ethanol, sulfites, citral, citronellol, d-limonene, geraniol, and linalol.

The medicine contains 7.5 mg of benzene acid in every 5 ml of oral suspension. Benzene acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
The medicine contains 50 mg of propylene glycol in every 5 ml of oral suspension. Before administering the medicine to a child under 4 weeks of age, you should consult a doctor or pharmacist, especially if the child is taking other medicines that contain propylene glycol or alcohol.
The medicine contains 11 mg of sodium in every 5 ml of oral suspension. This corresponds to 0.6% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine may contain trace amounts of alcohol (ethanol). A small amount of alcohol in this medicine will not cause noticeable effects.
This medicine may contain trace amounts of sulfites, which can cause severe allergic reactions and bronchospasm.

3. How to use Ursofalk oral suspension

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Recommendations for opening
Before use, the closed bottle should always be shaken.
To open the bottle, you should firmly press and turn the cap to the left.
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
Full measuring cup*
Equivalent in ml
51 to 65 kg
2½
12.50
66 to 80 kg
3
15.00
81 to 100 kg
4
20.00
over 100 kg
5
25.00
*1 measuring cup (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Using Ursofalk oral suspension
Ursofalk oral suspension 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 become calcified. The presence of calcifications is an indication to discontinue treatment.

Treating primary biliary cirrhosis (chronic bile duct inflammation)

Dosage
For the first 3 months of treatment, Ursofalk oral suspension 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.
*1 measuring cup (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Conversion table:
Ursodeoxycholic acid
(equivalent in mg)
1 measuring cup
5 ml
250 mg
¾ measuring cup
3.75 ml
187.5 mg
½ measuring cup
2.5 ml
125 mg
¼ measuring cup
1.25 ml
62.5 mg
Using Ursofalk oral suspension
The medicine should be taken regularly.
Duration of treatment
There are no time limits for taking Ursofalk oral suspension 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 happens, the doctor may reduce the daily dose of Ursofalk oral suspension and then gradually increase the dose (every week) until the recommended dose is reached.

Using in children (from 1 month to 18 years of age) to treat liver disorders in cystic fibrosis (mucoviscidosis)

Oral suspension
(equivalent in ml)

Dosage:
The recommended daily dose is 20 mg per kilogram of body weight, divided into 2-3 doses. If necessary, the doctor may recommend further increasing the dose to 30 mg per kilogram of body weight per day.
In children with a body weight below 10 kg, single doses should be measured using a syringe, as the attached measuring cup does not indicate volumes below 1.25 ml. Single-use 2 ml syringes with a 0.1 ml scale should be used. Note: Single-use syringes are not included in the packaging and should be purchased at a pharmacy.
To administer the required dose using a syringe, you should:

• 1. Shake the bottle before opening.
• 2. Pour a small amount of suspension into the attached measuring cup.
• 3. Draw a little more than the recommended volume of suspension into the syringe.
• 4. Tap the syringe with your fingers to remove air bubbles from the drawn suspension.
• 5. Check if the syringe contains the correct volume of suspension and adjust if necessary.
• 6. Carefully administer the contents of the syringe directly into the child's mouth.

Do not insert the syringe into the bottle. Do not pour unused suspension from the syringe or measuring cup back into the bottle.

Dosage in children with a body weight up to 10 kg using a single-use syringe as a measuring cup:

20 mg of ursodeoxycholic acid/kg body weight per day

In children with a body weight over 10 kg, the attached measuring cup can be used:

Dosage in children with a body weight over 10 kg using the attached measuring cup:

20-25 mg of ursodeoxycholic acid/kg body weight per day

* 1 measuring cup (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
Conversion table:
In case you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Ursofalk oral suspension than recommended

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

Missing a dose of Ursofalk oral suspension

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

Stopping Ursofalk oral suspension

Before stopping therapy with Ursofalk oral suspension or discontinuing it prematurely, you should consult your doctor.
In case of any further doubts related to 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 therapy for primary biliary cirrhosis: severe pain in the right upper quadrant of the abdomen, worsening of liver disease symptoms, which partially resolve after discontinuation of therapy;
• calcification of gallstones;
• hives.

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

• itching;
• nausea, vomiting.

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 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ursofalk oral suspension

Store in an upright position.
Do not store at a temperature above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use Ursofalk oral suspension after the expiration date stated on the bottle and carton after: EXP. The expiration date refers to the last day of the specified month.
Shelf life after first opening the bottle: 4 months.
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 packaging and other information

What Ursofalk oral suspension contains

• The active substance of the medicine is ursodeoxycholic acid. One measuring cup (5 ml of oral suspension) contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: benzene acid, xylitol, glycerol, Avicel RC-591 (microcrystalline cellulose + sodium carmellose), propylene glycol, sodium citrate, sodium cyclamate, citric acid, sodium chloride, lemon flavor (Givaudan PHL-134488, containing citral, citronellol, d-limonene, geraniol, linalol, ethanol, and sulfites), purified water.

What Ursofalk oral suspension looks like and what the pack contains

Ursofalk oral suspension is a white, homogeneous suspension with small air bubbles and a lemon flavor.
A brown glass bottle containing 250 ml of suspension with a plastic cap that protects against children and a 5 ml measuring cup with 4 engraved graduations: 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml.

Marketing authorization holder, manufacturer, and importer

Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany
To obtain 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 the last update of the leaflet: 11/2024