Ursofalk

Package Leaflet: Information for the User

Ursofalk, 250 mg, Capsules

Ursodeoxycholic Acid

Read the Package 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 Ursofalk Capsules and What is it 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 is Ursofalk Capsules and What is it Used For

Active Substance: Ursodeoxycholic Acid is a Naturally Occurring Bile Acid, Which is Found in Small Amounts in Human 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 (No Opacity on X-Ray), and the Gallbladder Function Must be Preserved Despite the Presence of Stones.
• Treatment of Symptomatic Primary Biliary Cirrhosis (a Chronic Inflammation of the Bile Ducts Associated with Liver Cirrhosis), Provided that Uncompensated Liver Cirrhosis (Acute Liver Disease at a Stage Where the Remaining Liver Tissue is No Longer Able to Compensate for the Limited Function) Does Not Occur.
• Liver Disorders in Cystic Fibrosis (Mucoviscidosis) in Children Aged 6 to 18 Years.

2. Important Information Before Taking Ursofalk Capsules

When Not to Take Ursofalk Capsules

• If the Patient has a Known Hypersensitivity (Allergy) to Bile Acids (i.e., Ursodeoxycholic Acid) or Any of the Other Ingredients of this Medication (See Section 6);
• If the Patient has Acute Cholecystitis or Bile Duct Inflammation;
• If the Patient has a Blockage of the Common Bile Duct or the Gallbladder Duct;
• If the Patient Experiences Frequent Upper Abdominal Pain Resembling Cramps (Biliary Colic Episodes);
• If the Patient has Calcified Gallstones that Give a Shadow on X-Ray;
• If the Patient has Impaired Gallbladder Contractility;
• If the Child has Bile Duct Atresia and Insufficient Bile Flow, Despite Surgical Intervention.

In Case of Doubts About the Above Symptoms, Consult a Doctor. If Any of the Above Symptoms Have Occurred in the Past, Inform Your Doctor.

Warnings and Precautions

Ursofalk Capsules Should be Taken Under Medical Supervision.
During Treatment with this Medication, the Doctor May Recommend Monitoring Liver Function Parameters Every 4 Weeks for the First 3 Months of Treatment, and Then Every 3 Months.
If Ursofalk Capsules are Used to Dissolve Gallstones, the Doctor Should Perform a Gallbladder Examination After the First 6-10 Months of Treatment.
Women Taking Ursofalk Capsules to Dissolve Gallstones are Advised to Use Effective Non-Hormonal Methods of Contraception, as Hormonal Contraceptives May Enhance the Formation of Gallstones.
In the Event of Treatment with Ursofalk Capsules for Primary Biliary Cirrhosis (PBC), Rarely, Symptoms Such as Itching May Worsen at the Beginning of Treatment.
In Such a Situation, the Doctor May Reduce the Initial Dose and Then Gradually Increase it (Every Week) Until the Recommended Dose is Reached.
If Chronic Diarrhea Occurs, Seek Medical Attention Immediately, as it May be Necessary to Reduce the Dose or Discontinue Treatment with Ursofalk Capsules.

Ursofalk Capsules and Other Medications

Tell Your Doctor About All Medications You are Currently Taking, or Have Recently Taken, as Well as Any Medications You Plan to Take.
The Effects of the Following Medications May be Altered (Interactions).
Ursofalk Capsules May Weaken the Effectof the Following Medications:
§
Cholestyramine, Colestipol (a Medication that Lowers Cholesterol Levels in the Blood) or Aluminum Hydroxide, Aluminum Compounds (Aluminum Oxide) Containing Acid-Neutralizing Agents (Antacids). If the Use of a Medication Containing One of These Substances is Necessary, it Should be Taken 2 Hours Before or After Taking Ursofalk Capsules.
§
Ciprofloxacin, Dapsone (an Antibiotic), Nitrendipine (Used to Lower Blood Pressure), and Other Medications Metabolized in a Similar Way. If Necessary, the Doctor May Adjust the Dose of These Medications.
Ursofalk Capsules May Alter the Effectof the Following Medications:
§
Cyclosporin (Reduced Effect on the Immune System). In Patients Treated with Cyclosporin, the Doctor May Recommend Monitoring its Blood Levels and, if Necessary, Reducing the Dose of Cyclosporin;
§
Rosuvastatin (a Medication Used to Lower High Cholesterol Levels in the Blood).
If You are Taking Ursofalk Capsules to Dissolve Gallstones, Inform Your Doctor About Any Medications You are Taking that Contain Estrogen or Cholesterol-Lowering Medications, Such as Clofibrate. These Medications May Stimulate the Formation of Gallstones, Which is Contrary to the Effect of Ursofalk Capsules Therapy.
Tell Your Doctor About All Medications You Have Recently Taken, Including Those Available Without a Prescription.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or are Planning to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication.
Effect on Fertility:
Animal Studies Have Not Shown Any Effect of this Medication on Fertility. There is No Available Data on the Effect of this Medication on Human Fertility.
Pregnancy:
There is Insufficient Data on the Use of Ursodeoxycholic Acid in Pregnant Women.
Animal Studies Have Shown a Risk of Fetal Damage.
Ursofalk Capsules Should Not be Used During Pregnancy, Unless the Doctor Considers it Absolutely Necessary.
Women of Childbearing Age Should Only Take this Medication with Concomitant Use of Effective Contraception Methods. Non-Hormonal Methods or Low-Dose Estrogen Oral Contraceptives are Recommended. However, in Patients Taking Ursofalk Capsules to Dissolve Gallstones, Effective Non-Hormonal Methods Should be Used, as Oral Hormonal Contraceptives May Enhance Gallstone Formation.
Before Starting Treatment with Ursofalk Capsules, it Should be Checked if the Woman is Not Pregnant.
Breastfeeding:
Only a Few Documented Cases of Ursodeoxycholic Acid Use During Breastfeeding are Available. The Concentration of Ursodeoxycholic Acid in Breast Milk is Very Low, and it is Unlikely to Cause Adverse Effects in Breastfed Infants.

Driving and Operating Machinery

Ursofalk Capsules Do Not Affect the Ability to Drive and Operate Machinery.

3. How to Take Ursofalk Capsules

This Medication Should Always be Taken as Directed by Your Doctor. If You are in Doubt, Consult Your Doctor or Pharmacist.
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
2 Capsules
Body Weight 61 - 80 kg
3 Capsules
Body Weight 81 - 100 kg
4 Capsules
Body Weight Over 100 kg
5 Capsules
Administration of Ursofalk Capsules
Capsules Should be Swallowed Whole with a Small Amount of Water or Other Liquid. The Medication Should be Taken in the Evening, Before Bedtime. The Medication Should be Taken Regularly.
Duration of Treatment
Usually, Dissolution of Gallstones Occurs Within 6-24 Months. If the Diameter of the Stones Does Not Decrease Within 12 Months, Treatment Should be Discontinued.
The Doctor Should Evaluate the Effectiveness of Treatment Every 6 Months. During Subsequent Visits, it Should be Checked if the Stones Have Become Calcified. The Presence of Calcifications is an Indication to Discontinue Treatment.

Treatment of Symptomatic Primary Biliary Cirrhosis (Chronic Inflammation of the Bile Ducts)

Dosage
For the First 3 Months of Treatment, Ursofalk Capsules Should be Taken in the Morning, at Noon, and in the Evening. Once Liver Function Parameters Have Improved, the Daily Dose May be Taken Once in the Evening.

Patients with Difficulty Swallowing Capsules or Patients with a Body Weight Below 47 kg May be Given Ursofalk as an Oral Suspension.
Administration of Ursofalk Capsules
Capsules Should be Swallowed Whole with a Small Amount of Water or Other Liquid. The Medication Should be Taken Regularly.
Duration of Treatment
There is No Time Limit for Taking Ursofalk Capsules 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 Capsules and Then Gradually Increase it (Every Week) Until the Recommended Dose is Reached.

Use in Children (Aged 6 to 18 Years) for the Treatment of Liver Disorders in 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 Medication is Too Strong or Too Weak, Consult Your Doctor or Pharmacist.

Use of a Higher Than Recommended Dose of Ursofalk Capsules

As a Result of Taking Too High a Dose of the Medication, Diarrhea May Occur. If Chronic Diarrhea Occurs, Seek Medical Attention Immediately. During Diarrhea, Fluids and Electrolytes Should be Replenished.

Missing a Dose of Ursofalk Capsules

Do Not Take a Double Dose to Make Up for a Missed Dose, Just Continue Treatment with the Prescribed Dose.

Stopping Treatment with Ursofalk Capsules

Before Stopping Treatment with Ursofalk Capsules or Stopping it Prematurely, Consult Your Doctor.
In Case of Any Doubts Related to the Use of this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, this Medication can Cause Side Effects, Although Not Everybody Gets Them.
Frequent:Not More Than 1 in 10 Treated Patients

• Light, Loose Stools or Diarrhea.

Very Rare:Not More Than 1 in 10,000 Treated Patients

• During Treatment for Primary Biliary Cirrhosis: Severe Pain in the Right Upper Abdominal Quadrant, Worsening of Liver Disease Symptoms, Which Partially Subside After Discontinuation of Treatment,
• Calcification of Gallstones,
• Hives.

Frequency Not Known:Frequency Cannot be Estimated from Available Data

• Itching,
• Nausea, Vomiting.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Leaflet, Inform Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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 Medication.

5. How to Store Ursofalk Capsules

Keep the Medication Out of Sight and Reach of Children.
Store in a Temperature Below 25°C.
Do Not Use Ursofalk Capsules After the Expiration Date Stated on the Blister Packs and Carton After: EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are No Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Ursofalk Capsules Contain

• The Active Substance of the Medication is Ursodeoxycholic Acid. One Capsule Contains 250 mg of Ursodeoxycholic Acid.
• Other Ingredients are: Corn Starch, Colloidal Silicon Dioxide, Magnesium Stearate, Gelatin, Titanium Dioxide, Sodium Lauryl Sulfate, Purified Water.

What Ursofalk Capsules Look Like and What the Pack Contains

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 Authorization Holder and Manufacturer

Dr. Falk Pharma GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany
To Obtain More Detailed Information, 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