Proursan

Package Leaflet: Information for the User

Proursan, 500 mg, Coated Tablets

Ursodeoxycholic Acid

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

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Proursan and What is it Used for
• 2. Important Information Before Taking Proursan
• 3. How to Take Proursan
• 4. Possible Adverse Reactions
• 5. How to Store Proursan
• 6. Package Contents 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 Gallstones, Formed as a Result of Excessive Cholesterol Accumulation in the Gallbladder (in Patients who are not Suitable for Surgical Treatment), 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 Characterized by Damage to the Bile Ducts in the Liver, Leading to Bile Accumulation. This may Cause Liver Scarring (Liver Cirrhosis). The Liver should not be so Damaged that its Normal Function is Impaired.
• -in Liver Disease in the Course of a Disease Called Cystic Fibrosis (Fibrotic Cystic Disease) in Children Aged 6 to 18.

2. Important Information Before Taking Proursan

When not to Take Proursan:

• if the Patient is Allergic to Bile Acids (such as Ursodeoxycholic Acid) or any of the other Ingredients of this Medication (listed in Section 6);
• if the Patient has Acute Inflammation of the Gallbladder and Bile Ducts;
• if the Patient has a Blockage of the Common Bile Duct or the Gallbladder Duct (Bile Duct Obstruction);
• if the Patient Experiences Frequent Pain in the Upper Abdomen, Resembling Cramps (Biliary Colic Episodes)
• if the Patient has Calcified Gallstones.
• 1 -
• if the Patient has Impaired Gallbladder Function
• if the Patient is a Child with a Diagnosis of Bile Duct Atresia (Bile Duct Closure) and Insufficient Bile Flow, even after 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 a Doctor.

Warnings and Precautions

Before Starting Proursan, Discuss it with a Doctor or Pharmacist. 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 Medication is Used to Dissolve Gallstones, the Doctor should Perform an Imaging Examination of the Gallbladder after the First 6-10 Months of Treatment. If the Patient is Taking Proursan to Dissolve Gallstones, they should Inform the Doctor about any Medications Containing Estrogen Hormones, as these Medications may Stimulate the Formation of Gallstones. In the Case of Treatment of Primary Biliary Cirrhosis of the Liver, Rarely, a Worsening of Symptoms may Occur at the Beginning of Treatment. In such a Situation, Consult a Doctor to Reduce the Initial Dose. In Case of Diarrhea, Immediately Contact a Doctor, as it may be Necessary to Reduce the Dose or Discontinue Treatment.

Children

Proursan can be Used Regardless of Age. The Use of Proursan Depends on Body Weight and the Type of Disease.

Proursan and Other Medications

Inform a Doctor if the Patient is Taking or Using Medications Containing the Following Active Substances. The Action of these Medications may be Altered (Interactions):

• Cholestyramine, Colestipol (a Medication that Lowers Blood Fat Levels) or Antacids Containing Aluminum Hydroxide or Aluminum Oxide (Medications that Bind Stomach Acid): If the Use of a Medication Containing any of these Substances is Necessary, it should be Taken at Least 2 Hours Before or After Proursan.

Proursan may Reduce the Actionof the Following Medications:

• Ciprofloxacin and Dapsone (Antibiotics), Nitrendipine (Used to Treat High Blood Pressure) and other Medications Metabolized in a Similar Way. If Necessary, the Doctor may Adjust the Doses of these Medications.

Proursan may Alter the Actionof the Following Medications:

• Cyclosporin (an Immunosuppressive Medication) In Patients Treated with Cyclosporin, the Doctor should Monitor the Cyclosporin Blood Level. If Necessary, the Doctor will Adjust the Dose.
• Rosuvastatin (Used to Treat High Cholesterol and Similar Diseases).

If the Patient is Taking Proursan to Dissolve Gallstones, they should Inform the Doctor about any Medications Containing Estrogen Hormones or Medications

• 2 -

Lowering Blood Cholesterol Levels, such as Clofibrate. These Medications Stimulate the Formation of Gallstones, i.e., they Act Against Proursan. Inform a Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to Have a Child, they should Consult a Doctor or Pharmacist Before Taking this Medication. Pregnancy There is Insufficient Data on the Use of Ursodeoxycholic Acid in Pregnant Women. Animal Studies have Shown a Harmful Effect on Reproduction. Proursan should not be Used in Pregnancy without a Clear Need. Women of Childbearing Age The Patient should Consult a Doctor, even if they are not Pregnant. Women of Childbearing Age should only Take this Medication with the Concurrent Use of Effective Contraception Methods: Non-Hormonal Methods or Low-Dose Estrogen Oral Contraceptives are Recommended. However, if the Patient is Taking Proursan to Dissolve Gallstones, they should Use Effective Non-Hormonal Contraceptive Methods, as Oral Hormonal Contraceptives may Stimulate the Formation of Gallstones. Before Starting Treatment, the Doctor must Rule out Pregnancy in the Patient. Breastfeeding It has been Shown in a Few Documented Cases that the Concentration of Ursodeoxycholic Acid in Breast Milk of Breastfeeding Women is Very Low, so no Adverse Reactions are Expected in Breastfed Infants. Fertility Animal 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 Operating Machinery

No Effect has been Observed on the Ability to Drive and Operate Machinery. Proursan ContainsSodium Glycolate Type A Starch The Medication Contains Less than 1 mmol (23 mg) of Sodium per Coated Tablet, i.e., the Medication is Considered "Sodium-Free".

3. How to Take Proursan

This Medication should Always be Taken as Directed by a Doctor or Pharmacist. In Case of Doubts, Consult a Doctor or Pharmacist.

To Dissolve Cholesterol Gallstones

• 3 -

over 100 kg 2½ Tablets For Patients with a Body Weight of Less than 47 kg or Unable to Swallow Proursan, other Forms of the Medication are Available (Suspension), Containing Ursodeoxycholic Acid.

Method of Administration

Tablets should be Swallowed Whole, with Water or another Liquid. Tablets should be Taken in the Evening, Before Bedtime. The Medication 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 Efficacy of Treatment every 6 Months. During Subsequent Visits, it should be Checked if 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

For the First 3 Months of Treatment, Proursan 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. Proursan, 500 mg, Coated Tablets

First 3 Months Later Therapy

Body Weight (kg) Morning Noon Evening Evening (Once a Day) 47-62 ½ ½ ½ 1½ 63-78 ½ ½ 1 2 79-93 ½ 1 1 2½ 94-109 1 1 1 3 over 110 1 1 1½ 3½ For Patients with a Body Weight of Less than 47 kg or Unable to Swallow Proursan, other Forms of the Medication are Available (Suspension), Containing Ursodeoxycholic Acid.

Method of Administration

Tablets should be Swallowed Whole (without Chewing), with Water or another Liquid. The Medication should be Taken Regularly.

Duration of Treatment

There are no Time Limits for Taking Proursan in Primary Biliary Cirrhosis of the Liver. Note: In Patients with Primary Biliary Cirrhosis of the Liver, a Worsening of Symptoms may Occur at the Beginning of Treatment. One of the Symptoms may be an Increase in Itching. This Happens in Rare Cases. If this Occurs, Treatment can be Continued, Using a Lower Daily Dose of Proursan. Then, the Doctor will Increase the Daily Dose every Week, until the Recommended Dose is Reached Again.

Use in Children (Aged 6 to 18) in the Treatment of Liver Disease in the Course of Cystic Fibrosis (Fibrotic Cystic Disease)

A Dose of Approximately 20 mg per kg of Body Weight per Day is Recommended, Divided into 2-3 Doses. If Necessary, the Doctor may Increase the Dose to 30 mg per kg of Body Weight per Day.

• 4 -

In Case of a Feeling that the Action of Proursan is too Strong or too Weak, Consult a Doctor or Pharmacist.

Overdose of Proursan

In Case of Overdose, Diarrhea may Occur. In Case of Chronic Diarrhea, Immediately Inform a Doctor. During Diarrhea, Drink Plenty of Fluids to Replenish Water and Electrolytes in the Body.

Missed Dose of Proursan

Do not Take a Double Dose to Make up for a Missed Dose, just Continue Treatment as Prescribed.

Discontinuation of Proursan

Before Discontinuing Treatment with Proursan or Stopping Therapy Early, Always Consult a Doctor. In Case of any Further Doubts about the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, Proursan can Cause Adverse Reactions, although not Everybody gets them. Common Adverse Reactions(may Occur in up to 1 in 10 People)

• Light, Loose Stools or Diarrhea

Very Rare Adverse Reactions(may Occur in up to 1 in 10,000 Patients)

• During Treatment of Primary Biliary Cirrhosis of the Liver: Severe Pain in the Right Upper Abdomen, Severe Worsening of Liver Scarring Symptoms, which Partially Subsides after Discontinuation of the Medication.
• Calcification of Gallstones due to Calcium Accumulation.
• Hives

Reporting Adverse Reactions

If any Adverse Reactions Occur, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Adverse Reactions can also be Reported to the Marketing Authorization Holder. By Reporting Adverse Reactions, more Information can be Collected on the Safety of the Medication.

5. How to Store Proursan

Store the Medication in a Place that is not Visible and not Accessible to Children. Do not Use this Medication after the Expiration Date Stated on the Box and Blister after "EXP". The Expiration Date Refers to the Last Day of the Specified Month. There are no Special Precautions for Storing the Medication. Medications should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Proursan Contains

• The Active Substance of Proursan is Ursodeoxycholic Acid. Each Tablet Contains 500 mg of Ursodeoxycholic Acid.
• Other Ingredients are:
• Tablet Core: Corn Starch, Corn Starch Glycolate, Carboxymethylcellulose (Type A), Colloidal Silicon Dioxide, Magnesium Stearate,
• Tablet Coating: Hypromellose 6, Titanium Dioxide, Macrogol 400.

What Proursan Looks Like and What the Package Contains

Proursan is a Almost White, Prolonged, Coated Tablet with a Break Line. The Tablet can be Divided into Equal Doses. Proursan is Available in Packages Containing 10, 20, 30, 50, 60, 90, or 100 Tablets. Not all Package 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 about this Medication, Contact the Local Representative of the Marketing Authorization Holder: PRO.MED.PL Sp. z o.o. Email: biuro@promedcs.com

This Medicinal Product is Authorized for Marketing in the Member States of the European Economic Area under the Following Names:

Germany: Ursonorm 500 mg Film-Coated Tablets Austria: Ursonorm 500 mg Film-Coated Tablets Czech Republic: URSOSAN FORTE Poland: Proursan Slovakia: URSOSAN FORTE 500 mg Film-Coated Tablets

Date of the Last Update of the Package Leaflet:

• 6 -