Ursopol

Package Leaflet: Information for the Patient

Ursopol, 150 mg, Hard Capsules

Ursopol, 300 mg, Hard Capsules

Ursodeoxycholic Acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ursopol and what is it used for
• 2. Important information before taking Ursopol
• 3. How to take Ursopol
• 4. Possible side effects
• 5. How to store Ursopol
• 6. Contents of the pack and other information

1. What is Ursopol and what is it used for

Ursopol is a medicine that contains ursodeoxycholic acid as the active substance - a bile acid that occurs naturally in small amounts in bile.
It inhibits the absorption of cholesterol in the intestines, reduces the secretion of cholesterol into bile, and causes the gradual dissolution of cholesterol gallstones. This prevents the formation of cholesterol gallstones and dissolves existing cholesterol gallstones (provided they are not too large or calcified). In liver and bile duct diseases, the medicine has a protective effect on liver cells, improves their secretory function, and regulates immune processes (i.e., processes involving the immune system).
Ursopol is used:

• to dissolve cholesterol gallstones with a diameter not exceeding 15 mm, permeable to X-rays, in patients who, despite the presence of gallstones, have preserved gallbladder function;
• to treat symptomatic primary biliary cirrhosis of the liver, provided that uncompensated cirrhosis does not occur;
• to treat symptomatic other liver and bile duct diseases of various etiologies;
• to treat symptomatic intrahepatic cholestasis of pregnancy in the second and third trimester of pregnancy;
• to treat symptomatic gastritis caused by bile reflux;
• to treat symptomatic liver and bile duct function disorders associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

2. Important information before taking Ursopol

When not to take Ursopol

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

Warnings and precautions

Ursopol should be taken under medical supervision.
During treatment with the medicine, the doctor will recommend monitoring liver function parameters every 4 weeks for the first 3 months of treatment, and then every 3 months.
If Ursopol is used to dissolve gallstones, the doctor should perform a gallbladder examination after the first 6-10 months of treatment.
In female patients taking Ursopol to dissolve gallstones, it is recommended to use effective non-hormonal methods of contraception, as oral hormonal contraceptives may exacerbate gallstone formation.
In the case of using Ursopol to treat primary biliary cirrhosis of the liver (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 consult a doctor, as it may be necessary to reduce the dose or discontinue treatment with Ursopol.

Children and adolescents

Ursopol can be used in children and adolescents with liver and bile duct function disorders associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

Ursopol and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The effect of Ursopol may be weaker when taken with the following medicines:

• cholestyramine, cholestypol (medicines that lower blood cholesterol levels)
• antacids containing aluminum compounds (used to alleviate symptoms of hyperacidity and heartburn). If it is necessary to take a medicine containing one of these substances, it should be taken 2 hours before or 2 hours after taking Ursopol.

Ursopol may reduce the effect of:

• ciprofloxacin (an antibiotic used to treat bacterial infections)
• dapsone (a medicine used to treat leprosy)
• nifedipine (used to lower blood pressure) and other medicines metabolized in a similar way. If necessary, the doctor will recommend changing the doses of these medicines.

Ursopol may change the effect of:

• cyclosporin (a medicine that suppresses the immune system, used, among other things, after transplants). In patients treated with cyclosporin, the doctor may recommend monitoring its blood levels and, if necessary, adjusting the dose of cyclosporin;
• rosuvastatin (a medicine used to lower high blood cholesterol levels).

If you are taking Ursopol 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, which is a counter-effect to the treatment with Ursopol.

Ursopol with food and drink

Ursopol should be taken during meals, with a small amount of liquid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ursopol should not be taken during pregnancy unless your doctor considers it absolutely necessary.
Before starting treatment, the doctor should ensure that you are not pregnant.
Early pregnancy should be ruled out before starting treatment.
Ursopol should not be taken during the first trimester of pregnancy without a clear need. Ursopol may be used during the second and third trimesters of pregnancy if the doctor considers it necessary.
Women of childbearing age taking Ursopol should use effective methods of contraception. In patients taking Ursopol to dissolve gallstones, effective non-hormonal methods should be used, as oral hormonal contraceptives may exacerbate gallstone formation.
Breastfeeding
In a few documented cases, it has been shown that the concentration of ursodeoxycholic acid in breast milk is very low, so it is not expected to cause side effects in breastfed children.

Driving and using machines

Ursopol has no influence or negligible influence on the ability to drive and use machines.

Ursopol 150 mg and 300 mg contains the colorant azorubine

The medicine may cause allergic reactions.

Ursopol 150 mg contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Ursopol 300 mg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Ursopol

This medicine should always be taken exactly as prescribed by your doctor. In case of doubts, consult your doctor or pharmacist.
Adults:
Gallstones
Orally, 8 to 10 mg/kg body weight per day in 2 or 3 divided doses during meals (e.g., for a patient weighing 75 kg, the dose is 2 capsules of 150 mg or 1 capsule of 300 mg twice a day). In obese patients, the dose is increased to 15 mg/kg body weight per day.
Treatment is long-term and usually lasts from 6 months to 2 years, depending on the size and composition of the gallstones. It is recommended to continue treatment for at least 3 months after radiological or ultrasonographic confirmation of gallstone dissolution.
Primary biliary cirrhosis
Orally, 13 to 15 mg/kg body weight per day in 2 or 3 divided doses over a period of 1 to 2 years (e.g., for a patient weighing 75 kg, the dose is 7 capsules of 150 mg per day, i.e., 2 capsules in the morning, 2 capsules at noon, and 3 capsules in the evening). You can also use capsules containing a higher dose of ursodeoxycholic acid. Capsules should be taken whole, during meals, with a small amount of liquid.
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 Ursopol and then gradually increase the dose (every week) until the recommended dose is reached.
Other liver and bile duct diseases of various etiologies:
From 10 to 20 mg/kg body weight per day in 3 divided doses. This corresponds to 4 to 14 capsules of 150 mg or 2 to 7 capsules of 300 mg. If it is not possible to divide the daily dose evenly, the larger dose should be given in the evening.
Intrahepatic cholestasis of pregnancy:
From 10 to 16 mg/kg body weight per day in 2-3 divided doses. This corresponds to 4 to 10 capsules of 150 mg or 2 to 5 capsules of 300 mg.
Gastritis caused by bile reflux:
3 capsules of 150 mg twice a day or 1 capsule of 300 mg three times a day.

Use in children and adolescents

Liver and bile duct function disorders associated with cystic fibrosis
Treatment should be started at 20 mg/kg body weight per day in 2-3 divided doses. This corresponds to, depending on body weight, 4 to 10 capsules of 150 mg or 2 to 5 capsules of 300 mg. If necessary, the dose can be increased to 30 mg/kg body weight per day.

Elderly patients

No dose adjustment is necessary.

Taking a higher dose of Ursopol than recommended

In case of taking too high a dose of the medicine, consult a doctor.
In case of taking too much medicine, diarrhea may occur. If it does, the doctor will reduce the dose, and if diarrhea persists despite this - will recommend discontinuing the medicine. During diarrhea, fluids and electrolytes should be supplemented.
However, the occurrence of symptomatic overdose of the medicine is unlikely, as increasing the dose worsens the absorption of ursodeoxycholic acid (more is excreted in the stool).

Missing a dose of Ursopol

In case of missing the next dose of the medicine, take it as soon as possible. However, if the time for the next dose is approaching, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ursopol

In case of any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• light-colored stools, diarrhea.

Very rare side effects (may affect up to 1 in 10,000 people):

• severe pain in the right upper quadrant of the abdomen (in patients with primary biliary cirrhosis)
• calcification of gallstones
• worsening of liver disease symptoms, which partially resolve after discontinuation of the medicine (in patients with primary biliary cirrhosis),
• hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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.
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 Ursopol

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ursopol contains

• The active substance of the medicine is ursodeoxycholic acid (150 mg/capsule or 300 mg/capsule).
• The other ingredients of the medicine are: Ursopol 150 mg: microcrystalline cellulose, lactose monohydrate, magnesium stearate, talc, yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, azorubine (E 122), quinoline yellow (E 104), patent blue V (E 131). Ursopol 300 mg: microcrystalline cellulose, colloidal silica, sodium lauryl sulfate, talc, magnesium stearate, yellow iron oxide (E 172), quinoline yellow (E 104), indigo carmine (E 132), titanium dioxide (E 171), gelatin, azorubine (E 122), patent blue V (E 131).

What Ursopol looks like and contents of the pack

Ursopol 150 mg: yellow-brown capsules filled with light cream powder.
Ursopol 300 mg: light green-brown capsules filled with light cream powder.
Blister packs of aluminum/PVC in a cardboard box.
Ursopol 150 mg: 20 capsules (2 blisters of 10 capsules), 50 capsules (5 blisters of 10 capsules)
Ursopol 300 mg: 50 capsules (5 blisters of 10 capsules)

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: