Aurourso

Package Leaflet: Information for the User

AuroUrso, 250 mg, hard capsules

Ursodeoxycholic acid

Read the package leaflet carefully before taking the medicine, 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 medicine has been prescribed to you by a doctor, 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 package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What is AuroUrso and what is it used for

This medicine contains ursodeoxycholic acid, a natural bile acid. However, only a small amount of it is found in human bile.

AuroUrso is used:

• to dissolve cholesterol gallstones. These stones must be radiolucent (not visible on a standard X-ray) and not larger than 15 mm in diameter. The gallbladder must be functioning despite the presence of a stone (stones).
• to treat reflux esophagitis caused by bile acid reflux.
• to treat symptomatic primary biliary cirrhosis of the liver (primary biliary cirrhosis, PBC, a disease of the bile ducts leading to liver cirrhosis), in patients without decompensated liver cirrhosis (a chronic liver disease at a stage where liver function impairment can no longer be compensated).
• to treat liver disorders associated with cystic fibrosis in children and adolescents aged 6 to 18 years.

2. Important information before taking AuroUrso

When not to take AuroUrso:

if you are allergic to ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6);
if you have acute inflammation of the gallbladder or bile ducts;
if your bile ducts are blocked (obstruction of the common or gallbladder duct);
if you have frequent pains in the upper abdomen resembling colic (biliary colic);
if your doctor has found calcified gallstones;
if your gallbladder contraction ability is reduced;
if you are a child with bile duct closure (bile duct atresia) and poor bile flow, even after surgery.
In case of doubts about the above symptoms, consult a doctor. If you have had any of these symptoms in the past or are unsure if they have occurred, also tell your doctor.

Warnings and precautions

Before taking AuroUrso, discuss it with your doctor or pharmacist. This medicine should be taken under medical supervision.
During the first 3 months of treatment, your doctor should check your liver function regularly every 4 weeks. Further checks should be performed every 3 months.
If you are taking AuroUrso to dissolve gallstones, your doctor should perform a gallbladder examination after the first 6-10 months of treatment.
Women taking AuroUrso to dissolve gallstones are advised to use effective non-hormonal methods of contraception, as hormonal contraceptives (birth control pills) may promote the formation of gallstones.
In the case of using this medicine to treat primary biliary cirrhosis, in rare cases, symptoms (e.g., itching) may worsen at the beginning of treatment. In such a situation, consult your doctor to reduce the initial dose.
If you experience diarrhea, consult your doctor, as it may be necessary to reduce the dose or discontinue treatment with AuroUrso.

Children

There are no age restrictions for taking AuroUrso, except for cystic fibrosis (in children aged 6 to 18 years).

AuroUrso and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The effects of the following medicines may be altered (interactions):

• Cholestyramine, colestipol (medicines used to lower blood lipid levels) or antacids containing aluminum hydroxide or smectite (aluminum oxide) (bile acid binders). If you are taking a medicine containing one of these active substances, take it at least 2 hours before or after taking AuroUrso.

Taking AuroUrso may reduce the effectof the following medicines:

• Ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to treat high blood pressure), and other medicines eliminated from the body in a similar way; if necessary, your doctor may adjust the dose of these medicines.

Taking AuroUrso may change the effectof the following medicines:

• Cyclosporine (a medicine that reduces the activity of the immune system). If you are being treated with cyclosporine, your doctor should check its level in your blood. If necessary, your doctor will adjust the dose;
• Rosuvastatin (a medicine used to treat high blood lipid levels).

If you are taking AuroUrso to dissolve gallstones, tell your doctor about any other medicines you are taking that contain estrogen hormones (e.g., birth control pills) and about certain cholesterol-lowering medicines, such as clofibrate. These medicines may promote the formation of gallstones and thus counteract their dissolution by AuroUrso.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are limited data on the use of ursodeoxycholic acid in pregnant women. Do not take AuroUrso during pregnancy unless your doctor considers it absolutely necessary. Based on animal studies, taking ursodeoxycholic acid during pregnancy may affect the development of the unborn child.
Women of childbearing age
Even if you are not pregnant, you should talk to your doctor. Women of childbearing age should only be treated with concurrent use of reliable non-hormonal methods of contraception. Non-hormonal contraceptives or hormonal contraceptives with low estrogen doses (birth control pills) are recommended. If you are taking AuroUrso to dissolve gallstones, you should use non-hormonal contraceptives, as hormonal contraceptives may promote the formation of gallstones.
Before starting treatment, your doctor should rule out pregnancy.
Breastfeeding
There are only a few documented cases of ursodeoxycholic acid use during breastfeeding. The concentration of ursodeoxycholic acid in breast milk is very low. Therefore, the occurrence of side effects in breastfed infants is unlikely.
Fertility
Animal studies have not shown any effect of this medicine on fertility. So far, there is no experience showing an effect of this medicine on human fertility.

Driving and using machines

No special precautions are necessary.

AuroUrso contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take AuroUrso

Take this medicine always as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.

Dissolving cholesterol gallstones

Dosage and administration of AuroUrso

The recommended dose is 10 mg of ursodeoxycholic acid per kg of body weight per day, as follows:
up to 60 kg
2 capsules

• 61 – 80 kg 3 capsules
• 81 – 100 kg 4 capsules above 100 kg 5 capsules

Swallow the capsules whole, with water or another liquid. Take the capsules in the evening before bedtime. Take the medicine regularly.

Duration of treatment

Dissolving gallstones usually takes 6-24 months. If the diameter of the gallstones does not decrease within 12 months, treatment should be discontinued.
Your doctor should assess the effectiveness of treatment every 6 months. During follow-up visits, your doctor should check if the gallstones have calcified since the last visit. If so, your doctor will discontinue treatment.

Treatment of reflux esophagitis

Dosage and administration of AuroUrso

Take one AuroUrso capsule in the evening before bedtime; swallow the capsule whole, with water or another liquid.

Duration of treatment

AuroUrso is usually taken for 10-14 days to treat reflux esophagitis. Your doctor will decide how long you should take the capsules, depending on the change in your condition.

Treatment of primary biliary cirrhosis of the liver (chronic bile duct inflammation)

Dosage and administration of AuroUrso

For the first 3 months of treatment, take AuroUrso in the morning, at noon, and in the evening. As liver function test results improve, the total daily dose may be taken once a day in the evening.

Duration of treatment

There is no time limit for taking AuroUrso for primary biliary cirrhosis of the liver.
If you feel that the effect of AuroUrso is too strong or too weak, consult your doctor or pharmacist.

Method of administration

Swallow the capsules whole, with water or another liquid. Take the capsules regularly. If you have difficulty swallowing or weigh less than 47 kg, other forms of ursodeoxycholic acid are available.

Use in children and adolescents (aged 6 to 18 years) for the treatment of liver disorders associated with cystic fibrosis

Dosage

The recommended daily dose is 20 mg/kg body weight, divided into 2-3 doses. If necessary, your doctor may increase the dose to 30 mg/kg body weight per day.

Taking a higher dose of AuroUrso than recommended

In case of overdose, diarrhea may occur. If chronic diarrhea occurs, consult your doctor immediately. During diarrhea, fluids should be replenished to maintain water and electrolyte balance.

Missing a dose of AuroUrso

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

Stopping treatment with AuroUrso

Before stopping treatment with AuroUrso or prematurely ending treatment, always consult your doctor.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, AuroUrso can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people)

• soft, loose stools or diarrhea.

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

• in the treatment of primary biliary cirrhosis: severe, right-sided, upper abdominal pain, severe worsening of liver fibrosis, which partially resolves after discontinuation of treatment;
• calcification of gallstones (hardening of gallstones due to calcium deposition);
• hives.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AuroUrso

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
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 AuroUrso contains

• The active substance of AuroUrso is ursodeoxycholic acid. Each capsule contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: cornstarch, colloidal silica, anhydrous, cornstarch, sodium lauryl sulfate, magnesium stearate.

Capsule shell
Cap and body:titanium dioxide (E 171), gelatin, sodium lauryl sulfate
Printing ink:shellac (E 904), iron oxide black (E 172), potassium hydroxide (E 525)

What AuroUrso looks like and contents of the pack

Hard capsules
AuroUrso, 250 mg, hard capsules: [Size approximately 22 mm]
White opaque cap and white opaque body, hard gelatin capsule size "0" with printing "UROH" on the cap and "250" on the body in black ink, filled with a white or off-white granular powder.
AuroUrso capsules are available in blisters.

Pack sizes:

Ursodeoxycholic acid capsules: 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 200 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Urso 250 Aurobindo Kapseln
Malta:
Ursodeoxycholic acid Aurobindo 250 mg capsules
Poland:
AuroUrso
Portugal:
Ácido ursodesoxicólico Generis

Date of last revision of the package leaflet: 10/2023