Aurourso

Package leaflet: Information for the user

AuroUrso, 250 mg, hard capsules
Acidum ursodeoxycholicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:

1. What AuroUrso is and what it is used for
2. What you need to know 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 AuroUrso is and what it is used for

This medicine contains ursodeoxycholic acid – a natural bile acid. However, only a small amount of it is normally present in human bile.
AuroUrso is used:

• to dissolve cholesterol gallstones. These stones must be radiolucent (not visible on a standard X-ray) and no larger than 15 mm in diameter. Gallbladder function should be preserved despite the presence of gallstone(s).
• in the treatment of bile acid reflux-induced gastritis (reflux gastritis).
• in the symptomatic treatment of primary biliary cirrhosis (PBC, a disease of the bile ducts progressing to liver cirrhosis), in patients without decompensated cirrhosis (diffuse chronic liver disease at a stage where the liver dysfunction associated with the disease can no longer be compensated).
• in the treatment of liver disorders associated with cystic fibrosis (mucoviscidosis) in children and adolescents aged 6 to 18 years.

2. Information before using AuroUrso

When not to use AuroUrso:
if the patient is allergic to ursodeoxycholic acid or to any of the other ingredients
of this medicine (listed in section 6);
if the patient has acute inflammation of the gallbladder or bile ducts;
if the patient's bile ducts are blocked (obstruction of the common bile duct or cystic duct);
if the patient experiences frequent upper abdominal pain resembling spasms (biliary colic);
if the doctor has diagnosed calcified gallstones in the patient;
if the patient has reduced gallbladder contractility;
if the patient is a child with blocked bile ducts (biliary atresia) and poor bile flow, even after surgery.
If in doubt about any of the above symptoms, consult a doctor.
If any of the above symptoms occurred in the past, or if the patient is unsure whether they occurred, this should also be reported to the doctor.

Warnings and precautions
Before starting treatment with AuroUrso, discuss it with your doctor or pharmacist. This medicine should be used under medical supervision.
During the first 3 months of treatment, the doctor should monitor liver function parameters regularly every 4 weeks. Subsequent checks should be performed every 3 months.
If this medicine is used to dissolve gallstones, the doctor should perform an ultrasound examination of the gallbladder after 6–10 months of treatment.
Female patients using this medicine to dissolve gallstones are advised to use effective non-hormonal methods of contraception, as hormonal contraceptives (e.g. "the pill") may promote gallstone formation.
When using this medicine to treat primary biliary cholangitis (PBC), symptoms (e.g. itching) may rarely worsen at the beginning of treatment. In such a case, contact your doctor to consider reducing the initial dose.
If diarrhoea occurs, consult your doctor, as it may be necessary to reduce the dose or discontinue treatment with AuroUrso.

Children
There are no age restrictions for the use of AuroUrso, except in cases of cystic fibrosis (in patients aged 6 to 18 years).

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

Medicines which, when taken together with AuroUrso, may reduce its effectiveness:

• colestyramine, colestipol (medicines used to lower blood lipid levels), or antacids containing aluminium hydroxide or smectite (aluminium oxide) (bile acid-binding agents). If the patient is taking a medicine containing any of these active substances, it should be taken at least 2 hours before or after AuroUrso.

Use of AuroUrso may reduce the effectiveness of 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, the doctor may adjust the dose of these medicines.

Use of AuroUrso may alter the effect of the following medicines:

• cyclosporine (a medicine that suppresses the immune system). If the patient is being treated with cyclosporine, the doctor should monitor its blood concentration. If necessary, the doctor will adjust the dose;
• rosuvastatin (a medicine used to treat high blood lipid levels).

If the patient is using AuroUrso to dissolve gallstones, they should inform the doctor about concomitant use of medicines containing oestrogen hormones (e.g. "the pill") and certain cholesterol-lowering medicines such as clofibrate. These medicines may promote gallstone formation and thus counteract the dissolving effect of AuroUrso.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data or limited data on the use of ursodeoxycholic acid in pregnant women. AuroUrso should not be used during pregnancy unless the doctor considers it absolutely necessary. Based on animal studies, the use of ursodeoxycholic acid during pregnancy may affect the development of the unborn child.

Women of childbearing potential
Even if the patient is not pregnant, she should discuss this with her doctor. Women of childbearing potential should only be treated if using reliable contraception. Non-hormonal contraceptives or hormonal contraceptives containing low-dose oestrogen ("the pill") are recommended. If the patient is taking AuroUrso to dissolve gallstones, non-hormonal contraceptives should be used, as hormonal contraceptives may promote gallstone formation.
Before starting treatment, the doctor should exclude 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, adverse effects in breastfed infants are unlikely.

Effect on fertility/reproductive capacity
Animal studies have not shown any effect of this medicine on fertility/reproductive capacity. There is currently no experience demonstrating an effect of this medicine on fertility/reproductive capacity in humans.

Driving and using machines
No special precautions are required.

AuroUrso contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use AuroUrso

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dissolution of 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
over 100 kg: 5 capsules
The capsules should be swallowed whole with water or another liquid. The capsules should be taken
in the evening before bedtime. The medicine should be taken regularly.
Duration of treatment
Dissolution of gallstones usually takes 6 to 24 months. If the diameter of the gallstones has not
decreased 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 whether calcification of the gallstones has occurred since the last visit. If this
occurs, your doctor will discontinue treatment.
Treatment of reflux gastritis
Dosage and administration of AuroUrso
Take one capsule of AuroUrso in the evening before bedtime; swallow the capsule whole with water or
another liquid.
Duration of treatment
AuroUrso is usually used for 10–14 days in the treatment of reflux gastritis. Your doctor will decide how
long you should continue taking the capsules, depending on your clinical response.
Treatment of primary biliary cirrhosis (chronic inflammation of the bile ducts)
Dosage and administration of AuroUrso
During the first 3 months of treatment, AuroUrso should be taken in the morning, at midday, and in the
evening. As liver function test results improve, the total daily dose may be taken once daily in the
evening.

Duration of treatment
There are no time limitations regarding the use of AuroUrso in primary biliary cirrhosis of the liver.
If the effect of AuroUrso appears too strong or too weak, consult a physician or pharmacist.
Method of administration
Capsules should be swallowed whole with water or another liquid. Capsules should be taken regularly. If a patient has difficulty swallowing or weighs less than 47 kg, other formulations containing 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, the physician may increase the dose up to 30 mg/kg body weight per day.

Overdose of AuroUrso
In case of overdose, diarrhoea may occur. If chronic diarrhoea develops,
consult a doctor immediately. During episodes of diarrhoea, fluids should be replenished
to maintain fluid and electrolyte balance.
Missed dose of AuroUrso
Do not use a double dose to make up for a missed dose; continue treatment with the prescribed dose.
Discontinuation of AuroUrso treatment
Before stopping treatment with AuroUrso or discontinuing treatment prematurely, always consult
your doctor.
If you have any further doubts regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common (may affect less than 1 in 10 people)

• soft, loose stools or diarrhoea.

Very rare (may affect less than 1 in 10,000 people)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store AuroUrso

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What AuroUrso contains

• The active substance is ursodeoxycholic acid. Each capsule contains 250 mg of ursodeoxycholic acid.
• The other ingredients are: maize starch, colloidal anhydrous silica, pregelatinized starch (maize), sodium lauryl sulfate, magnesium stearate.

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

What AuroUrso looks like and contents of the pack
Hard capsules
AuroUrso 250 mg, hard capsules: [Approximately 22 mm in size]
White opaque cap and white opaque body of a size "0" gelatin capsule printed with “UROH” on the cap and “250” on the body in black ink, filled with white or almost white granular powder.

AuroUrso capsules are available in blister packs.
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 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 medicinal product is authorised in 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