Ursobilane 500 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ursobilane 500 mg capsules

Ursodeoxycholic acid

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ursobilane 500 mg capsules are and what they are used for
2. What you need to know before taking Ursobilane 500 mg capsules
3. How to take Ursobilane 500 mg capsules
4. Possible adverse effects
5. How to store Ursobilane 500 mg capsules
6. Contents of the pack and other information

1. What Ursobilane 500 mg capsules are and what they are used for

The active substance in Ursobilane 500 mg capsules is ursodeoxycholic acid, which belongs to a group of medicines called bile acid dissolving agents.

It is used to dissolve radiolucent cholesterol gallstones when the gallbladder is functioning (this must have been confirmed by a test called oral cholecystography). Ursobilane is also used to treat a rare disease of the bile ducts and liver called primary biliary cirrhosis.

2. What you need to know before starting to take Ursobilane 500 mg capsules

Do not take Ursobilane 500 mg capsules

• If you are allergic to ursodeoxycholic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have gastric or duodenal ulcer.
• If you have a non-functioning gallbladder.
• If you have calcified cholesterol stones, radiopaque stones, or radiolucent pigment gallstones.
• If you have liver or intestinal disorders that may interfere with the blood circulation of bile salts.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor before starting to take Ursobilane 500 mg capsules:

• If you are taking medicines that may cause cholesterol accumulation in the bile, such as estrogens and hormonal contraceptives.
• If you are being treated with medicines that may potentially be toxic to the liver.

During treatment with Ursobilane 500 mg capsules, your doctor will carry out blood tests to monitor your liver function.

Children and adolescents

The safety and efficacy of Ursobilane have not been established in children; therefore, its use is not recommended in this population.

Other medicines and Ursobilane 500 mg capsules

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ursobilane 500 mg capsules may interfere with other medicines such as:

• Antacids containing aluminium.
• Cholestyramine or colestipol, or other drugs used to treat high cholesterol.
• Antibiotics: neomycin.
• Hormonal contraceptives, such as estrogens or progestogens.

Taking Ursobilane 500 mg capsules with food, drinks and alcohol

It is preferable to take the medicine with meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

This medicine should not be used during breastfeeding.

Driving and using machines:

Ursobilane 500 mg capsules have no effect on the ability to drive or operate machinery.

Ursobilane 500 mg capsules contain the colouring agent Orange Yellow S (E-110)

This medicine may cause allergic reactions because it contains Orange Yellow S (E-110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Ursobilane 500 mg capsules

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Ursobilane 500 mg capsules are intended for use in adults only.

The capsules should be swallowed whole, without chewing, with a little liquid. If you have difficulty swallowing, you may disperse the powder contained in the capsules into a liquid.

Take Ursobilane 500 mg capsules preferably with meals.

The recommended dose for the treatment of gallstones is 1 capsule per day (8–10 mg/kg/day).

It is important that you visit your doctor regularly so that your condition can be monitored. While taking this medicine, you will need to have laboratory tests every few months to check whether the gallstones are dissolving and to ensure your liver is functioning properly.

The recommended dose for the treatment of primary biliary cirrhosis is 2 capsules per day (13–15 mg/kg/day), divided into several doses.

Your doctor will advise you to follow a diet moderate in calories and cholesterol during treatment with Ursobilane 500 mg capsules.

If you take more Ursobilane 500 mg capsules than you should

The most common symptom of overdose with Ursobilane 500 mg capsules is diarrhea.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ursobilane 500 mg capsules

Do not take a double dose to make up for a missed dose.

If you stop taking Ursobilane 500 mg capsules

Do not stop treatment without consulting your doctor, as otherwise the intended effect will not be achieved.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects may occur with certain frequencies, defined as follows:

Very common: may affect more than 1 in every 10 patients.

Common: may affect between 1 and 10 in every 100 patients.

Uncommon: may affect between 1 and 10 in every 1,000 patients.

Rare: may affect between 1 and 10 in every 10,000 patients.

Very rare: may affect fewer than 1 in every 10,000 patients.

Frequency not known: frequency cannot be estimated from the available data.

Gastrointestinal disorders

Rare: nausea and vomiting, difficulty in digestion, taste disturbances, biliary pain, abdominal pain, sensation of gas, and constipation.

Very rare: diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Ursobilane 500 mg capsules

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ursobilane 500 mg capsules

The active substance is ursodeoxycholic acid. Each capsule contains 500 mg of ursodeoxycholic acid.

The other excipients are magnesium stearate, powdered cellulose, colloidal silicon dioxide, and sodium carboxymethyl starch (type A) (from potato).

Components of the capsule shell: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), orange yellow S (E-110), and indigotine (indigo carmine) (E-132).

Appearance of the medicine and contents of the pack

Green and orange capsules.

Aluminum-PVC/PVDC blister packs containing 60 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona - Spain

Manufacturer

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Laboratorio Aldo-Unión, S.L.

C/Baronesa de Maldá, 73

08950 Esplugues de Llobregat

(Barcelona) Spain

Date of the most recent review of this leaflet: January 2012

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)