URSOBILANE 500 mg CAPSULES

Introduction

Patient Information Leaflet

Ursobilane 500 mg capsules

Ursodeoxycholic acid

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Ursobilane 500 mg capsules are and what they are used for
2. What you need to know before you take Ursobilane 500 mg capsules
3. How to take Ursobilane 500 mg capsules
4. Possible side effects
5. Storing Ursobilane 500 mg capsules
6. Contents of the pack and further 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 stone dissolvers.

It is used to dissolve cholesterol gallstones, provided they are radiotransparent and the gallbladder is functioning (which should have been verified 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 you take Ursobilane 500 mg capsules

Do not take Ursobilane 500 mg capsules

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

Warnings and precautions

Consult your doctor before taking Ursobilane 500 mg capsules:

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

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

Children and adolescents

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

Other medicines and Ursobilane 500 mg capsules

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

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

• Antacids containing aluminum.
• Cholestyramine or colestipol, or other medicines for treating 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 have a baby, ask your doctor for advice before taking this medicine.

Do not take this medicine while breastfeeding.

Driving and using machines

Ursobilane 500 mg capsules have no effect on the ability to drive or use machines.

Ursobilane 500 mg capsules contain the yellow-orange S dye (E-110)

This medicine may cause allergic reactions because it contains the yellow-orange S dye (E-110).

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

3. How to take Ursobilane 500 mg capsules

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Ursobilane 500 mg capsules are only administered to adults.

The capsules should be swallowed whole, without chewing, with a little liquid. If you have difficulty swallowing, you can disperse the powder contained in the capsules in 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 essential that you visit your doctor regularly to check the progression of your disease. While taking this medicine, you will need to have laboratory tests every few months to check that the gallstones are dissolving and that your liver is functioning correctly.

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 moderate calorie and cholesterol diet during treatment with Ursobilane 500 mg capsules.

If you take more Ursobilane 500 mg capsules than you should

The most common symptom of an overdose of Ursobilane 500 mg capsules is the appearance of diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 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 forgotten doses.

If you stop taking Ursobilane 500 mg capsules

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

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

4. Possible side effects

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

These side effects may occur with certain frequencies, which are defined below:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

Very rare: may affect up to 1 in 10,000 people.

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

Gastrointestinal disorders

Rare:nausea and vomiting, difficulty digesting, alterations in taste, biliary pain, abdominal pain, feeling of gas, and constipation.

Very rare:diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 silica, and sodium carboxymethyl starch (type A) (from potato).

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

Appearance and packaging

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

You can request more information about this medicine from 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 last revision of this leaflet:January 2012

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)