Package Insert: Information for the User

Ursobilane 500 mg Capsules

Ursodeoxycholic Acid

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Ursobilane 500 mg capsules is ursodeoxycholic acid, which belongs to a group of medications called bile stone solvents.

It is used to dissolve cholesterol gallstones whenever these are radiolucent and the gallbladder is functioning (which has had to be verified by performing an oral cholecystography test). Ursobilane is also used to treat a rare disease of the bile ducts and liver called primary biliary cirrhosis.

Do not take Ursobilane 500 mg capsules

• If you are allergic to ursodeoxycholic acid or any of the other components of this medication (listed in section 6).
• If you have a gastric or duodenal ulcer.
• If you suffer from a non-functioning gallbladder.
• If you have calcified cholesterol stones, radiopaque stones, or radiotransparent pigment gallstones.
• 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 starting to take Ursobilane 500 mg capsules:

-If you are taking medications that may cause a buildup of bile cholesterol, such as estrogens and hormonal contraceptives.

• If you are being treated with medications that may be toxic to the liver.

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

Children and adolescents

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

Other medications and Ursobilane 500 mg capsules

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

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

• Antacids containing aluminum.
• Cholestyramine or colestipol, or other medications 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 recommended to take the medication with meals.

Pregnancy, breastfeeding, and fertility

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

This medication should not be used during breastfeeding.

Driving and operating machinery

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

Ursobilane 500 mg capsules contains yellow-orange colorant S (E-110)

This medication may cause allergic reactions because it contains yellow-orange colorant S (E-110).

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 to visit your doctor regularly for them to check the progression of your disease. While taking this medication, 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 maintain a moderate diet 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 an overdose of Ursobilane 500 mg capsules is 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 medication and the amount ingested.

If you forget to take Ursobilane 500 mg capsules

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ursobilane 500 mg capsules

Do not discontinue treatment without consulting your doctor, as this will not achieve the desired effect.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

These adverse effects may occur at certain frequencies, which are defined below:

Very frequent: may affect more than 1 in 10 patients.

Frequent: may affect between 1 and 10 in 100 patients.

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

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

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

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

Gastrointestinal disorders

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

Very rare:diarrhea.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Ursobilane 500 mg capsules

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

The other excipients are magnesium stearate, powdered cellulose, colloidal silica, and sodium carboxymethylcellulose (type A) (from potato).

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

Appearance of the product and content of the packaging

Green and orange capsules.

Aluminum-PVC/PVDC blister packaging containing 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona - Spain

Responsible for manufacturing

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Laboratorio Aldo-Unión, S.L.

C/Baronesa de Maldá, 73

08950 Esplugues de Llobregat

(Barcelona) Spain

Last review date of this prospectus:January 2012

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)