Package Insert: Information for the User

Ursobilane 300 mg Capsules

Ursodeoxycholic Acid

Read this entire 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 only for you, and you should not give it to others who may 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 300 mg capsules is ursodeoxycholic acid, which belongs to a group of medicines called bile stone solvents.

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

Do not take Ursobilane 300 mg capsules:

• If you are allergic to ursodeoxycholic acid or to any of the other components of this medication (listed in section 6).
• If you have a stomach ulcer or duodenal ulcer.
• If you have a non-functioning gallbladder or if you have cholesterol calcified gallstones, radio-opaque gallstones, or pigment gallstones that are radiotransparent.
• 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 300 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.

Other medications and Ursobilane 300 mg capsules

Ursobilane 300 mg capsules may interact with other medications such as:

• Antacids containing aluminum.
• Colestiramine or colestipol, or other medications to treat high cholesterol.
• Antibiotics: neomycin.

• Hormonal contraceptives, such as estrogens or progestogens.

Taking Ursobilane 300 mg capsules with food, drinks, and alcohol

No considerations apply.

Pregnancy, breastfeeding, and fertility

Before starting treatment, your doctor must know if you are or suspect you are pregnant or if you wish to become pregnant. The doctor will then decide whether or not to use Ursobilane 300 mg capsules.

This medication should not be used during breastfeeding.

Driving and operating machinery

Ursobilane 300 mg capsules do not interfere with the ability to drive vehicles or operate machinery.

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.

Remember to take your medication. .

Your doctor will prescribe the appropriate dose and treatment duration based on the nature of your disease, age, and weight. Do not discontinue treatment beforehand, as this will not achieve the desired effect.

Your doctor will advise you to maintain a moderate-calorie and cholesterol-restricted diet during treatment with Ursobilane 300 mg capsules.

If you estimate that the action of Ursobilane 300 mg capsules is too strong or weak, inform your doctor or pharmacist.

The capsules should be swallowed whole, without chewing, with a small amount of liquid. If you experience difficulty swallowing, you can disperse the powder contained in the capsules in a liquid.

Take Ursobilane 300 mg capsules preferably with meals.

The usual doses for the treatment of gallstones are as follows:

Adults: 2 capsules per day (8-10 mg/kg/day), divided into several doses.

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 undergo laboratory tests every few months to confirm that the gallstones are dissolving and your liver is functioning correctly.

The usual doses for the treatment of biliary cirrhosis are:

Adults: 3-4 capsules per day (13-15 mg/kg/day), divided into several doses.

If you take more Ursobilane 300 mg capsules than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptom of Ursobilane 300 mg capsule overdose is primarily the appearance of diarrhea. It is recommended to perform a regular check of liver function during treatment with Ursobilane 300 mg capsules.

If you forgot to take Ursobilane 300 mg capsules

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

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 may 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.

Unknown frequency: the frequency cannot be estimated from the available data.

Gastrointestinal disorders

Rare: nausea and vomiting, difficulty in digestion, alterations in taste, gallbladder pain, abdominal pain, sensation of gas 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 that does not appear 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 300 mg capsules

The active ingredient is ursodeoxycholic acid. Each capsule contains 300 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), and indigotin (indigo carmine) (E-132).

Appearance of the product and contents of the packaging

Yellow and green capsules.

Aluminum-PVC blister packaging containing 60 capsules.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Estedi S.L. Laboratory

Montseny, 41

08012 Barcelona - Spain

Responsible manufacturer

Estedi, S.L. Laboratory

Leopoldo Alas, 7

08012 Barcelona - Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aldo-Unión, S.L. Laboratory

C/ Baronesa de Maldá, 73

08950 Esplugues de Llobregat

(Barcelona) Spain

Last review date of this prospectus:January 2012

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)/