URSOBILANE 300 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Ursobilane 300 mg Capsules

Ursodeoxycholic Acid

Read this entire leaflet carefully before starting to take this medicine, as 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 to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Ursobilane 300 mg Capsules are and what they are used for
2. What you need to know before taking Ursobilane 300 mg Capsules
3. How to take Ursobilane 300 mg Capsules
4. Possible side effects
5. Storage of Ursobilane 300 mg Capsules
6. Package Contents and Additional Information

1. What Ursobilane 300 mg Capsules are and what they are used for

The active ingredient of Ursobilane 300 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 taking Ursobilane 300 mg Capsules

Do not take Ursobilane 300 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 or if you have calcified cholesterol gallstones, radio-opaque gallstones, or radiotransparent bile 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 taking Ursobilane 300 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.

Other Medicines and Ursobilane 300 mg Capsules

Ursobilane 300 mg Capsules may interact with other medicines, such as:

• Antacids containing aluminum.
• Colestyramine or colestipol, or other medicines for treating high cholesterol.
• Antibiotics: neomycin.

• Hormonal contraceptives, such as estrogens or progestogens.

Taking Ursobilane 300 mg Capsules with Food, Drinks, and Alcohol

No special considerations.

Pregnancy, Breastfeeding, and Fertility

Before starting treatment, your doctor should know if you are or suspect you may be pregnant, or if you plan to become pregnant. Your doctor will then decide whether or not to use Ursobilane 300 mg Capsules.

This medicine should not be used during breastfeeding.

Driving and Using Machines

Ursobilane 300 mg Capsules do not affect the ability to drive vehicles or use machinery.

3. How to Take Ursobilane 300 mg Capsules

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medicine.

Depending on the nature of your illness, age, and weight, your doctor will prescribe the correct dose and indicate the duration of treatment. Do not stop treatment prematurely, as this may not achieve the desired effect.

Your doctor will advise you to follow a moderate calorie and cholesterol diet during treatment with Ursobilane 300 mg Capsules.

If you think the effect of Ursobilane 300 mg Capsules is too strong or too weak, inform your doctor or pharmacist.

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 300 mg Capsules preferably with meals.

For the treatment of gallstones, the usual doses are as follows:

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

It is essential that you visit your doctor regularly to check the progress of your illness. 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.

For the treatment of primary biliary cirrhosis, the usual doses 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

The symptom of overdose of Ursobilane 300 mg Capsules is mainly the appearance of diarrhea. It is recommended that during treatment with Ursobilane 300 mg Capsules, regular monitoring of liver function be carried out.

If you forget to take Ursobilane 300 mg Capsules

Do not take a double dose to make up for forgotten doses.

If you have any other questions about 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 everyone gets them.

These side effects may occur with certain frequencies, which are defined below: Very common: may affect more than 1 in 10 patients.

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

Uncommon: 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 the available data.

Gastrointestinal Disorders

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

Very rare: diarrhea.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ursobilane 300 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 expiration date stated on the box after EXP. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

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 carboxymethyl starch (type A) (from potato).

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

Appearance of the Product and Package Contents

Green and yellow capsules.

Aluminum-PVC 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 the 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/)