URSOBILANE 150 MG CAPSULES

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ursobilane 150 mg capsules

Ursodeoxycholic acid

Read the entire leaflet carefully before you start taking 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 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Ursobilane 150 mg capsules are and what they are used for
2. What you need to know before taking Ursobilane 150 mg capsules
3. How to take Ursobilane 150 mg capsules
4. Possible adverse effects
5. How to store Ursobilane 150 mg capsules
6. Contents of the pack and other information

1. What Ursobilane 150 mg capsules is and what it is used for

The active substance in Ursobilane 150 mg is ursodeoxycholic acid, which belongs to a group of medicines called gallstone-dissolving agents.

It is used to dissolve radiolucent cholesterol gallstones in patients with a functioning gallbladder (confirmed by a test called oral cholecystography). Ursobilane is also used to treat a rare liver and biliary tract disease called primary biliary cirrhosis.

2. What you need to know before starting to take Ursobilane 150 mg capsules

Do not take Ursobilane 150 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 or 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 150 mg capsules:

• If you are taking medicines that may cause biliary accumulation of cholesterol, such as estrogens and hormonal contraceptives.
• If you are being treated with medicines that may potentially be hepatotoxic.

Other medicines and Ursobilane 150 mg capsules

Ursobilane 150 mg capsules may interfere with other medicines such as:

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

Taking Ursobilane 150 mg capsules with food, drinks and alcohol

No special considerations apply.

Pregnancy, breastfeeding and fertility

Before starting treatment, your doctor must know whether you are pregnant or suspect you may be pregnant, or if you are planning to become pregnant. Your doctor will then decide whether or not it is appropriate to use Ursobilane 150 mg capsules.

This medicine must not be used during breastfeeding.

Driving and using machines

Ursobilane 150 mg capsules do not affect the ability to drive or operate machinery.

3. How to take Ursobilane 150 mg capsules

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, 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 appropriate dose and advise you on the duration of treatment. Do not stop treatment prematurely, as otherwise the intended effect will not be achieved.

Your doctor will advise you to maintain a diet moderate in calories and cholesterol during treatment with Ursobilane 150 mg capsules.

If you feel that the effect of Ursobilane 150 mg capsules is too strong or too weak, inform your doctor or pharmacist.

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

Take Ursobilane 150 mg capsules preferably with meals.

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

Adults: 4 capsules per day (8–10 mg/kg/day), divided into several doses.

It is important to visit your doctor regularly so that the progression of 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 that your liver is functioning properly.

For the treatment of biliary cirrhosis, the usual doses are:

Adults: 6–7 capsules per day (13–15 mg/kg/day), divided into several doses.

If you take more Ursobilane 150 mg capsules than you should

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

The main symptom of overdose with Ursobilane 150 mg capsules is diarrhea. It is recommended that liver function be routinely monitored during treatment with Ursobilane 150 mg capsules.

If you forget to take Ursobilane 150 mg capsules

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

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 may produce 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 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 fewer than 1 in 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ursobilane 150 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are 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 150 mg capsules

The active substance is ursodeoxycholic acid. Each capsule contains 150 mg of ursodeoxycholic acid.

The other excipients are talc, magnesium stearate, colloidal silica, powdered cellulose and corn starch.

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

Appearance of the medicine and contents of the pack

Green and white 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 further information about this medicine by contacting 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 Health Products (AEMPS) (http://www.aemps.gob.es/)