Ursobil 250mg Hard Capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

URSODEOXYCHOLIC ACID

Available from:

ABC Farmaceutici S.P.A. Corso Vittorio Emanuele II, 72 - 10121 Torino, Italy

ATC code:

A05AA02

INN (International Name):

URSODEOXYCHOLIC ACID 250 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

URSODEOXYCHOLIC ACID 250 mg

Prescription type:

POM

Therapeutic area:

BILE AND LIVER THERAPY

Product summary:

Licence number in the source country: Italy - 024444 059 (20 capsules) 024444 109 (30 capsules)

Authorization status:

Authorised

Authorization date:

2015-07-02

Patient Information leaflet

URSOBIL 150 MG HARD CAPSULES
URSOBIL 250 MG HARD CAPSULES
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 signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What URSOBIL is and what it is used for
2. What you need to know before you take URSOBIL
3. How to take URSOBIL
4. Possible side effects
5. How to store URSOBIL
6. Contents of the pack and other information
1. WHAT URSOBIL IS AND WHAT IT IS USED FOR
URSOBIL is a preparation containing bile acids present naturally in
the body, which can solubilize
cholesterol in bile. This medicine is used to treat alterations in
bile production by the liver and to
improve the solubility of cholesterol, to avoid the formation of
calculi and to facilitate their
dissolution. This medicine is not effective against all types of
calculi, but only against those which
cannot be visualized on X-ray images (radiotransparent), in particular
cholesterol gallstones
(gallbladder functioning) and gallstones in the bile duct. It is also
used to treat digestive problems
due to malfunction of the gallbladder (biliary dyspepsia).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOBIL
DO NOT TAKE URSOBIL
- if you are allergic (hypersensitive) to ursodeoxycholic acid, to
bile acids, or to any component of
this medicine (listed in section 6);
- if you have an acute inflammation of the gallbladder or biliary
tract;
- if you have an obstruction of the biliary tract (occlusion of the
common bile duct or cystic dust);
- if you have frequent pains in the upper abdomen (biliary colic);
- if you have calcified gallstones visible on a X-ray;
- if your gal