Cholurso 500 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ursodeoxycholic acid

Tillgänglig från:

Laboratoires Mayoly Spindler

ATC-kod:

A05AA; A05AA02

INN (International namn):

Ursodeoxycholic acid

Dos:

500 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Bile acid preparations; ursodeoxycholic acid

Bemyndigande status:

Not marketed

Tillstånd datum:

2017-10-13

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHOLURSO 500 MG FILM-COATED TABLETS
Ursodeoxycholic acid
READ ALL OF 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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cholurso 500 mg film-coated tablets is and what it is used for
2. What you need to know before you take Cholurso 500 mg film-coated
tablets
3. How to take Cholurso 500 mg film-coated tablets
4. Possible side effects
5. How to store Cholurso 500 mg film-coated tablets
6. Contents of the pack and other information
1. WHAT CHOLURSO 500 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Cholurso contains the active substance ursodeoxycholic acid.
Ursodeoxycholic acid is a chemical present naturally in the body and
it helps to control the amount of
cholesterol in the blood.
CHOLURSO IS USED
– to dissolve gallstones caused by excess cholesterol in the gall
bladder (in patients for whom surgery
is not an option), where the gallstones are not visible on a plain
x-ray (gallstones that are visible will not
dissolve) and not more than 15 mm in diameter. The gall bladder should
still be working despite the
gallstone(s).
– for the treatment of a condition where the bile ducts in the liver
become damaged leading to a build-
up of bile. This may cause scarring of the liver. The liver should not
be so damaged that it is not
functioning properly. This condition is called primary biliary
cholangitis.
– for the treatment of liver disease associated with a condition
called cystic fibrosis in children and
adolescents aged 6 to 18 years.
2. W

Produktens egenskaper

Health Products Regulatory Authority
25 April 2022
CRN00CJLQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cholurso 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of ursodeoxycholic acid.
Excipient with known effect: soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White oblong tablet (19 mm long, 8.8 mm wide) with a score line on
each side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Treatment of primary biliary cholangitis (PBC, also known as primary
biliary cirrhosis) in adult patients without
decompensated cirrhosis.
- Dissolution of radiolucent cholesterol gallstones in patients for
whom surgical treatment is not indicated. The gallstones must
not produce any shadows on the radiograph, and should not be of a
greater diameter than 15 mm, and the gall bladder,
despite the gallstone(s), must be functioning.
Paediatric population
Hepatobiliar disorder associated with cystic fibrosis in children aged
6 years to less than 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
For patients weighing less than 47 kg or patients who are unable to
swallow Cholurso 500 mg film-coated tablets,
other
formulations with ursodeoxycholic acid (e g oral suspension) should be
checked for availability.
The following daily dose is recommended for the various indications:
_For treatment of primary biliary cholangitis (PBC) _
_Stage I-III _
The daily dose is dependent on body weight and ranges from 1½ to 3½
film-coated tablets (12-16 mg ursodeoxycholic acid
per kg of body weight).
During the first 3 months of treatment, Cholurso 500 mg film-coated
tablets should be taken at mealtime in divided doses
throughout the day. If liver function improves, the total daily dose
can be taken once daily in the evening.
Body weight (kg)
Daily dose (mg/kg Body weight
Cholurso 250 mg film-coated
tablets
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First 3 months
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