Proursan 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ursodeoxycholic acid

Available from:

PRO.MED.CS Praha a.s.

ATC code:

A05AA; A05AA02

INN (International Name):

Ursodeoxycholic acid

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bile acid preparations; ursodeoxycholic acid

Authorization status:

Not marketed

Authorization date:

2018-07-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROURSAN® 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
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 Proursan® is and what it is used for
2. What you need to know before you take Proursan®
3. How to take Proursan®
4. Possible side effects
5. How to store Proursan®
6. Contents of the pack and other information
1. WHAT PROURSAN® IS AND WHAT IT IS USED FOR
Ursodeoxycholic
acid,
the
active
substance
in
Proursan®, is a naturally-occurring bile acid. Small
amounts are found in human bile.
Proursan® is used:
– to dissolve gallstones caused by excess cholesterol in
the gall bladder 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).
– to treat the symptoms of primary biliary cholangitis
(PBC – a chronic biliary tract disorder, which may
progress
to
liver
cirrhosis)
in
patients
without
decompensated
liver
cirrhosis
(a
diffuse,
chronic
liver disease, in which poor liver function due to
disease can no longer be corrected),
– to treat liver disease associated with a condition
called cystic fibrosis in children aged 6 to 18 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROURSAN®
DO NOT TAKE PROURSAN® IF
– you are allergic to bile acids (like ursodeoxycholic
acid) or any of the other ingredients of this medicine
(listed in section 6),
– you have acute inflammation of the gall

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2022
CRN00D37X
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proursan 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of ursodeoxycholic acid (UDCA) as the
active ingredient.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Almost white, oblong film-coated tablets with a break line on each
side, length 17 mm and width
9 mm. The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For dissolution of cholesterol gallstones of the gall bladder. 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.
For symptomatic treatment of primary biliary cholangitis (PBC), as
long as there is no decompensated cirrhosis of the liver.
Paediatric population
For treatment of hepatobiliary disorders associated with cystic
fibrosis in children aged 6 to 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Proursan is suitable for patients with body weight of 47 kg and over.
For patients weighing less than 47 kg or patients who are
unable to swallow Proursan other formulations containing
ursodeoxycholic acid might be available.
Posology
The following daily dosage is recommended for the various indications:
Health Products Regulatory Authority
28 October 2022
CRN00D37X
Page 2 of 7
_For the dissolution of cholesterol gallstones_
Approx. 10 mg of ursodeoxycholic acid per kg of body weight
corresponding to:
up to 60 kg
1 film-coated tablet
61 to 80 kg
1 ½ film-coated tablets
81 to 100 kg
2 film-coated tablets
over 100 kg
2 ½ film-coated tablets
The film-coated tablets should be taken in the evening before bedtime.
The time required for dissolution of gallstones is likely to range
from 6 to 24 months. In case there is no reduction in gallstones
after 12 months, the therapy should not be continued.
The suc