Proursan 400 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ursodeoxycholic acid

Disponibil de la:

PRO.MED.CS Praha a.s.

Codul ATC:

A05AA02

INN (nume internaţional):

Ursodeoxycholic acid

Dozare:

400 milligram(s)

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

ursodeoxycholic acid

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2021-09-24

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
400 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid, the active substance in , is a
naturally-occurring bile acid.
Small amounts are found in human bile.
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
DO NOT TAKE IF:
-
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 ac

Caracteristicilor produsului

Health Products Regulatory Authority
28 September 2021
CRN009XWH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proursan 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of ursodeoxycholic acid
(UDCA).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Almost white, round biconvex film-coated tablet with a score line on
both sides, 12 mm in diameter. 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 show as shadows on X-ray and should not
exceed 15 mm in diameter. The gall bladder must be functioning despite
the gallstone(s).
For symptomatic treatment of primary biliary cholangitis (PBC),
provided there is no decompensated hepatic cirrhosis.
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
Posology
The following daily dosage is recommended for the various indications:
_For the dissolution of cholesterol gallstones_
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 pharmaceutical forms (suspension)
containing ursodeoxycholic acid are available.
Approx. 10 mg of ursodeoxycholic acid per kg of body weight
corresponding to:
up to 50kg
1 film-coated tablet
51 to 70 kg
1 ½ film-coated tablet
71 to 90 kg
2 film-coated tablets
91 to 110 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 success of treatment should be checked sonographically or
radiographically every 6 months. It should also be obser