Ursofalk 500mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Ursodeoxycholic acid

थमां उपलब्ध:

Dr. Falk Pharma GmbH

ए.टी.सी कोड:

A05AA; A05AA02

INN (इंटरनेशनल नाम):

Ursodeoxycholic acid

डोज़:

500 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Bile acid preparations; ursodeoxycholic acid

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2011-08-19

सूचना पत्रक

PACKAGE LEAFLET: Information for the user
Ursofalk
®
500mg 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 Ursofalk tablets are and what they are used for
2. What you need to know before you take Ursofalk tablets
3. How to take Ursofalk tablets
4. Possible side effects
5. How to store Ursofalk tablets
6. Contents of the pack and other information
1. WHAT URSOFALK 500MG FILM-COATED TABLETS ARE AND
WHAT THEY ARE USED FOR
Ursofalk tablets contain the active substance ursodeoxycholic acid
(UDCA). Small amounts of UDCA are found in human bile.
URSOFALK TABLETS ARE USED:
– for the treatment of primary biliary cirrhosis (PBC) 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 (cirrhosis of the liver).
The
liver should not be so damaged that it is not functioning properly.
– to dissolve cholesterol gallstones. These stones must not be
visible on a plain X-ray (radiolucent) and be no larger than 15 mm in
diameter because they will not dissolve with UDCA. The gall bladder
must still be working despite the gallstone(s).
– for 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
URSOFALK 500MG FILM-COATED TABLETS
DO NOT TAKE URSOFALK TABLETS IF:
– You are, or have been told you are, allergic (hypersensitive) to
bile
acids like UDCA or to any of the other ingredients of this medicine
(listed

उत्पाद विशेषताएं

Health Products Regulatory Authority
12 September 2019
CRN0099PG
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursofalk 500mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Ursofalk 500mg film-coated tablet contains 500mg of
ursodeoxycholic acid (UDCA) as the active substance.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Appearance: white, oval, biconvex film-coated tablets with a breakline
on both sides.
The tablet may be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of primary biliary cirrhosis (PBC), provided there
is no decompensated hepatic cirrhosis.
For the dissolution of cholesterol gallstones in the gall bladder. The
gallstones must not show as shadows on X-ray images
and should not exceed 15 mm in diameter. The gall bladder must be
functioning despite the gallstone(s).
Paediatric population
Hepatobiliary disorders associated with cystic fibrosis in children
aged 6 to 18 years
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
There are no age restrictions on the use of Ursofalk tablets in the
treatment of PBC and for the dissolution of radiolucent
gallstones. For patients weighing less than 47 kg or patients who are
unable to swallow Ursofalk tablets, Ursofalk capsules and
suspension are available.
The following daily dose is recommended for the various indications:
For the treatment of primary biliary cirrhosis (PBC)
The daily dose depends on body weight and ranges from 1½ to 3½
tablets (14 ± 2 mg of UDCA per kg of body weight).
For the first 3 months of treatment, Ursofalk tablets should be taken
divided over the day. With improvement of the liver
values the daily dose may be taken once daily in the evening.
Body
weight
(kg)
Daily
dose
(mg/kg
BW)
Film-coated tablets
first 3 months
subsequently
morning
midday
evening
evening
(1 x daily)
47 – 62
12 – 16
½
½
½
1½
63 – 78
13 – 16
½
½
1
2
79 – 93
13 – 16
½
1
1
2½
94 –
109
14 - 16
1
1
1
3
Over
110