Ursofalk® 250 mg Hard Capsules

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ursodeoxycholic acid

Tersedia dari:

Dr. Falk Pharma GmbH

Kode ATC:

A05AA; A05AA02

INN (Nama Internasional):

Ursodeoxycholic acid

Dosis:

250 milligram(s)

Bentuk farmasi:

Capsule, hard

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Bile acid preparations; ursodeoxycholic acid

Status otorisasi:

Marketed

Tanggal Otorisasi:

1984-11-14

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSOFALK® 250MG HARD CAPSULES
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 side
effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET:
1. What Ursofalk capsules are and what they are used for
2. What you need to know before you take Ursofalk capsules
3. How to take Ursofalk capsules
4. Possible side effects
5. How to store Ursofalk capsules
6. Contents of the pack and further information
1. WHAT URSOFALK 250MG HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid (UDCA), the active substance in Ursofalk
capsules, is a naturally
occurring bile acid. Small amounts are found in human bile.
URSOFALK CAPSULES ARE USED:

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
cirrhosis (PBC).

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).

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 250MG HARD CAPSULES
DO NOT TAKE URSOFALK CAPSULES IF

you are, or have been told you are, allergic (hypersensitive) to bile
acids like UDCA or to
any of the othe

Karakteristik produk

Health Products Regulatory Authority
29 June 2022
CRN00D014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursofalk® 250 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg of ursodeoxycholic acid (UDCA) as the
active substance.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
White opaque hard gelatin capsules (size 0) containing a white
compressed powder or granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary biliary cirrhosis (PBC) stages I – III.
For the dissolution of cholesterol gallstones in functioning
gallbladders with or without prior extracorporeal shock wave
lithotripsy.
_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 capsules in the
treatment of PBC and for the dissolution of gallstones. For
patients weighing less than 47kg or patients who are unable to swallow
Ursofalk capsules, Ursofalk suspension is available.
Ursofalk capsules are for oral administration.
The following daily dose is recommended for the various indications:
_Primary biliary cirrhosis (PBC) stages I – III:_
The daily dose depends on body weight, and ranges from 3 to 7 capsules
(14 ± 2 mg UDCA per kg of body weight).
For the first 3 months of treatment, Ursofalk capsules 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)
Ursofalk capsules
FIRST 3 MONTHS
subsequently
morning
midday
evening
evening
(1 x daily)
47 – 62
12 – 16
1
1
1
3
63 – 78
13 – 16
1
1
2
4
79 – 93
13 – 16
1
2
2
5
94 –
109
14 – 16
2
2
2
6
Over
110
2
2
3
7
Health Products Regulatory Authority
29 June 2022
CRN00D014
Page 2 of 6
The capsules should be swallowed whole with some liquid. Care should
be taken to ensure that they are taken regularly.
The use of Urs