Ursofalk 250 mg hard capsules

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Ursodeoxycholic acid

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

A05AA02; A05B

INN (Международно Name):

Ursodeoxycholic acid

дозиране:

250 milligram(s)

Лекарствена форма:

Capsule, hard

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

ursodeoxycholic acid; LIVER THERAPY, LIPOTROPICS

Статус Оторизация:

Authorised

Дата Оторизация:

2006-11-20

Листовка

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
URSOFALK
® 250 MG 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 250 MG 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 250 MG 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 other

Данни за продукта

Health Products Regulatory Authority
22 September 2022
CRN00D5NR
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursofalk 250 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg ursodeoxycholic acid (UDCA).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
_Product imported from Spain, Portugal and Romania_
White opaque hard gelatin capsules containing a white compressed
powder or granules.
4 CLINICAL PARTICULARS
As per PA0573/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0573/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Spain and Portugal_
Magnesium stearate
Maize starch
Colloidal anhydrous silica
Gelatin
Titanium dioxide (E171)
Sodium lauryl sulfate
_Product imported from Romania_
Magnesium stearate
Maize starch
Colloidal anhydrous silica
Capsule shell:
Gelatin
Titanium dioxide (E171)
Sodium lauryl sulfate
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
Health Products Regulatory Authority
22 September 2022
CRN00D5NR
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Keep the capsules in the original package in order to protect from
light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 60 or 100 hard capsules.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/183/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20 November 2006
Date of last renewal: 20 November 2011
10 DATE OF REVISION OF THE TEXT
September 2022