URSOFALK 250MG/5ML ORAL SUSPENSION

País: Chipre

Língua: grego

Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes ativos:

URSODEOXYCHOLIC ACID

Disponível em:

DR. FALK PHARMA GMBH (0000008100) LEINENWEBERSTR. 5, FREIBURG, D-79108

Código ATC:

A05AA02

DCI (Denominação Comum Internacional):

URSODEOXYCHOLIC ACID

Dosagem:

250MG/5ML

Forma farmacêutica:

ORAL SUSPENSION

Composição:

URSODEOXYCHOLIC ACID (0000128132) 250MG

Via de administração:

ORAL USE

Tipo de prescrição:

Εθνική Διαδικασία

Área terapêutica:

URSODEOXYCHOLIC ACID

Resumo do produto:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 250ML (280001501) 250 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Folheto informativo - Bula

_Dr. Falk Pharma GmbH_
_Ursofalk 250mg/5ml suspension_
_ENR.2140459_
PACKAGE LEAFLET: Information for the user
URSOFALK
® 250MG/5ML SUSPENSION
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
®
250mg/5ml suspension is and what it is used for
2.
What you need to know before you take Ursofalk
®
250mg/5ml suspension
3.
How to take Ursofalk
®
250mg/5ml suspension
4.
Possible side effects
5.
How to store Ursofalk
®
250mg/5ml suspension
6.
Contents of the pack and other information
1.
WHAT URSOFALK
® 250MG/5ML SUSPENSION IS AND WHAT IT IS USED FOR
Ursodeoxycholic acid, the active substance in Ursofalk
®
250mg/5ml suspension, is a naturally-
occurring bile acid. Small amounts are also found in human bile.
URSOFALK
® 250MG/5ML SUSPENSION IS USED:
-
for the treatment of primary biliary cirrhosis (PBC, a chronic disease
of the bile ducts which can
lead to cirrhosis of the liver), in patients without decompensated
liver cirrhosis (diffuse chronic
disease of the liver, at a stage when the disease-related reduction in
liver function can no longer
be compensated for).
to dissolve cholesterol gallstones. These stones must not show as
shadows on X-ray images and
should not exceed 15 mm in diameter. The gall bladder must be working
despite the gallstone(s).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK
® 250MG/5ML SUSPENSION
DO NOT TAKE URSOFALK
® 250MG/5ML SUSPENSION IF:
-
you are, or have been told you are hypersensitive (allergic) to bile
acids such as
ursode

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
URSOFALK
® 250MG/5ML SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml Ursofalk
®
250mg/5ml suspension (= 1 cup of Ursofalk
®
250mg/5ml suspension) contains
250 mg ursodeoxycholic acid (UDCA)
as the active substance.
Excipients with known effect: sodium compounds (carmellose sodium,
sodium chloride,
sodium citrate 2H
2
O, sodium cyclamate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Appearance: white, homogenous oral suspension with an odour of lemons.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of primary biliary cirrhosis (PBC), in patients
without 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.
Gall bladder function
must not be significantly impaired, despite the gallstone(s).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There are no age restrictions on the use of Ursofalk
®
250mg/5ml suspension. The following
daily dose is recommended for the various indications:
For dissolution of cholesterol gallstones
Approx. 10 mg of UDCA per kg of body weight daily, equivalent to:
Body weight
Cups *
equivalent to ml
5 to 7 kg
¼
1.25
8 to 12 kg
½
2.50
13 to 18 kg
¾ (=¼+½)
3.75
19 to 25 kg
1
5.00
26 to 35 kg
1½
7.50
36 to 50 kg
2
10.00
51 to 65 kg
2½
12.50
66 to 80 kg
3
15.00
81 to 100 kg
4
20.00
Over 100 kg
5
25.00
*1 cup (^ 5 ml oral suspension) contains 250 mg of UDCA.
Ursofalk
®
250mg/5ml suspension should be taken in the evening at bedtime. The
oral
suspension must be taken regularly.
The time required for dissolution of gallstones is generally 6-24
months. If there is no
reduction in the size of the gallstones after 12 months, the therapy
should not be continued.
The success of the treatment should be checked by means of ultrasound
or X-ray examination
every 6 months. At the follow-up examinations, a check should be