URSOFALK 250MG CAPSULE,HARD

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

URSODEOXYCHOLIC ACID

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

A05AA02

INN (Διεθνής Όνομα):

URSODEOXYCHOLIC ACID

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

CAPSULE,HARD

Σύνθεση:

URSODEOXYCHOLIC ACID (0000128132) 250MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

URSODEOXYCHOLIC ACID

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 50 CAPS IN BLISTER(S) (840044002) 50 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
URSOFALK
® 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 possible 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 other information
1.
WHAT URSOFALK
 CAPSULES ARE AND WHAT THEY ARE USED FOR
Ursodeoxycholic acid, the active substance in Ursofalk
®
capsules, is a naturally-occurring bile acid
with small amounts found in human bile.
URSOFALK
® CAPSULES ARE USED:
-
to dissolve cholesterol gallstones. These stones must be radiolucent
(not visible on a plain X-
ray) and no larger than 15 mm in diameter. The gall bladder must still
be working despite the
gallstone(s).
-
to treat bile reflux gastritis (inflammation of the stomach lining
caused by the reflux of bile
acids)
-
for the treatment of primary biliary cirrhosis (PBC, which is a
chronic inflammation of the bile
ducts associated with cirrhosis of the liver), provided there is no
decompensated liver cirrhosis
(severe disease of the liver, at a stage when the remaining liver
tissue can no longer compensate
for the reduced liver function).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK
 CAPSULES
DO NOT TAKE URSOFALK
 CAPSULES IF
-
You are, or have been told you are allergic (hypersensitive) to bile
acids (like ursodeoxycholic
acid) or to any of the other ingredients of this me

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
URSOFALK
® CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 hard capsule of Ursofalk
®
capsules contains 250 mg ursodeoxycholic acid (UDCA) as the
active substance.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Appearance: white, opaque hard gelatine capsules, capsule size 0,
which contain a white
compressed powder or granulate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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).
For the treatment of bile reflux gastritis.
For the treatment of primary biliary cirrhosis (PBC), provided there
is no decompensated
hepatic cirrhosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There are no age restrictions on the use of Ursofalk® capsules. For
patients weighing less than
47 kg or patients who are unable to swallow Ursofalk® capsules,
Ursofalk® suspension is
available.
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, equivalent to:
up to 60 kg
2 hard capsules
61 – 80 kg
3 hard capsules
81 – 100 kg
4 hard capsules
over 100 kg
5 hard capsules
The hard capsules should be swallowed whole with some liquid in the
evening at bedtime.
The capsules must be taken regularly.
proposed cy_8400440_spc.docx
1
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 made
to see whether
calcification of the stones has occurred in the meantime. Should this
be the case, the treatment
must be ended.
For the treatme