URSOFALK FILM-COATED TABLETS 500MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ursodeoxycholic acid

Available from:

DCH AURIGA SINGAPORE

ATC code:

A05AA02

Dosage:

500.00 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ursodeoxycholic acid 500.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Losan Pharma GmbH

Authorization status:

ACTIVE

Authorization date:

2014-05-02

Patient Information leaflet

 
PACKAGE INSERT 

1. 
NAME OF THE MEDICINAL PRODUCT  

URSOFALK

 500MG FILM-COATED TABLETS 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION  

One Ursofalk

 500mg film-coated tablet contains 500 mg of
ursodeoxycholic acid 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 break line on both sides 

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. Gall 
bladder must be functioning, despite the gallstones. 

For the symptomatic treatment of primary biliary cirrhosis (PBC),
in patients without 
decompensated hepatic cirrhosis. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For patients weighing less than 47 kg or patients who
are unable to swallow Ursofalk
® 
500mg film-coated tablets, Ursofalk
®
 capsules or suspension are available.  

The following daily dose is recommended for the various
indications: 

For dissolution of cholesterol gallstones 

Approx. 10 mg of ursodeoxycholic acid per kg of body weight,
equivalent to: 

up to 60 kg 

1 film-coated tablet 
61-80 kg 

1½ film-coated tablets 

81-100 kg 

2 film-coated tablets 
over 100 kg 

2½ film-coated tablets 

The film-coated tablets
should be swallowed whole with some liquid in the evening at 
bedtime. They must be taken regularly. 

The time required for the 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. A

Summary of Product characteristics

Ursofalk 500mg Filmtabletten Gebrauchsinformation (GI) für Singapur
Mat.-Nr.: 1228780 (Losan Pharma)
Falk-Datumscode: SG/12.23
Laetuscode: 566
Machart: plano
Druckfarben: (1/1) Schwarz
Format: 300 x 200 mm
Grammatur: 50 g/m
2
Schriftgröße/ZAB: 8pt/9,5pt
PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
URSOFALK
® 500MG
FILM-COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One Ursofalk® 500mg film-coated tablet contains 500 mg of ursodeoxy-
cholic acid 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 break
line
on both sides
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. Gall bladder must be functioning, despite
the gallstones.
For the symptomatic treatment of primary biliary cirrhosis (PBC), in
patients without decompensated hepatic cirrhosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For patients weighing less than 47 kg or patients who are unable to
swallow Ursofalk® 500mg film-coated tablets, Ursofalk® capsules or
suspension are available.
The following daily dose is recommended for the various indications:
For dissolution of cholesterol gallstones
Approx. 10 mg of ursodeoxycholic acid per kg of body weight,
equivalent to:
up to 60 kg
1 film-coated tablet
61-80 kg
1½ film-coated tablets
81-100 kg
2 film-coated tablets
over 100 kg
2½ film-coated tablets
The film-coated tablets should be swallowed whole with some liquid in
the evening at bedtime. They must be taken regularly.
The time required for the 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 s