Salofalk Gastro-resistant Prolonged-release Granules 3g sachet

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Mesalazine

Available from:

DCH AURIGA SINGAPORE

ATC code:

A07EC02

Dosage:

3000mg/ sachet

Pharmaceutical form:

GRANULE, DELAYED RELEASE

Composition:

Mesalazine 3000mg/ sachet

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Losan Pharma GmbH

Authorization status:

ACTIVE

Authorization date:

2013-11-08

Patient Information leaflet

Salofalk Granu-Stix Gebrauchsinformation (Outsert) für Singapur
Format: 528 x 157 mm  
Druckfarben: 2/2 (Schwarz + Pant. 644) inkl. Klebefläche
Mat.-Nr.: Mock-up (Losan Pharma)  Falk-Datumscode: SG/03.12 

Grammatur: 40g/m
2

Laetuscode: XXX
PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCTS
Salofalk
®
 Gastro-resistant Prolonged-release granules 500mg/sachet
Salofalk
®
 Gastro-resistant Prolonged-release granules 1g/sachet
Salofalk
®
 Gastro-resistant Prolonged-release granules 1.5g/sachet
Salofalk
®
 Gastro-resistant Prolonged-release granules 3g/sachet
Mesalazine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk
®
 granules 500mg contains 500 mg mesalazine.
Each sachet of Salofalk
®
 granules 1g contains 1000 mg mesalazine.
Each sachet of Salofalk
®
 granules 1.5g contains 1.5 g mesalazine.
Each sachet of Salofalk
®
 granules 3g contains 3 g mesalazine.
Excipients:
Each sachet of Salofalk
®
 granules 500mg contains 1.0 mg aspartame.
Each sachet of Salofalk
®
 granules 1g contains 2.0 mg aspartame.
Each sachet of Salofalk
®
 granules 1.5g contains 3.0 mg aspartame.
Each sachet of Salofalk
®
 granules 3g contains 6.0 mg aspartame.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant prolonged-release granules
Description: stick-formed or round, greyish white granules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of acute episodes and the maintenance of remission
of 
ulcerative colitis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults and the elderly_
For the treatment of acute episodes of ulcerative colitis:
Once daily, 1 sachet of Salofalk
®
 granules 3g, 1-2 sachets of Salofalk
®

granules 1.5g, 3 sachets of Salofalk
®
 granules 1g or 3 sachets of Salofalk
®

granules 500mg (equivalent to 1.5-3.0 g mesalazine daily) preferably
to  
be taken in the morning according to the individual clinical
requirement.
It is also possible to take the prescribed daily dose in three divided

Summary of Product characteristics

salofalk gastro resistant pr granules pi
1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCTS
Salofalk
®
Gastro-resistant Prolonged-release granules 500mg/sachet
Salofalk
®
Gastro-resistant Prolonged-release granules 1g/sachet
Salofalk
®
Gastro-resistant Prolonged-release granules 1.5g/sachet
Salofalk
®
Gastro-resistant Prolonged-release granules 3g/sachet
Mesalazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk granules 500mg contains 500 mg mesalazine.
Each sachet of Salofalk granules 1g contains 1000 mg mesalazine.
Each sachet of Salofalk granules 1.5g contains 1.5 g mesalazine.
Each sachet of Salofalk granules 3g contains 3 g mesalazine.
Excipients with known effect
Each sachet of Salofalk granules 500mg contains 1.0 mg aspartame and
0.02 mg sucrose.
Each sachet of Salofalk granules 1g contains 2.0 mg aspartame and 0.04
mg sucrose.
Each sachet of Salofalk granules 1.5g contains 3.0 mg aspartame and
0.06 mg sucrose.
Each sachet of Salofalk granules 3g contains 6.0 mg aspartame and 0.12
mg sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant prolonged-release granules
Description: stick-formed or round, greyish white granules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of acute episodes and the maintenance of remission
of ulcerative colitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and the elderly _
For the treatment of acute episodes of ulcerative colitis
Once daily, 1 sachet of Salofalk granules 3g, 1-2 sachets of Salofalk
granules 1.5g, 3 sachets of
Salofalk granules 1g or 3 sachets of Salofalk granules 500mg
(equivalent to 1.5-3.0 g mesalazine
daily) preferably to be taken in the morning according to the
individual clinical requirement.
It is also possible to take the prescribed daily dose in three divided
doses (1 sachet of Salofalk granules
500mg 3 times daily or 1 sachet of Salofalk granules 1g 3 times daily)
if this is more convenient to the
patient.
For the maintenance of remission of ulcerat