Salofalk Granu-Stix 500 mg magensaftresistentes Retardgranulat

Država: Nemčija

Jezik: nemščina

Source: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Aktivna sestavina:

Mesalazin

Dostopno od:

Dr. Falk Pharma GmbH (3076297)

Koda artikla:

A07EC02

INN (mednarodno ime):

mesalazine

Farmacevtska oblika:

magensaftresistentes Retardgranulat

Sestava:

Mesalazin (21958) 500 Milligramm

Pot uporabe:

zum Einnehmen

Status dovoljenje:

verlängert

Datum dovoljenje:

2001-10-16

Navodilo za uporabo

paleu-sag500-en11-jan21.docx
1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK 500MG GASTRO-RESISTANT
PROLONGED-RELEASE GRANULES
Mesalazine
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 Salofalk 500mg granules are and what they are used for
2.
What you need to know before you take Salofalk 500mg granules
3.
How to take Salofalk 500mg granules
4.
Possible side effects
5.
How to store Salofalk 500mg granules
6.
Contents of the pack and other information
1. WHAT SALOFALK 500MG GRANULES ARE AND WHAT THEY ARE USED FOR
Salofalk granules contain the active substance mesalazine, an
anti-inflammatory agent used to treat
inflammatory bowel disease.
Salofalk 500mg granules are used for
-
the treatment of acute episodes and prevention of further episodes
(recurrence) of an
inflammatory disease of the large intestine (colon), known by doctors
as ulcerative colitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALOFALK 500MG GRANULES
DO NOT TAKE SALOFALK GRANULES
-
if you are allergic to mesalazine, salicylic acid, to salicylates such
as Aspirin
®
or any of the
other ingredients of this medicine (listed in section 6).
-
if you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Salofalk 500mg granules
-
if you have a history of problems with your lungs, particularly if you
suffer from
BRONCHIAL
ASTHMA
-
if you have a
HISTORY OF ALLERGY TO SULPHASALAZINE
,
a substance related to mesalazine
-
if you suffer with problems of your
LIVER
-
if you suffer with proble

Lastnosti izdelka

spceu-sagall-en13-jan21.docx
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Salofalk 500mg gastro-resistant prolonged-release granules
Salofalk 1000mg gastro-resistant prolonged-release granules
Salofalk 1.5g gastro-resistant prolonged-release granules
Salofalk 3g gastro-resistant prolonged-release granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk 500mg granules contains 500 mg mesalazine.
Each sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.
Each sachet of Salofalk 1.5g granules contains 1.5 g mesalazine.
Each sachet of Salofalk 3g granules contains 3 g mesalazine.
Excipients with known effect:
Each sachet of Salofalk 500mg granules contains 1.0 mg aspartame and
0.02 mg sucrose.
Each sachet of Salofalk 1000mg granules contains 2.0 mg aspartame and
0.04 mg sucrose.
Each sachet of Salofalk 1.5g granules contains 3.0 mg aspartame and
0.06 mg sucrose.
Each sachet of Salofalk 3g granules 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 elderly _
_For the treatment of acute episodes of ulcerative colitis _
Once daily 1 sachet of Salofalk 3g granules, 1 or 2 sachets of
Salofalk 1.5g granules, 3
sachets of Salofalk 1000mg granules or 3 sachets of Salofalk 500mg
granules (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
500mg granules three times daily, or 1 sachet of Salofalk 1000mg
granules three times daily),
if this is more convenient to the patient.
_For the maintenance of remission of ulcerative