Salofalk 500 mg prolonged-release granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Dr. Falk Pharma GmbH

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

500 milligram(s)

Pharmaceutical form:

Prolonged-release granules

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

2003-08-08

Patient Information leaflet

palieuk-sag500-en8-jan23
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, 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 problems

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2023
CRN00DDGY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 500 mg prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk 500mg granules contains 500 mg mesalazine.
Excipients with known effect:
Each sachet of Salofalk 500mg granules contains 1.0 mg aspartame and
0.04 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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 mild to moderate 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 – 3.0g
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 colitis:
The standard treatment is 0.5g mesalazine three times daily (in the
morning, at midday and in the evening) corresponding to a
total dose of 1.5g mesalazine per day.
For patients known to be at increased risk for relapse for medical
reasons or due to difficulties to adhere to application of three
daily doses the dosing schedule can be adapted to 3.0g mesalazine
given as a single daily dose preferably in the morning.
Paediatric population:
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older:
ACTIVE DISEASE: To be determined individually,