Salofalk 3g 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:

3 gram(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:

2011-07-15

Patient Information leaflet

palieuk-sag3000-en8-jan23
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK 3G 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 3g granules are and what they are used for
2.
What you need to know before you take Salofalk 3g granules
3.
How to take Salofalk 3g granules
4.
Possible side effects
5.
How to store Salofalk 3g granules
6.
Contents of the pack and other information
1.
WHAT SALOFALK 3G 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 3g 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 3G GRANULES
DO NOT TAKE SALOFALK GRANULES
−
If you are allergic to mesalazine, salicylic acid, salicylates such as
Aspirin or to 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 3G 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 of your
KI

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2023
CRN00DDGY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 3g prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk 3g granules contains 3 g mesalazine.
Excipients with known effect:
Each sachet of Salofalk 3g granules contains 6.0 mg aspartame and 0.24
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 – 3.0 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 colitis_
The standard treatment is 0.5 g mesalazine three times daily (in the
morning, at midday and in the evening) corresponding to a
total dose of 1.5 g 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 3.0 g 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