SALOFALK GRANULES mesalazine 3g modified release granules sachet
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
19-01-2021
Summary of Product characteristics
(SPC)
20-01-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
mesalazine, Quantity: 3000 mg
Available from:
Dr Falk Pharma Australia Pty Ltd
INN (International Name):
Mesalazine
Pharmaceutical form:
Granules, modified release
Composition:
Excipient Ingredients: aspartame; carmellose sodium; microcrystalline cellulose; citric acid; hypromellose; magnesium stearate; methylcellulose; povidone; colloidal anhydrous silica; simethicone; sorbic acid; purified talc; titanium dioxide; triethyl citrate; methacrylic acid copolymer; Flavour
Administration route:
Oral
Units in package:
6, 30, 50
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
SALOFALK GRANULES granules are indicated in the treatment of acute ulcerative colitis of mild to moderate severity, and for the maintenance of remission and/or the long term treatment of ulcerative colitis.
Product summary:
Visual Identification: Greyish white granules; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-07-02
Patient Information leaflet
SALOFALK
®
GRANULES (500 mg, 1 g, 1.5 g, 3 g) modified release granules – CMI
Page 1 of 5
_ _
SALOFALK
® GRANULES
MODIFIED RELEASE GRANULES
_mesalazine _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
SALOFALK GRANULES
modified release granules. It
does not contain all of the
available information.
All medicines have risks and
benefits. Your doctor has
weighed the possible risks of
taking this medicine against
the expected benefits.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING
SALOFALK GRANULES.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it
again.
WHAT SALOFALK
GRANULES
MODIFIED RELEASE
GRANULES IS USED FOR
SALOFALK GRANULES
contain the active ingredient
mesalazine (5-aminosalicylic
acid), which is used to treat,
and prevent relapse of, mild
to moderate attacks of
ulcerative colitis (inflammation
of the large bowel).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason. SALOFALK
GRANULES are not
addictive.
It is not expected to affect
your ability to drive a car or
operate machinery.
This medicine is only
available on a doctor’s
prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SALOFALK
GRANULES MODIFIED
RELEASE GRANULES IF:
•
you are allergic to
mesalazine or aspirin-like
medicines, or any of the
ingredients listed at the
end of this leaflet.
Signs of allergic reactions
may include itchy skin
rash, shortness of breath
and swelling of the face or
tongue.
•
you suffer from a severe
kidney or liver problem
•
the expiry date (EXP)
printed on the pack has
passed. If you use this
medicine after the expiry
date has passed, it may
not work as well.
•
the package is torn or
shows signs of tampering.
DO NOT GIVE THIS MEDICINE TO
A CHILD BELOW 6 YEARS OF
AGE.
The safety and effectiveness
of this medicine in this group
have not been established.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR I
Read the complete document
Summary of Product characteristics
Salofalk
®
Granules - Product Information
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
SALOFALK
® GRANULES (MESALAZINE)
MODIFIED RELEASE GRANULES
1.
NAME OF THE MEDICINE
Mesalazine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALOFALK GRANULES modified release granules contain either 500 mg, 1
g, 1.5 g
or 3 g mesalazine as the active ingredient.
Excipients of known effect: aspartame
See section 4.4 Special warnings and precautions for use.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SALOFALK GRANULES modified release granules are presented as greyish
white
cylindrical or round granules.
They have a functional coating on the particles, which ensures
gastro-resistance to
allow a reliable distribution and pH-dependent release of the active
ingredient,
mesalazine, at the intended site of action starting in the ileocoecal
region. The
granules also contain a matrix system inside the particle core, which
releases
mesalazine independently of pH.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALOFALK GRANULES are indicated in the treatment of acute ulcerative
colitis of
mild to moderate severity, and for the maintenance of remission and/or
the long term
treatment of ulcerative colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
For adults and the elderly:
Unless otherwise prescribed, the recommended dose for acute ulcerative
colitis is
1.5 g to 3 g per day. For maintenance of remission and/or long term
treatment of
ulcerative colitis, the recommended dose is 1.5 g per day.
For children older than 6 years of age:
The recommended dose for acute ulcerative colitis, depending on
disease severity, is
30-50 mg mesalazine/kg/day. For maintenance of remission and/or long
term treatment
of ulcerative colitis, the recommended dose is 15-30 mg
mesalazine/kg/day.
DOSES MAY BE GIVEN IN ONE TO THREE DIVIDED DOSES.
It is generally recommended that half the adult dose may be given to
patients up to a
body weight of 40 kg; and the normal adult dose to those above 40 kg.
Salofalk
®
Granule
Read the complete document
