SALOFALK mesalazine 1g enteric coated tablet, blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

mesalazine, Quantity: 1 g

Tilgjengelig fra:

Dr Falk Pharma Australia Pty Ltd

Legemiddelform:

Tablet, enteric coated

Sammensetning:

Excipient Ingredients: povidone; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; calcium stearate; hypromellose; methacrylic acid copolymer; purified talc; titanium dioxide; iron oxide yellow; macrogol 6000

Administreringsrute:

Oral

Enheter i pakken:

50's, 10's, 90's, 60's, 100 tablets, 20's, 150's

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

SALOFALK tablets are indicated in the treatment of acute episodes and maintenance of remission of: i. Mild to moderate ulcerative colitis; and ii. Crohn?s ileitis and colitis

Produkt oppsummering:

Visual Identification: Yellow to ochre yellow, oblong enteric coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2018-01-16

Informasjon til brukeren

SALOFALK
®
tablets – Consumer Medicine Information
Page 1 of 4
SALOFALK
®
ENTERIC COATED TABLETS
_mesalazine _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
SALOFALK. It does not
contain all of the available
information. Reading this
leaflet does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the possible risks of
taking SALOFALK against the
expected benefits.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING
SALOFALK.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it
again.
WHAT SALOFALK IS
USED FOR
SALOFALK tablets contain
the active ingredient called
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) and Crohn’s
ileitis and colitis (inflammation
of the large bowel and last
section of the small bowel).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
SALOFALK TABLETS HAVE
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
SALOFALK is not addictive.
SALOFALK is not expected to
affect your ability to drive a
car or operate machinery.
SALOFALK is only available
on a doctor’s prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SALOFALK 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.
_CHILDREN OVER 6 YEARS OLD _
The dose of SALOFALK for
your child depends on
disease severity and body
weight. Your doctor will tell
you how much SALOFALK
your child shoul

Preparatomtale

SALOFALK
®
enteric coated tablets - Product Information
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
SALOFALK
®
(MESALAZINE)
ENTERIC COATED TABLETS
1 .
NAME OF THE MEDICINE
Mesalazine.
2 .
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALOFALK tablets contain either 500 mg or 1 g mesalazine, as the
active ingredient.
For the full list of excipients, see section 6.1 List of excipients.
Excipients with known effect in SALOFALK 500 mg tablets: each table
contains 49 mg of
elemental sodium.
See section 4.4 Special warnings and precautions for use.
3 .
PHARMACEUTICAL FORM
Salofalk tablets have a functional coating, 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.
SALOFALK 500 mg enteric coated tablets are presented as butter-yellow
to ochre, oblong,
lustreless with a smooth surface.
SALOFALK 1 g enteric coated tablets are presented as yellow to ochre,
oblong tablets.
4 .
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALOFALK tablets are indicated in the treatment of acute episodes and
maintenance of
remission of:
i .
Mild to moderate ulcerative colitis; and
ii.
Crohn’s ileitis and colitis
4.2
DOSE AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, the recommended doses given in one to
three divided doses
FOR ADULTS AND THE ELDERLY are as follows -:
For acute treatment of:
Ulcerative colitis -
1.5 g to 3 g per day
Crohn’s ileitis and colitis -
3 g to 4.5 g per day
For maintenance of remission and/or long term treatment of:
SALOFALK
®
enteric coated tablets - Product Information
Page 2 of 13
Ulcerative colitis -
1.5 g per day
Crohn’s ileitis and colitis -
1.5 g to 3 g per day
Depending on disease severity in CHILDREN OLDER THAN 6 YEARS OF AGE,
the recommended
doses, given in one to three divided doses, for the treatment of
ulcerative colitis are as
follows -:
For acute treatment: 30-50 mg mesalazine/kg/day.
For maintenance of remission and/or long term treatment: 1