SALOFALK ENEMAS mesalazine 4g/60mL enema bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

mesalazine, Quantity: 4000 mg

Tilgjengelig fra:

Dr Falk Pharma Australia Pty Ltd

Legemiddelform:

Enema

Sammensetning:

Excipient Ingredients: sodium benzoate; carbomer 934P; disodium edetate; potassium acetate; potassium metabisulfite; xanthan gum; purified water

Administreringsrute:

Rectal

Enheter i pakken:

7 enemas per carton, 1 enema per carton

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Salofalk enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

Produkt oppsummering:

Visual Identification: Very light tan to brown suspension.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2002-05-15

Informasjon til brukeren

SALOFALK
®
enema (2 g/30 mL, 2 g/60 mL & 4 g/60 mL) – Consumer Medicine
Information
Page 1 of 4
_ _
SALOFALK
®
ENEMA
_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
using SALOFALK against the
expected benefits.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT USING
SALOFALK.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it again.
WHAT SALOFALK IS
USED FOR
SALOFALK enemas contain the
active ingredient mesalazine (5-
aminosalicylic acid), which is
used to treat, and prevent
relapses of, mild to moderate
attacks of ulcerative colitis
(inflammation of the large
bowel).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
SALOFALK ENEMAS HAVE
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed SALOFALK 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 USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE 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.
DO NOT GIVE SALOFALK TO A
CHILD BELOW 12 YEARS OF AGE.
The safety and effectiveness of
SALOFALK in this group have
not been established.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF:
•
YOU HAVE ANY ALLERGIES
•
YOU ARE PREGNANT OR INTEND
TO BECOME

Preparatomtale

SALOFALK enemas – Product Information
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
SALOFALK
®
ENEMAS
(MESALAZINE)
1.
NAME OF THE MEDICINE
Mesalazine.
2 .
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALOFALK enemas contain either 2 g/30 mL, 2 g/60 mL or 4 g/60 mL
mesalazine as the active
ingredient.
Excipients with known effect: sulphites and benzoates
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 2 g/30 mL, 2 g/ 60 mL and 4 g/60 mL enemas are presented as a
very light tan to
brown, homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALOFALK enemas are indicated in the treatment of acute ulcerative
colitis of mild to moderate
severity and for the maintenance treatment of ulcerative colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Unless otherwise advised a dose of 2 g or 4 g mesalazine as SALOFALK
enema once a day is
used for the treatment of acute ulcerative colitis or maintenance of
remission.
The content of one enema bottle (2 g/30 mL, 2 g/60 mL, or 4 g/60 mL)
is instilled in the rectum
once every evening prior to going to bed.
The best results are achieved if the bowels are evacuated prior to
instillation of SALOFALK
enema. The action of SALOFALK is enhanced if the patient lies on the
left side when
introducing the enema. The dosage should be adjusted to suit the
progress of the condition.
Discontinuation of treatment should be under supervision of the
physician. Due to the
considerable variation in the severity of the ulcerative colitis and
the extent of the affected area it
is not possible to recommend a uniform dose of mesalazine which will
provide optimal effects. In
clinical trials, rectal doses of 2-4 g mesalazine/day as enemas have
been used in the therapy of
both acute ulcerative colitis and maintenance of remission.
SALOFALK enemas – Product Information
Page 2 of 11
USE IN CHILDREN
SALOFALK enemas should not be used in children 12 years old and under,
as there is lit