SALOFALK mesalazine 1g suppository strip pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

mesalazine, Quantity: 1000 mg

זמין מ:

Dr Falk Pharma Australia Pty Ltd

INN (שם בינלאומי):

Mesalazine

טופס פרצבטיות:

Suppository, moulded

הרכב:

Excipient Ingredients: Hard fat

מסלול נתינה (של תרופות):

Rectal

יחידות באריזה:

5, 30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Treatment of ulcerative proctitis

leaflet_short:

Visual Identification: Light beige coloured, torpedo-shaped; Container Type: Strip Pack; Container Material: PVC/PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2010-05-24

עלון מידע

SALOFALK
®
suppository (1 g) – Consumer Medicine Information
Page 1 of 4_ _
SALOFALK
® SUPPOSITORY
_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 suppositories
contain the active ingredient,
mesalazine (5-aminosalicylic
acid) and are used to treat
inflammatory bowel disease
limited to the rectum.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
SALOFALK SUPPOSITORIES
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 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 has
not been established.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF:
•
YOU HAVE ANY ALLERGIES
•
YOU ARE PREGNANT OR INTEND
TO BECOME PREGNANT OR ARE
BREASTFEEDING OR WISH TO
BREASTFEED.
Your doctor wi

מאפייני מוצר

SALOFALK
®
Suppositories - Product Information
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
SALOFALK
®
SUPPOSITORIES
(MESALAZINE)
1.
NAME OF THE MEDICINE
Mesalazine.
2 .
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALOFALK suppositories contain 1 g mesalazine as the active
ingredient.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SALOFALK suppositories are light beige coloured, torpedo-shaped
suppositories.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SALOFALK suppositories are indicated in the treatment of ulcerative
proctitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
One SALOFALK 1 g suppository should be inserted into the rectum once
daily at
bedtime. The best results are achieved if the bowels are evacuated
prior to insertion
of SALOFALK suppository.
USE IN CHILDREN
SALOFALK enemas should not be used in children 12 years old and under,
as there
is little experience with this age group.
4.3
CONTRAINDICATIONS
SALOFALK suppositories are contraindicated in patients with the
following:
•
hypersensitivity to salicylic acid, salicylic acid derivatives, e.g.
mesalazine/5-
ASA
•
hypersensitivity to any other ingredients in SALOFALK suppository
•
severe impairment of hepatic and renal function.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SALOFALK should be given/used under medical supervision.
USE IN PULMONARY FUNCTION IMPAIRMENT
SALOFALK should be used/given with caution in patients with pulmonary
function
impairment, particularly asthma and in patients with known
hypersensitivity to
sulfasalazine containing preparations. Treatment in the latter
patients should be
instituted with careful medical supervision. Treatment should be
discontinued
immediately if symptoms of acute intolerance, e.g. cramps, acute
abdominal pain,
SALOFALK
®
Suppositories - Product Information
Page 2 of 10
fever, severe headache and skin rash, occur.
USE IN HEPATIC IMPAIRMENT
Caution is recommended in patients with impaired hepatic function.
SALOFALK
suppositories are contraindicated in pat