SALOFALK 500 SUPPOSITORIES

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Available from:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (International Name):

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Units in package:

30 Pieces Pieces

Manufactured by:

VIFOR AG

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
SALOFALK
®
SUPPOSITORIES
Mesalazine 500 mg
1
What is in this leaflet
1. What Salofalk Suppositories are
used for
2. How Salofalk Suppositories work
3. Before you use Salofalk
Suppositories
4. How to use Salofalk Suppositories
5. While you are using it
6. Side effects
7. Storage and Disposal of Salofalk
Suppositories
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
What Salofalk Suppositories are
used for
Salofalk
Suppositories are used
for the treatment of acute episodes
of inflammatory disease at the
large intestine, rectum and anal
canal.
How Salofalk Suppositories work
Salofalk Suppositories contain the
active substance mesalazine, an anti-
inflammatory agent used to treat
inflammatory bowel disease.
Before you use Salofalk
Suppositories
-
When you must not use it
Do not use Salofalk Suppositories
-
if you are or have been told you
are hypersensitive (allergic) to
mesalazine, salicylic acid,
salicylates such as Aspirin or any
of the other ingredients of this
medicine.
-
if you have a serious liver and/or
kidney disease.
Pregnancy and breast-feeding
If you are pregnant or breast-
feeding, think you may be
pregnant or are planning to have a
baby, ask your doctor or
pharmacist for advice before
using this medicine.
You should only use Salofalk
Suppositories during pregnancy if your
doctor tells you to.
You should only use Salofalk Suppositories
during breast-feeding if your doctor tells you
to, as this medicine and its metabolites may
pass into breast milk. If the infant develops
diarrhoea, the breastfeeding should be
discontinued.
-
Before you start to use it
Before you start using this medicine you
should tell your doctor
-
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
kidney.
-
if you have ever de

Summary of Product characteristics

D3 Package insert_SAS500_Nov20-CLN
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Salofalk
®
500 Suppositories
Mesalazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One suppository contains 500 mg mesalazine as the medically active
ingredient.
Excipient with known effect: cetyl alcohol (Ph.Eur.)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories
Appearance: white to cream-coloured, torpedo-shaped suppositories
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute episodes of ulcerative colitis, proctitis and inflammation of
the anal canal.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
One Salofalk 500 suppository three times daily (equivalent to 1500 mg
mesalazine daily)
inserted into the rectum, according to the individual clinical
requirement.
As soon as remission has occurred, Salofalk 500 mg gastro-resistant
tablets can be used.
_ _
_Children and adolescents_
There is little experience and only limited documentation for an
effect in children.
Method of administration
When used three times daily, Salofalk 500 Suppositories should be
inserted into the rectum
in the morning, at midday and at bedtime.
Treatment with Salofalk 500 Suppositories must be administered
regularly and consistently,
because only in this way can healing be successfully achieved.
The duration of use is determined by the physician.
2 / 7
d3 package insert_sas500_nov20-cln
4.3
CONTRAINDICATIONS
Salofalk 500 Suppositories are contraindicated in patients with:
- known hypersensitivity to salicylates or any of the excipients.
- severe impairment of hepatic or renal function
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters like
ALT or AST; serum
creatinine) and urinary status (dip sticks) should be determined prior
to and during treatment,
at the discretion of the treating physician. As a guideline, follow-up
tests are recommended
14 days after commencement of treatment, then a further two to three
tests at intervals of