SULBACIN TABLET

Country: Malaysia

Language: English

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

Active ingredient:

SULTAMICILLIN TOSYLATE

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

SULTAMICILLIN TOSYLATE

Units in package:

10 Tablets

Manufactured by:

Unichem Laboratories Limited

Patient Information leaflet

SULBACIN TABLET
Sultamicillin (375 mg)
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What SULBACIN is used for
2.
How SULBACIN works
3.
Before you use SULBACIN
4.
How to use SULBACIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
SULBACIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT
IS
SULBACIN
IS
USED
FOR
Sulbacin
is
used
to
treat
stomach,
skin and soft tissue, respiratory tract,
ear,
nose,
throat,
genito-urinary
infection.
HOW SULBACIN WORKS
SULBACIN
contains sultamicillin,
which kills bacteria by inhibiting cell
wall formation. BEFORE YOU USE SULBACIN
_ _
_- When you must not use it _
Do not take SULBACIN if:
-
you
are
allergic
to
penicillin
or
cephalosporin
antibiotics,
or
any
other
ingredients
of
this
medicine
(listed in Product Description)
_ _
_-Before you start to use it _
Please
consult
your
doctor
or
pharmacist if you are/have:
- infectious mononucleosis (kissing
disease), as it may cause skin rash or
super infection
- pregnant, planning for pregnancy
or
breast-feeding
before using
any
medicine.
Sulbacin
can
cross
placental and secrete in breastmilk.
Safety use in pregnancy and lactation
has
not
been
established,
caution
should
be
exercised
when
administered
to
a
pregnancy
or
nursing woman.
_-Taking other medications _
Tell your doctor or pharmacist if you
are
taking
any
other
medicines,
including any that you buy without a
prescription
from
a
pharmacy,
supermarket or health food shop.
Medications that may interact with
Sulbacin are as following:
Antigout
medication:
allopurinol,
Probenecid
Blood thinning medication
Antibiotic:
chloramphenicol,
erythromycin,
sulfonamides
and
tetracyclines
Oral contraceptive
Immunosuppressive
medication:
methotrexate
Reagent:
Benedict's
reagent,
Fehling's reagent and Clinitest.
HOW TO USE SULBACIN
_-How much to use _
Adults
and
children
above
30kg:
Usual dose 1-2 tablets twice daily
for 5-14 days.
If
you
have
severe
kidney
impairment
(creatinine
clearance
less tha

Summary of Product characteristics

Store below 30°C. Protect from light and moisture.
AGENCY NAME: Unicorn Creation
DATE: 01-06-2020
PREFOLDED SIZE: ---------
NO. OF PREFOLDS: ---------
PACKING: -----
REASON: Updated storage condition text, updated Brand name as
“Sulbacin Tablet”, as per inputs received from Healol Malaysia.
20.05.20 text changes incorporated as per inputs received from Healol
RA in mail dated 16.05.2020.
01.06.20 Text updated with heading updated as Pharmacodynamics.
13012775
13012775
Date of Revision : 23 May, 2020
MAL No.: MAL20061565AZ
PRODUCT REGISTRATION HOLDER:
Healol Pharmaceuticals Sdn.Bhd
74-3, Jalan Wangsa Delima 6, KLSC Wangsa Maju,
53300 Kuala Lumpur, Malaysia.
SULBACIN
TABLETS
PHARMACODYNAMICS:
Sultamicillin is a double ester of a broad spectrum antibiotic
ampicillin with sulbactam, a semisynthetic b-lactamase
inhibitor, which extends the antibacterial spectrum of ampicillin to
include some b-lactamase producing strains of bacteria
that would otherwise be resistant.