TYSTATIN ORAL SUSPENSION

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

NYSTATIN

Tilgængelig fra:

IMEKS PHARMA SDN. BHD.

INN (International Name):

NYSTATIN

Enheder i pakken:

12ml mL; 30 ml mL; 60 ml mL

Fremstillet af:

T.O. CHEMICALS (1979) LTD.

Indlægsseddel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
TYSTATIN ORAL SUSPENSION
®
Nystatin (100,000 units per ml)
WHAT IS IN THE LEAFLET
1.
What Tystatin is used for
2.
How Tystatin works
3.
Before you use Tystatin
4.
How to use Tystatin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tystatin
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT TYSTATIN IS USED FOR
Tystatin
contains
the
active
ingredient
nystatin.
Nystatin is available as a 100,000 units/mL
oral suspension. It is used to prevent and
treat fungal infections of the mouth (thrush)
that caused by a fungus called Candida.
HOW TYSTATIN WORKS
Nystatin belongs to a group of medicines
called anti-fungal antibiotics. It works by
interfering with their cell membranes and
thus kill the fungi and treats the infection.
BEFORE YOU USE TYSTATIN
-
_When you must not use it_
•
Have ever had allergic reaction to nystatin,
the
active
ingredient,
or
to
any
of
the
excipients.
-
_Before you start to use it_
Tell your doctor if you:
•
Have allergies to any other medicines,
food, preservatives or dyes
•
Have a fungal infection in the lungs or on
the skin
•
Are pregnant, planning to become pregnant,
or are breast-feeding.
If you are not sure whether you should start
taking this medicine, consult your doctor.
-
_Taking other medicines_
Tell your doctor if you are taking any other
medicine, including any that you buy without
a prescription. You may need to use different
amounts of these medicines, or you may
need
to take different medicines.
-
_Pregnancy and lactation_
If you are pregnant or breast-feeding, think
that are pregnant or are planning to be
pregnant, ask your doctor or pharmacist for
advice before taking this medicine. It is not
known
whether
nystatin
can
cause
foetal
harm
when
administered
to
a
pregnant
woman. Nystatin should only be prescribed
during pregnancy if your doctor thinks it is
necessary.
It is not known whether nystatin gets into
breast milk therefore, ask your doctor for
advice

Produktets egenskaber

PLEASE
READ CAREFULLY
TYSTATIN ORAL SUSPENSION
CONTENT
Each ml contains 100,000 UNITS OF NYSTATIN, methyl paraben 1.8mg &
propyl paraben 0.2mg
as
preservatives
and
the
following
inactive
ingredients:
polyethylene
glycol
1500,
microcrystalline
cellulose,
carboxymethylcellulose
sodium,
saccharin
sodium,
glycerin,
polysorbate 80, raspberry essence and vanilla flavour.
DESCRIPTION
A yellow suspension with a raspberry-vanilla flavour.
INDICATION
_TYSTATIN ORAL SUSPENSION _is indicated for the treatment of candidal
infection of the oral_ _
cavity.
RECOMMENDED DOSAGE
_Infants_:_ _
One ml (equivalent to 100,000 units) four times daily after food.
Limited clinical_ _studies in
premature and low birth weight infants indicate that 1ml 4 times daily
is effective.
_Children and Adults_:
One to six ml (100,000 to 600,000 units) four times daily after food.
MODE OF ADMINISTRATION
The suspension should be swished throughout or be retained in the
mouth for as long as
possible before swallowing. Patients should avoid taking food or drink
earlier than one hour
after a dose. In infants and young children, apply one half of dose in
each side of mouth. The
dosage should be continued for 48 hours after lesions have resolved.
CONTRAINDICATIONS
_TYSTATIN ORAL SUSPENSION _is contraindicated in patients with a
history of hypersensitivity to_ _
the drug or any ingredient in the formulation.
WARNING AND PRECAUTIONS

_TYSTATIN ORAL SUSPENSION _is not to be used for the treatment of
systemic mycoses.
Discontinue treatment if sensitization or irritation is reported
during use.

Carcinogenesis, mutagenesis, impairment of fertility- No long-term
animal studies have
been performed to evaluate carcinogenic potential. There also have
been no studies
to determine mutagenicity or whether this medication affects fertility
in males or
females.
INTERACTIONS WITH OTHER MEDICAMENTS
None known
PREGNANCY AND LACTATION
It is not known whether _TYSTATIN ORAL SUSPENSION_ can cause foetal
harm if administered to
pregnant women. It is also not known whether