Nilstat Oral Tablets

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

nystatin, Quantity: 500000 IU

Διαθέσιμο από:

Aspen Pharma Pty Ltd

INN (Διεθνής Όνομα):

Nystatin

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate; ethylcellulose; purified water; Carnauba Wax; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

50 tablets

Kατηγορία:

Medicine Registered

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INDICATIONS AS AT 24 MAY 2005 : Intestinal candidiasis.

Περίληψη προϊόντος:

Visual Identification: Round, biconvex, buff coloured, film coated tablets,approximately 3/8" (9.5mm) in diameter; Container Type: Bottle; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1991-09-09

Φύλλο οδηγιών χρήσης

NILSTAT- Consumer Medicine Information
Page 1 of 3
NILSTAT
_nystatin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NILSTAT. It does not
contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking NILSTAT against the
benefits they expect it will have for
you.
_ _
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NILSTAT IS USED FOR
NILSTAT is used to treat a condition
called intestinal candidiasis or thrush.
This is an infection in your gut caused
by the fungus _Candida. _
_ _
NILSTAT belongs to a group of
medicines called antifungal agents. It
works by damaging the cell wall of the
_Candida _fungus, causing it to die.
NILSTAT only works inside your gut.
The amount of NILSTAT absorbed into
the bloodstream is minute and
therefore is not effective for treating
any other infections in your body.
Your doctor, however, may have
prescribed NILSTAT for another
purpose. Ask your doctor if you have
any questions about why
This medicine is only available with a
doctor’s prescription.
It is not addictive.
NILSTAT is not expected to affect your
ability to drive a car or operate
machinery.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NILSTAT IF YOU ARE
ALLERGIC TO NYSTATIN OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT USE IT IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you take it after the expiry date has
passed, it may not work as well.
DO NOT GIVE NILSTAT TO CHILDREN OR
INFANTS UNLESS YOUR DOCTOR TELLS YOU
TO.
Your doctor will check to make sure
that NILSTAT is the right treatment for
your child’s symptoms.
_BEFORE YOU START TO TAKE IT _
_ _
YOU MUST TELL YOUR DOCTOR IF:
1.
YOU HAVE ANY ALLERGIES TO:
�

Αρχείο Π.Χ.Π.

NILSTAT ORAL- pi-29jul20
1
AUSTRALIAN PRODUCT INFORMATION
NILSTAT ORAL (NYSTATIN) TABLETS AND CAPSULES
1
NAME OF THE MEDICINE
Nystatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NILSTAT ORAL TABLETS and CAPSULES contains Nystatin 500,000I.U
Excipients with known effect: Contains sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NILSTAT CAPSULES - Size 2, opaque, buff-coloured capsules, printed
"Nilstat" on cap and
body in back ink, and filled with a uniform, yellow granular powder.
NILSTAT TABLETS - Round, biconvex, buff-coloured, film-coated tablets
approximately
3/8" (9.5mm) in diameter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of intestinal infections caused by Candida albicans and
other candida species.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Usual Adult and Adolescent Dosage: 500,000 to 1 million units (1 to 2
tablets or capsules)
3 times daily.
Note that use is not recommended in infants and children up to 5 years
of age, as this
group may not be capable of using the tablet safely.
Treatment should generally be continued for at least 48 hours after
clinical cure to
prevent a relapse.
NILSTAT ORAL- pi-29jul20
2
4.3
C
ONTRAINDICATIONS
Hypersensitivity
to
the
drug.
Nystatin
is
contraindicated
in
individuals
who
are
hypersensitive to the drug or any ingredient in the respective
formulation. If irritation or
sensitization occurs, nystatin should be discontinued.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
NYSTATIN ORAL TABLETS OR CAPSULES should not be used in the treatment
of systemic
fungal infections since it is not absorbed from the gastrointestinal
tract
USE IN THE ELDERLY
No information is available on the relationship of age to the effects
of oral nystatin in
geriatric patients.
PAEDIATRIC USE
NYSTATIN ORAL TABLETS OR CAPSULES should not be used in infants and
children up
to 5 years of age. (See 4.2 DOSE AND METHOD OF ADMINISTRATION).
EFFECTS ON LABORATORY TESTS
No data available
4.5
I
NTER