FLUGAL 150 MG CAPSULE

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

FLUCONAZOLE

Dostupné z:

MEDISPEC (M) SDN.BHD

INN (Medzinárodný Name):

FLUCONAZOLE

Počet v balení:

1x1 Capsules; 10 x (1x1) Capsules

Výrobca:

Square Phamarceuticals Ltd.

Príbalový leták

FLUGAL CAPSULE
Fluconazole (150 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Flugal
_ _
is used for
2.
How Flugal
_ _
works
3.
Before you use Flugal
4.
How to use Flugal
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Flugal
_ _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FLUGAL_ _IS USED FOR
Flugal 150
_ _
is used to treat and prevent
certain
fungal
and
yeast
infections
including those with cancer (due to weak
immune system).
HOW FLUGAL_ _WORKS
Flugal
contains
fluconazole
as
active
ingredient,
an
antifungal
agent,
which
works by preventing the growth of the
fungal and yeast organisms causing your
infection.
_ _
BEFORE YOU USE FLUGAL_ _
_When you must not use it _
Do not use Flugal if you
_: _
•
have
allergies
to
fluconazole
or
related azole antibiotics or any other
ingredients in this medication (listed
in Product Description).
_ _
•
are taking cisapride (medicine to treat
heartburn)
_ _
•
are
taking
pimozide
(medicine
to
control involuntary movements)
_ _
•
are
taking
halofantrine
(medicine
used for treating malaria)
_ _
•
are taking terfenadine (medicine for
allergy) (not to be taken together with
fluconazole in multiple doses of 400
mg per day or higher)
_ _
_ _
-
_Before you start to use it _
Inform
your
doctor
if
you
have
such
conditions:
-
AIDS
-
kidney or liver impairment, or
-
suffer
from
any
heart
disease
or
taking medicine which may affect
the heart.
_Pregnancy and lactation _
_ _
Flugal may cause harm to your unborn
baby. You should not take
_ _
Flugal while
you are pregnant unless your doctor has
told you to. Inform your doctor if you are
pregnant
or
planning
to
become
pregnant.
If
you
are
a
woman
of
child-bearing
potential,
avoid
becoming
pregnant
during
treatment.
Use
effective
contraception during treatment and for 1
week after treatment.
Flugal
is
secreted
into
human
breast
milk, hence its use in nursing mothers is
not
recommended.
However,
breast-
feeding may be maintain

Súhrn charakteristických

FLUGAL
FLUCONAZOLE EP
1. NAME OF THE MEDICINAL PRODUCT: _FLUGAL_
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_FLUGAL_
3. PHARMACEUTICAL FORM
Capsule
PRODUCT DESCRIPTION: A hard gelatin capsule (Size#2) filled with white
powder
having a blue color cap and creamish color body imprinted “Square”
on both
parts.
ROUTE OF ADMINISTRATION : Oral
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy may be instituted before the results of the cultures and other
laboratory studies are known; however, once these results become
available,
anti-infective therapy should be adjusted accordingly.
1. Cryptococcosis, including cryptococcal meningitis and infections of
other
sites (e.g., pulmonary, cutaneous). Normal hosts and patients with
AIDS, organ
transplants or other causes of immunosuppression may be treated. _
FLUGAL_
can be used as maintenance therapy to prevent relapse of cryptococca l
disease in patients with AIDS.
2. Systemic candidiasis, including candidemia, disseminated
candidiasis and
other forms of invasive candidal infection. These include infections
of the
peritoneum. endocardium, eye and pulmonary and urinary tracts.
Patients with
malignancy, in intensive care units, receiving cytotoxic or
immunosuppressive
therapy, or with other factors predisposing to candidal infection may
be treated.
3.
Mucosal
candidiasis ,
these
include
oropharyngeal ,
esophageal ,
non-invasive bronchopulmonary infections, candiduria, mucocutaneous
and
chronic oral atrophic candidiasis (denture sore mouth). Normal hosts
and
patients with compromised immune function may be treated. Prevention
of
relapse of oropharyngeal candidiasis in patients with AIDS.
4. Genital candidiasis, vaginal candidiasis, acute or recurrent, and
prophylaxis
to reduce the incidence of recurrent vaginal candidiasis (3 or more
episodes a
year), candidal balanitis.
5.
Prevention
of
fungal
infections
in
patients
with
malignancy
who
are
predispose d to such infections as a result of cytotoxic chemotherap y
or
radiotherapy.
6. Dermatomycosis including tinea ped