APO-FLUCONAZOLE fluconazole 200mg capsule blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

fluconazole

Διαθέσιμο από:

Arrow Pharma Pty Ltd

INN (Διεθνής Όνομα):

Fluconazole

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

Apo-Fluconazole Capsules
1
APO-FLUCONAZOLE
_Contains the active ingredient fluconazole _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about fluconazole. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
your medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:

if there is anything you do not
understand in this leaflet,

if you are worried about taking
your medicine, or

to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Fluconazole. It contains the active
ingredient fluconazole.
It is used to treat certain fungal and
yeast infections.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Fluconazole belongs to a group of
medicines called azole antibiotics.
It works by preventing the growth of
the fungal and yeast organisms
causing your infection.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
THIS MEDICINE IS NOT SUITABLE FOR
CHILDREN WEIGHING LESS THAN 35 KG.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:

YOU ARE TAKING TERFENADINE (A
MEDICINE USED TO TREAT
ALLERGIES). IF Y

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION APO-FLUCONAZOLE (FLUCONAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Apo-fluconazole capsules come in two strengths and contain 50 mg, or
200 mg of fluconazole.
Fluconazole is a white to off-white crystalline powder which is
sparingly soluble in water and saline.
The capsules also contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-FLUCONAZOLE CAPSULES are intended for oral administration. Each
capsule contains fluconazole
50
mg or 200 mg
APO-FLUCONAZOLE 50MG CAPSULES
Blue and white, opaque, hard gelatin capsules. Each capsule contains
50 mg of fluconazole.
APO-FLUCONAZOLE 200MG CAPSULES
Violet and white, opaque, hard gelatin capsules. Each capsule contains
200 mg of fluconazole.
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CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Orally for treatment of cryptococcal meningitis in patients who are
unable to tolerate
amphotericin B.
NOTE. Data suggest that the clinical efficacy of fluconazole is lower
than that of amphotericin B in the
treatment of the acute phase of cryptococcal meningitis.
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with acquired
immune deficiency syndrome (AIDS).
Treatment of oropharyngeal and oesophageal candidiasis in AIDS and
other immunosuppressed
patients.
Secondary prophylaxis of oropharyngeal candidiasis in patients with
human immunodeficiency virus
(HIV) infection.
Serious and life-threatening _Candida_ infections in patients who are
unable to tolerate amphotericin
B.
NOTE. It remains to be shown that fluconazole is as effective as
amphotericin B in the treatment of
serious and life-threatening _Candida_ infections. Until such data are
available, amphotericin B
remains the drug of choice.
2
Vaginal candidiasis, when topical therapy has failed.
Treatment of extensive _Tinea corporis_, extensive _Tinea cruris_ and
extensive _Tinea pedis_ infections in
immunocompetent patients in whom topical therapy is no