FLUCONAZOLE APOTEX fluconazole 200 mg capsule blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

fluconazole, Quantity: 200 mg

MAH:

Arrotex Pharmaceuticals Pty Ltd

pharmaceutical_form:

Capsule, hard

composition:

Excipient Ingredients: purified water; lactose monohydrate; maize starch; patent blue V; magnesium stearate; titanium dioxide; erythrosine; Gelatin; colloidal anhydrous silica; sodium lauryl sulfate

administration_route:

Oral

units_in_package:

28 capsules per pack

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

FLUCONAZOLE APOTEX (fluconazole) capsules, given orally, are indicated for the following conditions: - 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 acute phase of cryptococcal meningitis. - Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with AIDS. - Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. - Secondary prophylaxis of oropharyngeal candidiasis in patients with 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 infecctions. Until such data are available, amphotericin B remains the drug of choice. - 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 therpy is not a practical treatment option. Usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks.

leaflet_short:

Visual Identification: Purple/white hard gelatin, self locked capsules of size '0' containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Registered

authorization_date:

2017-12-07

PIL

FLUCONAZOLE APOTEX
1
FLUCONAZOLE
APOTEX
_Fluconazole _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
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.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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 THIS MEDICINE IS
USED FOR
Fluconazole is used to treat some
types of fungal and yeast infections.
It belongs to a group of medicines
called azole antifungals.
_HOW IT WORKS _
Fluconazole works by preventing the
growth of the fungi and yeast that
have caused your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
fluconazole
•
other antifungal agents, such as
itraconazole or ketoconazole
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE FLUCONAZOLE IF YOU ARE
ALSO TAKING ANY OF THE FOLLOWING
MEDICINES:
•
terfenadine
•
cisapride
•
astemizole
•
erythromycin
•
pimozide
•
quinidine
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKI

SPC

AUSTRALIAN PRODUCT INFORMATION
FLUCONAZOLE APOTEX (FLUCONAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Fluconazole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole Apotex contains fluconazole 200 mg.
EXCIPIENT WITH KNOWN EFFECTS: CONTAINS SUGARS AS LACTOSE.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Capsule.
Purple/ white hard gelatin, self-locked capsules of size '0'
containing white to off white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
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 AIDS.
-
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
-
Secondary prophylaxis of oropharyngeal candidiasis in patients with
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.
-
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
not
a
practical
treatment option. Usually, topical therapy should be attempted first
because oral therapy
has a less favourable ratio of benefits to risks. (see section 4.8
ADVERSE EFFECTS
(UNDESIRABLE EFFECTS)).
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Fluconazole APOTEX capsules are intended for oral administration.
DOSAGE
ADULTS
_For cryptococcal meningitis in patients who are unable to take or
tolerate amphotericin B:_ The
usual dos