FLUCONAZOLE SANDOZ fluconazole 50 mg capsules blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

fluconazole, Quantity: 50 mg

Verfügbar ab:

Sandoz Pty Ltd

INN (Internationale Bezeichnung):

Fluconazole

Darreichungsform:

Capsule, hard

Zusammensetzung:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate; titanium dioxide; Gelatin; indigo carmine; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia

Verabreichungsweg:

Oral

Einheiten im Paket:

28

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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. 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 Adverse Reactions.)

Produktbesonderheiten:

Visual Identification: Hard gelatin capsules, snap-fit closure, turquoise cap white body with the imprint FC50, containing a white odourless powder.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2005-07-27

Gebrauchsinformation

FLUCONAZOLE SANDOZ
®
1
FLUCONAZOLE SANDOZ
®
_fluconazole capsules _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Fluconazole Sandoz.
It does not contain all 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 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 want to read it again.
WHAT
FLUCONAZOLE
SANDOZ IS USED
FOR
This medicine is used to treat certain
types of fungal or yeast infections.
It contains the active ingredient
fluconazole.
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.
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.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
FLUCONAZOLE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
fluconazole, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description
•
any other similar antifungal
medicines such as miconazole,
ketoconazole or clotrimazole.
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 THIS MEDICINE IF YOU
ARE TAKING:
•
cisapride, a medicine used to treat
stomach problems
•
terfenadine or astemizole, a
medicine used to treat allergies
•
erythromycin, a medicine used to
treat infections
•
pimozide, a medicine used to
treat mental illness
•
quinidi

Fachinformation

211202-Fluconazole Sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
FLUCONAZOLE SANDOZ (FLUCONAZOLE) CAPSULES
1.
NAME OF THE MEDICINE
Fluconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fluconazole Sandoz 50 mg capsules contains 50 mg fluconazole.
Each Fluconazole Sandoz 100 mg capsules contains 100 mg fluconazole.
Each Fluconazole Sandoz 150 mg capsules contains 150 mg fluconazole.
Each Fluconazole Sandoz 200 mg capsules contains 200 mg fluconazole.
_Excipients with known effect:_
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Fluconazole Sandoz 50 mg capsules - Hard gelatin capsules, turquoise
cap, white body with
the imprint FC50
Fluconazole Sandoz 100 mg capsules - Hard gelatin capsules, blue cap
white body with the
imprint FC100.
Fluconazole Sandoz 150 mg capsules* - Hard gelatin capsules, white cap
white body with the
imprint FC150.
Fluconazole Sandoz 200 mg capsules - Hard gelatin capsules, purple cap
white body with the
imprint FC200.
4.
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.
211202-Fluconazole San