FLUZOLE 200 fluconazole 200mg capsule blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

fluconazole, Quantity: 200 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

Fluconazole

formulario farmacéutico:

Capsule, hard

Composición:

Excipient Ingredients: magnesium stearate; erythrosine; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; purified talc; sodium lauryl sulfate; purified water; Gelatin; titanium dioxide; brilliant blue FCF

Vía de administración:

Oral

Unidades en paquete:

28 capsules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Fluconazole, given orally, is indicated 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 aquired 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

Resumen del producto:

Visual Identification: White free flowing powder filled in empty hard gelatin capsule of size '0' with a violet cap and a white body; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2006-08-17

Información para el usuario

FLUZOLE- Consumer Medicine Information
Page 1 of 4
FLUZOLE
fluconazole
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUZOLE capsules.
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 FLUZOLE
capsules 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 FLUZOLE IS USED
FOR
FLUZOLE capsules are used to treat
certain fungal and yeast infections.
This medicine 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 only available with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE FLUZOLE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
fluconazole
•
medicines related to fluconazole
such as miconazole,
ketoconazole or clotrimazole
•
any of the ingredients listed at
the end of this leaflet.
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.
FLUZOLE SHOULD NOT BE GIVEN IF
YOU ARE TAKING CISAPRIDE (A
MEDICINE USED TO TREAT STOMACH
PROBLEMS).
DO NOT TAKE THIS MEDICINE IF THE
EXPIRY DATE PRINTED ON THE
PACKAGING HAS PASSED 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 TAKING THIS
MEDICINE, TALK TO YOUR DOCTOR.
Before you start to take it
TELL

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION FLUZOLE (FLUCONAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluzole capsules come in three strengths and contain 50 mg, 150 mg or
200 mg of fluconazole.
Fluconazole is a white to off-white crystalline powder which is
sparingly soluble in water and saline.
EXCIPIENTS WITH KNOWN EFFECT:
Sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FLUZOLE 50
White free flowing powder filled in empty hard gelatin capsule of size
'4' with a blue
cap and a white body
FLUZOLE 150
White free flowing powder filled in empty hard gelatin capsule of size
'1' with a blue
cap and a blue body
FLUZOLE 200
White free flowing powder filled in empty hard gelatin capsule of size
'0' with a
violet cap and a white body
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.
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 not a p