Fluconazole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluconazole 50mg; Fluconazole 50mg; Fluconazole 50mg

Available from:

Viatris Limited

INN (International Name):

Fluconazole 50 mg

Dosage:

50 mg

Pharmaceutical form:

Capsule

Composition:

Active: Fluconazole 50mg Excipient: Erythrosine Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Patent blue V Pregelatinised maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Active: Fluconazole 50mg Excipient: Erythrosine Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Patent blue V Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Active: Fluconazole 50mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Patent blue V Ponceau 4R Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide

Units in package:

Blister pack, PVC/PVDC/Al 28's, 28 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

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. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 2. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium 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, oesophageal, 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. 4. Vaginal candidiasis, acute or recurrent. 5. Prevention of fungal infection in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant 6. Fluconazole 50 mg & 150 mg capsules are also indicated for the treatment of dermatomycoses including tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor & candidiasis.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2002-06-24

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FLUCONAZOLE
_FLUCONAZOLE 50 MG, 150 MG AND 200 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluconazole
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 using Fluconazole
capsules against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT FLUCONAZOLE IS
USED FOR AND HOW IT
WORKS
Your Fluconazole capsules contain
fluconazole. It belongs to a group of
medicines known as antifungals.
Fluconazole is used to treat certain
fungal and yeast infections. 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.
Fluconazole is only available with a
doctor's prescription.
BEFORE YOU TAKE
FLUCONAZOLE
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE FLUCONAZOLE IF YOU
HAVE AN ALLERGY TO THE FOLLOWING:

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.
Do not take this medicine if you are
taking any of the following
medicines:

CISAPRIDE (a medicine used
to treat stomach problems)

ASTEMIZOLE (an
antihistamine used to treat
allergies)

ERYTHROMYCIN (an antibiotic
used in the treatment of
infections)

PIMOZIDE (an antipsychotic
medicine)

QUINIDINE (a medicine used
to treat an irregular
heartbeat)

TERFENADINE (an
antih

Summary of Product characteristics

Page 1 of 20
NEW ZEALAND DATA SHEET
FLUCONAZOLE
1. PRODUCT NAME
Fluconazole, 50 mg, 150 mg and 200 mg, capsule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg, 150 mg or 200 mg of fluconazole.
Fluconazole capsules contains sulfites and sugars as lactose. For the
full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Fluconazole 50 mg: Size 4 hard gelatin capsule with white opaque body
and dark blue opaque cap.
The body has "FC 50" and the cap has "G" printed in black. The capsule
contains white to off-white
powder.
Fluconazole 150 mg: Size 1 hard gelatin capsule with white opaque body
and white opaque cap.
The body has "FC 150" and the cap has "G" printed in black. The
capsule contains white to off-white
powder.
Fluconazole 200 mg: Size 0 hard gelatin capsule with white opaque body
and blue opaque cap.
The body has "FC 200" and the cap has "G" printed in black. The
capsule contains white to off-white
powder.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Fluconazole is indicated for the treatment of the following
conditions:
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. Fluconazole can be used as
maintenance therapy to prevent
relapse of cryptococcal disease in patients with AIDS.
2.
Systemic candidiasis including candidaemia, disseminated candidiasis
and other forms of
invasive _candida_ infection including infections of the peritoneum,
endocardium and pulmonary
and urinary tracts. Patients with malignancy, in intensive care units,
receiving cytotoxic or
immunosuppressive therapy, or with other factors predisposing to _
candida_ infections may be
treated.
3.
Mucosal
candidiasis.
These
include
oropharyngeal,
oesophageal,
non-invasive
bronchopulmonary infections, candiduria, mucocutaneous and chronic
oral atrophic candidiasis
(denture sore mouth). Normal hosts and patients with compromised
immune f