Flucazole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluconazole 150mg; Fluconazole 150mg

Available from:

Viatris Limited

INN (International Name):

Fluconazole 150 mg

Dosage:

150 mg

Pharmaceutical form:

Capsule

Composition:

Active: Fluconazole 150mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Pregelatinised maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Active: Fluconazole 150mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide

Units in package:

Blister pack, PVC/PVDC/Al, 1 capsule

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Fluconazole is indicated for the treatment of vaginal candidiasis.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 1 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-09-03

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FLUCAZOLE
®
_FLUCONAZOLE CAPSULES 150 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Flucazole.
This leaflet answers some common
questions about Flucazole.
It does not contain all the
information available on this
medicine. It does not take the place
of talking to your pharmacist or
doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
Flucazole against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may want to read it
again.
WHAT FLUCAZOLE IS
TAKEN FOR AND HOW IT
WORKS
Your Flucazole capsule contains
fluconazole. It belongs to a group
of medicines known as antifungals.
Flucazole is used to treat vaginal
thrush infections. It works by
preventing the growth of fungal and
yeast organisms.
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.
Flucazole is available over the
counter at a pharmacy or with a
doctor’s prescription.
BEFORE YOU TAKE
FLUCAZOLE
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE FLUCAZOLE IF YOU HAVE
AN ALLERGY TO THE FOLLOWING:
•
ANY MEDICINE CONTAINING
FLUCONAZOLE
•
MEDICINES RELATED TO
FLUCONAZOLE SUCH AS
MICONAZOLE, KETOCONAZOLE,
ITRACONAZOLE, CLOTRIMAZOLE OR
VORICONAZOLE
•
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)
�

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
FLUCAZOLE
®
1. PRODUCT NAME
Flucazole, 150 mg, capsule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg of fluconazole.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
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.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Flucazole 150 mg, given orally, is indicated for vaginal candidiasis.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Fluconazole 150mg capsules are administered orally.
For vaginal candidiasis, fluconazole 150 mg should be administered as
a single oral dose.
The median time to onset of symptom relief following a 150 mg oral
dose for the treatment of vaginal
candidiasis is one day. The range of time to onset of symptoms relief
is one hour to nine days.
SPECIAL POPULATIONS
_RENAL IMPAIRMENT _
Fluconazole is predominantly excreted in the urine as unchanged
medicine. No adjustments in
single-dose therapy are necessary in patients with minor to moderate
renal impairment.
_PAEDIATRIC _
Single dose fluconazole is not recommended for use in children under
18 years of age except under
doctor supervision.
Page 2 of 14
_4.3_
_CONTRAINDICATIONS_
Flucazole 150 mg capsules should not be used in patients with known
sensitivity to fluconazole; to
related azole compounds; or to any of its excipients.
Co-administration of other drugs known to prolong the QT interval and
which are metabolised via
the enzyme CYP3A4 such as cisapride astemizole, erythromycin, pimozide
and quinidine are
contraindicated (see section 4.4).
Co-administration of terfenadine is contraindicated in patients
receiving fluconazole at multiple doses
of 400 mg per day or higher based upon results of a multiple dose
interaction study.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
Fluconazole should be administered with caution to patients