Diflucan One

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Fluconazole 150mg;  

Tillgänglig från:

JNTL Consumer Health (New Zealand) Limited

INN (International namn):

Fluconazole 150 mg

Dos:

150 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Fluconazole 150mg   Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch Patent blue V TekPrint black SW-9008 Titanium dioxide

Enheter i paketet:

Blister pack, PVC/AL foil; single capsule pack, 1 capsule

Klass:

Restricted

Receptbelagda typ:

Restricted

Tillverkad av:

Pfizer Pharmaceuticals LLC

Terapeutiska indikationer:

Vaginal candidiasis.

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/AL foil; single capsule pack - 1 capsules - 60 months from date of manufacture stored at or below 30°C

Tillstånd datum:

2004-05-17

Bipacksedel

DIFLUCAN
®
1
DIFLUCAN
®
_Fluconazole (flu-con-a-zole)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common 
questions about Diflucan.  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 Diflucan 
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 YOUR 
MEDICINE.
You may need to read it again.
WHAT DIFLUCAN IS USED 
FOR
Diflucan capsules (for adults) and 
oral suspension (for children) are 
used to treat certain fungal and yeast 
infections.
Diflucan 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 DIFLUCAN HAS 
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed 
Diflucan for another reason.
Diflucan is available only with a 
doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE 
DIFLUCAN
_WHEN YOU MUST NOT TAKE IT_
Do not take Diflucan 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.
DIFLUCAN 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 (EXP) 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

Produktens egenskaper

1
DIFLUCAN® ONE Data Sheet
Date of preparation: 13 July 2022
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
DIFLUCAN
®
ONE _Fluconazole Capsule 150 mg _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN
®
ONE contains its active ingredient fluconazole 150 mg as capsule.
DIFLUCAN
®
ONE
One also contains lactose and sugars
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
DIFLUCAN
®
ONE capsule has a light turquoise blue opaque cap and body marked
with FLU-150.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIFLUCAN
®
ONE, given orally, is indicated for vaginal candidiasis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DIFLUCAN
®
ONE is administered orally.
Use in Adults
For
vaginal
candidiasis,
fluconazole
150
mg
(DIFLUCAN
®
ONE)
should
be
administered as a single oral dose.
The median time to onset of symptom relief following a 150 mg single
oral dose for the
treatment of vaginal candidiasis is one day. The range of time to
onset of symptom
relief is one hour to nine days.
Use in Children
Single dose fluconazole is not recommended for use in children under
18 years of age
except under doctor supervision.
Use in 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.
2
DIFLUCAN® ONE Data Sheet
Date of preparation: 13 July 2022
4.3
CONTRAINDICATIONS
Fluconazole 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).
Coadministration of terfenadine is contraindicated in patients
receiving fluconazole at
multiple doses of 400mg per day or higher based upon results of a
multiple dose
interaction study.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Fluconazole should be admini