APOHEALTH FLUCONAZOLE ONE 150 mg capsule blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

fluconazole, Quantity: 150 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Fluconazole

Ravimvorm:

Capsule, hard

Koostis:

Excipient Ingredients: titanium dioxide; maize starch; sodium lauryl sulfate; colloidal anhydrous silica; patent blue V; lactose monohydrate; Gelatin; purified talc

Manustamisviis:

Oral

Ühikuid pakis:

one capsule

Retsepti tüüp:

(S3) Pharmacist Only Medicine

Näidustused:

Treatment of vaginal candidiasis.

Toote kokkuvõte:

Visual Identification: Hard gelatin capsules of size '1' with sky blue opaque body and cap.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2008-06-10

Infovoldik

APO-FLUCONAZOLE ONE
_Fluconazole_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about fluconazole. It does
not contain all the available
information. It does not take the
place of talking to your pharmacist.
All medicines have risks and
benefits. Your pharmacist has
weighed the risks of you using this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Fluconazole is used to treat a fungal
infection known as vaginal thrush
(vaginal candidiasis). Fluconazole
belongs to a group of medicines
known as azole antifungals.
Vaginal thrush is an infection caused
by a yeast-like fungus called
Candida. Candida is one of the many
organisms that live in the vagina and
its growth is normally balanced by
your body's immune system. If this
natural balancing is upset, Candida
can multiply in the vagina to cause
the symptoms of thrush.
_HOW IT WORKS_
Fluconazole works by preventing the
growth of the fungi causing your
infection.
ASK YOUR PHARMACIST IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your pharmacist may have
prescribed this medicine for another
reason
This medicine is available without a
doctor's prescription, but your
pharmacist's advice is required.
This medicine is not addictive.
This medicine is not recommended
for children under 18 years of age,
except under doctor advice.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
fluconazole
•
any other azole antifungals e.g.
clotrimazole
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION – APO-FLUCONAZOLE
ONE CAPSULE (FLUCONAZOLE)
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole, as its active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Each capsule contains sugars (as lactose) and sulfites.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Fluconazole is available as a hard gelatin capsule of size ‘1’
with sky blue body and cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of vaginal candidiasis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Fluconazole is intended for oral administration.
ADULTS
One capsule (150 mg fluconazole) should be administered as a single
oral dose.
USE IN RENAL IMPAIRMENT
Fluconazole is predominantly excreted in the urine as unchanged drug.
No adjustments in
single-dose therapy are necessary in patients with minor or moderate
renal impairment.
CHILDREN
Fluconazole is not recommended in children under 18 years of age
except under medical,
advice.
2
4.3
CONTRAINDICATIONS
•
Known sensitivity to fluconazole; to related azole compounds or to any
of the
excipients of this product.
•
Co-administration of terfenadine is contraindicated in patients
receiving fluconazole
at multiple doses of 400mg/day or higher based upon results of a
multiple dose
interaction study
•
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 in patients receiving
fluconazole (see 4.5-
Interactions with other medicines and other forms of interactions).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Anaphylaxis has been reported in rare instances.
Patients have rarely developed exfoliative cutaneous reactions, such
as Stevens-Johnson
Syndrome and toxic epidermal necrolysis, during treatment with
fluconazole. AIDS patients
are more prone to the development of serious cutaneous reactions to
many drugs.