OZOLE fluconazole 150 mg capsule blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

fluconazole, Quantity: 150 mg

Saatavilla:

Sun Pharma ANZ Pty Ltd

INN (Kansainvälinen yleisnimi):

Fluconazole

Lääkemuoto:

Capsule, hard

Koostumus:

Excipient Ingredients: Gelatin; colloidal anhydrous silica; maize starch; titanium dioxide; lactose monohydrate; magnesium stearate; purified water; sodium lauryl sulfate; patent blue V; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Antoreitti:

Oral

Kpl paketissa:

1 capsule per pack

Prescription tyyppi:

(S3) Pharmacist Only Medicine

Käyttöaiheet:

For the treatment of vaginal candidiasis, when topical therapy has failed.

Tuoteyhteenveto:

Visual Identification: Blue/blue hard gelatin, self locked capsules of size '1' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2006-10-06

Pakkausseloste

OZOLE
_Fluconazole 150 mg Capsule _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about OZOLE (fluconazole
150 mg) 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 OZOLE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING/TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with this medicine.
You may need to read it again.
WHAT OZOLE IS
USED FOR
OZOLE contains the active
ingredient fluconazole. It is used to
treat vaginal thrush in women, when
topical treatment has failed. If this is
the first time you have had
symptoms, talk to your doctor before
using any treatment.
_TREATING VAGINAL THRUSH IN _
_WOMEN _
Taken by mouth, OZOLE treats the
yeast infection, vaginal thrush, which
is caused by a yeast called Candida
albicans. Most women have vaginal
thrush some time during their lives.
Many women have this yeast living
harmlessly within their bodies.
However, the natural balance that
keeps Candida albicans under control
can be upset by other factors, e.g.
antibiotics, diabetes, the Pill, wearing
tight clothing, or using perfumed
soaps, bath additives and vaginal
deodorants. When the levels of yeast
become too high, thrush develops.
You may have one or more of these
common symptoms:
•
Vaginal itching
•
Vaginal burning and redness
•
Pain during intercourse
•
A white, curdy, odourless
discharge from the vagina (like
cottage cheese)
Rubbing and scratching can
aggravate the soreness and itching.
Also, the salt in urine can sting the
sore tissue.
BEFORE YOU TAKE
OZOLE
DO NOT USE OZOLE:
•
If you are pregnant, suspect you
might be pregnant or are trying to
become pregnant or are breast-
feeding
•
If you are allergic to any of the
ingredients in OZOLE or other
thrush treatments such as
miconazole, clotrimazole or
ketoconazole
•
If you are tak

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
OZOLE (FLUCONAZOLE) CAPSULE
1 NAME OF THE MEDICINE
Fluconazole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each OZOLE capsule contains fluconazole 150 mg as the active
ingredient.
Other ingredients: lactose. For the full list of excipients, see
section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
OZOLE capsules are a size 1, hard gelatin capsule, with a blue opaque
body and a blue
opaque cap. The body and the cap has RANBAXY printed in black edible
ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OZOLE, given orally, is indicated for vaginal candidiasis.
4.2 DOSE AND METHOD OF ADMINISTRATION
OZOLE is administered orally.
ADULTS
For vaginal candidiasis, fluconazole 150 mg (OZOLE) should be
administered as a single oral
dose.
USE IN RENAL IMPAIRMENT
Impaired Renal Function. Fluconazole is predominantly excreted in the
urine as unchanged
drug. No adjustments in single-dose therapy are necessary in patients
with minor to
moderate renal impairment.
PAEDIATRIC USE
Children. Single-dose fluconazole is not recommended for use in
children under 18 years of
age except under physician supervision.
Version 3, dated 21 Aug 2018
Page 1 of 13
4.3 CONTRAINDICATIONS
OZOLE is contraindicated in patients with known sensitivity to
fluconazole, related azole
compounds or any of the excipients of OZOLE.
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 SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In rare cases, as with other azoles, anaphylaxis has been reported.
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.
Fluconazole should not be used again if a rash develops which is
attributa