Canesoral

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Fluconazole 150mg

Dostupné z:

Bayer New Zealand Limited

INN (Medzinárodný Name):

Fluconazole 150 mg

Dávkovanie:

150 mg

Forma lieku:

Capsule

Zloženie:

Active: Fluconazole 150mg Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-17823 Sodium laurilsulfate Titanium dioxide Water

Typ predpisu:

Restricted

Výrobca:

Mylan Laboratories Limited

Terapeutické indikácie:

Canesoral Fluconazole Capsule, given orally, is indicated for vaginal candidiasis.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, white PVC/PVDC/Al - 1 capsules - 36 months from date of manufacture stored at or below 30°C

Dátum Autorizácia:

2014-11-28

Príbalový leták

_Canesoral Fluconazole CMI _
_22 September 2016_
Consumer Medicine Information
1
CANESORAL
 FLUCONAZOLE CAPSULE
FLUCONAZOLE ORAL CAPSULE 150 MG
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Canesoral Fluconazole
Capsule.
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 or pharmacist has
weighed the risks of
you taking Canesoral Fluconazole Capsule against the benefits expected
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CANESORAL FLUCONAZOLE CAPSULE IS USED FOR
Canesoral Fluconazole Capsule is used to treat a type of fungal
infection called vaginal
thrush.
Canesoral Fluconazole Capsule contains the active ingredient
fluconazole, which belongs to
a group of medicines called azole antifungals. These medicines work by
preventing the
growth of the fungi causing your infection.
_WHAT IS VAGINAL THRUSH? _
Vaginal thrush is a common name for vaginal candidiasis, an infection
caused by a yeast-like
fungus called _Candida_. _Candida_ is one of many organisms that live
in the vagina. Your
body’s natural balance (immune system) normally keeps _Candida_
under control, but when
this natural balance is upset, _Candida_ can multiply and can cause
thrush symptoms.
Common symptoms of vaginal thrush include:

itching, burning or soreness around the vagina

cottage cheese-like discharge

swelling or irritation of the infected area
THINGS THAT MAY HELP YOU TO AVOID THRUSH IN FUTURE

wear cotton briefs, stockings and loose fitting clothing rather than
tight synthetic
clothing

wash regularly, but do not wash and dry yourself harshly
_Canesoral Fluconazole CMI _
_22 September 2016_
Consumer Medicine Information
2

avoid perfumed soaps, bath additives and vaginal deodorants
Your doctor or pharmacist may have more information on things you can
d

Súhrn charakteristických

_ _
_Canesoral Data Sheet _
_1 May 2023_
NEW ZEALAND DATA SHEET
Page 1 of 15
CANESORAL
®
FLUCONAZOLE ORAL CAPSULE 150 MG
1.
NAME OF THE MEDICINAL PRODUCT
Canesoral
A powder-filled oral capsule containing 150 mg fluconazole.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatine capsule, powder-filled.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesoral Fluconazole Capsule, given orally, is indicated for vaginal
candidiasis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Canesoral Fluconazole Capsule must be used as a single dose treatment
only.
_ADULTS _
One capsule, swallowed whole, in a single dose. Consult a healthcare
professional if over 60 years of age.
_PAEDIATRIC POPULATION _
Fluconazole should not be taken by children under 18 years of age
unless directed by their physician.
_PATIENTS WITH IMPAIRED RENAL FUNCTION _
There is no separate dosage schedule in patients with renal impairment
for the single dose treatment.
_Canesoral Data Sheet _
_1 May 2023_
Page 2 of 15
_ _
4.3 CONTRAINDICATIONS
Canesoral should not be used in patients with known sensitivity to
fluconazole; to related azole compounds; or to
any of the excipients listed in section 6.1.
Coadministration of other medicines 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
Fluconazole should be administered with caution to patients with liver
dysfunction. Fluconazole has been
associated with rare cases of serious hepatic toxicity including
fatalities, primarily in patients with serious
underlying medical conditions. In cases of fluconazole-associated
hepatotoxicity, no obvious relationship to total
daily dose, duration of therapy, sex or age of patient has been
observed. Canesoral should not be used again if
cli