Canesoral Duo

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Fluconazole 150mg; Clotrimazole 10 mg/g

Tilgjengelig fra:

Bayer New Zealand Limited

INN (International Name):

Fluconazole 150 mg

Dosering :

150mg & 10mg/g

Legemiddelform:

Combination

Sammensetning:

Active: Fluconazole 150mg Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-17823 Sodium laurilsulfate Titanium dioxide Water Active: Clotrimazole 10 mg/g Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate

Resept typen:

Restricted

Produsert av:

Mylan Laboratories Limited

Indikasjoner:

Vaginal candidiasis. Cream can be used for relief of external itching/irritation and the management of candida vulvovaginitis or infection of the peri-anal area.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, white opaque PVC/PVdC-aluminium - 1 capsules - 0 days Not applicable - Combination pack, 1 tube plus one capsule - 1 dose units - 36 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C. cream - Tube, aluminium, PE screw cap with spike - 10 g - 0 months Not applicable

Autorisasjon dato:

2014-11-28

Informasjon til brukeren

_Canesoral Duo CMI _
_13 July 2015_
Consumer Medicine Information
1
CANESORAL
 FLUCONAZOLE CAPSULE &
CLOTRIMAZOLE CREAM DUO
FLUCONAZOLE ORAL CAPSULE 150 MG & CLOTRIMAZOLE CREAM 10 MG/G
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Canesoral Fluconazole
Capsule &
Clotrimazole Cream Duo (referred to in the rest of this leaflet as
Canesoral Duo).
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 using Canesoral Duo against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CANESORAL DUO IS USED FOR
Canesoral Duo is used to treat a type of fungal infection called
vaginal thrush.
Canesoral Duo contains two components: Canesoral Fluconazole Capsule
is an oral capsule
which contains the active ingredient fluconazole; Canesten cream
contains the active
ingredient clotrimazole. Both of these ingredients belong to a group
of medicines called
azole antifungals.
Canesoral Fluconazole Capsule is taken by mouth and works from the
inside to prevent the
growth of the fungi causing your infection. Canesten cream is applied
to the irritated area
and provides soothing relief from external itching and irritation.
_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
_Canesoral Duo CMI _
_13 July 2015_
Consumer Medicine Information
2

swelling or irritati

Preparatomtale

_ _
_Canesoral Duo Data Sheet _
_1 May 2023_
NEW ZEALAND DATA SHEET
Page 1 of 17
CANESORAL
® DUO
FLUCONAZOLE ORAL CAPSULE 150 MG
CLOTRIMAZOLE TOPICAL CREAM 10 MG/G
1.
NAME OF THE MEDICINAL PRODUCT
Canesoral Duo
A powder-filled capsule containing 150 mg fluconazole and a topical
cream containing 10 mg/g clotrimazole.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole. Each gram of cream contains
10 mg clotrimazole (10 mg/g, 1% w/w).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatine capsule, powder-filled and topical cream in a vanishing
cream base.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesoral Duo is indicated for vaginal candidiasis.
The cream can also be used for relief of external itching/irritation
and the management of Candida vulvovaginitis
or infection of the peri-anal area.
4.2 DOSE AND METHOD OF ADMINISTRATION
The fluconazole capsule must be used as a single dose treatment only.
The clotrimazole cream should be used in conjunction with the
fluconazole capsule for relief of external
itching/irritation and the management of Candida vulvovaginitis or
infection of the peri-anal area.
_ADULTS _
One fluconazole 150 mg capsule, swallowed whole, in a single dose.
Consult a healthcare professional if over
60 years of age.
Apply the cream thinly to the affected areas and rub in gently, two or
three times daily.
_Canesoral Duo Data Sheet _
_1 May 2023_
Page 2 of 17
_PAEDIATRIC POPULATION _
Canesoral Duo 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 fluconazole treatment.
_ _
4.3 CONTRAINDICATIONS
Canesoral Duo should not be used in patients with known sensitivity to
fluconazole; clotrimazole; 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 metabol