Canesten Thrush Duo 150mg Oral capsules & External 2% cream

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Tillgänglig från:

Bayer Plc

ATC-kod:

n/a

Läkemedelsform:

Not applicable

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 07020200; GTIN: 5010605620140

Bipacksedel

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Canesten
Duo
Thrush Duo Oral Capsule & ExtCream 150mg 2percent
Leaflet
Malta/UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
150 mg
Packaging Site Approval:
ARTWORK
APPROVAL PANEL
Name:
Date:
Action:
Country Approval:
Name:
Date:
Action:
Main Text (body copy):
Height (based on lower case x):
9 pt
1.3 mm
FONT SIZE PANEL
N/A
N/A
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1
LTH
PANTONE 485 C
2
LTH
PANTONE Cool Gray 11 C
Colours
BAY252556Q
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Canesten Thrush Duo Oral & Cream carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not
imp
rove in 7 days.
•
If you have any unusual effects after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Thrush Duo and what is it used for?
2.
Before you use Canesten Thrush Duo
3.
How to use Canesten Thrush Duo
4.
Possible side effects
5.
How to store Canesten Thrush Duo
6.
Further information
1. WHAT IS CANESTEN® THRUSH
DUO® AND WHAT IS IT USED FOR?
Canesten Thrush Duo is a complete and convenient treatment for
vaginal or penile thrush.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY
YOUR DOCTOR AS HAVING THRUSH.
The active substances in the capsule and cream are fluconazole
and clotrimazole, respectively. Fluconazole and clotrimazole
belong to a group of medicines called azoles and are antifungal
agents which fight the cause of infections such as thrush.
2.BEFORE YOU USE CANESTEN®
THRUSH DUO®
DO NOT USE CANESTEN® THRUSH DUO®:
•
If you are allergic (hypersensitive) to fluconazole,
clotrimazole, to other medicines you have taken to treat
fungal infections or to any of the othe

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Duo Oral Capsule & External Cream 150mg / 2% w/w
capsule &
cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule of Canesten Thrush Oral Capsule contains 150 mg
fluconazole.
Canesten Thrush External Cream contains Clotrimazole 2% w/w.
Excipients with known effects:
Capsule: lactose
Cream: cetostearyl alcohol
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Hard capsule.
Opaque light blue capsule (size 1) with “Canesten
®
” printed in black between two
black lines.
Cream.
White cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Thrush Oral Capsule is indicated for the treatment of
candidal vaginitis,
acute or recurrent. It should also be used for the treatment of
partners with associated
candidal balanitis.
Canesten Thrush External Cream is indicated for the treatment of
candida vulvitis.
It should be used as an adjunct to treatment of candidal vaginitis.
It can also be used for treatment of the sexual partner’s penis to
prevent re-infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (16 TO 60):
One capsule should be swallowed whole.
The cream should be applied thinly two or three times daily to the
vulva and
surrounding area and rubbed in gently.
Treatment with the cream should be continued until symptoms of the
infection
disappear. However, if after concomitant treatment of the vaginitis,
the symptoms do
not improve within seven days, the patient should consult a doctor.
If the cream is being used for treatment of the sexual partner’s
penis it should be
applied two or three times daily for up to two weeks.
CHILDREN (UNDER 16):
Paediatric use is not recommended.
ELDERLY:
Not recommended in patients over 60.
RENAL IMPAIRMENT:
There is no separate dosage schedule in patients with renal impairment
for single dose
therapy.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances (fluconazole and
clotrimazole),
related azole substances or to any of the excipients