Canesten Thrush Oral 150mg capsules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Fluconazole

Disponibil de la:

Bayer Plc

Codul ATC:

J02AC01

INN (nume internaţional):

Fluconazole

Dozare:

150mg

Forma farmaceutică:

Oral capsule

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 05020100; GTIN: 5010605620072

Prospect

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Canesten
Oral
Canesten Thrush Oral Capsule 150mg
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
150 g
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
1.4 mm
FONT SIZE PANEL
N/A
N/A
N/A
N/A
N/A
]
1
LTH
PANTONE 485 C
2
LTH
PANTONE Cool Gray 11 C
3
LTH
Process Black
Colours
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 Oral Capsule 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
improve 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 Oral Capsule and what is it used for?
2.
Before you use Canesten Thrush Oral Capsule
3.
How to use Canesten Thrush Oral Capsule
4.
Possible side effects
5.
How to store Canesten Thrush Oral Capsule
6.
Further information
1. WHAT IS CANESTEN® THRUSH
ORAL CAPSULE AND WHAT IS IT
USED FOR?
Canesten Thrush Oral Capsule is a full course of treatment for
thrush.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED
BY YOUR DOCTOR AS HAVING THRUSH.
The active substance in Canesten Thrush Oral Capsule is
fluconazole. Fluconazole belongs to a group of medicines called
azoles and is an antifungal agent which fights the cause of
infections such as thrush.
2. BEFORE YOU USE CANESTEN®
THRUSH ORAL CAPSULE
DO NOT USE CANESTEN® THRUSH ORAL CAPSULE:
•
If you are allergic (hypersensitive) to fluconazole, to other
medicines you
have taken to treat fungal infections or to
any of the other ingredients of Canesten Thr

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Oral Capsule 150mg capsule
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg fluconazole.
Excipients with known effects: lactose.
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Thrush Oral Capsule is recommended for the treatment of
candidal
vaginitis, acute or recurrent. It should also be used for the
treatment of partners
with associated candidal balanitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (16 TO 60):
One capsule should be swallowed whole.
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.
CONTRA-INDICATIONS
Hypersensitivity to the active substance, to related azole substances
or to any
of the excipients in this product.
Coadministration of other medicinal products known to prolong the QT
interval and which are metabolised via the cytochrome P450 (CYP) 3A4
such
as cisapride, astemizole, pimozide, quinidine and erythromycin are
contraindicated in patients receiving fluconazole (see sections 4.4
and 4.5).
Coadministration of terfenadine is contraindicated based upon results
of a
multiple dose interaction study.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product available from pharmacies without prescription will
include a
leaflet that advises the patient - _Do not use _Canesten Thrush Oral
Capsule_ _
_without first consulting your doctor:_
If you are under 16 or over 60 years of age
If you are allergic to any of the ingredients in Canesten Thrush Oral
Capsule
or other antifungals and other thrush treatments (see section “After
Taking
Canesten Thrush Oral Capsule”).
If you are taking any other medicine other than the Pi