Canesten Thrush Cream

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

CLOTRIMAZOLE

Διαθέσιμο από:

Bayer PLC

Φαρμακολογική κατηγορία (ATC):

D01AC01

INN (Διεθνής Όνομα):

CLOTRIMAZOLE

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

CLOTRIMAZOLE 2 % (W/W)

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-05-07

Φύλλο οδηγιών χρήσης

BR
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PHARMACODE NO/NE:
Canesten
Cream
Thrush External 2percent
Leaflet
UK
CUTTER
GUIDES
TECHNICAL & NON PRINTING ITEMS
BAYER ARTWORK PANEL
N/A ml
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
17/11/17
C
N/A
N/A
001011100(603)
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White Paper
1
LTH
PANTONE 485 C
2
LTH
PANTONE COOL GRAY 11 C
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 External 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 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 External Cream and what is it
used for?
2.
Before you use Canesten Thrush External Cream
3.
How to use Canesten Thrush External Cream
4.
Possible side effects
5.
How to store Canesten Thrush External Cream
6.
Further information
1. WHAT IS CANESTEN® THRUSH
EXTERNAL CREAM AND WHAT
IS IT USED FOR?
Canesten Thrush External Cream relieves irritation of the
vulva (vulvitis) which is caused by vaginal thrush (candidiasis).
Although this cream provides relief from the external
irritation caused by vaginal thrush, it cannot treat any internal
(vaginal) cause of the infection. Ask your doctor or
pharmacist to recommend a treatment for this.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY
DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH.
Some women suffer from recurrent attacks of thrush.
To reduce the frequency of these attacks, the sexual partner’s
penis can be treated with th

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush External Cream 2% w/w cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 2% w/w.
Excipient with known effect: cetostearyl alcohol
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Cream for topical use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Canesten Thrush External Cream is recommended for the treatment of
candidal 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
Canesten Thrush External Cream should be applied to the vulva and
surrounding area.
It can also be applied to the sexual partner’s penis to prevent
re-infection.
Adults
The cream should be applied thinly two or three times daily and rubbed
in gently.
Treatment 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
There is no clinical experience in the use of Canesten Thrush External
Cream in
children.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical advice should be sought if this is the first time the patient
has experienced
symptoms of candidal vaginitis.
Before using Canesten Thrush External Cream medical advice must be
sought if any of
the following are applicable:
-
more than two infections of candidal vaginitis in the last six months
-
previous history of a sexually transmitted disease or exposure to
partner with
sexually transmitted disease
-
pregnancy or suspected pregnancy
-
aged under 16 or over 60 years
-
known hypersensitivity to imidazoles or other vaginal antif