Canesten Athlete's Foot 1% cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Infovoldik Infovoldik (PIL)
20-04-2020
Toote omadused Toote omadused (SPC)
18-07-2018
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
20-04-2020

Toimeaine:

Clotrimazole

Saadav alates:

Bayer Plc

ATC kood:

D01AC01

INN (Rahvusvaheline Nimetus):

Clotrimazole

Annus:

10mg/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13100200; GTIN: 5010605054853 5010605610509

Infovoldik

                                ATHLETE'S
FOOT
10/O
W/W
CREAM
clotrimazole
READ
ALL OF
THIS
LEAFLET CAREFULLY
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR
YOU
.
This
medicine
is
availab
le wit
hout
prescription.
However,
you
still
need
to
use
Canesten
Athlete's
Foot
1%
w/w
cream
carefully
to
get
the
best
results
from
it.
•
Keep
this
leaflet.
You
may
need
to
read
it
aga
i
n.
•
Ask
your
pharmacist
if
you
need
more
i
nformation
or
adv
i
ce.
•
You
must
contact
a
doctor
or
pharmacist
if
your
symptoms
worsen
or
do
not
i
mprove.
•
If
you
have
any
unusual
effects
after
using
this
product,
te
ll
your
doctor
or
pharmacist.
IN
THIS
LEAFLET
1.
What
is
Canesten
Ath
l
ete's
Foot
cream
and
what
is it
used
_foe _
2.
Before
you
use
Canesten
Ath
let
e's
Foot
cream
3.
How
to
use
canesten
Athlete
's
Foot
cream
4.
Possible
side
effects
5.
How
to
store
Canesten
Athlete
's
Foot
cream
6.
Further
i
nformation
1.
WHAT
IS
CANESTEN
®
ATHLETE'S
FOOT
CREAM
ANO
WHAT
IS
IT
USED
FOR?
Canesten
Athlete
's
Foot
cream
is
an
effective
treatment
for
ath
le
te's
foot
or
jock
itch.
If
YOU
ARE
UNSURE
WHETHER
YOU
HAVE
ONE
OF
THESE
FUNGAL
SKIN
INFECTIONS,
SEEK
THE
ADVICE
OF
YOUR
DOCTOR
OR
PHARMACIST.
The
active
substance
IN
Canesten
Athlete
's
Foot
cream
is
clotrimazole.
clotrimazole
belongs
to
a
group
of
medicines
called
imidazoles
and
is
an
antifungal
agent
which
fights
the
cause
of
fungal
skin
i
nfectio
n
s.
2.
BEFORE
YOU
USE
CANESTEN
®
ATHLETE'S
FOOT
CREAM
DO
NOT
USE
CANESTEN
ATHLETE'S
FOOT
CREAM:
•
If
you
are
allergic
(hypersensitive)
to
clotrimazole
or
any
of
the
other
ingred
i
ents
of
Canesten
Ath
l
ete's
Foot
cream
(listed
in
section
6)
including
cetostearyl
alcohol.
•
To
treat
na
il
or
scalp
i
nfections.
PREGNANCY
AND
BREAST-FEEDING:
If
you
are
pregnant
or
breast-feeding
or
trying
fo
r a
baby,
tell
your
doctor
or
mi
dw
ife
before
using
I
871591
59
indd
1
Canesten
Athlete
's
Foot
cream.
If
you
have
informed
your
doctor
or
midwife
al
ready,
follow
his/her
instructions
carefully.
IMPORTANT INFORMATION ABOUT
SOME
OF
THE
INGREDIENTS:
This
product
contains
cetostearyl
a
                                
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Toote omadused

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Dual Action 1% w/w Cream
Canesten Athlete’s Foot 1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w.
Excipient with known effect: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white cream for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of tinea pedis and tinea cruris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in
gently. A strip of
cream (½ cm long) is enough to treat an area of about the size of the
hand. If the feet
are infected they should be washed and dried, especially between the
toes, before
applying the cream. The treatment should be continued for at least one
month to prevent
re-infection; however a physician should be consulted if symptoms do
not improve
within 7 days.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Do not use the cream to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This
product
contains
cetostearyl
alcohol,
which
may
cause
local
skin
reactions (e.g. contact dermatitis).
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6
FERTILITY, PREGNANCY AND LACTATION
Fertility:
No human studies of the effects of clotrimazole on fertility have been
performed;
however, animal studies have not demonstrated any effects of the drug
on fertility.
Pregnancy:
There is a limited amount of data from the use of clotrimazole in
pregnant women.
Animal studies with clotrimazole have shown reproductive toxicity at
high oral doses
(see section 5.3). At the low systemic exposures of clotrimazole
following topical
treatment, harmful effects with respect to reproductive toxicity are
not predicted.
Clotrimazole can be used during pregnancy
                                
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