Canesten Solution 1% w/v

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

CLOTRIMAZOLE

Dostupno od:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC koda:

D01AC01

INN (International ime):

CLOTRIMAZOLE 1 % (W/V)

Farmaceutski oblik:

CUTANEOUS SOLUTION

Sastav:

CLOTRIMAZOLE 1 % (W/V)

Tip recepta:

OTC

Područje terapije:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Status autorizacije:

Suspended

Datum autorizacije:

2006-03-09

Uputa o lijeku

Black
Pantone 200 U
Kontur
1 2
KVP Kiel
–
82192670
CANESTEN LOESG 1%
148 x 210 mm
18.06.2015 KP
123
24.06.2015 KP
–
–
–
–
MetaPlusBold Caps, Roman, Italic, MetaPlusBook Caps, Roman, Italic,
ITC Franklin Gothic Book, Helvetica Neue LT W1G Roman
7 pt
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 Solution 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.
•
If you have any unusual effects after using this product,
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Solution and what is it used for?
2.
Before you use Canesten Solution
3.
How to use Canesten Solution
4.
Possible side effects
5.
How to store Canesten Solution
6.
Further information
1. WHAT IS CANESTEN
® SOLUTION
AND WHAT IS IT USED FOR?
Canesten Solution is used to treat fungal skin infections
such as ringworm, athlete’s foot, fungal intertrigo and
fungal infections of the outer and middle ear.
IF YOU ARE UNSURE WHETHER YOU HAVE ONE OF THESE FUNGAL
SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR
PHARMACIST.
The solution is particularly suitable for use on hairy skin.
The active substance in Canesten Solution is clotrimazole.
Clotrimazole belongs to a group of medicines called
imidazoles and is an antifungal agent which fights the
cause of fungal skin and ear infections.
2. BEFORE YOU USE CANESTEN
®
SOLUTION
DO NOT USE CANESTEN
® SOLUTION:
•
If you are allergic (hypersensitive) to clotrimazole
or the other ingredient of Canesten Solution,
macrogol 400.
USING OTHER MEDICINES:
Canesten Solution and Sofradex drops may cause a heat
reaction when used together. Consult your doctor before
using these products together in the ear.
PREGNANCY AND BREAST-FEEDING:
If you are pregnant, breast-feeding or trying for a baby,

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/v.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
A clear solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Canesten
Solution
should
be
used
to
treat
all
fungal
skin
infections
due
to
dermatophytes, yeasts, moulds and other fungi.
It is particularly suitable for use on hairy skin and in fungal
infections of the outer ear
(otitis externa) and middle ear (otomycoses).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Solution should be thinly and evenly applied to the affected
area 2 or 3 times a
day and gently rubbed in. A few drops are enough to treat an area of
about the size of
the hand. To prevent relapse, treatment should be continued for at
least two weeks after
the disappearance of all signs of infection.
There is no separate dosage schedule for the elderly or the young.
4.3.
CONTRAINDICATIONS
Hypersensitivity to clotrimazole or macrogol 400.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None known.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There
have
been
reports
of
a
heat
reaction
when
Canesten
Solution
is
used
concomitantly with Sofradex drops in the ear.
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, but only under the
supervision of a
physician or midwife.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown
excretion of
clotrimazol