Terbinafine 1% cream

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Terbinafine hydrochloride

Prieinama:

Sigma Pharmaceuticals Plc

ATC kodas:

D01AE15

INN (Tarptautinis Pavadinimas):

Terbinafine hydrochloride

Dozė:

10mg/1gram

Vaisto forma:

Cutaneous cream

Vartojimo būdas:

Cutaneous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 13100200

Pakuotės lapelis

IN THIS LEAFLET:
1.
What Terbinafine cream is and what it is
used for
2.
Before you use Terbinafine cream
3.
How to use Terbinafine cream
4.
Possible side effects
5.
How to store Terbinafine cream
6.
Further information
1.
WHAT TERBINAFINE CREAM IS AND
WHAT IT IS USED FOR
Terbinafine cream belongs to a group of
medicines called antifungals which are used to
treat fungal infections, especially of the skin. It
can be used in the treatment of infections, such
as Athlete’s foot, ringworm, itchy rash of the
groin and fungal infections of the skinfolds
(intertrigo).
2.
BEFORE YOU USE TERBINAFINE
CREAM
DO NOT USE TERBINAFINE CREAM IF:
•
you are allergic (hypersensitive) to
terbinafine hydrochloride or any of the other
ingredients of the cream (listed in Section 6
Further Information)
•
you are under 16 years of age
•
you are breast-feeding.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or trying for a baby, tell your
doctor before using the cream. If you have
already informed your doctor, follow his/her
instructions carefully. Do not use Terbinafine
cream if you are breastfeeding.
DRIVING AND USING MACHINES
Using Terbinafine cream does not affect your
ability to drive or use machinery.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF TERBINAFINE CREAM.
The cream contains cetyl alcohol and steryl
alcohol, which may cause local skin reactions
(e.g. contact dermatitis).
3.
HOW TO USE TERBINAFINE CREAM
TAKE SPECIAL CARE WITH TERBINAFINE CREAM AS:
•
your Terbinafine cream is for external use
only and should not be put in the mouth or
swallowed. If swallowed accidentally, seek
medical advice immediately and take this
leaflet with you.
•
you must keep the cream away from your
eyes. If the cream gets in your eyes wipe
the cream from around the eye and then
rinse with clean water. Seek medical advice
immediately.
Before use, invert the cap over the end of the
tube and press to pierce the tube seal.
ADULTS INCLUDING THE ELDERLY
Your doctor will tell you how much cream to use
and how long to use it for. Always

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine 1% cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 10 mg terbinafine hydrochloride equivalent
to 8.89 mg of
terbinafine.
Excipients with known effect:
Each gram of cream contains 10 mg benzyl alcohol, 40 mg cetostearyl
alcohol and 40
mg cetyl alcohol
.
For the full list of excipients, see section
6.1.
3
PHARMACEUTICAL FORM
Cream
White or almost white
cream, with a slight almond odour
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete’s foot) and tinea cruris
(dhobie itch/jock
itch)
Fungal infections of the skin caused by dermatophytes such as species
of
Trichophyton
(e.g.
_T. _
_rubrum, _
_T. _
_mentagrophytes, _
_T. _
_verrucosum, _
_T. _
_violaceum_), _Microsporum canis and Epidermophyton floc_cosum.
Infections of the skin caused by _Candida_ (e.g. _Candida albicans_).
Pityriasis (tinea) versicolor caused by _ Pityrosporum orbiculare_
(_Malassezia _
_furfur_).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (>12 years of _
_age) _
_ _
Duration and frequency of
treatment:
Terbinafine can be applied once or twice daily.
The likely duration of each treatment is as follows:
Tinea
pedis: 1
week.
Tinea cruris and Tinea corporis: 1 to 2
weeks.
Cutaneous candida: 2
weeks.
Pityriasis versicolor: 2
weeks.
Relief of symptoms is usually obtained within a few
days.
Irregular use or an inadequate treatment period increases the risk of
the symptoms
returning.
If no improvement is obtained after 2 weeks, the diagnosis should be
re-
evaluated.
_Elderly_
There has been nothing to indicate that elderly patients require a
different dosage or
have
a
side effects profile different from younger
patients.
_Paediatric population_
Terbinafine 1 % Cream is not recommended for children below 12 years
of age due to
insufficient
data on safety. The experience in children is
limited.
Method of administration
For cutaneous
use.
The skin should be clean and dry. The cream