Terbinafine 1% cream

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Terbinafine hydrochloride

Disponible desde:

Viatris UK Healthcare Ltd

Código ATC:

D01AE15

Designación común internacional (DCI):

Terbinafine hydrochloride

Dosis:

10mg/1gram

formulario farmacéutico:

Cutaneous cream

Vía de administración:

Cutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 13100200; GTIN: 5016695002545 5016695002538 5016695003153

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
TERBINAFINE 1 % CREAM
(terbinafine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Terbinafine 1% cream is and what it is
used for
2. What you need to know before you use
Terbinafine 1% cream
3. How to use Terbinafine 1% cream
4. Possible side effects
5. How to store Terbinafine 1% cream
6. Contents of the pack and other information.
1. WHAT TERBINAFINE 1% CREAM IS AND WHAT IT
IS USED FOR
Terbinafine 1% Cream contains the active ingredient
terbinafine hydrochloride which is an antifungal. It
kills fungi, which cause skin infections. Terbinafine
1% cream is used for the local treatment of fungal
infections of the skin only.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
TERBINAFINE 1% CREAM
DO NOT USE Terbinafine 1% cream
•
if you are allergic to terbinafine hydrochloride or any
of
t
he
other
ingredients
of this medic
i
ne (listed in
section 6
)
.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Terbinafine 1% Cream.
This cream is for external use only.
Avoid contact with the eyes. If the cream gets
in your eyes accidentally, rinse thoroughly with
running water and tell your doctor IMMEDIATELY.
In the event of allergic reaction, the cream should
be removed and the treatment interrupted.
Do not smoke or go near naked flames - risk of
severe burns. Fabric (clothing, bedding, dressings
etc) that has been in contact with this product
burns more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product

Ficha técnica

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