Terbinafine 1% cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Terbinafine hydrochloride

Saadav alates:

Alliance Healthcare (Distribution) Ltd

ATC kood:

D01AE15

INN (Rahvusvaheline Nimetus):

Terbinafine hydrochloride

Annus:

10mg/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13100200

Infovoldik

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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terbinafine Hydrochloride 1% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine hydrochloride 1% w/w
For the fill list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
White homogenous cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fungal
infection
of
the
skin
caused
by
_Trichophyton _
_(e.g. _
_T.rubrum, _
_T. _
_mentagrophytes, _
_T. _
_verrucosum, _
_T. _
_violaceum), _
_Microsporum _
_canis _
_and _
_Epidermophyton floccosum. _
Yeast infections of the skin, principally those caused by the genus
_Candida (e.g. C. _
_albicans). _
Pityriasis
(tinea)
versicolor
due
to
Pityrosporum
orbiculare
(also
known
as
_Malassezia furfur)._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Terbinafine Hydrochloride 1% Cream can be applied once or twice daily
DURATION AND FREQUENCY OF TREATMENT:
The likely durations of each treatment are as follows:
•
Tinea corporis , cruris:
1 to 2 weeks
•
Tinea pedis:
1 week
•
Cutaneous candidosis:
2 weeks
•
Pityriasis versicolor:
2 weeks
Relief of clinical symptoms usually occurs within a few days.
Irregular use or
premature discontinuation of treatment carries the risk of recurrence.
If there are no
signs of improvement after two weeks, the diagnosis should be
verified.
DOSING IN SPECIAL POPULATIONS:
PAEDIATRIC POPULATION
The experience with topical Terbinafine Hydrochloride 1% Cream in
children is still
limited and its use cannot therefore be recommended.
ELDERLY PATIENTS:
There is no evidence to suggest that elderly patients require
different dosage or
experience side-effects different to those of younger patients.
Method of administration
For cutaneous use.
Cleanse and dry the affected areas thoroughly before application of
Terbinafine
Hydrochloride 1% Cream. Apply the cream to the affected skin and
surrounding area
in
a
thin
layer
and
rub
in
lightly.
In
the
case
of
intertriginous
infections
(submammary, interdigital, intergluteal, inguinal) the application may
be covered
with a