Terbinafine-Asteria cream for external use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

terbinafine (terbinafine hydrochloride)

Available from:

Hankook Korus Pharm Co.

ATC code:

D01AE15

INN (International Name):

terbinafine (terbinafine hydrochloride)

Dosage:

10mg/g

Pharmaceutical form:

cream for external use

Units in package:

aluminium tube 30g

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-09-05

Patient Information leaflet

ATC CODE D01AE15
TO BE PRESCRIBED
TERBINAFINE-ASTERIA CREAM (TERBINAFIN HCL)
[COMPOSITION]
Each 1g cream contains:
Active ingredient
Terbinafine hydrochloride ……………………………….10.0mg
(8.888mg as a Terbinafine)
Excipients: Stearyl Alcohol, Cetyl Alcohol, Paraffin Liquid, Propylene
glycol, Purified water,
Sorbitan Monostearate, Polysorbate 60, Sodium hydroxide, Methyl
Parahydroxybenzoate, Propyl
parahydroxybenzoate.
[INDICATION]
The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie
itch/jock itch) caused by
_Trichophyton _
(e.g.
_T. _
_rubrum, _
_T. _
_mentagrophytes, _
_T. _
_verrucosum, _
_T. _
_violaceum) _
_and _
_Epidermophyton floccosum_
[DOSAGE AND ADMINISTRATION]
Adults and children over 16 years of
age
Terbinafine Hydrochloride Cream is applied once daily.
Duration and frequency of treatment
Duration of treatment is one week for tinea pedis and tinea cruris.
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 by a physician.
Dosing in special populations:
Paediatric population
The experience with topical Terbinafine Hydrochloride Cream in
children is still limited
and its use in children under 16 years cannot therefore be
recommended.
Elderly patients
There is no evidence to suggest that elderly patients require
different dosages or
experience side-effects different to those of younger patients.
Method of administration
For cutaneous use.
The affected area should be cleaned and dried thoroughly before
application of Terbinafine
Hydrochloride Cream. The cream should be applied to the affected skin
and surrounding area in
a
thin
layer
and
rubbed
in
lightly.
In
the
case
of
intertriginous
infections
(interdigital,
intergluteal, inguinal) the application may be covered with a gauze
strip, especially at night.
[CONTRAINDICATION]
Hypersensitivity to terbinafine or to any of the excipients contai

Summary of Product characteristics

Summary of Product Characteristics
Terbinafine-Asteria
1.
NAME OF THE MEDICINAL PRODUCT
Terbinafine-Asteria Cream 30g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/g
Use
1
Terbinafine Hydrochloride
10.0 mg
(8.888mg as Terbinafine)
Active ingredient
Excipient(s)
No.
Chemical Name
Quantity/g
Use
1
Stearyl Alcohol
50.0 mg
Base
2
Cetyl Alcohol
50.0 mg
Base
3
Paraffin Liquid
67.9 mg
Base
4
Propylene Glycol
150.0 mg
Base
5
Purified Water
q.s
Base
6
Sorbitan Monostearate
20.0 mg
Emulsifier
7
Polysorbate 60
20.0 mg
Emulsifier
8
Sodium Hydroxide
q.s
pH Adjuster
9
Methylparaben
0.5 mg
preserved agent
10
Propylparaben
0.5 mg
preserved agent
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie
itch/jock itch) caused by
Trichophyton
(e.g.
T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and
Epidermophyton floccosum.
4.2
Posology and method of administration
Adults and children over 16 years of age
Terbinafine Hydrochloride Cream is applied once daily.
Duration and frequency of treatment
Duration of treatment is one week for tinea pedis and tinea cruris.
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 by a physician.
Dosing in special populations:
Paediatric population
The experience with topical Terbinafine Hydrochloride Cream in
children is still limited and
its use in children under 16 years cannot therefore be recommended.
Elderly patients
There is no evidence to suggest that elderly patients require
different dosages or experience
side-effects different to those of younger patients.
Method of administration
For cutaneous use.
The affected area should be cleaned and dried thoroughly before
application of Terbinafine
Hydrochloride Cream. The cream should be applied to the affected skin
and