Terbisil tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

terbinafine (terbinafine hydrochloride)

Available from:

Gedeon Richter PLC

ATC code:

D01BA02

INN (International Name):

terbinafine (terbinafine hydrochloride)

Dosage:

250mg

Pharmaceutical form:

tablets

Units in package:

(14/1x14/) in blister, (28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-11-11

Summary of Product characteristics

INSTRUCTION
FOR MEDICAL USE FOR SPECIALISTS
1.
NAME OF THE MEDICINAL PRODUCT
Trade name: TERBISIL
®
INN: Terbinafine
Pharmaceutical form: tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _250 mg terbinafine (in the form of 281.25 mg
terbinafine hydrochloride) in each
tablet.
For the full list of excipients, see section 6.1.
3.
DESCRIPTION OF PHARMACEUTICAL FORM
White or almost white, round, biconvex tablets with a score line on
one side and “250” engraved on the
other, diameter 11 mm. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Onychomycosis caused by dermatophyte fungi (fungal infection of the
nails).

Tinea capitis.

Tinea (tinea corporis, tinea cruris, tinea pedis) and yeast infection
of the skin caused primarily
by the _Candida_ genus (_Candida albicans_) if systhemic therapy is
needed due to the localisation,
severity and extent of the infection.
_Remark: _Contrary to local Terbisil treatment, Terbisil tablets are
not effective in the treatment of
pityriasis versicolor (known also as tinea versicolor), caused by
_Pityrosporum orbiculare_ (known also
as _Malessezia furfur)_.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
One 250 mg tablet daily is recommended for the treatment of adults.
Duration of the treatment
The duration of treatment depends on the indication and severity of
infection.
_Onychomycosis:_
In most patients the duration of successful treatment is 6-12 weeks.
In case of fingernail infection a treatment period of 6 weeks is
usually sufficient.
In case of toenail infection, especially of the big toenail, a
treatment period of 12 weeks is required.
In some cases, especially if nail outgrowth is poor, longer therapy
might be necessary.
The optimal clinical effect can be seen some months after mycological
cure. This can be related to the
period required for the outgrowth of healthy nail.
2
_Skin infections: _
In case of tinea pedis (interdigital, plantar, moccasin type) the
duration of oral trea