TERBINAFINE TEVA 250 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

TERBINAFINE AS HYDROCHLORIDE

Διαθέσιμο από:

TEVA ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

D01BA02

Φαρμακοτεχνική μορφή:

CAPLETS

Σύνθεση:

TERBINAFINE AS HYDROCHLORIDE 250 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Θεραπευτική ομάδα:

TERBINAFINE

Θεραπευτική περιοχή:

TERBINAFINE

Θεραπευτικές ενδείξεις:

Fungal infections of the skin caused by dermatophytes such as trichophyton (e.g. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Oral Terbinafine should only be used to treat extensive, severe ringworm infections ( tinea corporis, tinea cruris and tinea pedis). Oral Terbinafine is not effective against vaginal candidiasis or pityriasis (tinea) versicolor.Onychomycoses ( tinea unguium, ringworm of the nails) due to infection with dermatophyte organisms ( hyphomycetes).

Ημερομηνία της άδειας:

2020-05-31

Φύλλο οδηγιών χρήσης

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
TERBINAFINE TEVA 250 MG
Caplets
COMPOSITION
Each caplet contains:
Terbinafine (as hydrochloride) 250 mg
For information about inactive ingredients see section 6 –
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for your treatment. Do not
pass it on to others. It may harm them even if it seems to you
that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treatment of fungal infections of the skin and nails.
THERAPEUTIC CLASS
An oral antifungal agent.
Terbinafine Teva caplets are used for the treatment of fungal
infections of the fingernails and toenails, fungal infection of the
hair and scalp (tinea capitis), of the groin and other areas of the
body and of the feet (athlete’s foot), as well as yeast infections
of the skin.
When taken orally, terbinafine reaches the location of infection
in sufficiently strong concentrations to eradicate the fungus or
halt its growth.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to
any of the other ingredients this medicine contains (see
section 6 – “Additional information”).
•
You have or have had a liver disease.
•
You are breastfeeding.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
Before treatment with Terbinafine Teva 250 mg, you should
check whether the following conditions apply to you. If they do,
inform the doctor or pharmacist, as Terbinafine Teva 250 mg
may not be the right medicine for you:
•
You are pregnant or trying to become pregnant
•
You have any kidney or liver function problems.
•
You have psoriasis.
•
You have lupus.
•
You have a rash due to high level of white blood cells.
CHI

Αρχείο Π.Χ.Π.

Terbinafine Teva 250 mg OKD 11/2021 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
Terbinafine Teva 250 mg Caplets
1.
NAME OF THE MEDICINAL PRODUCT
Terbinafine Teva 250 mg Caplets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains 281.3mg terbinafine hydrochloride, equivalent to
250mg
terbinafine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Caplets for oral administration.
White to off-white, capsule shaped biconvex tablet; on one side scored
and
debossed "T" on each side of the score; plain on the other side of the
tablet.
Terbinafine Teva 250 mg can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Fungal infections of the skin caused by dermatophytes such as
trichophyton
(e.g.
T.
rubrum,
T.
mentagrophytes,
T.
verrucosum,
T.
violaceum),
Microsporum canis and Epidermophyton floccosum.

Oral Terbinafine should only be used to treat extensive, severe
ringworm
infections (tinea corporis, tinea cruris and tinea pedis).

Oral Terbinafine is not effective against vaginal candidiasis or
pityriasis
(tinea) versicolor.

Onychomycoses (tinea unguium, ringworm of the nails) due to infection
with
dermatophyte organisms (hyphomycetes).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The duration of treatment varies according to the indication and the
severity of the
infection.
ADULTS
250mg once daily.
SKIN INFECTIONS_ _
Recommended duration of treatment:

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks.

Tinea corporis, cruris: 2 to 4 weeks.

Cutaneous candidiasis: 2 to 4 weeks.
Complete resolution of the signs and symptoms of infection may not
occur until
several weeks after mycological cure.
Terbinafine Teva 250 mg OKD 11/2021 Notification
HAIR AND SCALP INFECTIONS
Recommended duration of treatment:

Tinea capitis: 4 weeks.
Tinea capitis occurs primarily in children
_ _
ONYCHOMYCOSIS_ _
For most patients the duration of successful treatment is 6 to 12
weeks.
Fingernail
onychomycosis:
Six
weeks
of
therapy
is
suf