TERBINAFINE LICONSA 250 Milligram Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

TERBINAFINE

Mevcut itibaren:

Laboratorios LICONSA, S.A.

ATC kodu:

D01BA02

INN (International Adı):

TERBINAFINE

Doz:

250 Milligram

Farmasötik formu:

Tablets

Uygulama yolu:

Oral use

Paketteki üniteler:

14, 28 and 98 tablets

Reçete türü:

Product subject to prescription which may be renewed (B)

Tarafından üretildi:

LABORATORIOS LICONSA, S.A

Terapötik grubu:

Antifungals for systemic use

Terapötik alanı:

Antifungals for systemic use

Terapötik endikasyonlar:

It is indicated in the treatment of the following skin and nail fungal infections: Treatment of Tinea corporis, Tinea cruris and Tinea pedis, when oral therapy is considered appropriate depending on the site, severity or extent of the infection and for the treatment of onychomycosis caused by dermatophytes

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-06-19

Bilgilendirme broşürü

PIL Ireland (12/2013)
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERBINAFINE LICONSA 250 MG TABLETS
Terbinafine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
.
WHAT IS IN THIS LEAFLET
1. What Terbinafine Liconsa 250 mg tablets is and what it is used for
2. What you need to know before you take Terbinafine Liconsa 250 mg
tablets
3. How to take Terbinafine Liconsa 250 mg tablets
4. Possible side effects
5. How to store Terbinafine Liconsa 250 mg tablets
6. Contents of the pack and other information
1.
WHAT TERBINAFINE LICONSA 250 MG TABLETS IS AND WHAT IT IS USED FOR
Terbinafine Liconsa 250 mg tablets contains terbinafine, a substance
which belongs to a group of
medicines called antifungal agents, which inhibit the growth of fungi.
This medicine is indicated in the
treatment of the following terbinafine sensitive skin and nail fungal
infections:
Tinea corporis (ringworm)
Tinea cruris (ringworm of the groin)
Tinea pedis (ringworm of the foot)
Onychomycosis (fungal infection of the nail).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERBINAFINE LICONSA 250 MG
TABLETS
Read the information below before you take this medicine.
DO NOT TAKE TERBINAFINE LICONSA 250 MG TABLETS:

If you are allergic to Terbinafine or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Terbinafine Liconsa
250 mg tablets.
-If you take other medicines
-If you have ever had liver or kidney problems
-
If you have or experienced thickened patches of red/silver skin
(psori

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbinafine Liconsa 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of terbinafine (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White oblong tablets scored on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Terbinafine is indicated in the treatment of the following skin and
nail fungal infections_:_ Treatment of Tinea
corporis, Tinea cruris and Tinea pedis, when oral therapy is
considered appropriate depending on the site, severity
or extent of the infection.
-
Treatment of onychomycosis caused by dermatophytes.
In contrast
to topical
Terbinafine,
oral
Terbinafine (Terbinafine Liconsa 250 mg tablets) is not
effective in treating
pityriasis versicolor.
Consideration should be given to official local guidance regarding
microbial resistance and on the appropriate use and
prescription of antifungal agents
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
250 mg (1 tablet) once daily.
Treatment duration will vary depending on the indication and severity
of the infection.
SKIN INFECTIONS
The likely durations of treatment for Tinea pedis, Tinea corporis and
Tinea cruris are 2-4 weeks. For Tinea pedis
(interdigital, plantar/mocassin-type): recommended treatment periods
may be up to 6 weeks
Complete resolution of the signs and symptoms of infection may not
occur until several weeks after mycological cure.
ONYCHOMYCOSIS
For most patients, effective treatment takes between 6 to 12 weeks.
_Fingernail onychomycosis_
Six weeks of treatment is sufficient in most cases for fingernail
infections.
_Toenail onychomycosis_
Twelve weeks of treatment is sufficient in most cases for toenail
infections.
Patients with poor nail outgrowth may require longer treatment periods
(6 months or longer).
Optimal
clinical
effect
is seen some months after mycological
cure and cessation of treatment.
This is the period
nece