Terbasil 250mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

D01BA; D01BA02

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Dosage:

250 Base Milligrams

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use; terbinafine

Authorization status:

Marketed

Authorization date:

2006-05-05

Patient Information leaflet

TERBASIL 250 MG TABLETS
Terbinafine (as Terbinafine Hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
BBBA2957
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 further questions, please ask your doctor or
your 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.
1
WHAT TERBASIL TABLETS ARE AND WHAT THEY ARE
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE TERBASIL
TABLETS
3
HOW TO USE TERBASIL TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE TERBASIL TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT TERBASIL TABLETS ARE AND WHAT THEY ARE
USED FOR
Terbasil Tablets contain terbinafine which is an anti-fungal
agent. Terbasil tablets are used in adults and older people for
the treatment of infections such as:
• fungal infections of the skin and nails
• ringworm
Terbasil tablets kills the fungus or stops it growing.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE TERBASIL
TABLETS
DO NOT USE TERBASIL TABLETS:
• if you are ALLERGIC to terbinafine or any of the other
ingredients of this medicine (listed in section 6).
• if you have or had any liver problems
• if you are breast-feeding
• if you are pregnant or trying to become pregnant. Do not
take Terbasil if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Terbasil.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Terbasil Tablets
if you:
• have or had any LIVER PROBLEMS. If test of liver functionality
shows an increase, then terbinafine should be discontinued
immediately.
•
have KIDNEY PROBLEMS consult your doctor before taking
these tablets.
• are taking any OTHER MEDICATIO

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2019
CRN008N85
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbasil 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Terbinafine (as Terbinafine hydrochloride)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, round, scored, flat tablet marked T above and 1 below the score
on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin and nails caused by _Trichophyton_ (e.g.
_T. rubrum, _
_T.mentagrophytes, T. verrucosum, T. violaceum_), _Microsporum canis_
and
_Epidermophyton floccosum_.
Oral terbinafine is indicated in the treatment of ringworm (tinea
corporis, tinea cruris
and tinea pedis) where oral therapy is considered appropriate due to
the site,
severity or extent of the infection.
Onychomycosis (nail infections) caused by dermatophyte fungi.
Complete resolution of the signs and symptoms of infection may not
occur until
several weeks after mycological cure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: 250mg once daily.
The duration of treatment varies according to the indication and the
severity of the
infection.
Health Products Regulatory Authority
04 January 2019
CRN008N85
Page 2 of 16
Skin infections
Likely durations of treatment are as follows:
Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks
Tinea corporis: 4 weeks
Tinea cruris: 2 to 4 weeks
Onychomycosis
The duration of treatment for most patients is between 6 weeks and 3
months.
Treatment periods of less than 3 months can be anticipated in patients
with
fingernail infection, toenail infection other than of the big toe, or
patients of younger
age. In the treatment of toenail infections, 3 months is usually
sufficient although a
few patients may require treatment of 6 months or longer. Poor nail
outgrowth
during the first weeks of treatment may enable identification of those
patients in
whom long