Terbasil 250mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbinafine

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

D01BA; D01BA02

INN (International Name):

Terbinafine

Dosage:

250 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Antifungals for systemic use; terbinafine

Authorization status:

Marketed

Authorization date:

2017-05-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TERBASIL 250 MG TABLETS
Terbinafine (as Terbinafine Hydrochloride)
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.
WHAT IS IN THIS LEAFLET:
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 t

Summary of Product characteristics

Health Products Regulatory Authority
08 June 2021
CRN00C3T8
Page 1 of 10
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.
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 longer
therapy is required.
Complete resolution of the signs and symptoms of infection