Fungasil 250mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbinafine

Available from:

Clonmel Healthcare Ltd

ATC code:

D01BA; D01BA02

INN (International Name):

Terbinafine

Dosage:

250 milligram(s)

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:

2009-08-12

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUNGASIL 250MG TABLETS
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 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fungasil is and what it is used for
2.
What you need to know before you take Fungasil
3.
How to take Fungasil
4.
Possible side effects
5.
How to store Fungasil
6.
Contents of the pack and other information
1. WHAT FUNGASIL IS AND WHAT IT IS USED FOR
Fungasil contains the active substance terbinafine hydrochloride.
Terbinafine belongs to a group of
medicines called antifungal agents.
FUNGASIL IS USED TO:

treat fungal skin infections caused by parasitic fungus that infects
the skin (dermatophytes) such as:
- Tinea corporis (fungal infection anywhere on the skin except on the
head, hands, feet or groin.
This especially affects the hairless parts of the skin).
- Tinea cruris (a fungal infection of the groin)
- Tinea pedis (commonly called Athlete’s Foot – a fungal infection
of the feet. This usually affects
the skin between the toes)

treat fungal infections of the nails (onychomycosis) which are caused
by parasitic fungus that
infects the skin (dermatophytes).
Terbinafine is not effective against Pityriasis versicolor (a skin
infection caused by yeasts).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUNGASIL
DO NOT TAKE FUNGASIL

if you are allergic to terbinafine hydrochloride or to any of the
other ingredients of this medicine
(listed in section 6).

if you suffer from severe kidney disease (when your kidneys are not
working prop

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2021
CRN009WG1
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fungasil 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg terbinafine (as hydrochloride).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, or almost white round, biconvex tablets with a break line on
one side and 250 engraved on the other.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Treatment of Terbinafine sensitive fungal infections such as Tinea
corporis, Tinea cruris and Tinea pedis (caused by
Dermatophytes see Section 5.1) where oral therapy is considered
appropriate due to the site, severity or extent of the infection.
2. The treatment of onychomycosis (terbinafine-sensitive fungal
infection of the nails) caused by dermatophytes.
N.B. Orally administered terbinafine tablets are not effective against
Pityriasis versicolor.
Consideration should be given to official guidance on the appropriate
use of antifungal agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral use
The duration of treatment is dependent on the indication and the
degree of severity of the infection.
_Adults:_250mg once daily.
_Skin infections_
The likely durations of treatment for Tinea pedis, Tinea corporis and
Tinea cruris are 2 - 4 weeks.
For Tinea pedis (interdigital, plantar/moccasin-type): recommended
treatment periods may be up to 6 weeks.
Complete disappearance of the symptoms of the infection may not occur
until several weeks after mycological cure.
_Onychomycosis_
In most patients the duration of successful treatment is 6-12 weeks.
Fingernail onychomycosis: In most cases 6 weeks' treatment is
sufficient in fingernail onychomycosis.
Toenail onychomycosis: In most cases 12 weeks' treatment is sufficient
in toenail onychomycosis although a few patients may
require treatment up to 6 months. Poor nail outgrowth during the first
weeks of treatment ma