Nailderm 250 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbinafine hydrochloride

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

D01BA; D01BA02

INN (International Name):

Terbinafine hydrochloride

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:

2005-06-17

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NAILDERM
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 Nailderm is and what it is used for
2.
What you need to know before you take Nailderm
3.
How to take Nailderm
4.
Possible side effects
5.
How to store Nailderm
6.
Contents of the pack and other information.
1.
WHAT NAILDERM IS AND WHAT IT IS USED FOR
Nailderm contains a medicine called terbinafine as terbinafine
hydrochloride, which belongs to a
group of medicines called antifungals. It is used in adults and older
people to treat a number of fungal
infections of the skin and nails such as athlete’s foot, groin
infections, ringworm and also
onychomycosis (a fungal infection of the nails). It kills the fungus
and stops it growing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAILDERM
DO NOT TAKE NAILDERM:

if you are allergic to terbinafine or any of the other ingredients of
this medicine (listed in
section 6).

if you have severe kidney problems.

if you have or had liver problems.

if you are breastfeeding.

if you are pregnant or trying to become pregnant.
Do not take Nailderm if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Nailderm.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nailderm:

if you have or have experienced patches of red/silver skin
(psoriasis), or facial rash, joint pain,
muscle disorder, fever (cutaneous and systemic lupus erythematosus

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2022
CRN00CQGN
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nailderm 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride, equivalent to 250 mg
terbinafine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, round, biconvex tablet with TF scoreline 250 on
one side and G on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin caused by Trichophyton (e.g. _T. rubrum,
T. mentagrophytes, T. verrucosum, T. violaceum_)
_Microsporum canis _and _Epidermophyton floccosum. _
_ _
Oral Terbinafine tablets are 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.
The treatment of onychomycosis (terbinafine-sensitive fungal infection
of the nails) caused by dermatophyte fungi.
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
Posology
_Adults_
250 mg once daily.
The duration of treatment is varies according to the indication and
the degree of severity of the infection.
_Skin infections_
The 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 infections, toenail infection
other than of the big toe, or patiens of younger age.
In the treatment of toenail infection, 3 months is usually sufficient
although a few patients m