LAMISIL 250 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBINAFINE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

D01BA02

INN (International Name):

TERBINAFINE

Dosage:

250 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antifungals for systemic use

Authorization status:

Authorised

Authorization date:

1994-12-12

Patient Information leaflet

1 of 2
Live Text:

Yes /

No /

Both
Production Site:
Wehr
WO:
1700748
ACC:
Morath, Kerstin
Comp. Description:
LFT LAMISIL TAB 250MG IE
Printing Colours:
Black
Comp. No. New:
2208679 IE WEH
Comp. No. Old:
2197074 IE WEH
Format/Dimension:
190 x 297 mm
Tech. Drawing No.:
2208679
Technical Colours:
Cutting
Min. Font Size Text:
8.5 pt
Font Type:
News Gothic
Proof No.:
1
Date: 10 Apr 2018
J.N.: 339233
Braille:
N/A
! PLEASE TURN OVERPRINTING ON !
Telephone [phone]
[e-mail]
www.perigord-as.com
Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15
2208679 IE WEH
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMISIL
® 250 MG 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
• This medicine will be referred to as Lamisil
in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Lamisil is and what it is used for
2. What you need to know before you take
Lamisil
3. How to take Lamisil
4. Possible side effects
5. How to store Lamisil
6. Contents of the pack and other information
1. WHAT LAMISIL IS AND WHAT IT IS USED FOR
Lamisil contains a medicine called terbinafine
hydrochloride. It is an “anti-fungal” medicine.
Lamisil is used in adults and older people to
treat a number of fungal infections of the skin
and nails. It kills the fungus or stops it growing.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMISIL
DO NOT TAKE LAMISIL IF:
• you are allergic to terbinafine hydrochloride or
any of the other ingredients of this
medicine (l

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamisil 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride, equivalent to 250mg
terbinafine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Circular, biconvex, bevelled-edge, white or off-white tablets about
11mm in diameter. One face is scored and the
reverse is marked ‘Lamisil 250’.
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 Lamisil 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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 may not
occur until several weeks after mycological cure.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
__