Lamisil Tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Terbinafine hydrochloride

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

LAMISIL
®
 TABLETS

_terbinafine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lamisil tablets. It
does not contain information about
other forms of Lamisil that are
available without a prescription from
your pharmacy.
It does not contain all the available
information about Lamisil tablets. It
does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LAMISIL TABLETS
ARE USED FOR
Lamisil tablets are used to treat:
•
fungal infections of the finger
nails and toe nails
•
tinea (ringworm) infections of the
groin and body
•
tinea infections of the feet,
commonly called "athlete's foot."
These infections are caused by a
group of fungi called dermatophytes.
Terbinafine, the active ingredient in
Lamisil tablets, works by killing the
dermatophytes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Lamisil tablets are only available
with a doctor's prescription. This
medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE
LAMISIL TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LAMISIL IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO

Summary of Product characteristics

1 

LAMISIL
®
 TABLETS   
(TERBINAFINE HYDROCHLORIDE) 

NAME OF THE MEDICINE 

Active ingredient:  
terbinafine hydrochloride 
Chemical name: 
(E)-N)-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- 

naphthalenemethanamine hydrochloride  
CAS number:   
78628-80-5 
Molecular formula:   C
21
H
26
 ClN 
Molecular weight: 
327.90 
Chemical structure:   
N
C
CH
3
C
CH
3
CH
3
CH
3
.
 HCl 

DESCRIPTION 

Terbinafine hydrochloride is a white to
off-white, finely crystalline powder.  It is soluble in 
isopropyl alcohol (> 70 mg/mL at 25°C) and ethanol (> 70
mg/mL at 25°C), and slightly 
soluble in water (6.3 mg/mL at 25°C). Each Lamisil tablet
contains terbinafine hydrochloride 
equal to either 125 mg or 250 mg terbinafine base. Each tablet
also contains magnesium 
stearate, hypromellose, sodium starch
glycollate, and cellulose - microcrystalline. Lamisil 
250 mg tablets also contain silica-colloidal
anhydrous.  Lamisil 125 mg tablets also contain 
lactose.

PHARMACOLOGY 

PHARMACODYNAMICS 

Pharmacotherapeutic group: Oral antifungal agent, ATC Code:
D01B A02 

Terbinafine is an allylamine with antifungal
activity mainly against dermatophytes, including 
Trichophyton (e.g. _T. rubrum, T. mentagrophytes, T. verrucosum,
T. violaceum), _
_Microsporum_ _canis_, and _Epidermophyton floccosum. _

2 

MECHANISM OF ACTION: 
Terbinafine interferes specifically with fungal sterol biosynthesis
at an early step.  This leads 
to a deficiency in ergosterol and to an intracellular accumulation
of squalene, resulting in 
fungal cell death.  Terbinafine acts by inhibition of
squalene epoxidase in the fungal cell 
membrane.  The enzyme squalene epoxidase is not linked to the
cytochrome P450 system.   
When given orally, the drug concentrates in skin and nails at levels
associated with antifungal 
activity. 

PHARMACOKINETICS 
_ _
ABSORPTION:  
Following oral admin