LAMISIL 250 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Novartis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO 250 mg TERBINAFINE

Authorization status:

Registered

Authorization date:

1992-11-05

Patient Information leaflet

Page 1 of 4
PATIENT INFORMATION LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING LAMISIL TABLETS

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
LAMISIL
®
125 mg TABLETS
LAMISIL
®
250 mg TABLETS
1.
COMPOSITION OF THE MEDICINE (I.E., WHAT THIS MEDICINE CONTAINS):
125 MG TABLETS

The ACTIVE SUBSTANCE of LAMISIL
®
is terbinafine hydrochloride.

The OTHER INGREDIENTS are magnesium stearate; hydroxypropylmethyl
cellulose; microcrystalline
cellulose; lactose; sodium carboxymethyl starch.
250 MG TABLETS

The ACTIVE SUBSTANCE of LAMISIL
®
is terbinafine hydrochloride.

The OTHER INGREDIENTS are magnesium stearate; silica colloidal
anhydrous; hydroxypropylmethyl
cellulose; microcrystalline cellulose; sodium carboxymethyl starch.
2.
APPROVED INDICATION AND USE (I.E., WHAT THIS MEDICINE IS USED FOR):
LAMISIL
®
tablets are used to treat fungal infections of the fingernails and
toenails.
LAMISIL
®
tablets are also used to treat tinea (ringworm) infections of the
scalp and hair, groin and other
body areas and the feet (athlete’s foot), as well as yeast
infections of the skin.
Terbinafine belongs to the group of medicines called antifungal agents
and is used to treat fungal
infections
of
the
skin,
hair
and
nails. When
taken
by
mouth,
it
reaches
the
site
of
infection
in
concentrations strong enough to kill the fungus or stop it growing.
3.
BEFORE TAKING THE MEDICINE:
It is important to tell your doctor if you have other medical problems
or if you are taking other medicines
DO NOT TAKE LAMISIL
®

If you are allergic (hypersensitive) to terbinafine or any of the
other ingredients of LAMISIL
®
listed at
the beginning of this leaflet.

If you have or had any liver problems.

If you

Summary of Product characteristics

Page 1 of 12
SCHEDULING STATUS:
PROPRIETARY NAME (AND DOSAGE FORM):
LAMISIL
®
125 mg tablet
LAMISIL
®
250 mg tablet
COMPOSITION:
_Active ingredient: _
_ _
Each 125 mg tablet contains 125 mg terbinafine as terbinafine
hydrochloride.
Each 250 mg tablet contains 250 mg terbinafine as terbinafine
hydrochloride
_List of excipients _
_LAMISIL_
_® _
_125 mg: _
Magnesium stearate; silica colloidal anhydrous; hydroxypropylmethyl
cellulose;
microcrystalline cellulose; lactose; sodium carboxymethyl starch.
_LAMISIL_
_® _
_250 mg: _
_ _
Magnesium stearate; silica colloidal anhydrous; hydroxypropylmethyl
cellulose;
microcrystalline cellulose; sodium carboxymethyl starch.
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2. Antimicrobial (Chemotherapeutic) agents. Fungicides.
PHARMACOLOGICAL ACTION:
Terbinafine is an allylamine which has a broad spectrum of antifungal
activity. At low
concentrations terbinafine is fungicidal against dermatophytes, moulds
and certain dimorphic
fungi. Its activity against yeasts is fungicidal or fungistatic,
depending on the species.
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 cell
S4
Page 2 of 12
death. Terbinafine acts by inhibition of squalene epoxidase in the
fungal cell membrane. The
enzyme squalene epoxidase is not linked to the cytochrome P-450
system.
_PHARMACOKINETICS: _
_ _
A single oral dose of 250 mg terbinafine results in peak plasma
concentrations of 1.3
microgram/mL within 1.5 hours of administration.
At steady-state, in comparison to a single dose, peak concentration of
terbinafine was on
average 25% higher and plasma AUC increased by a factor of 2.3. From
the increase in
plasma AUC an effective half-life of ~30 hours can be calculated.
The bioavailability of terbinafine is affected by food but dose
adjustments are not required.
Terbinafine binds strongly to plasma proteins (99%). It rapidly
diffuses through the dermis and
concentrates in the