LAMISIL terbinafine 250mg (as hydrochloride) tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

terbinafine hydrochloride, Quantity: 281.25 mg (Equivalent: terbinafine, Qty 250 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; sodium starch glycollate; hypromellose; colloidal anhydrous silica

Administration route:

Oral

Units in package:

28, 14, 42 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as Trichophyton (eg. T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis and Epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. Onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

Product summary:

Visual Identification: Circular, biconvex, bevelled edge, "scored on one side and coded Lamisil 250 (circular) on the other", 11mm diameter, white to yellow-tinged white.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-09-24

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:
•
terbinafine,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LAMISIL
® (TERBINAFINE HYDROCHLORIDE)
125 MG AND 250 MG TABLET
1
NAME OF THE MEDICINE
Terbinafine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipients with known effect: Lamisil 125 mg tablets contain lactose.
3
PHARMACEUTICAL FORM
Lamisil
250
mg
tablet:
250
mg
terbinafine,
as
the
hydrochloride
(11
mm,
white
to
yellow-tinged, circular, biconvex, bevelled edges, scored on one side
and coded “LAMISIL
250” (circular) on the other side).
Lamisil 125 mg tablet: 125 mg terbinafine, as the hydrochloride (9 mm,
white to white-tinged
yellow, circular, biconvex, bevelled edges, scored and coded LP on one
side).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS

Treatment in adults of ringworm (tinea corporis, tinea cruris and
tinea pedis) due to
infection
caused
by
dermatophytes
such
as
_Trichophyton_
(e.g.
_T. _
_rubrum, _
_T. _
_mentagrophytes, T. verrucosum, T. violaceum_
),
_Microsporum canis_
and
_Epidermophyton _
_floccosum_
, where oral therapy is considered appropriate owing to the site,
severity or extent
of the infection, and the infection is not responsive to topical
therapy.

Onychomycosis in adults (fungal infection of the nail) caused by
dermatophyte fungi.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGES AND INTERVALS
ADULTS
_Skin infections:_
250 mg once a day
_Onychomycosis:_
250 mg once a day
2
ADMINISTRATION
Lamisil tablets should be taken orally. The bioavailability of
terbinafine is not affected by a
light meal.
DURATION OF TR