TAMSIL terbinafine (as hydrochloride) 250 mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

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

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

terbinafine hydrochloride

formulario farmacéutico:

Tablet

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

28 tablets, 14 tablets, 42 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: White to off-white, round, beveled edge tablets embossed with 'R250' on one side and score (bisect) line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2010-07-13

Información para el usuario

TAMSIL Page 1 of 5
TAMSIL 250 MG TABLETS
_ Terbinafine (as hydrochloride) _ CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
TAMSIL 250 mg tablets. It does
not contain information about
other forms of terbinafine
hydrochloride that are available
without a prescription from your
pharmacy.
It does not contain all the
available information about
TAMSIL. It does not take the
place of talking to your doctor
or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
TAMSIL against the benefits
they expect it will provide.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TAMSIL TABLETS ARE
USED FOR
Tamsil 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 Tamsil 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.
Tamsil 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 TAMSIL
TABLETS
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TAMSIL IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
Terbinafine, the active
ingredient, or to any of the
other ingredients listed at
the end of this leaflet
•
Any other medicines, foods,
preservatives or dyes
Your doctor will want to know if
you are prone to allergies.
Some of the symptoms of an
allergic reaction may include:
•
Shortness of breath
•
Wheezing or difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of
the bo

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION – TAMSIL (TERBINAFINE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Terbinafine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Terbinafine hydrochloride equivalent to
terbinafine 250 mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TAMSIL tablets, equivalent terbinafine base 250 mg (White to off white
round, flat bevelled edge
tablets embossed “R250” on one side and Score (bisect) line on the
other 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
Terbinafine 250mg once a day, taken orally.
The bioavailability of terbinafine is not affected by a light meal.
The duration if treatment varies according to the indication and the
severity of the infection.
Skin infections.
Likely treatment durations are as follows. _Tinea pedis
_(interdigital, planar/moccasin type): two to six
weeks.
2
Tinea corporis, cruris: two to four weeks.
Complete resolution of the signs and symptoms of infection may not
occur until several weeks after
mycological cure.
Onychomycosis
For most patients the duration for successful treatment is between six
weeks and three months.
Infections of fingers and toenails (other than big toe) usually
respond to the shorter duration of
treatment, particularly in patients of younger age with a normal rate
of nail outgrowth. In patients
with slow nail growth, treatment for up to three months is usually
adequate. However, for infections
in the big toe, or if the nai