TINASIL terbinafine 250mg (as hydrochloride) tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

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

Dostopno od:

Alphapharm Pty Ltd

INN (mednarodno ime):

terbinafine hydrochloride

Farmacevtska oblika:

Tablet, uncoated

Sestava:

Excipient Ingredients: croscarmellose sodium; purified talc; colloidal anhydrous silica; magnesium stearate; povidone; microcrystalline cellulose

Pot uporabe:

Oral

Enote v paketu:

28 tablets, 42 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

Visual Identification: White to off-white, round, uncoated, scored, biconvex tablets with "TF" over a break-line over "250" on one, and "G" on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2004-07-23

Navodilo za uporabo

TINASIL
®
_TABLETS_
_Terbinafine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TINASIL tablets.
It does not contain all the available
information about TINASIL 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.
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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TINASIL TABLETS
ARE USED FOR
TINASIL tablets are used to treat:
•
fungal infections fingernails and
toenails
•
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
TINASIL 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.
TINASIL tablets are only 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
TINASIL TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TINASIL 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.
S

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
TINASIL
®
_Terbinafine hydrochloride tablets _
1
NAME OF THE MEDICINE
Terbinafine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TINASIL tablet contains terbinafine hydrochloride equivalent to
250 mg of terbinafine base as the active
ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TINASIL tablets are round, white to off-white biconvex tablets with
“TF/250” (“TF” over breakline over
“250”) on one side and “G” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_Skin infections: _
250 mg once a day
_Onychomycosis: _
250 mg once a day
ADMINISTRATION
Terbinafine tablets should be taken orally. The bioavailability of
terbinafine is not affected by a light meal.
DURATION OF TREATMENT
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_
or Tinea cruris: 2 to 4 weeks
TINASIL
®
– PRODUCT INFORMATION
2
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 6
weeks and 3 months.
Infections of finger and toenails (other than big toe) usually respond
to the shorter duration of treatment,