APO-TERBINAFINE terbinafine 250mg (as hydrochloride) tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

terbinafine hydrochloride, Quantity: 281.3 mg (Equivalent: terbinafine, Qty 250 mg)

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

terbinafine hydrochloride

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: methylcellulose; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

42 tablets

Kατηγορία:

Medicine Registered

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

APO-TERBINAFINE is indicated for: Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infections 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.

Περίληψη προϊόντος:

Visual Identification: White, round, biconvex tablet with bevelled edges engraved "APO" on one side, "TER" over "250" scored through centre on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2005-04-15

Φύλλο οδηγιών χρήσης

APO-TERBINAFINE
_Terbinafine hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. 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 this medicine
against the benefits they expect it
will have for you.
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 THIS MEDICINE IS
USED FOR
Terbinafine is 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 works by killing
dermatophytes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
It is available only with a doctor's
prescription.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
terbinafine
•
any of the ingredients listed at the
end of this leaflet
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 body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD A PROBLEM WITH
YOUR LIVER.
This medicine is not recommended if
you currently have a liver problem
because it may make the problem
worse. If you had a liver problem in
the past and your liver is functioning
normally now, your doctor may
prescribe this med

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
APO-TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Terbinafine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg terbinafine (as hydrochloride) as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White, round, uncoated biconvex tablets with bevelled edges engraved
with “APO” on one
side and “TER” over “250” and scored through the centre of the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Terbinafine is indicated for:
•
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
APO-Terbinafine tablets are intended for oral administration.
DOSAGE
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
Oral terbinafine should be prescribed only after topical therapy has
failed and for the shortest
time possible.
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, cruris: 2 to 4 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 6
weeks and 3 months.