Terbinafine-DRLA terbinafine (as hydrochloride) 250 mg tablet blister pack

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:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

terbinafine hydrochloride

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

28 tablets, 14 tablets, 42 tablets

Class:

Medicine Registered

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 (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.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2010-07-13

Patient Information leaflet

TERBINAFINE-DRLA Tablets
1
TERBINAFINE-DRLA
TABLETS
_terbinafine_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Terbinafine-DRLA
tablets. It does not contain
information about other forms of
terbinafine that are available without
a prescription from your pharmacy.
It does not contain all the available
information about terbinafine tablets.
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 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 TERBINAFINE-
DRLA TABLETS ARE
USED FOR
Terbinafine-DRLA 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
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.
Terbinafine-DRLA
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
TERBINAFINE-DRLA
TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TERBINAFINE-DRLA 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
body
•
r

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TERBINAFINE-DRLA
(TERBINAFINE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Terbinafine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terbinafine hydrochloride equivalent to 250 mg
terbinafine base.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TERBINAFINE-DRLA TABLETS are 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.
_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