TERBINAFINE SANDOZ 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:

Sandoz Pty Ltd

INN (International Name):

terbinafine hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

42, 14, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment 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 other available treatments. Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.

Product summary:

Visual Identification: White or almost white, round, scored on both sides, convex tablet, coded 'TER 250' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-08-12

Patient Information leaflet

TERBINAFINE SANDOZ
1
TERBINAFINE SANDOZ
®
_terbinafine hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Terbinafine Sandoz.
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 TERBINAFINE
SANDOZ IS USED
FOR
Terbinafine Sandoz is used to treat
infections caused by dermatophytes,
a type of fungi, including the
following:

fungal infections of the finger
nails and toe nails

tinea (ringworm) infections of the
groin and body

tinea infections of the feet
("athlete's foot").
It contains the active ingredient
terbinafine.
Terbinafine belongs to a group of
medicines called antifungal agents of
the allylamine type.
It works by killing the fungi which
cause the infection.
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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
TERBINAFINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:

terbinafine, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description.
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 ANY OF THE
FOLLOWING MEDICAL CONDITIONS:

problems with your kidneys

a problem with your liver. This
medicine is not recommended

Summary of Product characteristics

180508-Terbinafine Sandoz-pi
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
TERBINAFINE SANDOZ
® TABLETS (TERBINAFINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Terbinafine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Terbinafine Sandoz tablets contain terbinafine hydrochloride.
Terbinafine hydrochloride is a white to off-white, finely crystalline
powder. It is soluble in
isopropyl alcohol (> 70 mg/mL at 25ºC) and ethanol (> 70 mg/mL at
25ºC), and slightly soluble
in water (6.3 mg/mL at 25ºC).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Terbinafine Sandoz 250 mg tablets: white or almost white, round,
scored on both sides, convex
tablet, coded TER 250 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
_DOSAGE _
_ADULTS _
_Skin infections:_
250 mg once a day.
_Onychomycosis:_
250 mg once a day.
_DURATION OF TREATMENT_
_ _
The duration of treatment varies according to the indication and the
severity of the infection.
_Skin infections _
Likely treatment durations 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.
180508-Terbinafine Sandoz-pi
Page 2 of 11
_ONYCHOMYCOSIS _
For most patients the duration for successful treatment is between six
weeks and three months.
Infections of finger and t