Lamisil Once 1% solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terbinafine hydrochloride

Available from:

Haleon UK Ltd

ATC code:

D01AE15

INN (International Name):

Terbinafine hydrochloride

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5051562014801

Summary of Product characteristics

OBJECT 1
LAMISIL ONCE
Summary of Product Characteristics Updated 02-Nov-2016 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Lamisil
®
Once
TM
1% cutaneous solution
2. Qualitative and quantitative composition
Each gram contains 10 mg terbinafine (as hydrochloride).
For excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous solution.
Clear to slightly opaque viscous solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment for tinea pedis (athlete's foot).
Lamisil Once 1% cutaneous solution is indicated for Adults 18 years of
age and over.
4.2 Posology and method of administration
FOR CUTANEOUS USE
ADULTS 18 YEARS OF AGE AND OVER: single administration.
DURATION AND FREQUENCY OF TREATMENT
Lamisil Once 1% cutaneous solution should be applied once on both
feet, even if lesions are visible on
one foot only. This ensures elimination of the fungi (dermatophytes)
that might be found in areas of the
foot where no lesions are visible.
Relief of clinical symptoms usually occurs within a few days. If there
are no signs of improvement after
one week, patients should see a doctor. There are no data on repeated
treatment with Lamisil Once 1%
cutaneous solution. Therefore a second treatment cannot be recommended
within a particular episode of
athlete's foot.
DOSING IN SPECIAL POPULATIONS
Paediatric population
Lamisil Once 1% cutaneous solution has not been studied in the
paediatric population. Its use is therefore
not recommended in patients below 18 years of age.
Elderly patients
There is no evidence to suggest that elderly patients require
different dosages or experience side effects
different from those in younger patients.
METHOD OF ADMINISTRATION
Patients should wash and dry both feet and hands before applying the
product. They should treat one foot,
then the other.
Starting between the toes, patients should apply a thin layer evenly
between and all around the toes, as
well as cover the sole and sides of the foot for up to 1.5 cm. The
product should be applied in the same
way to