Athlete's foot treatment (Foot tinea).

Usual dosage
Cleanse and dry the affected skin areas thoroughly before applying Lamisil Pedisan.
Adults and adolescents aged 12 years and above:
Lamisil Pedisan cream
Apply Lamisil Pedisan cream once per day. Apply the cream to the affected skin and
surrounding area in a thin layer and lightly rub-in. In case of interdigital infection, the
application site may be covered with a gauze strip, especially at night.
Lamisil Pedisan spray
Apply Lamisil Pedisan spray once per day. If Lamisil Pedisan spray is used, sufficiently
impregnate affected and surrounding skin areas.
Duration of treatment:
Cream: 1 week
Spray: 1 week

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature
discontinuation of treatment carries the risk of recurrence. If there are no signs of
improvement after one week, the diagnosis should be verified.
Special dosage instructions
Elderly patients
There is no evidence to suggest that elderly patients require different dosages or experience
adverse reactions different from those of younger patients.
Children less than 12 years of age
The safety and efficacy in children <12 years of age have not been established. Due to
limited clinical data, application of Lamisil Pedisan in children less than 12 years of age is not
recommended.

Lamisil Pedisan is for external use only.
Contact with the eyes should be avoided. In case of accidental contact with the eyes, eye
irritation may occur. In case of accidental contact with the eyes, rinse the eyes and
conjunctival sac thoroughly with running water.
Infants and young children should not come into contact with the treated skin areas.
Do not inhale Lamisil Pedisan Spray.
In case of skin lesions, use Lamisil Pedisan spray with care because it contains alcohol and
propylene glycol which can be irritating.
Lamisil Pedisan cream contains cetyl alcohol and stearyl alcohol, which may cause local
skin reactions (e.g. contact dermatitis).
 

Interactions
No interaction studies have been performed with Lamisil Pedisan. There are no known drug
interactions with Lamisil Pedisan cream or spray.

Pregnancy/Lactation
Pregnancy
No controlled studies are available in pregnant women. Reproduction studies in animals did
not demonstrate any risk for the foetus.
In case of local application of Lamisil Pedisan, less than 5% of the applied dose is absorbed.
Lamisil Pedisan should not be used during pregnancy unless absolutely necessary.
Lactation
Terbinafine is excreted in small quantities in breast milk. It is not known if this small amount
present in the breast milk may have a deleterious effect on the infant. Lamisil Pedisan
should not be used during lactation.
Infants and young children should not come into contact with the treated skin areas.

Effects on ability to drive and use machines
No corresponding study has been conducted.

Undesirable effects
The application can cause local reactions such as erythema, pruritus or desquamation.
However, these benign symptoms must be distinguished from hypersensitivity reactions,
which are reported in sporadic cases but require immediate discontinuation. These reactions
can be accompanied by redness, papules, vesicles and pruritus, which can also occur
beyond the contact zone (so-called dispersion reaction).
The following adverse effects are listed by system organ class and by frequency; they have
been observed with the topical use of terbinafine. Frequencies are defined as follows:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare
(≥1/10,000 <1/1000), very rare (<1/10,000).
Immune system disorders
Very rare: hypersensitivity reactions such as urticaria, allergic exanthema (including
dispersion reactions), papules, vesicular changes.
Isolated cases: angio-oedema, anaphylactic shock.

Eye disorders
Rare: irritation.
Skin and subcutaneous tissue disorders
Common: desquamation, pruritus.
Uncommon: skin lesions, scabs, other skin changes, pigmentation disorders, erythema,
burning sensation.
Rare: dry skin, contact dermatitis, eczema.
Very rare: skin eruption or papula.
General disorders and administration site conditions
Uncommon: application site pain or irritation.In rare cases, the underlying fungal infection may be aggravated.
Reporting suspected adverse reactions after authorisation of the medicinal product is very
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose
The low systemic absorption of topical terbinafine renders overdose extremely unlikely.
Accidental ingestion of, for example, 2 tubes of Lamisil Pedisan cream or a 30 ml bottle of
Lamisil Pedisan spray containing 300 mg of terbinafine hydrochloride is comparable to the
ingestion of a 250 mg Lamisil tablet (corresponding to a standard adult oral dose).

If a larger quantity of topical Lamisil Pedisan is ingested, adverse reactions similar to those
observed with an overdose of Lamisil tablets are to be expected, such as headaches,
nausea, epigastric pain and dizziness.
In the event of accidental ingestion of Lamisil Pedisan spray, the 28.87% (v/v) alcohol
content must be taken into account.
Treatment of overdose
In the event of accidental oral ingestion, additional symptomatic treatment may be
administered if necessary. If ingestion is recent, activated charcoal can be administered.

To reports any side effect(s):
 Saudi Arabia:  The National Pharmacovigilance Centre (NPC):
 SFDA Call Center: 19999
 E-mail: npc.drug@sfda.gov.sa
 Website: https://ade.sfda.gov.sa/

ATC code
D01AE15
Mechanism of action
Terbinafine is an antifungal which has a broad spectrum of allylamine activity. It exerts
a fungicidal action on dermatophytes.
Terbinafine interferes specifically with ergosterol biosynthesis in the fungal cell membrane at
an early step. Inhibition of squalene epoxidase enzyme leads to ergosterol deficiency and
accumulation of intracellular squalene, resulting in fungal cell lysis. Terbinafine inhibits
squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not
linked to the cytochrome P450 system. Therefore, terbinafine has no effect on the
metabolism of hormones or other medicinal products.
Minimum inhibitory concentration in vitro

Fungal species μg/ml
Susceptible:
Trichophyton rubrum 0.003-0.006
T. mentagrophytes 0.003-0.01
T. tonsurans 0.003
T. verrucosum 0.003
T. schönleinii 0.006
Microsporum canis 0.006-0.01
M. versicolor 0.003
M. gypseum 0.006
Epidermophyton floccosum 0.003-0.006

Missing information.
Clinical efficacy

Lamisil Pedisan may be recommended for short-term treatment (1 week). In most patients
with foot tines, no relapse occurred for 2 months after Lamisil Pedisan treatment for one
week.

Absorption
In humans, less than 5% of the applied topical dose is absorbed. Systemic exposure is
therefore very low.
Distribution
After topical application, terbinafine penetrates the skin and accumulates in the stratum
corneum. After a 7-day topical application, terbinafine can be measured at a fungicidal
concentration in the stratum corneum for an additional 7 days.
Metabolism
Systemically absorbed terbinafine is rapidly and completely metabolised in the liver to
inactive metabolites by several CYP450 isoenzymes.
Elimination
Three quarters of terbinafine metabolites are eliminated in the urine and a quarter is
eliminated in the faeces. After systemic administration, the elimination half-life is
approximately 30 hours.

Long-term toxicity
In long-term studies (up to 1 year) in rats and dogs on the oral administration of the active
substance, terbinafine, no toxic effects have been observed at doses up to 100 mg/kg/day.
At high oral doses, the liver and, to a lesser extent, the kidneys have been identified as
potential target organs.
Mutagenicity
A standard battery of genotoxicity tests performed in vitro and in vivo revealed no mutagenic
or clastogenic evidence of the product.
Carcinogenicity
In a two-year carcinogenicity study with oral administration in mice, no neoplastic or other
abnormal findings were observed at dosages up to 130 mg/kg (males) and 156 mg/kg
(females) per day. In a two-year carcinogenicity study with oral administration in rats at the

highest dose level of 69 mg/kg per day, an increased incidence of liver tumours was
observed in males. These changes, which may be associated with peroxisome proliferation,
have been shown to be species-specific since they were not seen in the carcinogenicity
study in mice or in other studies in mice, dogs or monkeys.
Reproductive toxicity
No adverse event on fertility or other reproduction parameters were observed with the active
substance terbinafine in studies in rats or rabbits. No malformations were observed; the periand
post-natal development phases were also not affected.
Other data (local toxicity)

Repeated dermal use of Lamisil Pedisan Once in rats and guinea pigs has resulted in 50–
100 times lower plasma terbinafine levels than those observed in routine animal toxicity
studies. No systemic side effects are to be expected. Tolerance studies did not reveal any
sensitisation due to Lamisil Pedisan Once.

Cetyl alcohol, cetyl palmitate, isopropyl myristate, sodium hydroxide, polysorbate 60, stearyl
alcohol, sorbitan stearate, benzyl alcohol and purified water.
Spray:
Ethanol, macrogol cetostearyl ether, propylene glycol (E1520) and purified water.

NA

Special precautions for storage
Store at 15-30°C.
Keep out of the reach of children.

Cream: 15 g [D]
Spray: 15 ml and 30 ml [D]

NA