DermGelTM 1% Gel
Qualitative and quantitative composition
One gram of gel contains 10 mg terbinafine base.
For excipients, see List of
White to off-white glossy gel.
Therapeutic indications: Fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T.
verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as
Posology and method of administration
For cutaneous use.
Adults: Lamisil DermGel is applied once daily for all indications. Cleanse
and dry the affected areas thoroughly before applying Lamisil DermGel. The
emulsion gel should be rubbed in lightly to the affected skin and
surrounding area. In the case of intertriginous infection (submammary,
interdigital, intergluteal, inguinal), the area to which the gel has been
applied may be covered with gauze, especially at night.
Before first use, the sealing membrane of the tube must be pierced using the
point incorporated into the screw cap.
Duration and frequency of
Tinea corporis, tinea cruris : 1
week, once a day
Tinea pedis (interdigital type) :
1 week, once a day
Pityriasis versicolor : 1 week,
once a day
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
Use of Lamisil DermGel in the elderly (>=65 years): There is no evidence to
suggest that elderly patients require different dosages or experience side
effects different from those in younger patients.
Use of Lamisil DermGel in children (<18 years): There is limited experience
with the use of Lamisil DermGel in children, and, Lamisil DermGel is
therefore not recommended for use in children.
Known hypersensitivity to terbinafine or to any of the excipients.
Special warnings and special precautions for use
Lamisil DermGel should be used with caution in patients with lesions where
alcohol could be irritating. Lamisil DermGel is for external use only. It
may be irritating to the eyes.
In case of accidental contact with the eyes, rinse eyes thoroughly with
running water and consult a physician if any symptoms persist.
Interactions with other medicinal products and other forms of Interaction
drug interactions are known with Lamisil DermGel.
Pregnancy and lactation
Pregnancy: Animal studies did not reveal any teratogenic or embryofetotoxic
potential of terbinafine. No cases of malformations in humans have been
reported with Lamisil to date. However, since clinical experience in
pregnant women is very limited, Lamisil DermGel should not be used during
pregnancy unless the potential benefits outweigh any potential risks.
Lactation: Terbinafine is excreted in breast milk and therefore, mothers
should not use Lamisil DermGel whilst breastfeeding. In addition, infants
must not come into contact with any treated skin area, including the
Effects on ability to drive and use machines
Cutaneous application of Lamisil DermGel does not affect the ability to
drive and use machines.
Redness, itching or stinging may occur at the site application; however,
treatment rarely has to be discontinued for this reason. These harmless
symptoms must be distinguished from allergic reaction (such as pruritus,
rash, bullous eruptions and hives) which are very rare  but require
discontinuation of treatment.
The low systemic absorption of topical terbinafine emulsion gel renders
overdosage extremely unlikely. Accidental ingestion of the contents of one
30g tube of Lamisil DermGel, which contains 300mg terbinafine, is comparable
to one Lamisil 250mg tablet (adult oral unit dose).