LAMISIL CUT FL 30ML 1%

LAMISIL 1% CUTANEA

active ingredients

Active ingredient: 10 mg terbinaphine hydrochloride for 1 g solution (1% p/p). Excipients with known effects: ethanol 96% (250 mg/g) and glycol propylene (E1520) (50 mg/g). For the full list of excipients, see paragraph 6.1.

Excellent

Perpilene glycol (E1520) Macrogol cetostearile ether

Therapeutic indications

Lamisil solution is indicated in the treatment of mycotic infections of the skin caused by dermatophytes and pityriasis (tinea) versicolor in adults (see paragraph 4.4).

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Skin use. Population Adults Lamisil solution must be applied once or twice a day, depending on the indication.

Duration and frequency of treatment
Interdigital pedis tinea:	1 time per day for 1 week
Tinea corporis, cruris:	1 time per day for 1 week
Pityriasis versicolor:	2 times a day for 1 week

The reduction of clinical symptoms is normally observed after a few days. Irregular use or premature termination of treatment involves the risk of relapse. Method of administration Clean and dry the infected areas carefully before applying the solution. A sufficient quantity of solution must be applied to completely wet the area or areas to be treated and to cover the infected skin and the nearby area. Posology in particular patients populations Pediatric population The use of Lamisil solution is not recommended in children due to lack of data on safety and effectiveness. Senior Patients There are no evidence of clinical data suggesting a different dose in elderly patients, nor are there reports of different side effects than those found in younger patients.

Conservation

Do not store at temperature above 30 ° C. Do not refrigerate or freeze.

Warnings

Lamisil solution should be used with caution in patients with injuries where alcohol can be irritating. It should not be applied on the face. Lamisil solution is exclusively for external use. It can be irritating to the eyes. In case of accidental contact with the eyes, rinse thoroughly with running water. Lamisil solution must be kept out of the reach of children. Information about excipients This medicine contains 250 mg/g of ethanol 96%. It can cause burning sensation on damaged skin. This medicine contains 50 mg/g of glycol propylene.

Interactions

There are no known interactions of Lamisil solution with other drugs.

Effects

Summary of security profile Symptoms such as itching, skin dequamation, pain, irritation, skin discromies, burning sensation, erythema, crusts, etc. These harmless symptoms must be distinguished from hypersensitivity reactions, including the rash, reported in sporadic cases and requiring suspension of treatment. In case of accidental contact with the eyes, terbinaphine may cause irritation. In rare cases, the underlying fungal infection may worsen. Tabulated list of adverse reactions Adverse reactions are listed below according to the classification for systems and organs. The frequencies are defined as: very common (≥1/10); common (≥1/100 and Classification for Systems and Organs   Reaction Frequency Immune system disorders   Notable Hypersensitivity* Pathologies of the eye Rare Irritation in the eyes Pathologies of skin and subcutaneous tissue Town Skin dequamation, itching Not common Skin lesions, crusts, skin changes, discromies, erythema, skin burning sensation Rare Skin dryness, contact dermatitis, eczema Notable Rash Systemic pathologies and conditions for administration   Not common Pain, pain in the application site, irritation to the application site Rare Aggravement of conditions * on the basis of post-marketing experience Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Overdose is extremely unlikely due to the low systemic absorption of terbinafina solution administered by topical use. The accidental ingestion of the content of a 30 ml bottle of Lamisil solution, containing 300 mg of terbinaphine hydrochloride, is comparable to the ingestion of a tablet of Lamisil 250 mg (posological unit by mouth for adults). In case a greater quantity of Lamisil is inadvertently ingested, adverse effects similar to those observed as a result of overdose with Lamisil tablets are expected. Such reactions include headache, nausea, epigastric pain and dizziness. In case of accidental ingestion, the alcohol content (28,87% v/v) of Lamisil must be considered. Treatment of overdose In case of accidental ingestion, the recommended treatment of overdose is to eliminate the active ingredient, mainly through the administration of activated carbon, and if necessary to provide symptomatic support therapy.

Pregnancy There is no clinical experience with terbinaphine in pregnant women. Studies of fetal toxicity in the animal have not shown any adverse effects (see paragraph 5.3). Lamisil solution should not be used during pregnancy if not in case of actual need. Food Terbinafina is excreted in breast milk. Lamisil solution should not be used during breastfeeding. In addition, infants should not be allowed to come into contact with treated skin areas, including breasts. Fertility Animal studies have not shown any effect of terbinaphine on fertility (see paragraph 5.3).

Source: Farmadati