Lamisil, cream 1% 15 g

Antifungal drug for external use, which has a broad spectrum of antifungal activity. In low concentrations terbinafine has fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare).

Indications

Prevention and treatment of fungal skin infections: mycosis of the feet (tinea pedis); keratinization, cracks, itching and flaking of the skin caused by foot fungus; inguinal athlete’s foot (tinea craris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum; yeast infections of the skin, mainly those caused by fungi of the genus Candida (for example, Candida albicans), in particular diaper rash; pityriasis versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

Pharmacological effect

An antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare).

Special instructions

A decrease in the severity of clinical manifestations is usually observed in the first days of treatment. In case of irregular use or premature cessation, there is a risk of recurrence of infection.

The drug is intended for external use only.

Avoid contact of the drug with the eyes, because it may cause irritation. In case of accidental contact with the eyes, rinse immediately with running water, and in case of persistent irritation, consult a doctor.

If allergic reactions develop, the drug must be discontinued.

Lamisil® cream for external use contains cetyl and stearyl alcohols, which can cause local allergic reactions (contact dermatitis) at the sites of application.

Caution should be exercised when applying Lamisil® spray to damaged areas of the skin, as… the ethanol contained in it may cause irritation. Lamisil® Spray is for external use only. Lamisil® spray should not be used on the face. If Lamisil® spray was accidentally introduced into the respiratory tract during inhalation, then if any symptoms appear and especially if they persist, you should consult a doctor. Lamisil® Spray contains propylene glycol, which may cause skin irritation in some cases. It should also be taken into account that the drug contains ethanol 96%.

Impact on the ability to drive vehicles and machinery

No effect.

Active ingredient

Terbinafine

Composition

1 g of cream contains:

Active substance:

terbinafine hydrochloride 10 mg;

Excipients:

benzyl alcohol;

sodium hydroxide;

sorbitan stearate;

cetyl palmitate;

stearyl alcohol;

cetyl alcohol;

polysorbate 60;

isopropyl myristate;

purified water.

Pregnancy

Because clinical experience with Lamisil® Cream in pregnant women is very limited, it should not be used unless absolutely necessary. During pregnancy, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus. You should consult your doctor.

Contraindications

Hypersensitivity to terbinafine or to any of the inactive ingredients included in the drug; breastfeeding period; children’s age up to 12 years.

Side Effects

Determination of the frequency of side effects (WHO): very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000), including individual reports.

From the immune system: isolated reports – hypersensitivity reactions (rash).

On the part of the organ of vision: rarely – eye irritation.

From the skin: often – peeling of the skin, itching; uncommon – skin damage, crust formation, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rarely – a feeling of dry skin, contact dermatitis, eczema; individual reports – rash.

Local reactions: uncommon – pain, pain at the site of application, irritation at the site of application; rarely – exacerbation of symptoms of the disease. In areas where the drug is applied, itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning, erythema, and crusts may occur. These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen.

If any of these side effects worsen, or the patient notices any other side effects, the doctor should be informed.

Interaction

Currently, drug interactions with Lamisil® are unknown.

Overdose

No cases of overdose of Lamisil® have been reported.

Symptoms: Accidental ingestion of 30 ml of Lamisil® spray containing 300 mg of terbinafine hydrochloride is comparable to taking 1 tablet of Lamisil® with a dosage of 250 mg (single dose for an adult).

Clinical pharmacology

When applied topically, absorption is less than 5% and has little systemic effect.

Short product description

Lamisil cream is used to prevent and treat fungal skin infections, including athlete’s foot. The active substance of the cream Lamisil terbinafine has a fungicidal effect, with which it fights infection that causes fungus (mycosis) of the foot.*

Suitable for use in adults and children over 12 years of age.*

* Instructions for medical use, RU No P N008851 dated 06/10/2010

Recommendations for use

The drug is prescribed with caution to patients with liver and/or renal failure, patients with chronic alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

Storage conditions

At a temperature not exceeding 30 °C (do not freeze).

Shelf life

3 years

Manufacturer

GSK Consumer Healthcare S.A., Switzerland