Expiration date: 12/2025

Release form and composition:

The solution is for external use only 1% of a film-forming transparent or slightly opaque, viscous, colorless to light yellow in color, with the smell of ethanol.

1 g contain terbinafine hydrochloride 11.25 mg, that corresponds to the content of 10 mg terbinafine

Excipients: acrylic acid copolymer and octylacrylamide (Dermakril 79), medium chain triglycerides, giproloza, ethanol 96%.

4 g - tube laminated (1) with a first opening control system - packings Valium planimetric (1) - packs cardboard with a window.

Pharmachologic effect:

Antifungal agent for external use, allylamine derivative. It has broad spectrum antifungal activity. At low concentrations terbinafine has fungicidal activity against dermatophytes Trichphytn (including Trichphytn rubrum, Trichphytn mentagrphytes, Trichphytn verrucsum, Trichphytn viaceum, Trichphytn tnsurans), Micrsprum canis and Epidermphytn fccsum, molds (mainly Candida abicans) and certain dimorphic fungi (Pityrsprum rbicuare or Maasseia furfur). Activity against yeast fungi, depending on their type, may be a fungicidal or fungistatic.

Terbinafine specifically alters the early stage of the biosynthesis of sterols, occurring in fungi. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, which causes death of fungal cells. Terbinafine action effected by the enzyme squalene epoxidase inhibiting located on the cell membrane of the fungus. Squalene epoxidase is not associated with the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.

Pharmacokinetics:

After application of terbinafine Uno skin imperceptible solution forms a transparent film which remains on the skin for 72 hours rapidly penetrates From terbinafine film stratum corneum:. 60 min after treatment 16-18% of applied dose found in the stratum corneum. Terbinafine release is progressive in nature, the active ingredient is present in the horny layer after 13 days at a concentration greater than the minimum inhibitory concentration of terbinafine in vitr against dermatophytes.

Systemic bioavailability is very low. For external use the absorption of the drug for less than 5%. Terbinafine Uno has little systemic effect.

relapse rate after 3 months of the drug is low (not higher than 12.5%).

Indications:

• Mycosis (tinea) foot (tinea pedis).
  

Dosage and administration:

The drug is used topically, once.

Adults and adolescents over the age of 15 years, the film-forming solution is applied terbinafine Uno 1 times on both feet, even if fungal infection is observed only on one foot. This ensures the destruction of fungi (dermatophytes) that might be on the areas of the foot where the lesion is not visually noticeable.

Before applying the drug should wash and dry your feet and hands. Initially treated one foot, then the other. Starting procedure on interdigital areas should be applied uniformly thin layer between and around the toes on their entire surface and also on the sole side of the foot and a height of 1.5 cm. Use a sufficient amount of the drug required to cover the skin surface, usually 1.2 tubes for each processing stops.

Likewise, should be processed and the other foot, even if the skin looks healthy thereon. Dry the solution for 1-2 minutes prior to film formation. After handling the stop you need to wash your hands.

Do not apply the drug again in the treated skin. Uno terbinafine should not be rubbed into the skin.

Side effects:

Side effects are very rare, mild and are short-lived.

Systemic reactions: very rarely (1/10 000 t) - allergic reactions (rash, redness, bullous dermatitis and urticaria).

Local reactions: seldom (gt1 / 1000, t 1/100) - dryness, skin irritation or burning sensation in the treated area of ??skin medication.

Contraindications:

• Hypersensitivity to terbinafine or to any of the inactive ingredients in the drug.
  

Precautions should be prescribed the drug for liver and / or kidney failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, vascular occlusive diseases of the extremities, as well as children under the age of 15 years (due to lack of sufficient clinical experience).

Pregnancy and lactation:

Clinical experience with Lamisil Uno in pregnancy is very limited, so the product can be used only on strict conditions.

It is known that Terbinafine is excreted in breast milk, so the drug should not be used during breastfeeding.

In experimental studies, the teratogenic properties of terbinafine is not revealed. So far no reports about any developmental defects in the application of Lamisil Uno.

Special instructions:

Terbinafine Uno is not recommended in case of chronic plantar hyperkeratosis caused by Tinea pedis (mokassinovogo type).

Terbinafine Uno is designed for external use only. The drug should not be applied on the skin, it can cause eye irritation. In case of accidental contact with the eye should be thoroughly rinsed with running water. The drug should not be taken internally!

In the case of an allergic reaction to the drug tape should be removed with an organic solvent (eg, denatured alcohol), and then wash the feet with soap and water.

With the development of allergic reactions need to stop the drug.

the treated area should not be washed for the best results within 24 hours after the procedure. Therefore terbinafine Uno is recommended to apply after taking a shower or bath, and again the next day to wash the feet at the same time.

Use this amount of drug that will be required for applying the film on both feet, by performing the above procedure procedure. The unutilized balance of the drug should be destroyed.

Improvement of clinical symptoms usually occurs within a few days. If after a week no signs of improvement, the diagnosis should be verified.

There is no evidence that the treatment of elderly patients require different doses, or other side effects occur than in younger patients.

Use in Pediatrics

The action of terbinafine Uno in pediatric patients has not been studied. Therefore, it is not recommended to use the drug in children under the age of 15 years.

Effects on ability to drive vehicles and management mechanisms

For external use terbinafine Uno does not affect the ability to drive or perform work with mechanisms.

Overdose:

No cases of overdose have been reported. Overdose is unlikely, because the drug is available in the quantity required for a single use and is designed for outdoor use.

Symptoms: Accidental taking the drug into possible headache, nausea, epigastric pain and dizziness.

Treatment: the appointment of activated charcoal, if necessary spend symptomatic therapy in the hospital.

Drug Interactions:

Currently, drug interactions Lamisil Uno is not known.

Conditions and terms:

The drug should be stored at a temperature no higher than 30 ° C in the original packaging of the reach of children. Shelf life - 3 years.