Topical Antifungal Ingredient | Adult Use Only

Product Description
Lamisilate Monodose 1% is a single-use topical solution containing terbinafine, intended for application on the skin of the feet. The formula forms a thin transparent film after application. This film allows the active ingredient to remain on the skin surface for an extended period.

This product is designed for one single application only and is intended for adults (18+).

Active Ingredient
• Terbinafine 1% (10 mg terbinafine base per gram; 11.25 mg terbinafine hydrochloride)

Other Ingredients
Acrylates/octylacrylamide copolymer, hydroxypropylcellulose, medium-chain triglycerides, ethanol (96%).

Suggested Use

• Apply once only on both feet, even if only one appears affected.
• Clean and dry both feet before use.
• Apply 50% of the tube to each foot.
• Spread gently over the entire sole, between the toes, and along the sides of the foot.
• Do not rub or massage.
• Allow the product to dry for 1–2 minutes until a film forms.
• Do not wash or wet the feet for 24 hours after application.
• Wash hands with soap and water after applying.

Do not apply a second time.
Do not use on broken or irritated skin.

Warnings

• Adults only (18+). Not for use in children or adolescents.
• For external use only.
• Avoid contact with the face, eyes, or mucous membranes.
• Do not use if you are allergic to terbinafine or any of the listed ingredients.
• If accidental contact with eyes occurs, rinse thoroughly with water.
• Contains alcohol; keep away from flames or heat sources.
• Do not combine with other topical antifungal medicines on the same area.
• If irritation, redness, swelling, or discomfort occurs, wash the area with warm soapy water.
• Discontinue use if adverse reactions occur.
• Consult a healthcare professional if symptoms do not improve after one week.
• In pregnancy or breastfeeding, use only if advised by a healthcare professional.
• Keep out of reach of children.

Potential Skin Reactions

May include temporary redness, itching, burning sensation, dryness, flaking, or localized irritation.
If severe irritation occurs, remove the film using denatured alcohol, then wash the feet with warm soapy water.

Packaging

4 g tube (single-use).

Please read the following full disclosure before purchasing or using this product. 

PRODUCT CHARACTERISTICS SUMMARY (RCP)

ANSM – Updated: 12/05/2023

1. NAME OF THE MEDICINAL PRODUCT

LAMISILATE MONODOSE 1%, cutaneous solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Terbinafine .......................................................................................... 10.00 mg
As terbinafine hydrochloride ............................................................. 11.25 mg
Per 1 g of solution.

Excipient with known effect: Ethanol 96% (863.75 mg/g).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous solution.

Viscous, colorless, clear to slightly opalescent solution.

4. CLINICAL DATA

4.1 Therapeutic indications

Lamisilate Monodose is indicated for the treatment of interdigital/interplantar tinea pedis (athlete’s foot) in adults (see section 4.4).

4.2 Posology and method of administration

For cutaneous use only.

Posology

Adults 18 years and older
Duration and frequency of treatment:

LAMISILATE MONODOSE 1% must be applied once only on both feet, even if only one foot appears to have lesions. This ensures eradication of dermatophytes present on non-visible lesions.

Clinical symptoms generally begin to improve after a few days.

If symptoms have not improved one week after the end of treatment, patients should seek advice from a pharmacist to verify correct use, or consult a doctor to confirm the diagnosis.

No data exist on repeated treatments; therefore, a second treatment cannot be recommended for a given episode of tinea pedis.

Special populations

Paediatric population
Safety in children has not been established. Not recommended for patients under 18 years.

Method of administration

Apply the solution after carefully washing and drying both feet and hands. Treat one foot, then the other.

Apply a thin layer starting between the toes (interdigital spaces and surrounding areas), then over the entire sole and lateral sides of the foot up to 1.5 cm height.

Repeat on the other foot even if it does not appear affected.

Allow the solution to dry for 1–2 minutes until a film forms.
Wash hands afterwards.
Do not massage the treated area.

For best results, do not wash the treated area for 24 hours after application.

Therefore, it is recommended to apply LAMISILATE MONODOSE 1% immediately after washing (bath or shower) and wait 24 hours before gently washing the feet again. Then dry the feet by gently patting.

A sufficient amount must be used to treat both feet. Any remaining solution in the tube must be discarded.

Elderly
No evidence indicates different adverse effects or need for dosage adjustment versus younger adults.

4.3 Contraindications

Known hypersensitivity to the active substance or any excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Use with caution on lesions that may be irritated by alcohol (after sun exposure or severe desquamation).
Do not apply to the face.

For external use only.

May be irritating to the eyes.

In case of accidental eye contact, rinse thoroughly with running water.

Keep LAMISILATE MONODOSE 1% out of sight and reach of children.

Not recommended for treating moccasin-type tinea pedis (chronic hyperkeratotic plantar dermatophytosis).

In case of allergic reaction, remove the film using an organic solvent such as denatured alcohol, then rinse feet with warm soapy water.

Information about excipients

Contains ethanol; keep away from heat sources.

This medicine contains 3316.8 mg of alcohol per daily dose, equivalent to 863.75 mg/g of 96% ethanol.

Ethanol may cause burning on damaged skin.

4.5 Interaction with other medicinal products and other forms of interaction

No known drug interactions.

4.6 Fertility, pregnancy and lactation

Pregnancy

No adequate data available for use of terbinafine in pregnant women. Animal studies show no harmful effects on pregnancy or fetal health.

Use during pregnancy only if necessary.

Breastfeeding

Terbinafine is excreted in breast milk.
Systemic exposure after topical use is expected to be low.

Use in breastfeeding women only if expected benefit justifies the potential risk to the infant.
Infants must not come into contact with treated skin areas, especially the breasts.

Fertility

Animal studies show no impact on fertility.

4.7 Effects on ability to drive and use machines

LAMISILATE MONODOSE 1% has no or negligible influence on ability to drive or operate machines.

4.8 Undesirable effects

Summary of safety profile

Adverse effects are minor and reversible local reactions. In very rare cases, allergic reactions may occur.

Tabulated list of adverse effects

Skin and subcutaneous tissue disorders:
• Very rare (<1/10,000 including isolated cases): allergic reactions such as pruritus, rash, bullous or urticarial eruptions.
• Frequency not known: skin exfoliation, discoloration, erythema.

General disorders:
• Uncommon (>1/1,000 <1/100): skin dryness, skin irritation, burning sensation at application site.
• Frequency not known: pain at application site.

Eye disorders:
• Frequency not known: eye irritation.

Reporting of suspected adverse reactions

Healthcare professionals should report suspected adverse reactions via the national reporting system: ANSM & CRPVs – www.signalement.social-sante.gouv.fr.

4.9 Overdose

In case of accidental ingestion, consider the ethanol content (81.05% v/v).

Overdose is unlikely as the tube contains only a single cutaneous dose.

Accidental ingestion of one 4 g tube (40 mg terbinafine) is far below the oral adult dose (250 mg tablet).

If several tubes were ingested, effects similar to oral terbinafine overdose may occur (headache, nausea, stomach pain, dizziness).

Treatment

Administer activated charcoal and treat symptomatically.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Topical antifungals, ATC code D01AE15.

Terbinafine (an allylamine) inhibits ergosterol synthesis by blocking squalene epoxidase, leading to fungal cell membrane disruption.
Active against dermatophytes including Trichophyton, Microsporum canis, Epidermophyton floccosum.

A single application showed clinical efficacy in tinea pedis affecting toes, soles, and lateral sides of the foot.

Relapse rate under 12.5% at 3 months.

5.2 Pharmacokinetic properties

After application, a film forms and delivers terbinafine into the stratum corneum.
Remains in stratum corneum up to 13 days.

Washing the film reduces terbinafine penetration; therefore washing should be avoided for 24 hours.

Occlusion increases terbinafine concentration 2.7-fold.

Systemic exposure is very low.

5.3 Preclinical safety data

No significant toxicity in long-term studies in rats and dogs at doses up to 100 mg/kg/day.

Carcinogenicity studies showed no relevant risk except liver tumors in male rats at high doses, an effect not seen in other species.

High doses in monkeys produced reversible retinal refraction changes.

No mutagenicity.

No effects on fertility.

Cutaneous studies show systemic exposure after topical use is 50–100 times lower than doses causing toxicity in animals.

The acrylate/octylacrylamide copolymer excipient has been tested for safety with no concerning findings.

6. PHARMACEUTICAL DATA

6.1 List of excipients

Acrylates/octylacrylamide copolymer, hydroxypropylcellulose, medium-chain triglycerides, ethanol 96%.

6.2 Incompatibilities

None.

6.3 Shelf life

3 years.

6.4 Storage conditions

Store in original packaging, protected from light.
Store below 30°C.

6.5 Nature and contents of container

4 g laminated aluminum tube (PE/Al/PE) with polyethylene cap.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

KARO HEALTHCARE AB
BOX 16184
103 24 STOCKHOLM
SWEDEN

8. MARKETING AUTHORIZATION NUMBERS

• 34009 377 068 4 1: 4 g tube (PE/Al/PE)

9. DATE OF FIRST AUTHORIZATION / RENEWAL

[To be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION / DISPENSING STATUS

Medicine not subject to medical prescription.