Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Lamisil AT 1% Spray

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Terbinafine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Terbinafine hydrochloride
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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Lamisil AT 1% Spray contains the active ingredient terbinafine which is an antifungal used to treat skin problems caused by fungi in: e Athlete's foot (tinea pedis) – Athlete's foot appears only on the feet (usually both, but not always), where it often appears in between the toes. It can also appear on the instep, soles, or other areas of the feet. The most common type of athlete's foot causes cracking or scaling of the skin, but you may also have mild swelling, blisters, or weeping ulcers. Lamisil AT 1% Spray is recommended for athlete's foot when it occurs between the toes. If you have a fungal nail infection (fungus inside and under the nail) with discolouration of the nails and changes in nail texture (thick or flaky), you should consult your doctor because Lamisil AT 1% Spray is not appropriate for this type of infection. Dhobie itch/jock itch (tinea cruris) – Dhobie itch appears in the groin and inner thigh area, usually on both sides but often with one side more than the other, where it can spread further between the legs to the buttocks, or up towards the stomach. Dhobie itch looks like a clearly bordered rash, which may have blisters.

2. BEFORE YOU USE LAMISIL AT 1% SPRAY DO NOT use Lamisil AT 1% Spray if you have: ¢ an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 and end of Section 2). The spray is NOT recommended for children under 16 years of age. Take special care with Lamisil AT 1% Spray The spray is for application on the skin only. © Avoid inhaling the product. © Eyes, mouth or face – avoid contact of the spray. In case of accidental contact with eyes, rinse thoroughly with running water. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Do not apply other medicines on the areas you are treating with Lamisil AT 1% Spray. Pregnancy and breast-feeding If you are pregnant ask your doctor before using this medicine. Do not use the spray if you are breast-feeding. Driving and using machines Lamisil AT 1% Spray is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Lamisil AT 1% Spray Propylene glycol – contains 9.7 mg propylene glycol in each daily dose which is equivalent to 50 mg/g. May cause skin reactions. Alcohol – contains 46.56 mg alcohol (ethanol) in each daily dose which is equivalent to 250 mg/g of 96% ethanol. It may cause burning sensation on damaged skin.

How to take it

LAMISIL AT 1% SPRAY Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist. Adults Lamisil AT 1% Spray is applied once a day, for one week only, for all fungal infections. © Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin. © Remove the cap from the spray bottle – If using the medicine for the first time, press the pump a few times until you achieve an even spray. Spray enough of the solution from a distance of 5 to 10 cm to thoroughly wet the affected skin. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night. © Replace the cap on the spray bottle and wash your hands. 5055722 GB / 2003437_2

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LAMISIL SPRAY

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LAMISIL SPRAY 10MG/G 15ML GB Reason forchange: Correction date: Artworker:

karo healthcare Update to Delpharm 08/04/2024

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Even though you will not be using Lamisil AT 1% Spray during the second week, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.

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Artwork No: Prev Artwork component no: Karo SKU No: Component Type: Pharma code: Language: Manufacturing Site: Approving Market: Product Market Name: Site Component No: Prev Site Component No: Site Change Control No: Body Text Size: Leading Horizontal Scale Smallest Text Size Micro Text:

2003437_2 2003437_1 1003139 Leaflet 199 English Delpharm Great Britain LAMISIL 5055722 GB 5054797 GB

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Children under 16 years NOT recommended. Avoid Inhallng the spray. If the product accidentally gets into your eyes, rinse thoroughly with running water. Consult your doctor if any discomfort persists. If you accidently swallow Lamisil AT 1% Spray Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some spray. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain.

8.0pt 10.0pt 100% 8.0pt No

If you forget to use Lamisil AT 1% Spray If you miss an application, apply the spray as soon as possible then carry on as before. If you only remember at the time of your next application, just apply the spray and cary on as normal. It is important to try to use the spray at the correct times as forgotten applications could risk the infection retuming. If you stop using Lamisil AT 1% Spray You should not stop using the spray before the recommended time as this may reduce the effectiveness of treatment or the infection may return. If you have any further questions on the use of this product, ask your doctor or pharmacist

Print Colours: Colourmatch to Pantone Matching System.

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4, POSSIBLE SIDE EFFECTS

K

Technical (Non Printing).

Cutter

Guides

OVERPRINT PREVIEW

Karo Healthcare AB owns this artwork and is not responsible for any changes made by the CMO/printing

house. Changes must

be communicated with us and we will supply a new print PDF file.

Both CMO and printing house are responsible for the printed end result to match the intended colours.

Like all medicines, Lamisil AT 1% Spray can cause side effects, although not everybody gets them. STOP using the spray and seek medical help Immedlately if you have any of the following very rare allergic reactions: © Difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (Severe allergic reaction).

  • Severe itching of the skin, with red rash or raised lumps, hives or blisters. Common (may affect up to 7 in 10 people): skin peeling, itching. Uncommon (may affect up to 1 in 100 people} skin lesions, scab, skin colour changes, redness, burning, pain and irritation at the site of application. These common and uncommon side effects are usually harmless and you can carry on using the spray. Rare (may affect up to 1 in 1000 people): eye irritation,

dry skin, contact dermatitis, eczema, worsening of symptoms. Reporting of side affects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

LAMISIL AT 1% SPRAY Keep out of the sight and reach of children. Do not store Lamisil AT 1% Spray above 30°C (do not refrigerate). Keep the bottle closed and in its carton. Do not use or keep this medicine after the expiry (EXP) date shown on the box and container. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of Medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Lamisil AT 1% Spray contains The active ingredient is terbinafine hydrochloride 1% w/w. The other ingredients are purified water, ethanol, propylene glycol and cetomacrogal 1000 (see also Section 2 'Important information about some of the ingredients of Lamisil AT 1% Spray'). What Lamisil AT 1% Spray looks like and contents of the pack The spray is available in white, round, 15 ml plastic bottles with a spray pump. Marketing Authorisation Holder Karo Healthcare AB, Box 16184, 103 24 Stockholm, Sweden. Manufacturer Delpharm Huningue SAS, 26 Rue de la Chapelle, 68330 Huningue, France This leaflet was last revised April 2024.

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Frequently asked questions about Lamisil AT 1% Spray

How do I take Lamisil AT 1% Spray?

Lamisil AT 1% Spray comes as spray. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Lamisil AT 1% Spray?

The active substance in Lamisil AT 1% Spray is terbinafine hydrochloride.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Lamisil AT 1% Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Lamisil AT 1% Spray without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Terbinafine hydrochloride (7 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie (jock) itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2. Posology and method of administration

Adults

Lamisil AT 1% Spray is applied once daily, for one week.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week.

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 two weeks, a physician should be consulted.

Dosing in special populations:

Paediatric population

Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended.

Elderly patients

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Method of Administration

For cutaneous use.

Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

4.3. Contraindications

Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see section 6.1 List of excipients).

4.4. Special warnings and precautions for use

Lamisil AT 1% Spray should be used with caution in patients with lesions where alcohol could be irritating.

Lamisil AT 1% Spray is for external use only. It may be irritating to the eyes. Lamisil AT 1% Spray should not be used on the face.

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

Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist.

Lamisil AT 1% Spray contains 46.56 mg alcohol (ethanol) in each daily dose which is equivalent to 250 mg/g of 96% ethanol. It may cause burning sensation on damaged skin.

Lamisil AT 1% Spray contains 9.7 mg propylene glycol in each daily dose which is equivalent to 50 mg/g

4.5. Interaction with other medicinal products and other forms of interaction

No drug interactions are known with Lamisil AT 1% Spray, however as a precaution it is recommended that other medicinal products are not applied on the treated areas.

4.6. Fertility, pregnancy and lactation

Pregnancy

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine.

No cases of malformations in humans have been reported with Lamisil to date. There is limited clinical experience in pregnant women. Foetal toxicity studies in animals suggest no adverse effects (see section 5.3).

Lamisil AT 1% Spray should not be used during pregnancy unless clearly necessary.

Lactation

Terbinafine is excreted in breast milk. Therefore, mothers should not receive

Lamisil AT 1% Spray whilst breast-feeding. Infants must not be allowed to come into contact with any treated skin, including the breast.

Fertility

No effect of terbinafine on fertility have been seen in animal studies (see section 5.3).

4.7. Effects on ability to drive and use machines

Lamisil AT 1% Spray has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application.

These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritus, rash, bullous eruptions and hives, which are reported in sporadic cases and require discontinuation.

In case of accidental contact with the eyes terbinafine hydrochloride may be irritating to the eyes.

In rare cases the underlying fungal infection may be aggravated.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Not known: Hypersensitivity

Eye disorders

Rare: Eye irritation

Skin and subcutaneous tissue disorders

Common: Skin exfoliation, pruritus

Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation

Rare: Dry skin, dermatitis contact, eczema

Not known: Rash

General disorders and administration site conditions

Uncommon: Pain, application site pain, application site irritation

Rare: Condition aggravated

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

The low systemic absorption of topical terbinafine renders overdosage extremely unlikely.

Accidental ingestion of the contents of one 30 ml bottle of Lamisil AT1% Spray, solution, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one Lamisil 250 mg tablet (adult oral unit dose).

Should a larger amount of Lamisil AT 1% Spray be inadvertently ingested, adverse effects similar to those observed with an overdosage of Lamisil tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

In case of accidental oral ingestion, the alcohol content has to be considered. Lamisil AT 1% Spray contains 23.5%w/w alcohol.

Treatment of overdose

If accidentally ingested, the recommended treatment of overdosage consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • FUNGISIL MK 10 mg/g over the counterTERBINAFINUM · skin / topical
  • TERBINAFINA ARENA 250 mg prescriptionTERBINAFINUM · taken by mouth
  • LAMISIL 10 mg/g over the counterTERBINAFINUM · skin / topical
  • EXOTERFYN 78,22 mg/ml over the counterTERBINAFINUM · skin / topical
  • TAFICEN 10 mg/g over the counterTERBINAFINUM · skin / topical
  • TERBINAFINA OZONE 10 mg/g over the counterTERBINAFINUM · skin / topical

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • LamisilattTerbinafini hydrochloridum
  • LamisilTerbinafini hydrochloridum · taken by mouth
  • TerbidermTerbinafini hydrochloridum
  • MyconafineTerbinafinum · taken by mouth
  • Undofen MaxTerbinafini hydrochloridum
  • ErfinTerbinafinum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Lamisil AT 1% Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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