Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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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.
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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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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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.
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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
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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).
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.
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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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.
The active substance in Lamisil AT 1% Spray is terbinafine hydrochloride.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see section 6.1 List of excipients).
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
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.
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).
Lamisil AT 1% Spray has no influence on the ability to drive and use machines.
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.
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.
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.
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 →
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.
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 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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